{"id":"chembl-chembl939","_fda":{"id":"8aa73f33-2813-4dfa-939f-e4291081449a","set_id":"0afc12dd-12f8-4def-9027-f38412a862b9","openfda":{"nui":["N0000175605","N0000175076"],"upc":["0367184053124"],"unii":["S65743JHBS"],"route":["ORAL"],"rxcui":["349472"],"spl_id":["8aa73f33-2813-4dfa-939f-e4291081449a"],"brand_name":["Gefitinib"],"spl_set_id":["0afc12dd-12f8-4def-9027-f38412a862b9"],"package_ndc":["67184-0531-1","67184-0531-2","67184-0531-3"],"product_ndc":["67184-0531"],"generic_name":["GEFITINIB"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["GEFITINIB"],"pharm_class_epc":["Kinase Inhibitor [EPC]"],"pharm_class_moa":["Protein Kinase Inhibitors [MoA]"],"manufacturer_name":["Qilu Pharmaceutical Co., Ltd."],"application_number":["ANDA211591"],"is_original_packager":[true]},"version":"7","pregnancy":["8.1 Pregnancy Risk Summary Based on its mechanism of action and animal data, gefitinib tablets can cause fetal harm when administered to a pregnant woman. In animal reproductive studies, oral administration of gefitinib from organogenesis through weaning resulted in fetotoxicity and neonatal death at doses below the recommended human dose ( see Animal Data ). Advise pregnant women of the potential hazard to a fetus or potential risk for loss of the pregnancy. The background risk of major birth defects and miscarriage for the indicated population is unknown; however, the background risk in the U.S. general population of major birth defects is 2-4% and miscarriage is 15-20% of clinically recognized pregnancies. Data Animal Data A single dose study in rats showed that gefitinib crosses the placenta after an oral dose of 5 mg/kg (30 mg/m 2 , about 0.2 times the recommended human dose on a mg/m 2 basis). When pregnant rats were treated with 5 mg/kg from the beginning of organogenesis to the end of weaning there was a reduction in the number of offspring born alive. This effect was more severe at 20 mg/kg (approximate the human clinical dose on a mg/m 2 basis) and was accompanied by high neonatal mortality soon after parturition. In rabbits, a dose of 20 mg/kg/day (240 mg/m 2 , about twice the recommended dose in humans on a mg/m 2 basis) caused reduced fetal weight."],"overdosage":["10 OVERDOSAGE Twenty three patients were treated weekly with doses from 1500 mg to 3500 mg, and gefitinib tablets exposure did not increase with increasing dose. Adverse events were mostly mild to moderate in severity, and were consistent with the known safety profile of gefitinib tablets. In the event of suspected overdose, interrupt gefitinib tablets, institute supportive care, and observe until clinical stabilization. There are no specific measures/treatments that should be taken following gefitinib tablets overdosing."],"description":["11 DESCRIPTION Gefitinib is a kinase inhibitor. The chemical name of gefitinib is 4-Quinazolinamine N -(3-chloro-4-fluorophenyl)-7-methoxy-6-[3-(4-morpholinyl) propoxy] and the following structural formula: Gefitinib has the molecular formula C 22 H 24 ClFN 4 O 3 , a relative molecular mass of 446.9 daltons and is a white-colored powder. Gefitinib is a free base. The molecule has pK a s of 5.4 and 7.2. Gefitinib can be defined as sparingly soluble at pH 1, but is practically insoluble above pH 7, with the solubility decreasing sharply between pH 4 and pH 6. In non-aqueous solvents, gefitinib is freely soluble in glacial acetic acid and dimethyl sulfoxide, soluble in pyridine, sparingly soluble in tetrahydrofuran, and slightly soluble in methanol, ethanol (99.5%), ethyl acetate, propan-2-ol and acetonitrile. Gefitinib tablets are available as brown film-coated tablets, containing 250 mg of gefitinib, for oral administration. The inactive ingredients of the tablet core of gefitinib tablets are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone, sodium lauryl sulfate and magnesium stearate. The tablet coating is composed of polyvinyl alcohol-part hydrolysed, polyethylene glycol 3350, talc, titanium dioxide, red ferric oxide, ferrosoferric oxide and yellow ferric oxide. structural formula for gefitinib"],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING Gefitinib is available as 250 mg tablets. Gefitinib tablets 250 mg are round, biconvex face, brown film-coated, debossed with “QL” on one side and plain on the other side. Gefitinib tablets are supplied as: Bottles of 30 Tablets (NDC 67184-0531-1) Bottles of 500 Tablets (NDC 67184-0531-2) Blisters of 3 Cards ×10 (NDC 67184-0531-3), each carton contains “30 tablets: 1 overwrap contains 3 unit dose blister cards. Each blister card contains 10 tablets.” Store at controlled room temperature 20°C-25°C (68°F-77°F) [see USP Controlled Room Temperature ]."],"geriatric_use":["8.5 Geriatric Use Of the 823 patients enrolled in two randomized, active-controlled clinical trials 374 patients (45%) were 65 years and older, and 93 patients (11%) were 75 years and older. No overall differences in safety were observed between patients 65 years and older and those younger than 65 years. There is insufficient information to assess for differences in efficacy between older and younger patients."],"pediatric_use":["8.4 Pediatric Use The safety and effectiveness of gefitinib tablets in pediatric patients have not been established."],"effective_time":"20230222","clinical_studies":["14 CLINICAL STUDIES Non-Small Cell Lung Cancer (NSCLC) Study 1 The efficacy and safety of gefitinib tablets for the first-line treatment of patients with metastatic NSCLC containing EGFR exon 19 deletions or L858R substitution mutations was demonstrated in a multicenter, single-arm, open-label clinical study (Study 1). A total of 106 treatment-naive patients with metastatic EGFR mutation positive NSCLC received gefitinib tablets at a dose of 250 mg once daily until disease progression or intolerable toxicity. The major efficacy outcome measure was objective response rate (ORR) according to RECIST v1.1 as evaluated by both a Blinded Independent Central Review (BICR) and investigators. Duration of response (DOR) was an additional outcome measure. Eligible patients were required to have a deletion in EGFR exon 19 or L858R, L861Q, or G719X substitution mutation and no T790M or S768I mutation or exon 20 insertion in tumor specimens as prospectively determined by a clinical trial assay. Tumor samples from 87 patients were tested retrospectively using the therascreen ® EGFR RGQ PCR Kit. The study population characteristics were: median age 65 years, age 75 years or older (25%), age less than 65 years (49%), white (100%), female (71%), never smokers (64%), WHO PS 0 (45%), WHO PS 1 (48%), WHO PS 2 (7%), and adenocarcinoma histology (97%). Sixty patients had exon 19 deletions (65%), 29 patients had L858R substitution (31%), while two patients each had tumors harboring L861Q or G719X substitution mutation. The median duration of treatment was 8.0 months. Efficacy results from Study 1 are summarized below. Table 3 – Efficacy Results in Study 1 Efficacy Parameter BICR BICR, Blinded Independent Central Review Assessment (n=106) 17 patients without target lesion at baseline detected by BICR were deemed non responders Investigator Assessment (n=106) Objective Response Rate Determined by RECIST v 1.1 (95% CI) 50% (41, 59) 70% (61, 78) Complete Response Rate 0.9% 1.9% Partial Response Rate 49% 68% Median Duration of Response (months) (95% CI) 6.0 (5.6, 11.1) 8.3 (7.6, 11.3) The response rates were similar in patients whose tumors had EGFR exon 19 deletions and exon 21 L858R substitution mutations. Two partial responses were observed in both patients whose tumors had G719X substitution mutation with duration of response of at least 2.8 months and 5.6 months, respectively. One of two patients whose tumors had L861Q substitution mutation also achieved a partial response with duration of response of at least 2.8 months. Study 2 The results of Study 1 were supported by an exploratory analysis of a subset of a randomized, multicenter, open-label trial (Study 2) conducted in patients with metastatic adenocarcinoma histology NSCLC receiving first-line treatment. Patients were randomized (1:1) to receive gefitinib tablets 250 mg orally once daily or up to 6 cycles of carboplatin/paclitaxel. The efficacy outcomes included progression-free survival (PFS) and objective response rate (ORR) as assessed by BICR. The subset population consisted of 186 of 1217 patients (15%) determined to be EGFR positive by the same clinical trial assay as used in Study 1 and had radiographic scans available for a retrospective assessment by BICR. In this subset, there were 88 gefitinib tablets-treated patients and 98 carboplatin/paclitaxel-treated patients. Demographic and baseline characteristics of this subset were a median age of 59 years, age 75 years or older (7%), age less than 65 (70%), Asian (100%), female (83%), never smokers (96%), adenocarcinoma histology (100%), and PS 0-1 (94%). The median duration of treatment for gefitinib tablets-treated patients was 9.8 months. The hazard ratio for PFS favored the gefitinib tablets-treated patients [HR of 0.54 (95% CI: 0.38, 0.79)] with a median PFS of 10.9 months for the gefitinib tablets-treated patients and 7.4 months for the carboplatin/paclitaxel-treated patients as assessed by BICR. In addition, the objective response rate was 67% (95% CI: 56, 77) for gefitinib tablets-treated patients and 41% (95% CI: 31, 51) for carboplatin/paclitaxel-treated patients based on BICR assessment. The median duration of response was 9.6 months for gefitinib tablets-treated patients and 5.5 months for carboplatin/paclitaxel-treated patients."],"pharmacokinetics":["12.3 Pharmacokinetics Absorption and Distribution The mean oral bioavailability of gefitinib is 60%, with peak plasma levels occurring 3-7 hours after dosing. Food does not alter gefitinib bioavailability to a clinically meaningful extent. Gefitinib tablets can be administered with or without food. Gefitinib is extensively distributed throughout the body with a mean steady state volume of distribution of 1400 L following intravenous administration. In vitro binding of gefitinib to human plasma proteins (serum albumin and αl-acid glycoprotein) is 90%, independent of drug concentrations. Gefitinib is a substrate for the membrane transport P-glycoprotein (P-gp), but it is unlikely to influence gefitinib absorption as P-gp is saturated at higher concentrations. Metabolism and Elimination Gefitinib undergoes extensive hepatic metabolism in humans, predominantly by CYP3A4. Three sites of biotransformation have been identified: metabolism of the N-propoxymorpholino-group, demethylation of the methoxy-substituent on the quinazoline, and oxidative defluorination of the halogenated phenyl group. Five metabolites have been fully identified in fecal extracts and the major active component was O-desmethyl gefitinib produced by CYP2D6 metabolism and accounted for 14% of the dose. Eight metabolites were identified in human plasma. Only O-desmethyl gefitinib has exposure comparable to gefitinib. Although this metabolite has similar EGFR-TK activity to gefitinib in the isolated enzyme assay, it had only 1/14 of the potency of gefitinib in one of the cell-based assays. Gefitinib is cleared primarily by the liver, with total plasma clearance and elimination half-life of 48 hours after intravenous administration. The inter-subject variability (coefficient of variation) for AUC in healthy subjects was 67%. Daily oral administration of gefitinib to cancer patients resulted in a two-fold accumulation compared to single dose administration. Steady state plasma concentrations are achieved within 10 days after daily dosing. Excretion of gefitinib and its metabolites is predominantly via the feces (86%), with renal elimination accounting for less than 4% of the administered dose. Specific Populations Age, gender, body weight, ethnicity or renal function : Population pharmacokinetic analyses suggest that patient age, body weight, ethnicity (populations included) or creatinine clearance (above 20 mL/min) has no clinically meaningful effect on predicted steady state trough concentration of gefitinib. Population pharmacokinetic analyses of Study 1 showed that women had 27% higher exposure than men; however, this difference was not identified in the analyses of other gefitinib clinical studies. No dose adjustment based on patient gender is recommended. Hepatic Impairment : The systemic exposure of gefitinib was compared between patients with mild, moderate, or severe hepatic impairment due to cirrhosis (according to Child-Pugh classification) and healthy subjects with normal hepatic function (N=10/group). The mean systemic exposure (AUC0-∞) was increased by 40% in patients with mild impairment, 263% in patients with moderate impairment, and 166% in patients with severe hepatic impairment. In a study comparing 13 patients with liver metastases and moderate hepatic impairment to 14 patients with liver metastases and normal hepatic function, the systemic exposure of gefitinib was similar [ see Warnings and Precautions (5.2) , Use in Specific Populations (8.7) ]. CYP2D6 Poor metabolizer : CYP2D6 metabolizes gefitinib to O-desmethyl gefitinib in vitro . In healthy CYP2D6 poor metabolizers, O-desmethyl gefitinib concentration was not measurable and the mean exposure to gefitinib was 2-fold higher as compared to the extensive metabolizers. This increase in exposure in CYP2D6 poor metabolizers may be clinically important because some adverse drug reactions are related to higher exposure of gefitinib. No dose adjustment is recommended in patients with a known CYP2D6 poor metabolizer genotype, but these patients should be closely monitored for adverse reactions. The impact of CYP2D6 inhibiting drugs on gefitinib pharmacokinetics has not been evaluated. However, similar precautions should be used when administering CYP2D6 inhibitors with gefitinib tablets because of the possibility of increased exposure in these patients. An exploratory exposure response analysis showed an increase in the incidence of interstitial lung disease (ILD) with a greater than 2-fold increase in the gefitinib exposure [ see Warnings and Precautions (5.1) ]. Drug-Drug Interactions Strong CYP3A4 Inducer: Concomitant administration of rifampicin (600 mg QD for 16 days), a strong inducer of CYP3A4, with gefitinib (500 mg single dose on Day 10 of gefitinib administration) reduced mean AUC of gefitinib by 83% [ see Dosage and Administration (2.4) , Drug Interactions (7) ]. CYP3A4 Inhibitor: Concomitant administration of itraconazole (200 mg QD for 12 days), an inhibitor of CYP3A4, with gefitinib (250 mg single dose on Day 4 of itraconazole administration) to healthy male subjects, increased mean gefitinib AUC by 80% [ see Drug Interactions (7) ]. Drugs Affecting Gastric pH: Co-administration of high doses of ranitidine with sodium bicarbonate (to maintain the gastric pH above pH 5.0) to healthy subjects decreased mean gefitinib AUC by 47% [ see Drug Interactions (7) ]. In human liver microsome studies, gefitinib had no inhibitory effect on CYP1A2, CYP2C9, and CYP3A4 activities at concentrations ranging from 2-5000 ng/mL. At the highest concentration studied (5000 ng/mL), gefitinib inhibited CYP2C19 by 24% and CYP2D6 by 43%. Exposure to metoprolol, a substrate of CYP2D6, was increased by 30% when it was given on Day 15 of gefitinib dosing (500 mg daily for 28 days) in patients with solid tumors."],"adverse_reactions":["6 ADVERSE REACTIONS The following adverse drug reactions are discussed in more detail in other sections of the labeling: • Interstitial Lung Disease [ see Warnings and Precautions (5.1) ] • Hepatotoxicity [ see Warnings and Precautions (5.2) ] • Gastrointestinal Perforation [ see Warnings and Precautions (5.3) ] • Severe or Persistent Diarrhea [ see Warnings and Precautions (5.4) ] • Ocular Disorders including Keratitis [ see Warnings and Precautions (5.5) ] • Bullous and Exfoliative Skin Disorders [ see Warning and Precautions (5.6) ] The most commonly reported adverse drug reactions (ADRs), reported in more than 20% of the patients and greater than placebo were skin reactions and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact QILU PHARMA, INC. at 484-838-0633 / 484-875-3013 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of gefitinib tablets is based on the data from 2462 patients with NSCLC who received gefitinib tablets 250 mg daily monotherapy in three randomized clinical studies (Study 2, Study 3 and Study 4). Patients with a history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis that required steroid treatment or any evidence of clinically active interstitial lung disease were excluded from these studies. Controlled Studies: Study 2 was a randomized, multicenter, open-label trial in which 1217 patients were randomized to receive first-line treatment for metastatic NSCLC; 607 patients received gefitinib tablets 250 mg daily and 589 patients received carboplatin/paclitaxel. The median duration of treatment with gefitinib tablets was 5.9 months. The study population characteristics were: median age 57 years, age less than 65 years (73%), female (79%), Asian (100%), NSCLC adenocarcinoma histology (100%), never smoker (94%), light ex-smoker (6%), ECOG PS 0 or 1 (90%). Study 3 was a randomized, multicenter, double-blind, placebo-controlled trial in which 1692 patients were randomized to receive second- or third-line treatment for metastatic NSCLC; of which 1126 patients received gefitinib tablets 250 mg daily and 562 patients received placebo. The median duration of treatment with gefitinib tablets was 2.9 months. The study population characteristics were: median age 62 years, age less than 65 years (60%), female (33%), Caucasian (75%), Asian (21%), NSCLC adenocarcinoma histology (48%), never smoker (22%), ECOG PS 0 or 1 (65%), PS 2 (29%), PS 3 (5%) and two or more prior therapies (51%). Study 4 was a randomized, multicenter, open-label trial in which 1466 patients were randomized to receive second-line treatment for metastatic NSCLC; 729 patients received gefitinib tablets 250 mg daily and 715 patients received docetaxel. The median duration of treatment with gefitinib tablets was 2.4 months. The study population characteristics were: median age 61 years, age less than 65 years (61%), female (36%), Caucasian (79%), Asian (21%), NSCLC adenocarcinoma histology (54%), never smoker (20%), ECOG PS 0 or 1 (88%) and two or more prior therapies (16%). The pooled safety database from the three randomized trials was used to evaluate for serious and uncommon adverse drug reactions. Common adverse reactions were evaluated in Study 3. The most frequent adverse reactions in Study 3 (incidence of >20% and greater than placebo) reported in gefitinib tablets-treated patients were skin reactions (47%)and diarrhea (29%). The most frequent fatal adverse reactions in gefitinib tablets-treated patients were respiratory failure (0.9%), pneumonia (0.8%), and pulmonary embolism (0.5%). Approximately 5% of gefitinib tablets-treated patients and 2.3% of placebo-treated patients discontinued treatment due to an adverse event. The most frequent adverse reactions that led to discontinuation in patients treated with gefitinib tablets were nausea (0.5%), vomiting (0.5%) and diarrhea (0.4%). Table 1 - Selected Adverse Drug Reactions Occurring with an Incidence Rate ≥ 5% and an Increase of >2% of Gefitinib Tablets-treated Patients in Study 3 Percentage (%) of patients Gefitinib Tablets (N=1126) Placebo (N=562) Adverse Reaction All Grades Grade 3 and 4 All Grades Grade 3 and 4 Skin and subcutaneous tissue disorders Skin reactions Includes Acne, Acne pustular, Dermatitis, Dermatitis acneiform, Dermatitis exfoliative, Drug eruption, Dry skin, Erythema, Exfoliative rash, Folliculitis, Pruritus, Pruritus generalized, Rash, Rash erythematous, Rash generalized, Rash macular, Rash maculo-papular, Rash papular, Rash pruritic, Rash pustular, Rash vesicular, Skin exfoliation, Skin toxicity, Xeroderma 47% 2% 17% 0.4% Nail disorders Includes Ingrowing nail, Nail bed infection, Nail disorder, Nail infection, Onychoclasis, Onycholysis, Paronychia 5% 0.1% 0.7% 0% Gastrointestinal disorders Diarrhea Includes Diarrhea, Feces soft, Frequent bowel movements 29% 3% 10% 1% Vomiting 14% 1.2% 10% 0.4% Stomatitis Includes Aphthous stomatitis, Cheilitis, Glossodynia, Mouth ulceration, Mucosal inflammation, Oral mucosal blistering, Stomatitis, Tongue disorder, Tongue ulceration 7% 0.3% 4% 0.2% Metabolism and nutrition disorders Decreased appetite 17% 2.3% 14% 2.0% Eye disorders Conjunctivitis/blepharitis/dry eye Includes Blepharitis, Conjunctival hyperemia, Conjunctivitis, Dry eye, Eye irritation, Eye pruritus, Eye swelling, Eyelid irritation, Eyelid edema, Eyelids pruritus 6% 0% 3.2% 0% Table 2 - Treatment Emergent Laboratory Abnormalities Occurring More Frequently in Gefitinib Tablets-Treated Patients in Study 3 Gefitinib Tablets Placebo Adverse Reaction All Grades % Grade 3 and 4 % All Grades % Grade 3 and 4 % Alanine aminotransferase increased Patients were allowed to enter the clinical study with lab values of ALT or AST CTCAE grade 1 or 2 38% 14% gefitinib patients and 10% placebo patients were CTC grade 1 or 2 ALT at baseline 2.4% 23% 1.4% 0.2% of placebo patients were CTC grade 3 at baseline Aspartate aminotransferase increased 40% 15% gefitinib patients and 12% placebo patients were CTC grade 1 or 2 AST at baseline 2.0% 25% 1.3% 0.4% of placebo patients were CTC grade 3 at baseline Proteinuria 35% 4.7% 31% 3.3% The following adverse reactions have been reported with gefitinib tablets across NSCLC trials (Study 2, Study 3 and Study 4) and are not listed elsewhere in Section 6: nausea (18%), asthenia (17%), pyrexia (9%), alopecia (4.7%), hemorrhage (including epistaxis and hematuria) (4.3%), dry mouth (2%), dehydration (1.8%), elevations in blood creatinine (1.5%), allergic reactions including angioedema and urticaria (1.1%), palmar-plantar erythrodysesthesia syndrome (0.2%) and pancreatitis (0.1%). 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of gefitinib tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Renal and urinary disorders : cystitis, hemorrhagic cystitis Skin and subcutaneous tissue disorders : cutaneous vasculitis"],"contraindications":["4 CONTRAINDICATIONS None. None. (4)"],"drug_interactions":["7 DRUG INTERACTIONS •CYP3A4 Inducer: Increase gefitinib tablets to 500 mg daily in patients receiving a strong CYP3A4 inducer. ( 2.4 , 7.1 ) •CYP3A4 Inhibitor: Monitor adverse reactions if concomitant use with gefitinib tablets. ( 7.1 ) •Drugs Affecting Gastric pH: Avoid concomitant use of gefitinib tablets with proton pump inhibitors, if possible. ( 7.1 ) •Hemorrhage in patients taking warfarin: Monitor changes in prothrombin time or INR. ( 7.2 ) 7.1 Drugs Affecting Gefitinib Exposure CYP3A4 Inducer Drugs that are strong inducers of CYP3A4 increase the metabolism of gefitinib and decrease gefitinib plasma concentrations. Increase gefitinib tablets to 500 mg daily in patients receiving a strong CYP3A4 inducer (e.g., rifampicin, phenytoin, or tricyclic antidepressant) and resume gefitinib tablets at 250 mg 7 days after discontinuation of the strong inducer [ see Dosage and Administration (2.4) , Clinical Pharmacology (12.3) ]. CYP3A4 Inhibitor Drugs that are strong inhibitors of CYP3A4 (e.g., ketoconazole and itraconazole) decrease gefitinib metabolism and increase gefitinib plasma concentrations. Monitor adverse reactions when administering strong CYP3A4 inhibitors with gefitinib tablets. Drugs Affecting Gastric pH Drugs that elevate gastric pH (e.g., proton pump inhibitors, histamine H 2 -receptor antagonists, and antacids) may reduce plasma concentrations of gefitinib. Avoid concomitant use of gefitinib tablets with proton pump inhibitors, if possible. If treatment with a proton-pump inhibitor is required, take gefitinib tablets 12 hours after the last dose or 12 hours before the next dose of the proton-pump inhibitor. Take gefitinib tablets 6 hours after or 6 hours before an H 2 -receptor antagonist or an antacid [ see Clinical Pharmacology (12.3) ]. 7.2 Hemorrhage in Patients taking Warfarin International Normalized Ratio (INR) elevations and/or hemorrhage have been reported in some patients taking warfarin while on gefitinib tablets therapy. Patients taking warfarin should be monitored regularly for changes in prothrombin time or INR."],"mechanism_of_action":["12.1 Mechanism of Action The epidermal growth factor receptor (EGFR) is expressed on the cell surface of both normal and cancer cells and plays a role in the processes of cell growth and proliferation. Some EGFR activating mutations (exon 19 deletion or exon 21 point mutation L858R) within NSCLC cells have been identified as contributing to the promotion of tumor cell growth, blocking of apoptosis, increasing the production of angiogenic factors and facilitating the processes of metastasis. Gefitinib reversibly inhibits the kinase activity of wild-type and certain activating mutations of EGFR, preventing autophosphorylation of tyrosine residues associated with the receptor, thereby inhibiting further downstream signaling and blocking EGFR-dependent proliferation. Gefitinib binding affinity for EGFR exon 19 deletion or exon 21 point mutation L858R mutations is higher than its affinity for the wild-type EGFR. Gefitinib also inhibits IGF and PDGF-mediated signaling at clinically relevant concentrations; inhibition of other tyrosine kinase receptors has not been fully characterized."],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action The epidermal growth factor receptor (EGFR) is expressed on the cell surface of both normal and cancer cells and plays a role in the processes of cell growth and proliferation. Some EGFR activating mutations (exon 19 deletion or exon 21 point mutation L858R) within NSCLC cells have been identified as contributing to the promotion of tumor cell growth, blocking of apoptosis, increasing the production of angiogenic factors and facilitating the processes of metastasis. Gefitinib reversibly inhibits the kinase activity of wild-type and certain activating mutations of EGFR, preventing autophosphorylation of tyrosine residues associated with the receptor, thereby inhibiting further downstream signaling and blocking EGFR-dependent proliferation. Gefitinib binding affinity for EGFR exon 19 deletion or exon 21 point mutation L858R mutations is higher than its affinity for the wild-type EGFR. Gefitinib also inhibits IGF and PDGF-mediated signaling at clinically relevant concentrations; inhibition of other tyrosine kinase receptors has not been fully characterized. 12.3 Pharmacokinetics Absorption and Distribution The mean oral bioavailability of gefitinib is 60%, with peak plasma levels occurring 3-7 hours after dosing. Food does not alter gefitinib bioavailability to a clinically meaningful extent. Gefitinib tablets can be administered with or without food. Gefitinib is extensively distributed throughout the body with a mean steady state volume of distribution of 1400 L following intravenous administration. In vitro binding of gefitinib to human plasma proteins (serum albumin and αl-acid glycoprotein) is 90%, independent of drug concentrations. Gefitinib is a substrate for the membrane transport P-glycoprotein (P-gp), but it is unlikely to influence gefitinib absorption as P-gp is saturated at higher concentrations. Metabolism and Elimination Gefitinib undergoes extensive hepatic metabolism in humans, predominantly by CYP3A4. Three sites of biotransformation have been identified: metabolism of the N-propoxymorpholino-group, demethylation of the methoxy-substituent on the quinazoline, and oxidative defluorination of the halogenated phenyl group. Five metabolites have been fully identified in fecal extracts and the major active component was O-desmethyl gefitinib produced by CYP2D6 metabolism and accounted for 14% of the dose. Eight metabolites were identified in human plasma. Only O-desmethyl gefitinib has exposure comparable to gefitinib. Although this metabolite has similar EGFR-TK activity to gefitinib in the isolated enzyme assay, it had only 1/14 of the potency of gefitinib in one of the cell-based assays. Gefitinib is cleared primarily by the liver, with total plasma clearance and elimination half-life of 48 hours after intravenous administration. The inter-subject variability (coefficient of variation) for AUC in healthy subjects was 67%. Daily oral administration of gefitinib to cancer patients resulted in a two-fold accumulation compared to single dose administration. Steady state plasma concentrations are achieved within 10 days after daily dosing. Excretion of gefitinib and its metabolites is predominantly via the feces (86%), with renal elimination accounting for less than 4% of the administered dose. Specific Populations Age, gender, body weight, ethnicity or renal function : Population pharmacokinetic analyses suggest that patient age, body weight, ethnicity (populations included) or creatinine clearance (above 20 mL/min) has no clinically meaningful effect on predicted steady state trough concentration of gefitinib. Population pharmacokinetic analyses of Study 1 showed that women had 27% higher exposure than men; however, this difference was not identified in the analyses of other gefitinib clinical studies. No dose adjustment based on patient gender is recommended. Hepatic Impairment : The systemic exposure of gefitinib was compared between patients with mild, moderate, or severe hepatic impairment due to cirrhosis (according to Child-Pugh classification) and healthy subjects with normal hepatic function (N=10/group). The mean systemic exposure (AUC0-∞) was increased by 40% in patients with mild impairment, 263% in patients with moderate impairment, and 166% in patients with severe hepatic impairment. In a study comparing 13 patients with liver metastases and moderate hepatic impairment to 14 patients with liver metastases and normal hepatic function, the systemic exposure of gefitinib was similar [ see Warnings and Precautions (5.2) , Use in Specific Populations (8.7) ]. CYP2D6 Poor metabolizer : CYP2D6 metabolizes gefitinib to O-desmethyl gefitinib in vitro . In healthy CYP2D6 poor metabolizers, O-desmethyl gefitinib concentration was not measurable and the mean exposure to gefitinib was 2-fold higher as compared to the extensive metabolizers. This increase in exposure in CYP2D6 poor metabolizers may be clinically important because some adverse drug reactions are related to higher exposure of gefitinib. No dose adjustment is recommended in patients with a known CYP2D6 poor metabolizer genotype, but these patients should be closely monitored for adverse reactions. The impact of CYP2D6 inhibiting drugs on gefitinib pharmacokinetics has not been evaluated. However, similar precautions should be used when administering CYP2D6 inhibitors with gefitinib tablets because of the possibility of increased exposure in these patients. An exploratory exposure response analysis showed an increase in the incidence of interstitial lung disease (ILD) with a greater than 2-fold increase in the gefitinib exposure [ see Warnings and Precautions (5.1) ]. Drug-Drug Interactions Strong CYP3A4 Inducer: Concomitant administration of rifampicin (600 mg QD for 16 days), a strong inducer of CYP3A4, with gefitinib (500 mg single dose on Day 10 of gefitinib administration) reduced mean AUC of gefitinib by 83% [ see Dosage and Administration (2.4) , Drug Interactions (7) ]. CYP3A4 Inhibitor: Concomitant administration of itraconazole (200 mg QD for 12 days), an inhibitor of CYP3A4, with gefitinib (250 mg single dose on Day 4 of itraconazole administration) to healthy male subjects, increased mean gefitinib AUC by 80% [ see Drug Interactions (7) ]. Drugs Affecting Gastric pH: Co-administration of high doses of ranitidine with sodium bicarbonate (to maintain the gastric pH above pH 5.0) to healthy subjects decreased mean gefitinib AUC by 47% [ see Drug Interactions (7) ]. In human liver microsome studies, gefitinib had no inhibitory effect on CYP1A2, CYP2C9, and CYP3A4 activities at concentrations ranging from 2-5000 ng/mL. At the highest concentration studied (5000 ng/mL), gefitinib inhibited CYP2C19 by 24% and CYP2D6 by 43%. Exposure to metoprolol, a substrate of CYP2D6, was increased by 30% when it was given on Day 15 of gefitinib dosing (500 mg daily for 28 days) in patients with solid tumors."],"indications_and_usage":["1 INDICATIONS AND USAGE Gefitinib tablets are indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test [ see Clinical Studies (14) ]. Limitation of Use: Safety and efficacy of gefitinib tablets have not been established in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations [ see Clinical Studies (14) ]. Gefitinib tablets are a tyrosine kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. (1) Limitation of Use: Safety and efficacy of gefitinib tablets have not been established in patients whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations. (1)"],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS •Interstitial lung disease (ILD): ILD occurred in patients taking gefitinib tablets. Withhold gefitinib tablets for worsening of respiratory symptoms. Discontinue gefitinib tablets if ILD is confirmed. ( 2.4 , 5.1 ) •Hepatotoxicity: Obtain periodic liver function testing. Withhold gefitinib tablets for Grade 2 or higher for ALT and/or AST elevations. Discontinue for severe hepatic impairment. ( 2.4 , 5.2 ) •Gastrointestinal perforation: Discontinue gefitinib tablets for gastrointestinal perforation. ( 2.4 , 5.3 ) •Diarrhea: Withhold gefitinib tablets for Grade 3 or higher diarrhea. ( 2.4 , 5.4 ) •Ocular Disorders including Keratitis: Withhold gefitinib tablets for signs and symptoms of severe or worsening ocular disorders including keratitis. Discontinue for persistent ulcerative keratitis. ( 2.4 , 5.5 ) •Bullous and Exfoliative Skin Disorders: Withhold gefitinib tablets for Grade 3 or higher skin reactions or exfoliative conditions. ( 2.4 , 5.6 ) •Embryo-fetal Toxicity: Can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception. ( 5.7 , 8.1 , 8.3 ) 5.1 Interstitial Lung Disease (ILD) ILD or ILD-like adverse drug reactions (e.g., lung infiltration, pneumonitis, acute respiratory distress syndrome, or pulmonary fibrosis) occurred in 1.3% of the 2462 patients who received gefitinib tablets across clinical trials; of these, 0.7% were Grade 3 or higher and 3 cases were fatal. Withhold gefitinib tablets and promptly investigate for ILD in any patient who presents with worsening of respiratory symptoms such as dyspnea, cough and fever. Permanently discontinue gefitinib tablets if ILD is confirmed [ see Dosage and Administration (2.4) , Adverse Reactions (6.1) ]. 5.2 Hepatotoxicity In patients who received gefitinib tablets across clinical trials, 11.4% of patients had increased alanine aminotransferase (ALT), 7.9% of patients had increased aspartate aminotransferase (AST), and 2.7% of patients had increased bilirubin. Grade 3 or higher liver test abnormalities occurred in 5.1% (ALT), 3.0% (AST), and 0.7% (bilirubin) of patients. The incidence of fatal hepatotoxicity was 0.04%. Obtain periodic liver function testing. Withhold gefitinib tablets in patients with worsening liver function and discontinue in patients with severe hepatic impairment [ see Dosage and Administration (2.4) , Adverse Reactions (6.1) , Use in Specific Populations (8.7) ]. 5.3 Gastrointestinal Perforation Gastrointestinal perforation occurred in three (0.1%) of the 2462 gefitinib tablets-treated patients across clinical trials [ see Adverse Reactions (6.1) ]. Permanently discontinue gefitinib tablets in patients who develop gastrointestinal perforation [ see Dosage and Administration (2.4) ]. 5.4 Severe or Persistent Diarrhea Grade 3 or 4 diarrhea occurred in 3% of 2462 gefitinib tablets-treated patients across clinical trials. Withhold gefitinib tablets for severe or persistent (up to 14 days) diarrhea [ see Dosage and Administration (2.4) , Adverse Reactions (6.1) ]. 5.5 Ocular Disorders including Keratitis Ocular disorders [keratitis (0.1%), corneal erosion and aberrant eyelash growth (0.2%), conjunctivitis, blephritis and dry eye (6.7%)] occurred in the 2462 gefitinib tablets-treated patients across clinical trials. The incidence of Grade 3 ocular disorders was 0.1% [ see Adverse Reactions (6.1) ]. Interrupt or discontinue gefitinib tablets for severe, or worsening ocular disorders [ see Dosage and Administration (2.4) ]. 5.6 Bullous and Exfoliative Skin Disorders Bullous conditions including toxic epidermal necrolysis, Stevens Johnson syndrome and erythema multiforme have been reported from treatment with gefitinib tablets. Erythema multiforme and dermatitis bullous have been reported in two patients (0.08%) across NSCLC trials (Study 2, Study 3 and Study 4). Gefitinib tablets treatment should be interrupted or discontinued if the patient develops severe bullous, blistering or exfoliating conditions. 5.7 Embryo-fetal Toxicity Based on its mechanism of action and data from animal reproduction studies gefitinib tablets can cause fetal harm when administered to a pregnant woman. In animal reproductive studies, oral administration of gefitinib from organogenesis through weaning resulted in fetotoxicity and neonatal death at doses below the recommended human dose. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with gefitinib tablets and for at least two weeks following completion of therapy [ see Use in Specific Population ( 8.1 , 8.3 ) ]."],"clinical_studies_table":["
Table 3 – Efficacy Results in Study 1
Efficacy ParameterBICRBICR, Blinded Independent Central Review Assessment(n=106)17 patients without target lesion at baseline detected by BICR were deemed non respondersInvestigator Assessment (n=106)
Objective Response RateDetermined by RECIST v 1.1(95% CI)50%(41, 59)70%(61, 78)
Complete Response Rate0.9%1.9%
Partial Response Rate49%68%
Median Duration of Response (months)(95% CI)6.0(5.6, 11.1)8.3(7.6, 11.3)
"],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Gefitinib has been tested for genotoxicity in a series of in vitro (bacterial mutation, mouse lymphoma, and human lymphocyte) assays and an in vivo rat micronucleus test. Under the conditions of these assays, gefitinib did not cause genetic damage. In a two-year carcinogenicity study in mice, administration of gefitinib at a dose of 270 mg/m 2 /day (approximately twice the recommended daily dose of 250 mg on a mg/m 2 basis; dose reduced from 375 mg/m 2 /day from week 22) caused hepatocellular adenomas in females. In a two-year carcinogenicity study in rats, administration of gefitinib at 60 mg/m 2 /day (approximately 0.4 times the recommended daily clinical dose on a mg/m 2 basis) caused hepatocellular adenomas and hemangiomas/hemagiosarcomas of the mesenteric lymph nodes in female rats. The clinical relevance of these findings is unknown. In a dedicated fertility study in rats at doses ≥120 mg/m 2 (approximately equal to the recommended human dose of gefitinib on a mg/m 2 basis), animals presented with an increased incidence of irregular estrous, decreased corpora lutea, and decreases in uterine implants and live embryos per litter."],"adverse_reactions_table":["
Table 1 - Selected Adverse Drug Reactions Occurring with an Incidence Rate ≥ 5% and an Increase of >2% of Gefitinib Tablets-treated Patients in Study 3
Percentage (%) of patients
Gefitinib Tablets (N=1126)Placebo (N=562)
Adverse ReactionAll GradesGrade 3 and 4All GradesGrade 3 and 4
Skin and subcutaneous tissue disorders
Skin reactionsIncludes Acne, Acne pustular, Dermatitis, Dermatitis acneiform, Dermatitis exfoliative, Drug eruption, Dry skin, Erythema, Exfoliative rash, Folliculitis, Pruritus, Pruritus generalized, Rash, Rash erythematous, Rash generalized, Rash macular, Rash maculo-papular, Rash papular, Rash pruritic, Rash pustular, Rash vesicular, Skin exfoliation, Skin toxicity, Xeroderma47%2%17%0.4%
Nail disordersIncludes Ingrowing nail, Nail bed infection, Nail disorder, Nail infection, Onychoclasis, Onycholysis, Paronychia5%0.1%0.7%0%
Gastrointestinal disorders
DiarrheaIncludes Diarrhea, Feces soft, Frequent bowel movements29%3%10%1%
Vomiting14%1.2%10%0.4%
StomatitisIncludes Aphthous stomatitis, Cheilitis, Glossodynia, Mouth ulceration, Mucosal inflammation, Oral mucosal blistering, Stomatitis, Tongue disorder, Tongue ulceration7%0.3%4%0.2%
Metabolism and nutrition disorders
Decreased appetite17%2.3%14%2.0%
Eye disorders
Conjunctivitis/blepharitis/dry eyeIncludes Blepharitis, Conjunctival hyperemia, Conjunctivitis, Dry eye, Eye irritation, Eye pruritus, Eye swelling, Eyelid irritation, Eyelid edema, Eyelids pruritus6%0%3.2%0%
","
Table 2 - Treatment Emergent Laboratory Abnormalities Occurring More Frequently in Gefitinib Tablets-Treated Patients in Study 3
Gefitinib TabletsPlacebo
Adverse ReactionAll Grades%Grade 3 and 4%All Grades%Grade 3 and 4%
Alanine aminotransferase increasedPatients were allowed to enter the clinical study with lab values of ALT or AST CTCAE grade 1 or 238%14% gefitinib patients and 10% placebo patients were CTC grade 1 or 2 ALT at baseline2.4%23%1.4%0.2% of placebo patients were CTC grade 3 at baseline
Aspartate aminotransferase increased40%15% gefitinib patients and 12% placebo patients were CTC grade 1 or 2 AST at baseline2.0%25%1.3%0.4% of placebo patients were CTC grade 3 at baseline
Proteinuria35%4.7%31%3.3%
"],"information_for_patients":["17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labelling (Patient Information). Interstitial Lung Disease : Advise patients to immediately contact their healthcare provider for new onset or worsening of pulmonary symptoms such as dyspnea, cough and fever [ see Warnings and Precautions (5.1) ]. Hepatotoxicity : Inform patients that they will need to undergo lab tests to monitor for liver function. Advise patients to contact their healthcare provider to report any new symptoms indicating hepatic toxicity [ see Warnings and Precautions (5.2) ]. Gastrointestinal Perforation : Advise patients that gefitinib tablets can increase the risk of gastrointestinal perforation and to seek immediate medical attention for severe abdominal pain [ see Warnings and Precautions (5.3) ]. Severe or Persistent Diarrhea : Advise patients to contact their healthcare provider for severe or persistent diarrhea [ see Warnings and Precautions (5.4) ]. Ocular Disorders including Keratitis : Advise patients promptly to contact their healthcare provider if they develop eye symptoms, lacrimation, light sensitivity, blurred vision, eye pain, red eye or changes in vision [ see Warnings and Precautions (5.5) ]. Bullous and Exfoliative Skin Disorders : Advise patients that gefitinib tablets can increase the risk of bullous and exfoliative skin disorders and to seek immediately medical attention for severe skin reactions [ see Warnings and Precautions (5.6) ]. Embryo-fetal Toxicity : Advise pregnant women of the potential risk to a fetus or potential risk for loss of the pregnancy [ see Warnings and Precautions (5.7) , Use in Specific Populations (8.1) ]. Advise females of reproductive potential to use effective contraception during treatment with gefitinib tablets and for at least two weeks following completion of therapy [ see Use in Specific Populations (8.3) ]. Lactation : Advise women to discontinue breast-feeding during treatment with gefitinib tablets [ see Use in Specific Populations (8.2) ]. Revised: 4/2022 Manufactured by: Qilu Pharmaceutical (Hainan) Co., Ltd. Haikou, 570314, China"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION Recommended dose is 250 mg orally, once daily with or without food. (2.2) 2.1 Patient Selection Select patients for the first-line treatment of metastatic NSCLC with gefitinib tablets based on the presence of EGFR exon 19 deletions or exon 21 L858R mutations in their tumor or plasma specimens[ see Indications and Usage (1) , Clinical Studies (14) ]. If these mutations are not detected in a plasma specimen, test tumor tissue if feasible. Information on FDA-approved tests for the detection of EGFR mutations in NSCLC is available at: http://www.fda.gov/CompanionDiagnostics . 2.2 Recommended Dose The recommended dose of gefitinib tablets is 250 mg orally once daily with or without food until disease progression or unacceptable toxicity. Do not take a missed dose within 12 hours of the next dose. 2.3 Administration to Patients Who Have Difficulty Swallowing Solids Immerse gefitinib tablets in 4 to 8 ounces of water by dropping the tablet in water, and stir for approximately 15 minutes. Immediately drink the liquid or administer through a naso-gastric tube. Rinse the container with 4 to 8 ounces of water and immediately drink or administer through the naso-gastric tube. 2.4 Dose Modification Dose Modifications for Adverse Drug Reactions Withhold gefitinib tablets (for up to 14 days) for any of the following: •Acute onset or worsening of pulmonary symptoms (dyspnea, cough, fever) [ see Warnings and Precautions (5.1) ] •NCI CTCAE Grade 2 or higher in ALT and/or AST elevations [ see Warnings and Precautions (5.2) ] •NCI CTCAE Grade 3 or higher diarrhea [ see Warnings and Precautions (5.4) ] •Signs and symptoms of severe or worsening ocular disorders including keratitis [ see Warnings and Precautions (5.5) ] •NCI CTCAE Grade 3 or higher skin reactions [ see Warnings and Precautions (5.6) ] Resume treatment with gefitinib tablets when the adverse reaction fully resolves or improves to NCI CTCAE Grade 1. Permanently discontinue gefitinib tablets for: •Confirmed interstitial lung disease (ILD) [ see Warnings and Precautions (5.1) ] •Severe hepatic impairment [ see Warnings and Precautions (5.2) ] •Gastrointestinal perforation [ see Warnings and Precautions (5.3) ] •Persistent ulcerative keratitis [ see Warnings and Precautions (5.5) ] Dose Modifications for Drug Interactions Strong CYP3A4 Inducers Increase gefitinib tablets to 500 mg daily in the absence of severe adverse drug reaction, and resume gefitinib tablets at 250 mg seven days after discontinuation of the strong CYP3A4 inducer [ see Drug Interactions (7) , Clinical Pharmacology (12.3) ]."],"spl_product_data_elements":["Gefitinib Gefitinib GEFITINIB GEFITINIB LACTOSE MONOHYDRATE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM POVIDONE K30 SODIUM LAURYL SULFATE MAGNESIUM STEARATE POLYVINYL ALCOHOL, UNSPECIFIED POLYETHYLENE GLYCOL 3350 TALC TITANIUM DIOXIDE FERRIC OXIDE RED FERROSOFERRIC OXIDE FERRIC OXIDE YELLOW biconvex QL"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS 250 mg tablets: round, biconvex face, brown film-coated, debossed with \"QL\" on one side and plain on the other side. Tablets: 250 mg. (3)"],"spl_patient_package_insert":["Patient Information Gefitinib tablets What are gefitinib tablets? Gefitinib tablets are a prescription medicine used to treat people with non-small cell lung cancer (NSCLC) that has spread to other parts of the body and: •that have certain types of abnormal epidermal growth factor receptor (EGFR) genes, and •who have not had previous treatment for cancer Your healthcare provider will perform a test to make sure that gefitinib tablets are right for you. It is not known if gefitinib tablets are safe and effective in people with NSCLC that have other types of EGFR genes. It is not known if gefitinib tablets are safe and effective in children. Before taking gefitinib tablets, tell your healthcare provider about all of your medical conditions, including if you: •have lung or breathing problems •ever had liver problems •have vision or eye problems •are pregnant or plan to become pregnant. Gefitinib tablets can harm your unborn baby. Females who are able to become pregnant should use an effective method of birth control during treatment with gefitinib tablets and for at least 2 weeks after the last dose of gefitinib tablets. You should avoid becoming pregnant during treatment with gefitinib tablets. Tell your healthcare provider right away if you become pregnant during treatment with gefitinib tablets. •are breastfeeding or plan to breastfeed. It is not known if gefitinib tablets pass into your breast milk. Do not breastfeed during treatment with gefitinib tablets. Talk to your healthcare provider about the best way to feed your baby during this time. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. If you take a proton pump inhibitor (PPI), H2 blocker, or an antacid medicine, talk to your healthcare provider about the best time to take it during treatment with gefitinib tablets. If you take a blood thinner called warfarin, your healthcare provider should do blood tests regularly to check how fast your blood clots, during treatment with gefitinib tablets. How should I take gefitinib tablets? •Take gefitinib tablets exactly as your healthcare provider tells you to take it. •Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with gefitinib tablets if you have side effects. •Take gefitinib tablets 1 time each day. •You can take gefitinib tablets with or without food. •If you miss a dose of gefitinib tablets, take it as soon as you remember. If it is less than 12 hours until your next dose, skip the missed dose. Take your next dose at your regular time. •If you take too much gefitinib tablets, call your healthcare provider or go to the nearest emergency room right away. • If you cannot swallow gefitinib tablets whole: place your dose of gefitinib tablets in a container with 4 to 8 ounces of water and stir for about 15 minutes drink the mixture right away place another 4 to 8 ounces of water in the same container, and drink it right away What are the possible side effects of gefitinib tablets? Gefitinib tablets may cause serious side effects, including: • lung or breathing problems . Gefitinib tablets may cause inflammation of the lung that may lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your healthcare provider right away if you have any new or worsening lung problems, or any combination of the following symptoms: trouble breathing or shortness of breath, cough, or fever. • liver problems . Gefitinib tablets may cause inflammation of the liver that may lead to death. Tell your healthcare provider right away if you have any symptoms of a liver problem which may include: yellowing of your skin or the white part of your eyes (jaundice) dark or brown (tea colored) urine light-colored bowel movements (stools) decreased appetite pain on the right side of your stomach (abdomen) Your healthcare provider will do blood tests to check your liver function during your treatment with gefitinib tablets. • a tear in the wall of your stomach or intestines (perforation) . Get emergency medical help right away if you have severe stomach (abdomen) pain. • diarrhea . Diarrhea is common with gefitinib tablets and can sometimes be severe. Tell your healthcare provider right away if you have severe diarrhea or diarrhea that will not go away. • eye problems . Tell your healthcare provider if you get watery eyes, sensitivity to light, blurred vision, eye pain, eye redness, or vision changes. • skin reactions . Skin redness, rash, itching, and acne are common with gefitinib tablets. This may occur on any part of your body. Get medical help right away if you develop severe skin reactions such as peeling or blistering of your skin. Gefitinib tablets may cause fertility problems in females. Talk to your healthcare provider if you plan to become pregnant. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of gefitinib tablets. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store gefitinib tablets? Store gefitinib tablets at room temperature between 68˚F to 77˚F (20˚C to 25˚C) Keep gefitinib tablets and all medicines out of the reach of children. General information about the safe and effective use of gefitinib tablets. Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflet. Do not use gefitinib tablets for a condition for which it was not prescribed. Do not give gefitinib tablets to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about gefitinib tablets that is written for health professionals. What are the ingredients in gefitinib tablets? Active ingredient : gefitinib Inactive ingredients : lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone, sodium lauryl sulfate, magnesium stearate Tablet coating contains:polyvinyl alcohol-part hydrolysed, polyethylene glycol 3350, talc, titanium dioxide, red ferric oxide, ferrosoferric oxide and yellow ferric oxide Manufactured by: Qilu Pharmaceutical (Hainan) Co., Ltd. Haikou, 570314, China This Patient Information has been approved by the U.S. Food and Drug Administration Revised: April 2022"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS Lactation: Discontinue breast-feeding. (8.2) 8.1 Pregnancy Risk Summary Based on its mechanism of action and animal data, gefitinib tablets can cause fetal harm when administered to a pregnant woman. In animal reproductive studies, oral administration of gefitinib from organogenesis through weaning resulted in fetotoxicity and neonatal death at doses below the recommended human dose ( see Animal Data ). Advise pregnant women of the potential hazard to a fetus or potential risk for loss of the pregnancy. The background risk of major birth defects and miscarriage for the indicated population is unknown; however, the background risk in the U.S. general population of major birth defects is 2-4% and miscarriage is 15-20% of clinically recognized pregnancies. Data Animal Data A single dose study in rats showed that gefitinib crosses the placenta after an oral dose of 5 mg/kg (30 mg/m 2 , about 0.2 times the recommended human dose on a mg/m 2 basis). When pregnant rats were treated with 5 mg/kg from the beginning of organogenesis to the end of weaning there was a reduction in the number of offspring born alive. This effect was more severe at 20 mg/kg (approximate the human clinical dose on a mg/m 2 basis) and was accompanied by high neonatal mortality soon after parturition. In rabbits, a dose of 20 mg/kg/day (240 mg/m 2 , about twice the recommended dose in humans on a mg/m 2 basis) caused reduced fetal weight. 8.2 Lactation Risk Summary It is not known whether gefitinib tablets are excreted in human milk. Animal studies indicate the gefitinib and its metabolites are present in rat milk at a concentration higher than those in maternal plasma. Because of the potential for serious adverse reactions in nursing infants from gefitinib tablets, advise women to discontinue breast-feeding during treatment with gefitinib tablets. Data Animal Data Levels of gefitinib and its metabolites were 11-to-19-fold higher in milk than in blood, after oral exposure of lactating rats to a dose of 5 mg/kg. 8.3 Females and Males of Reproductive Potential Contraception Based on its mechanism of action and animal data, gefitinib tablets can cause fetal harm when administered to a pregnant woman [ see Use in Specific Populations (8.1) ]. Advise females of reproductive potential to use effective contraception during treatment with gefitinib tablets and for at least two weeks following completion of therapy. Infertility Gefitinib tablets may result in reduced fertility in females of reproductive potential [ see Nonclinical Toxicology (13.1) ]. 8.4 Pediatric Use The safety and effectiveness of gefitinib tablets in pediatric patients have not been established. 8.5 Geriatric Use Of the 823 patients enrolled in two randomized, active-controlled clinical trials 374 patients (45%) were 65 years and older, and 93 patients (11%) were 75 years and older. No overall differences in safety were observed between patients 65 years and older and those younger than 65 years. There is insufficient information to assess for differences in efficacy between older and younger patients. 8.6 Renal Impairment Less than four percent (<4%) of gefitinib and its metabolites are excreted via the kidney. No clinical studies were conducted with gefitinib tablets in patients with severe renal impairment. 8.7 Hepatic Impairment The systemic exposure of gefitinib was compared in patients with mild, moderate, or severe hepatic impairment due to cirrhosis (according to Child-Pugh classification) and healthy subjects with normal hepatic function (N=10/group). The mean systemic exposure (AUC 0-∞ ) was increased by 40% in patients with mild impairment, 263% in patients with moderate impairment, and 166% in patients with severe hepatic impairment. Monitor adverse reactions when gefitinib tablets are administered to patients with moderate and severe hepatic impairment. In a study comparing 13 patients with liver metastases and moderate hepatic impairment (addition of CTC grade of baseline AST/SGOT, ALP, and bilirubin equals 3 to 5) to 14 patients with liver metastases and normal hepatic function, the systemic exposure of gefitinib was similar [ see Warnings and Precautions (5.2) ]."],"package_label_principal_display_panel":["PACKAGE LABEL – 250mg tablets, 30 count, bottle NDC 67184-0531-1 30 tablets Gefitinib Tablets 250 mg Manufactured by: Qilu Pharmaceutical (Hainan) Co., Ltd. Haikou, 570314, China Gefitinib Tablets 250mg - 30 tablets count bottle label","PACKAGE LABEL – 250mg tablets, 500 count, bottle NDC 67184-0531-2 500 tablets Gefitinib Tablets 250 mg Manufactured by: Qilu Pharmaceutical (Hainan) Co., Ltd. Haikou, 570314, China Gefitinib Tablets 250mg - 500 tablets count bottle label","PACKAGE LABEL – 250mg tablets, 30 count, blister pack NDC 67184-0531-3 30 tablets in one overwrap (3 cards of 10 tablets) Gefitinib Tablets 250 mg Manufactured by: Qilu Pharmaceutical (Hainan) Co., Ltd. Haikou, 570314, China Gefitinib Tablets 250mg - 30 tablets count blister label"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Gefitinib has been tested for genotoxicity in a series of in vitro (bacterial mutation, mouse lymphoma, and human lymphocyte) assays and an in vivo rat micronucleus test. Under the conditions of these assays, gefitinib did not cause genetic damage. In a two-year carcinogenicity study in mice, administration of gefitinib at a dose of 270 mg/m 2 /day (approximately twice the recommended daily dose of 250 mg on a mg/m 2 basis; dose reduced from 375 mg/m 2 /day from week 22) caused hepatocellular adenomas in females. In a two-year carcinogenicity study in rats, administration of gefitinib at 60 mg/m 2 /day (approximately 0.4 times the recommended daily clinical dose on a mg/m 2 basis) caused hepatocellular adenomas and hemangiomas/hemagiosarcomas of the mesenteric lymph nodes in female rats. The clinical relevance of these findings is unknown. In a dedicated fertility study in rats at doses ≥120 mg/m 2 (approximately equal to the recommended human dose of gefitinib on a mg/m 2 basis), animals presented with an increased incidence of irregular estrous, decreased corpora lutea, and decreases in uterine implants and live embryos per litter."]},"safety":{"boxedWarnings":[],"drugInteractions":[{"drug":"Strong CYP3A4 Inducers (e.g., rifampicin, phenytoin, tricyclic antidepressants)","severity":"major","mechanism":"Increase metabolism of gefitinib leading to decreased plasma concentrations","management":"Increase gefitinib dose to 500 mg daily; resume 250 mg 7 days after discontinuation of the strong inducer","clinicalEffect":"Reduced efficacy of gefitinib"},{"drug":"Strong CYP3A4 Inhibitors (e.g., ketoconazole, itraconazole)","severity":"moderate","mechanism":"Decrease metabolism of gefitinib leading to increased plasma concentrations","management":"Monitor for adverse reactions","clinicalEffect":"Increased risk of adverse reactions"},{"drug":"Proton Pump Inhibitors","severity":"moderate","mechanism":"Elevation of gastric pH leading to reduced plasma concentrations of gefitinib","management":"Avoid concomitant use if possible; if necessary, take gefitinib 12 hours before or after the PPI","clinicalEffect":"Reduced efficacy of gefitinib"},{"drug":"Histamine H2-Receptor Antagonists","severity":"minor","mechanism":"Elevation of gastric pH leading to reduced plasma concentrations of gefitinib","management":"Take gefitinib 6 hours before or after the H2-receptor antagonist","clinicalEffect":"Potential reduction in efficacy of gefitinib"},{"drug":"Antacids","severity":"minor","mechanism":"Elevation of gastric pH leading to reduced plasma concentrations of gefitinib","management":"Take gefitinib 6 hours before or after the antacid","clinicalEffect":"Potential reduction in efficacy of gefitinib"},{"drug":"Warfarin","severity":"major","mechanism":"Potential alteration in warfarin metabolism or effect","management":"Monitor changes in prothrombin time or INR","clinicalEffect":"Elevations in INR and/or hemorrhage"}],"commonSideEffects":[{"effect":"Skin reactions","drugRate":"47%","severity":"common","organSystem":""},{"effect":"Diarrhea","drugRate":"29%","severity":"common","organSystem":""}],"seriousAdverseEvents":[{"effect":"Respiratory failure","drugRate":"0.9%","severity":"serious"},{"effect":"Pneumonia","drugRate":"0.8%","severity":"serious"},{"effect":"Pulmonary embolism","drugRate":"0.5%","severity":"serious"}]},"_chembl":null,"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=GEFITINIB","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T05:12:16.833285+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T05:13:13.555532+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T05:12:22.587525+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=GEFITINIB","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T05:12:22.809368+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T05:12:15.620717+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T05:12:15.620745+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T05:13:09.098389+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T05:12:15.620749+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Epidermal growth factor receptor erbB1 inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T05:12:23.872943+00:00"},"safety.drugInteractions":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T05:12:56.194327+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL939/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T05:12:23.522696+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA211591","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T05:12:15.620752+00:00"}},"_dailymed":{"setId":"1a3c0ce7-06a1-4e04-9106-14ddb2a866a5","title":"GEFITINIB TABLET, FILM COATED [NATCO PHARMA USA LLC]"},"aiSummary":"Ge fitinib is a marketed first-line treatment for metastatic NSCLC with specific EGFR mutations. Its key strength lies in its established position as an effective targeted therapy for patients with EGFR mutations. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.","mechanism":{"drugClass":"Kinase Inhibitor [EPC]"},"_scrapedAt":"2026-03-27T23:32:06.669Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T05:13:13.555609+00:00","fieldsConflicting":0,"overallConfidence":0.95},"indications":{"approved":[{"id":"chembl-chembl939-first-line-treatment-of-metast","name":"First-line treatment of metastatic NSCLC with specific EGFR mutations","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations","pivotalTrial":null,"restrictions":[],"patientPopulation":"Patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations","diagnosticRequired":"EGFR exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test","brandNameForIndication":""}]},"trialDetails":[{"nctId":"NCT07477457","phase":"PHASE2","title":"A Study of Gefitinib, Trametinib, Disulfiram, and Sunitinib in Addition to Standard Chemotherapy in People With Osteosarcoma","status":"RECRUITING","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2026-03-11","conditions":"Osteosarcoma, Metastasis","enrollment":45},{"nctId":"NCT07458919","phase":"EARLY_PHASE1","title":"Therapy for Advanced NSCLC With EGFR 19delins Mutation","status":"NOT_YET_RECRUITING","sponsor":"Fuzhou General Hospital","startDate":"2026-03-30","conditions":"Lung Cancer","enrollment":94},{"nctId":"NCT07143045","phase":"","title":"A Prospective Cohort Study of Zorifertinib as a First-line Treatment in Patients With Epidermal Growth Factor Receptor-mutant Advanced Non-small Cell Lung Cancer With Central Nervous System (CNS) Metastases","status":"RECRUITING","sponsor":"Alpha Biopharma (Jiangsu) Co., Ltd.","startDate":"2025-12-29","conditions":"EGFR Mutant Advanced Non-small Cell Lung Cancer, Central Nervous System (CNS) Metastases","enrollment":800},{"nctId":"NCT03040973","phase":"PHASE2","title":"Study to Allow Patients Previously Participating in a Novartis Sponsored Trial to Continue Receiving Capmatinib Treatment as Single Agent or in Combination With Other Treatments or the Combination Treatment Alone","status":"ACTIVE_NOT_RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2017-08-23","conditions":"Advanced Solid Tumors Which Are cMET-dependent","enrollment":29},{"nctId":"NCT06675695","phase":"","title":"Emulation of the FLAURA (NCT02296125) Trial Using Specialty Oncology Electronic Health Records Databases","status":"COMPLETED","sponsor":"Brigham and Women's Hospital","startDate":"2024-10-30","conditions":"Non Small Cell Lung Cancer","enrollment":4864},{"nctId":"NCT02411448","phase":"PHASE3","title":"A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Eli Lilly and Company","startDate":"2015-05-06","conditions":"Metastatic Non-Small Cell Lung Cancer","enrollment":545},{"nctId":"NCT03333343","phase":"PHASE1","title":"Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC","status":"ACTIVE_NOT_RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2018-01-29","conditions":"EGFR-mutant Non-small Cell Lung Cancer","enrollment":105},{"nctId":"NCT07338396","phase":"","title":"A Prospective Multicenter Study of the Association Between TCM Syndromes and EGFR-TKI Efficacy in Lung Cancer Patients","status":"NOT_YET_RECRUITING","sponsor":"Guangzhou University of Traditional Chinese Medicine","startDate":"2026-01","conditions":"Non Small Cell Lung Cancer NSCLC","enrollment":3000},{"nctId":"NCT02296125","phase":"PHASE3","title":"AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2014-12-03","conditions":"Locally Advanced or Metastatic EGFR Sensitising Mutation Positive Non Small Cell Lung Cancer","enrollment":674},{"nctId":"NCT06630325","phase":"PHASE2","title":"A Precision Medicine Approach (SMMART-ACT) for the Treatment of Patients With Advanced Sarcoma, Prostate, Breast, Ovarian or Pancreatic Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"OHSU Knight Cancer Institute","startDate":"2025-06-24","conditions":"Advanced Breast Carcinoma, Advanced Malignant Solid Neoplasm, Advanced Ovarian Carcinoma","enrollment":30},{"nctId":"NCT07271446","phase":"PHASE1","title":"An Autologous NK/CIK Cell Product (PB101) in Combination With EGFR-TKI for Treating Lung Cancer","status":"COMPLETED","sponsor":"Precision Biotech Taiwan Corp.","startDate":"2018-09-01","conditions":"Non-small Cell Lung Cancer","enrollment":8},{"nctId":"NCT02157883","phase":"PHASE1","title":"Study to Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of AZD9291, in Patients With EGFR Positive Non-small Cell Lung Cancer. Patients Will be Chosen From Those Who Have Already Been Prescribed an EGFR TKI Medicine (Such as Iressa or Tarceva)","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2014-11-06","conditions":"Advanced Non Small Cell Lung Cancer, Advanced (Inoperable) Non Small Cell Lung Cancer","enrollment":39},{"nctId":"NCT03122717","phase":"PHASE1, PHASE2","title":"Osimertinib and Gefitinib in EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Dana-Farber Cancer Institute","startDate":"2017-05-09","conditions":"Non-Small Cell Lung Cancer","enrollment":48},{"nctId":"NCT02856893","phase":"PHASE2","title":"Osimertinib Treatment on EGFR T790M Plasma Positive NSCLC Patients (APPLE)","status":"ACTIVE_NOT_RECRUITING","sponsor":"European Organisation for Research and Treatment of Cancer - EORTC","startDate":"2017-10-10","conditions":"NSCLC","enrollment":156},{"nctId":"NCT03653546","phase":"PHASE2, PHASE3","title":"First Line Treatment in EGFR Mutation Positive Advanced NSCLC Patients With Central Nervous System (CNS) Metastases","status":"COMPLETED","sponsor":"Alpha Biopharma (Jiangsu) Co., Ltd.","startDate":"2018-10-29","conditions":"Non-small Cell Lung Cancer, EGFR Gene Mutation, Brain Metastases","enrollment":492},{"nctId":"NCT07036016","phase":"","title":"Interstitial Pneumonitis Associated With EGFR-TKI and Combined With PD-1/PD-L1","status":"COMPLETED","sponsor":"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","startDate":"2015-01-01","conditions":"Non-Small Cell Lung Cancer (NSCLC)","enrollment":67818},{"nctId":"NCT03292133","phase":"PHASE2","title":"A Study of EGF816 and Gefitinib in TKI-naïve EGFR-mutant Non-Small Cell Lung Cancer","status":"TERMINATED","sponsor":"Massachusetts General Hospital","startDate":"2017-10-31","conditions":"Lung Cancer","enrollment":11},{"nctId":"NCT00328562","phase":"PHASE1","title":"ZD1839 With Hypofractionated Radiation Therapy With an Immobilization Device for Advanced Non-Small Cell Lung Cancer","status":"COMPLETED","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University","startDate":"2003-12","conditions":"Non-Small Cell Lung Carcinoma (NSCLC)","enrollment":13},{"nctId":"NCT03787992","phase":"PHASE3","title":"Alflutinib Mesylate Versus Gefitinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer （FLAG）","status":"ACTIVE_NOT_RECRUITING","sponsor":"Allist Pharmaceuticals, Inc.","startDate":"2019-05-30","conditions":"Locally Advanced or Metastatic EGFR Sensitising Mutation Positive Non-small Cell Lung Cancer","enrollment":358},{"nctId":"NCT05834348","phase":"","title":"A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway.","status":"COMPLETED","sponsor":"Pfizer","startDate":"2023-06-23","conditions":"Non-Small Cell Lung Cancer","enrollment":5279},{"nctId":"NCT02424617","phase":"PHASE1, PHASE2","title":"A Study of BGB324 (Bemcentinib) in Combination With Erlotinib in Patients With Non-Small Cell Lung Cancer","status":"COMPLETED","sponsor":"BerGenBio ASA","startDate":"2015-04-19","conditions":"Non-Small Cell Lung Cancer","enrollment":40},{"nctId":"NCT03944772","phase":"PHASE2","title":"Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)","status":"ACTIVE_NOT_RECRUITING","sponsor":"AstraZeneca","startDate":"2019-06-25","conditions":"Non-Small Cell Lung Cancer","enrollment":247},{"nctId":"NCT06071013","phase":"PHASE1, PHASE2","title":"Nintedanib Plus EGFR TKI In EGFR-mutated Non-small Cell Lung Cancer Patients","status":"RECRUITING","sponsor":"China Medical University Hospital","startDate":"2024-02-23","conditions":"Non-small Cell Lung Cancer, EGFR Gene Mutation, EGFR-TKI Resistant Mutation","enrollment":20},{"nctId":"NCT06592989","phase":"","title":"A Clinical Study of Sorafenib Combined With Gefitinib for the Treatment of pNET","status":"RECRUITING","sponsor":"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine","startDate":"2024-09-30","conditions":"Pancreatic Neuroendocrine Neoplasm, Sorafenib, Gefitinib","enrollment":20},{"nctId":"NCT02588261","phase":"PHASE3","title":"A Study of ASP8273 vs. Erlotinib or Gefitinib in First-line Treatment of Patients With Stage IIIB/IV Non-small Cell Lung Cancer Tumors With EGFR Activating Mutations","status":"TERMINATED","sponsor":"Astellas Pharma Global Development, Inc.","startDate":"2016-02-11","conditions":"Non-small Cell Lung Cancer (NSCLC)","enrollment":530},{"nctId":"NCT02347839","phase":"PHASE2","title":"NEoadjuvant Gefitinib fOllowed by Surgery and gefiTinib In unresectAble sTage III NSCLC With EGFR Mutations.","status":"WITHDRAWN","sponsor":"Sun Yat-sen University","startDate":"2016-01-01","conditions":"Lung Cancer","enrollment":""},{"nctId":"NCT04248829","phase":"PHASE3","title":"Clinical Trial of YH25448(Lazertinib) as the First-line Treatment in Patients With EGFR Mutation Positive Locally Advanced or Metastatic NSCLC (LASER301)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Yuhan Corporation","startDate":"2020-02-13","conditions":"Non-Small Cell Lung Cancer","enrollment":393},{"nctId":"NCT04322890","phase":"PHASE2","title":"Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation","status":"RECRUITING","sponsor":"Hunan Province Tumor Hospital","startDate":"2020-04-16","conditions":"Non Small Cell Lung Cancer, EGFR Gene Mutation, ALK Gene Mutation","enrollment":6000},{"nctId":"NCT03866499","phase":"PHASE3","title":"A Study of BPI-7711 Capsule in Non-small Cell Lung Cancer Patients","status":"ACTIVE_NOT_RECRUITING","sponsor":"Beta Pharma Shanghai","startDate":"2021-04-30","conditions":"NSCLC","enrollment":369},{"nctId":"NCT01513174","phase":"PHASE1, PHASE2","title":"Study With Gefitinib in Combination With Olaparib (AZD2281) Versus Gefitinib Alone","status":"COMPLETED","sponsor":"Spanish Lung Cancer Group","startDate":"2011-08","conditions":"Non Small Cell Lung Cancer","enrollment":186},{"nctId":"NCT04143607","phase":"PHASE3","title":"ASK120067 Versus Gefitinib as First-line Treatment for EGFRm Locally Advanced or Metastatic NSCLC","status":"ACTIVE_NOT_RECRUITING","sponsor":"Jiangsu Aosaikang Pharmaceutical Co., Ltd.","startDate":"2019-07-23","conditions":"Locally Advanced or Metastatic NSCLC","enrollment":337},{"nctId":"NCT00198380","phase":"PHASE2","title":"Treatment of Lung Adenocarcinoma With Bronchioloalveolar Feature","status":"COMPLETED","sponsor":"Intergroupe Francophone de Cancerologie Thoracique","startDate":"2005-04","conditions":"Pneumonic-type Adenocarcinoma (P-ADC), Lung Adenocarcinoma With Bronchiolo-alveolar Feature","enrollment":90},{"nctId":"NCT04401059","phase":"PHASE4","title":"Synergistic Effect of Elemene Plus TKIs Compared With TKIs in EGFR-mutated Advanced NSCLC：Prospective Study","status":"RECRUITING","sponsor":"Tian Xie","startDate":"2020-11-09","conditions":"Carcinoma, Non-Small-Cell Lung Cancer, Adenocarcinoma","enrollment":744},{"nctId":"NCT03647592","phase":"","title":"Real World Study on Erlotinib/Gefitinib Combined With Bevacizumab in Advanced Non-aquamous Non-small Cell Lung Cancer","status":"UNKNOWN","sponsor":"Hunan Province Tumor Hospital","startDate":"2018-06-01","conditions":"Non Small Cell Lung Cancer","enrollment":30},{"nctId":"NCT04397432","phase":"","title":"Synergistic Effect of Elemene Plus TKIs Compared With TKIs in EGFR-mutated Advanced NSCLC：Retrospective Study","status":"ACTIVE_NOT_RECRUITING","sponsor":"Tian Xie","startDate":"2020-08-28","conditions":"Carcinoma, Non-Small-Cell Lung","enrollment":878},{"nctId":"NCT01185158","phase":"PHASE2","title":"A Phase II Study of 250-mg ZD1839 Monotherapy in Recurrent or Metastatic or Both Recurrent and Metastatic Squamous Cell Carcinoma","status":"COMPLETED","sponsor":"University of Chicago","startDate":"2002-05","conditions":"Head and Neck Cancer","enrollment":46},{"nctId":"NCT01485809","phase":"PHASE2","title":"Efficacy and Safety Study of Gefitinib in Squamous NSCLC Patients Who Failed First-Line Chemotherapy","status":"COMPLETED","sponsor":"Seoul Veterans Hospital","startDate":"2011-10","conditions":"Squamous Cell Carcinoma of Bronchus","enrollment":36},{"nctId":"NCT01774721","phase":"PHASE3","title":"ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC.","status":"COMPLETED","sponsor":"Pfizer","startDate":"2013-05-09","conditions":"Non-small Cell Lung Cancer With EGFR-Activating Mutations","enrollment":452},{"nctId":"NCT00483561","phase":"PHASE2","title":"Gefitinib and Etoposide in Treating Patients With Advanced Prostate Cancer That Did Not Respond to Hormone Therapy","status":"TERMINATED","sponsor":"University of Nebraska","startDate":"2004-01","conditions":"Prostate Cancer","enrollment":26},{"nctId":"NCT00352079","phase":"PHASE3","title":"BCG With or Without Gefitinib in Treating Patients With High-Risk Bladder Cancer","status":"TERMINATED","sponsor":"NCIC Clinical Trials Group","startDate":"2007-01-04","conditions":"Bladder Cancer","enrollment":41},{"nctId":"NCT04642547","phase":"NA","title":"Lenvatinib Combined With Gefitinib in the Treatment of Lenvatinib-resistant Hepatocellular Carcinoma","status":"COMPLETED","sponsor":"RenJi Hospital","startDate":"2020-12-02","conditions":"Hepatocellular Carcinoma, Molecular Targeted Therapy","enrollment":30},{"nctId":"NCT01833572","phase":"PHASE2","title":"Preoperative Gefitinib for EGFR Mutant II-IIIa NSCLC (ECTOP-1001)","status":"COMPLETED","sponsor":"Fudan University","startDate":"2013-05","conditions":"Non-small-cell Lung Cancer","enrollment":36},{"nctId":"NCT05934461","phase":"","title":"A Retrospective Study of Radiotherapy Combined With EGFR-TKI for Stage III EGFR Mutant Lung Cancer","status":"COMPLETED","sponsor":"Laibin People's Hospital","startDate":"2014-12-01","conditions":"The Primary Study Metric is Progression-free Survival (PFS)","enrollment":48},{"nctId":"NCT05445791","phase":"PHASE3","title":"Metformin Plus Tyrosine Kinase Inhibitors for Treatment of Patients With Non-small Cell Lung Cancer With EGFR Mutations","status":"UNKNOWN","sponsor":"Instituto Nacional de Cancerologia de Mexico","startDate":"2021-07-15","conditions":"Non Small Cell Lung Cancer","enrollment":312},{"nctId":"NCT04179890","phase":"","title":"The Study Observes How Long Patients With Non-small Cell Lung Cancer (NSCLC) Benefit From Treatment With Epidermal Growth Factor Tyrosine Kinase Inhibitor (EGFR-TKI) When Given Either for Uncommon Mutations or for Common Mutations in the Sequence Afatinib Followed by Osimertinib","status":"COMPLETED","sponsor":"Boehringer Ingelheim","startDate":"2019-12-17","conditions":"Non-squamous, Non-Small Cell Lung Cancer","enrollment":462},{"nctId":"NCT01185171","phase":"PHASE2","title":"Trial of Induction Chemotherapy With Carboplatin and Paclitaxel, Followed by Concurrent Chemotherapy/Radiation Therapy With ZD1839 (IRESSA), 5-FU, Hydroxyurea, and Twice-Daily Radiation, Followed by Adjuvant ZD1839 Monotherapy in Patients With Locally Advanced Head & Neck Cancer","status":"COMPLETED","sponsor":"University of Chicago","startDate":"2003-01-27","conditions":"Head and Neck Cancer","enrollment":70},{"nctId":"NCT02805530","phase":"NA","title":"Radical Treatment of Synchronous Oligometastatic Non-Small Cell Lung Carcinoma","status":"COMPLETED","sponsor":"Instituto Nacional de Cancerologia de Mexico","startDate":"2015-06","conditions":"Carcinoma, Non-Small-Cell Lung, Synchronous Neoplasms","enrollment":36},{"nctId":"NCT01994057","phase":"","title":"A Retrospective Study of EGFR-TKIs,Gefitinib, Erlotinib and Osimertinib in NSCLC Patients Treatment","status":"RECRUITING","sponsor":"Sun Yat-sen University","startDate":"2012-09","conditions":"Non-small Cell Lung Cancer (NSCLC), EGFR-TKI Resistant Mutation, EGFR-TKI Sensitizing Mutation","enrollment":1000},{"nctId":"NCT01570296","phase":"PHASE1","title":"A Trial of Gefitinib in Combination With BKM120 in Patients With Advanced Non-Small Cell Lung Cancer, With Enrichment for Patients Whose Tumours Harbour Molecular Alterations of PI3K Pathway and Known to Overexpress EGFR","status":"COMPLETED","sponsor":"National Cancer Centre, Singapore","startDate":"2011-10-03","conditions":"Non-Small Cell Lung Cancer, Solid Tumors","enrollment":38},{"nctId":"NCT03599518","phase":"PHASE1","title":"DS-1205c With Gefitinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer","status":"TERMINATED","sponsor":"Daiichi Sankyo Co., Ltd.","startDate":"2018-09-21","conditions":"Non Small Cell Lung Cancer","enrollment":20},{"nctId":"NCT03849768","phase":"PHASE3","title":"A Study to Evaluate Safety and Efficacy of HS-10296 as First-Line Treatment in Patients","status":"UNKNOWN","sponsor":"Jiangsu Hansoh Pharmaceutical Co., Ltd.","startDate":"2019-02-01","conditions":"Non Small Cell Lung Cancer","enrollment":429},{"nctId":"NCT02039674","phase":"PHASE1, PHASE2","title":"A Study of Pembrolizumab (MK-3475) in Combination With Chemotherapy or Immunotherapy in Participants With Non-small Cell Lung Cancer (MK-3475-021/KEYNOTE-021)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2014-02-21","conditions":"Non-small Cell Lung Carcinoma","enrollment":267},{"nctId":"NCT01982955","phase":"PHASE1, PHASE2","title":"Tepotinib With Gefitinib in Participants With Locally Advanced or Metastatic NSCLC (INSIGHT)","status":"COMPLETED","sponsor":"Merck KGaA, Darmstadt, Germany","startDate":"2013-12-23","conditions":"Non-small Cell Lung Cancer","enrollment":88},{"nctId":"NCT02551718","phase":"NA","title":"High Throughput Drug Sensitivity Assay and Genomics- Guided Treatment of Patients With Relapsed or Refractory Acute Leukemia","status":"COMPLETED","sponsor":"University of Washington","startDate":"2015-09-11","conditions":"Recurrent Acute Leukemia of Ambiguous Lineage, Recurrent Acute Lymphoblastic Leukemia, Recurrent Acute Myeloid Leukemia","enrollment":34},{"nctId":"NCT03758287","phase":"PHASE1, PHASE2","title":"Ningetinib (CT053PTSA) Plus Gefitinib in Stage IIIB or IV NSCLC Patients With EGFR Mutation and T790M Negative","status":"UNKNOWN","sponsor":"Sunshine Lake Pharma Co., Ltd.","startDate":"2016-11","conditions":"Non-small Cell Lung Cancer","enrollment":158},{"nctId":"NCT03170180","phase":"PHASE2","title":"Exploratory Study of Drug Sensitivity Prediction Software (IRCR-DReSS) With Patient-derived Tumor Cells of Metastatic Gastric Cancer","status":"COMPLETED","sponsor":"Samsung Medical Center","startDate":"2017-03-01","conditions":"Stomach Neoplasms","enrollment":66},{"nctId":"NCT02447419","phase":"PHASE2","title":"Study to Evaluate the Safety and Efficacy of Gefitinib, in Subjects With EFGR Amplification Refractory Solid Tumors","status":"COMPLETED","sponsor":"Samsung Medical Center","startDate":"2014-12-03","conditions":"Solid Tumor","enrollment":16},{"nctId":"NCT00522145","phase":"PHASE2","title":"Study of XL647 in Subjects With NSCLC Who Have Progressed After Responding to Treatment With Gefitinib or Erlotinib","status":"COMPLETED","sponsor":"Kadmon Corporation, LLC","startDate":"2007-05","conditions":"Carcinoma, Non-Small-Cell Lung","enrollment":41},{"nctId":"NCT02088112","phase":"PHASE1","title":"MEDI4736 (Anti PD-L1) Combined With Gefitinib in Subjects With Non-Small Cell Lung Cancer(NSCLC).","status":"COMPLETED","sponsor":"MedImmune LLC","startDate":"2014-03-24","conditions":"Carcinoma, Non-Small-Cell Lung","enrollment":56},{"nctId":"NCT02932345","phase":"","title":"Gefitinib Long-term Survivor Study","status":"TERMINATED","sponsor":"AstraZeneca","startDate":"2016-10-31","conditions":"EGFR Mutation Positive Advanced Non-small-cell Lung Cancer","enrollment":59},{"nctId":"NCT01951469","phase":"PHASE3","title":"Gefitinib With or Without Chemotherapy in Brain Metastases From Non-small Cell Lung Cancer","status":"UNKNOWN","sponsor":"Sun Yat-sen University","startDate":"2016-01","conditions":"Non-small Cell Lung Cancer, Brain Metastases, EGFR Mutation","enrollment":160},{"nctId":"NCT03239015","phase":"PHASE2","title":"Efficacy and Safety of Precision Therapy in Refractory Tumor","status":"UNKNOWN","sponsor":"Baodong Qin","startDate":"2017-01-01","conditions":"Rare Tumor, Refractory Tumor","enrollment":300},{"nctId":"NCT00317772","phase":"PHASE1, PHASE2","title":"Topotecan and Gefitinib (Iressa) for Ovarian, Peritoneal, or Fallopian Tube Cancer","status":"COMPLETED","sponsor":"M.D. Anderson Cancer Center","startDate":"2004-09-02","conditions":"Ovarian Cancer, Peritoneal Neoplasms, Fallopian Tube Cancer","enrollment":19},{"nctId":"NCT01288430","phase":"PHASE1","title":"A Study of DS-2248 in Participants With Advanced Solid Tumors","status":"TERMINATED","sponsor":"Daiichi Sankyo","startDate":"2011-03-29","conditions":"Solid Tumors, Non-small Cell Lung Carcinoma","enrollment":60},{"nctId":"NCT02736513","phase":"PHASE2","title":"Intracranial Activity of AZD9291 (TAGRISSO) in Advanced EGFRm NSCLC Patients With Asymptomatic Brain Metastases","status":"UNKNOWN","sponsor":"Soroka University Medical Center","startDate":"2016-05","conditions":"Lung Cancer","enrollment":40},{"nctId":"NCT03382795","phase":"PHASE2","title":"Retreatment With Epidermal Growth Factor Receptor(EGFR) Tyrosine Kinase Inhibitor in EGFR Mutation Positive Patients","status":"UNKNOWN","sponsor":"Korea University Guro Hospital","startDate":"2018-01-03","conditions":"EGFR Positive Non-small Cell Lung Cancer","enrollment":63},{"nctId":"NCT02804776","phase":"PHASE2","title":"PRe-Operative Gefitinib in Resectable EGFR Mutation Positive Lung Cancer With Sector Sequencing for Biomarker Discovery","status":"COMPLETED","sponsor":"National Cancer Centre, Singapore","startDate":"2015-01-27","conditions":"Non-small Cell Lung Cancer","enrollment":15},{"nctId":"NCT04874844","phase":"PHASE2, PHASE3","title":"JY025 is a First-line Treatment for EGFR Mutated NSCLC Phase II and III Clinical Trials of Efficacy and Safety","status":"UNKNOWN","sponsor":"Beijing Dongfang Biotech Co., Ltd.","startDate":"2021-07-30","conditions":"NSCLC","enrollment":420},{"nctId":"NCT01610336","phase":"PHASE2","title":"A Safety and Efficacy Study of INC280 and Gefitinib in Patients With EGFR Mutated, c-MET-amplified NSCLC Who Have Progressed After EGFRi Treatment","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2012-04-05","conditions":"Non-small Cell Lung Cancer","enrollment":161},{"nctId":"NCT03595644","phase":"PHASE2","title":"Maintenance Targeted Therapy With or Without Stereotactic Body Radiation Therapy for Stage IV Non-small Cell Lung Cancer","status":"COMPLETED","sponsor":"Tongji Hospital","startDate":"2017-02-12","conditions":"Stage IV Non-small Cell Lung Cancer","enrollment":74},{"nctId":"NCT02025218","phase":"PHASE2","title":"Iressa Re-challenge in Advanced NSCLC EGFR-mutated Patients","status":"TERMINATED","sponsor":"Amsterdam UMC, location VUmc","startDate":"2014-01","conditions":"Lung Cancer","enrollment":21},{"nctId":"NCT02747953","phase":"PHASE2","title":"Gilotrif (Afatinib) in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib","status":"COMPLETED","sponsor":"Samsung Medical Center","startDate":"2011-07","conditions":"Non-small Cell Lung Cancer","enrollment":50},{"nctId":"NCT02893332","phase":"PHASE3","title":"Stereotactic Body Radiation Therapy (SBRT) in Newly Diagnosed Advanced Staged Lung Adenocarcinoma (Sindas)","status":"TERMINATED","sponsor":"Sichuan Provincial People's Hospital","startDate":"2016-01-15","conditions":"Stage IV EGFR Mutated Non-Small Cell Lung Cancer","enrollment":200},{"nctId":"NCT04390984","phase":"PHASE1","title":"Drug-drug Interaction Study of Gefitinb on Apatinib in NSCLC Patients","status":"UNKNOWN","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2020-05-26","conditions":"NSCLC","enrollment":22},{"nctId":"NCT01556191","phase":"PHASE2","title":"Lung Cancer in Women Treated With Anti-oestrogens anD Inhibitors of EGFR","status":"COMPLETED","sponsor":"Intergroupe Francophone de Cancerologie Thoracique","startDate":"2012-05-15","conditions":"Stage IV Lung Cancer","enrollment":379},{"nctId":"NCT02762877","phase":"","title":"Concordance of Key Actionable Genomic Alterations as Assessed in Tumor Tissue and Plasma in Non Small Cell Lung Cancer","status":"TERMINATED","sponsor":"Genomic Health®, Inc.","startDate":"2016-04","conditions":"Non Small Cell Lung Carcinoma","enrollment":140},{"nctId":"NCT02788201","phase":"PHASE2","title":"Genomic Based Assignment of Therapy in Advanced Urothelial Carcinoma","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","startDate":"2017-03-27","conditions":"Urothelial Carcinoma, Bladder Cancer, Urinary Bladder Neoplasms","enrollment":8},{"nctId":"NCT00052208","phase":"PHASE1, PHASE2","title":"Gefitinib and Radiation Therapy in Treating Patients With Glioblastoma Multiforme","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","startDate":"2002-03","conditions":"Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma","enrollment":158},{"nctId":"NCT04575415","phase":"","title":"Bevacizumab Plus EGFR-TKIs in Chinese Patients With EGFR-mutant NSCLC: a Real-world Study","status":"UNKNOWN","sponsor":"Guangdong Association of Clinical Trials","startDate":"2020-10-07","conditions":"NSCLC","enrollment":272},{"nctId":"NCT00553254","phase":"PHASE2","title":"Trial Of PF-00299804 In Patients With Advanced Refractory Lung Cancer","status":"COMPLETED","sponsor":"Pfizer","startDate":"2008-02-05","conditions":"Carcinoma, Non Small Cell Lung","enrollment":55},{"nctId":"NCT01544179","phase":"PHASE3","title":"A Study of IRESSA Treatment Beyond Progression in Addition to Chemotherapy Versus Chemotherapy Alone","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2012-03-15","conditions":"Non-Small Cell Lung Cancer","enrollment":265},{"nctId":"NCT03267654","phase":"PHASE2","title":"Gefitinib With Chemotherapy or Anti-angiogenesis in NSCLC Patients With Bim Deletion or Low EGFR Mutation Abundance","status":"UNKNOWN","sponsor":"Qilu Pharmaceutical Co., Ltd.","startDate":"2017-10-12","conditions":"Non-small-cell Lung Cancer","enrollment":100},{"nctId":"NCT03457337","phase":"PHASE2","title":"S-1 Plus Gefitinib Versus Gefitinib Monotherapy in Patients With EGFR-sensitive Mutation Advanced Non-squamous NSCLC","status":"UNKNOWN","sponsor":"Henan Cancer Hospital","startDate":"2018-03-28","conditions":"Advanced NSCLC With EGFR Mutation","enrollment":200},{"nctId":"NCT04425187","phase":"PHASE2","title":"Bevacizumab Combined With Gefitinib in the Treatment of Advanced NSCLC","status":"UNKNOWN","sponsor":"Fudan University","startDate":"2020-06-08","conditions":"PFS","enrollment":120},{"nctId":"NCT04115410","phase":"","title":"PD-1 Immune Checkpoint Inhibitors and Immune-Related Adverse Events: a Cohort Study","status":"UNKNOWN","sponsor":"Sungkyunkwan University","startDate":"2020-07-01","conditions":"Carcinoma, Non-Small-Cell Lung, Immune-Related Adverse Events","enrollment":4724},{"nctId":"NCT02374645","phase":"PHASE1","title":"A Phase I Study of Safety and Pharmacokinetics of Volitinib in Combination With Gefitinib in EGFR(+) NSCLC","status":"COMPLETED","sponsor":"Hutchison Medipharma Limited","startDate":"2015-04","conditions":"Non-Small Cell Lung Cancer","enrollment":64},{"nctId":"NCT04358562","phase":"PHASE2","title":"Gefitinib With Anlotinib in Advanced Non-squamous NSCLC Patients With Uncleared Plasma ctDNA EGFRm After First-line Treatment With Gefitinib","status":"UNKNOWN","sponsor":"Second Affiliated Hospital of Nanchang University","startDate":"2020-05-01","conditions":"Non-small Cell Lung Cancer, EGFR Gene Mutation","enrollment":240},{"nctId":"NCT01466660","phase":"PHASE2","title":"LUX-Lung 7: A Phase IIb Trial of Afatinib(BIBW2992) Versus Gefitinib for the Treatment of 1st Line EGFR Mutation Positive Adenocarcinoma of the Lung","status":"COMPLETED","sponsor":"Boehringer Ingelheim","startDate":"2011-12-13","conditions":"Lung Neoplasms","enrollment":319},{"nctId":"NCT00025116","phase":"PHASE2","title":"ZD 1839 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy","status":"COMPLETED","sponsor":"NCIC Clinical Trials Group","startDate":"2001-04-24","conditions":"Prostate Cancer","enrollment":40},{"nctId":"NCT03119519","phase":"PHASE2","title":"Local Non-salvage Radiotherapy for Synchronous Oligometastatic Non-small-cell Lung Cancer.","status":"UNKNOWN","sponsor":"Southern Medical University, China","startDate":"2017-12-11","conditions":"Stage IV Non-small Cell Lung Cancer","enrollment":148},{"nctId":"NCT01405079","phase":"PHASE3","title":"Gefitinib Versus Vinorelbine/Platinum as Adjuvant Treatment in Stage II-IIIA(N1-N2) NSCLC With EGFR Mutation","status":"UNKNOWN","sponsor":"Guangdong Association of Clinical Trials","startDate":"2011-09-19","conditions":"Non-small Cell Lung Cancer","enrollment":222},{"nctId":"NCT01933347","phase":"PHASE2","title":"Third-line Treatment of Gefitinib in NSCLC Patients","status":"COMPLETED","sponsor":"Guangdong Association of Clinical Trials","startDate":"2014-04-07","conditions":"Non Small Cell Lung Cancer","enrollment":46},{"nctId":"NCT04239833","phase":"PHASE3","title":"A Study of SH-1028 Tablets Versus Gefitinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer","status":"UNKNOWN","sponsor":"Nanjing Sanhome Pharmaceutical, Co., Ltd.","startDate":"2020-01-31","conditions":"Non-Small Cell Lung Cancer","enrollment":240},{"nctId":"NCT02416739","phase":"PHASE2, PHASE3","title":"Anticancer Activity of Nicotinamide on Lung Cancer","status":"UNKNOWN","sponsor":"Il Yeong Park, Ph.D.","startDate":"2015-03","conditions":"Non-Small-Cell Lung Carcinoma","enrollment":110},{"nctId":"NCT02745691","phase":"","title":"Psychometric Properties of the EORTC QLQ-LC29","status":"COMPLETED","sponsor":"University Hospital Regensburg","startDate":"2016-04-01","conditions":"Lung Cancer","enrollment":523},{"nctId":"NCT04193007","phase":"PHASE2","title":"The Role of Brain Radiotherapy in Patients With Asymptomatic Brain Metastasis in the Era of Targeted Therapy for NSCLC","status":"UNKNOWN","sponsor":"Second Affiliated Hospital of Nanchang University","startDate":"2019-12-01","conditions":"Non Small Cell Lung Cancer, Brain Metastases","enrollment":100},{"nctId":"NCT03529084","phase":"PHASE3","title":"Phase III Study of Nazartinib (EGF816) Versus Erlotinib/Gefitinib in First-line Locally Advanced / Metastatic NSCLC With EGFR Activating Mutations","status":"WITHDRAWN","sponsor":"Novartis Pharmaceuticals","startDate":"2018-07-24","conditions":"Carcinoma, Non-small Cell Lung","enrollment":""},{"nctId":"NCT02976116","phase":"PHASE2","title":"A Phase II Study of Fruquintinib in Combination With Gefitinib in Patients With Advanced Non-small Cell Lung Cancer","status":"COMPLETED","sponsor":"Hutchison Medipharma Limited","startDate":"2016-12","conditions":"NSCLC","enrollment":50},{"nctId":"NCT04028778","phase":"PHASE3","title":"Gefitinib in Combination With Anlotinib or Placebo in Previously Untreated EGFR-mutant NSCLC","status":"UNKNOWN","sponsor":"Sun Yat-sen University","startDate":"2019-04-10","conditions":"Lung Cancer, Nonsmall Cell","enrollment":310},{"nctId":"NCT00014183","phase":"PHASE2","title":"ZD 1839 in Treating Patients With Stage IV or Recurrent Kidney Cancer","status":"COMPLETED","sponsor":"University of Maryland, Baltimore","startDate":"2001-01","conditions":"Kidney Cancer","enrollment":""}],"_emaApprovals":[],"_faersSignals":[{"count":604,"reaction":"MALIGNANT NEOPLASM PROGRESSION"},{"count":485,"reaction":"DRUG RESISTANCE"},{"count":220,"reaction":"ACQUIRED GENE MUTATION"},{"count":170,"reaction":"DIARRHOEA"},{"count":146,"reaction":"DISEASE PROGRESSION"},{"count":141,"reaction":"RASH"},{"count":109,"reaction":"METASTASES TO CENTRAL NERVOUS SYSTEM"},{"count":108,"reaction":"EGFR GENE MUTATION"},{"count":105,"reaction":"DEATH"},{"count":92,"reaction":"NAUSEA"}],"administration":{"route":"Oral"},"crossReferences":{"chemblId":"CHEMBL939"},"_approvalHistory":[],"publicationCount":8303,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"approved","brandName":"GEFITINIB","genericName":"GEFITINIB","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"2003","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T05:13:13.555609+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}