{"id":"placebo-gefitinib","safety":{"commonSideEffects":[]},"_chembl":{"chemblId":"CHEMBL939","moleculeType":"Small molecule","molecularWeight":"446.91"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Placebo Gefitinib refers to an inactive control formulation used in clinical trials to compare against active gefitinib treatment. It contains no active pharmaceutical ingredient and produces no pharmacological effect. The placebo arm allows researchers to isolate the true efficacy of gefitinib by controlling for patient expectation and natural disease progression.","oneSentence":"This is a placebo control arm, not an active drug, and contains no therapeutic mechanism.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:27:31.093Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Control arm in gefitinib clinical trials (Phase 3)"}]},"trialDetails":[{"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":"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":"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":"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":"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":"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":"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":"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":"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":"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":"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":"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":"NCT02889692","phase":"PHASE3","title":"Clinical Study of Chinese Medicine Plus Targeted Therapy Maintenance in Advanced Pulmonary Adenocarcinoma","status":"COMPLETED","sponsor":"Shanghai University of Traditional Chinese Medicine","startDate":"2013-03","conditions":"Cancer","enrollment":23},{"nctId":"NCT02929693","phase":"PHASE3","title":"Clinical Study of YYJD Decoction Combined With Gefitinib in Advanced Pulmonary Adenocarcinoma","status":"UNKNOWN","sponsor":"Shanghai University of Traditional Chinese Medicine","startDate":"2016-10","conditions":"Cancer","enrollment":198},{"nctId":"NCT03856697","phase":"PHASE3","title":"Abivertinib Maleate Versus Geifitinib in Patients With Advanced Non-small Cell Lung Cancer With Sensitive EGFR Mutation","status":"UNKNOWN","sponsor":"Hangzhou ACEA Pharmaceutical Research Co., Ltd.","startDate":"2019-03","conditions":"Advanced Non-small Cell Lung Cancer","enrollment":406},{"nctId":"NCT00683306","phase":"","title":"Open Label Extension Study With Gefitinib (IRESSA™) for Completing Trial Patients Who May Benefit From Further Treatment","status":"APPROVED_FOR_MARKETING","sponsor":"AstraZeneca","startDate":"","conditions":"Non Small Cell Lung Cancer (NSCLC)","enrollment":""},{"nctId":"NCT01864681","phase":"PHASE2","title":"Combination of Metformin With Gefitinib to Treat NSCLC","status":"COMPLETED","sponsor":"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University","startDate":"2013-05","conditions":"NSCLC, EGFR Gene Amplification, Advanced Cancer","enrollment":224},{"nctId":"NCT01310855","phase":"PHASE2","title":"Cediranib Maleate With or Without Gefitinib in Treating Patients With Recurrent or Progressive Glioblastoma","status":"TERMINATED","sponsor":"University College, London","startDate":"2011-05","conditions":"Glioblastoma","enrollment":38},{"nctId":"NCT01256437","phase":"PHASE2","title":"Evaluating Preventive Therapy With Oint Threolone, Synthomycine or Aqua Cream, for EGFR'I Induced Acneiform Rash","status":"COMPLETED","sponsor":"Rabin Medical Center","startDate":"2011-01","conditions":"Acneiform Rash","enrollment":90},{"nctId":"NCT00091247","phase":"NA","title":"Tetracycline in Preventing Skin Rash in Patients Who Are Receiving Drugs Such as Gefitinib and Cetuximab for Cancer","status":"COMPLETED","sponsor":"Alliance for Clinical Trials in Oncology","startDate":"2004-12","conditions":"Unspecified Adult Solid Tumor, Protocol Specific","enrollment":130},{"nctId":"NCT00059722","phase":"PHASE2","title":"This Study is to Compare the Efficacy of ZD6474 and ZD1839 in Subjects With NSCLC.","status":"COMPLETED","sponsor":"Genzyme, a Sanofi Company","startDate":"2003-05","conditions":"Carcinoma, Non-Small-Cell Lung","enrollment":160},{"nctId":"NCT00656136","phase":"PHASE3","title":"BIBW 2992 and BSC Versus Placebo and BSC in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib (LUX-LUNG 1)","status":"COMPLETED","sponsor":"Boehringer Ingelheim","startDate":"2008-04","conditions":"Carcinoma, Non-Small-Cell Lung","enrollment":585},{"nctId":"NCT01745302","phase":"","title":"Efficacy Study of Chinese Medicine Plus EGFR-TKI Versus EGFR-TKI in Advanced Pulmonary Adenocarcinoma","status":"UNKNOWN","sponsor":"Shanghai University of Traditional Chinese Medicine","startDate":"2011-11","conditions":"Cancer","enrollment":470},{"nctId":"NCT02824458","phase":"PHASE3","title":"A Study of Gefitinib With or Without Apatinib in Patients With Advanced Non-squamous Non-Small-Cell Lung Cancer Harboring EGFR Mutations","status":"UNKNOWN","sponsor":"Sun Yat-sen University","startDate":"2016-06","conditions":"EGFR Tyrosine Kinase Inhibitors Plus VEGFR Inhibitors","enrollment":246},{"nctId":"NCT00259064","phase":"PHASE2, PHASE3","title":"Iressa v BSC (Best Supportive Care) in First Line NSCLC","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2004-09","conditions":"NSCLC","enrollment":216},{"nctId":"NCT00770588","phase":"PHASE4","title":"Assess the Efficacy, Safety and Tolerability of Gefitinib (Iressa® 250mg) as Maintenance Therapy in Locally Advanced or Metastatic (Stage IIIB/IV) Non Small Cell Lung Cancer (NSCLC)","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2008-09","conditions":"Non-small Cell Lung Cancer (NSCLC)","enrollment":296},{"nctId":"NCT00229697","phase":"PHASE2","title":"Phase II Metastatic ER+/PgR+ Nolvadex +/- Iressa Study","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2003-10","conditions":"Breast Neoplasms","enrollment":317},{"nctId":"NCT00088907","phase":"PHASE3","title":"Phase III Trial Of Docetaxel Versus Docetaxel Plus ZD1839 In Head And Neck Cancer","status":"TERMINATED","sponsor":"National Cancer Institute (NCI)","startDate":"2004-08","conditions":"Recurrent Head and Neck Cancer, Metastatic Head and Neck Cancer","enrollment":270},{"nctId":"NCT02387086","phase":"PHASE2, PHASE3","title":"Gefitinib Combined With Thalidomide to Treat NSCLC","status":"UNKNOWN","sponsor":"Bai Jun","startDate":"2015-05","conditions":"NSCLC","enrollment":380},{"nctId":"NCT02350361","phase":"PHASE2, PHASE3","title":"Endostar Combination With Chemotherapy and EGFR-TKI in Lung Cancer Rechallenging Treatment After Acquired Resistance.","status":"UNKNOWN","sponsor":"Peking University Third Hospital","startDate":"2014-01","conditions":"Lung Cancer","enrollment":60},{"nctId":"NCT00049543","phase":"PHASE3","title":"Gefitinib in Treating Patients With Stage IB, II, or IIIA Non-small Cell Lung Cancer That Was Completely Removed by Surgery","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","startDate":"2002-09","conditions":"Adenocarcinoma of the Lung, Adenosquamous Cell Lung Cancer, Bronchoalveolar Cell Lung Cancer","enrollment":503},{"nctId":"NCT00077025","phase":"PHASE2","title":"Comparing Anastrozole-Placebo to the Combination Anastrozole-ZD1839 in Postmenopausal Patients With Estrogen Receptor and/or Progesterone Receptor Metastatic Breast Cancer","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2004-01","conditions":"Breast Cancer","enrollment":174},{"nctId":"NCT00006049","phase":"PHASE3","title":"ZD 1839 Plus Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer","status":"UNKNOWN","sponsor":"AstraZeneca","startDate":"2000-05","conditions":"Lung Cancer","enrollment":""},{"nctId":"NCT00006048","phase":"PHASE3","title":"ZD 1839 Plus Combination Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer","status":"UNKNOWN","sponsor":"AstraZeneca","startDate":"2000-05","conditions":"Lung Cancer","enrollment":""},{"nctId":"NCT00066378","phase":"PHASE2","title":"Anastrozole With or Without Gefitinib in Treating Postmenopausal Women With Metastatic or Locally Recurrent Breast Cancer","status":"COMPLETED","sponsor":"European Organisation for Research and Treatment of Cancer - EORTC","startDate":"2003-05","conditions":"Breast Cancer","enrollment":71},{"nctId":"NCT00020709","phase":"PHASE3","title":"Combination Chemotherapy and Radiation Therapy With or Without Gefitinib in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","startDate":"2001-06","conditions":"Adenocarcinoma of the Lung, Bronchoalveolar Cell Lung Cancer, Large Cell Lung Cancer","enrollment":840},{"nctId":"NCT00090675","phase":"PHASE3","title":"Maintenance ZD1839 (IRESSA®) Following Completion of Front Line, Platinum-Based, Double Chemotherapy in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer","status":"WITHDRAWN","sponsor":"AstraZeneca","startDate":"2006-01","conditions":"Non-Small-Cell Lung Carcinoma","enrollment":""},{"nctId":"NCT01243398","phase":"PHASE3","title":"Gefitinib in Treating Patients With Esophageal Cancer That is Progressing After Chemotherapy","status":"COMPLETED","sponsor":"University of Oxford","startDate":"2009-03","conditions":"Adenocarcinoma of the Gastroesophageal Junction, Esophageal Cancer","enrollment":450},{"nctId":"NCT01502202","phase":"PHASE2","title":"Intercalated Administration of PamCis With Gefitinib or Placebo as First Line Lung Adenocarcinoma in Never Smokers","status":"UNKNOWN","sponsor":"National Cancer Center, Korea","startDate":"2012-03","conditions":"Non Small Cell Lung Cancer, Adenocarcinoma","enrollment":162},{"nctId":"NCT00234468","phase":"PHASE3","title":"Iressa vs Placebo as Maintenance Therapy in Locally Advanced NSCLC","status":"TERMINATED","sponsor":"AstraZeneca","startDate":"2004-01","conditions":"Non Small Cell Lung Carcinoma","enrollment":490},{"nctId":"NCT00239343","phase":"PHASE2","title":"Phase II Trial of Preoperative Therapy With Gefitinib and Chemotherapy in Patients With ERneg Breast Cancer","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2004-10","conditions":"Breast Cancer","enrollment":160},{"nctId":"NCT00319787","phase":"PHASE2","title":"Combination Casodex® and Iressa™ in Locally Advanced Prostate Cancer","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2003-12","conditions":"Locally Advanced Prostate Cancer","enrollment":102},{"nctId":"NCT00080743","phase":"PHASE2","title":"Gefitinib With or Without Tamoxifen in Treating Patients With Tamoxifen-Resistant Metastatic Breast Cancer","status":"COMPLETED","sponsor":"Dartmouth-Hitchcock Medical Center","startDate":"2004-01","conditions":"Breast Cancer","enrollment":2},{"nctId":"NCT00229723","phase":"PHASE2","title":"IRESSA™ (Gefitinib) With Cisplatin Plus Radiotherapy for the Treatment of Previously Untreated Unresected Late Stage III/IV Non-Metastatic Head and Neck Squamous Cell Carcinoma","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2004-11","conditions":"Neoplasms, Squamous Cell","enrollment":224},{"nctId":"NCT00242801","phase":"PHASE3","title":"Iressa vs Best Supportive Care - 2nd/3rd Line Survival Study","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2003-07","conditions":"NSCLC","enrollment":1692},{"nctId":"NCT00255463","phase":"PHASE2","title":"Phase II Neoadjuvant ER+/PgR + Arimidex +/- Iressa Study","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2004-01","conditions":"Breast Cancer","enrollment":185},{"nctId":"NCT00247481","phase":"PHASE2","title":"ZD1839 (Iressa™) In Combination With Docetaxel As First-Line Treatment In Patients With Metastatic Breast Cancer","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2002-09","conditions":"Breast Cancer","enrollment":77},{"nctId":"NCT00234429","phase":"PHASE2, PHASE3","title":"A Phase 2 Study of Tomudex & Iressa as Second Line Chemotherapy in Subjects With Colorectal Carcinoma","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2003-11","conditions":"Colorectal Cancer","enrollment":74},{"nctId":"NCT00319618","phase":"PHASE2","title":"Combination Weekly Taxotere™ With Iressa™ /Placebo in Metastatic Breast Cancer","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2003-06","conditions":"Metastatic Breast Cancer","enrollment":66}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Gefitinib (Iressa)"],"phase":"phase_3","status":"active","brandName":"Placebo Gefitinib","genericName":"Placebo Gefitinib","companyName":"Nanjing Sanhome Pharmaceutical, Co., Ltd.","companyId":"nanjing-sanhome-pharmaceutical-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This is a placebo control arm, not an active drug, and contains no therapeutic mechanism. Used for Control arm in gefitinib clinical trials (Phase 3).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":true,"score":3}}