Adults 18 to 130, any sex, with Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-Free Survival (Site Read, Investigator Assessment)Primary· Radiologic evaluations were carried out every 6 weeks from randomization until documented progression, withdrawal of consent, loss to follow up, death or the primary data cut off (DCO) for the analysis, assessed up to 50 weeks
PFS is the time from randomisation until the date of objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) or death (by any cause in the absence of progression). Progression is defined using RECIST (v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.
Group
Value
95% CI
Gefitinib
98
4.5 – 5.7
Placebo
107
4.6 – 5.5
Median Progression-Free Survival (Site Read, Investigator Assessment)Primary· Radiologic evaluations were carried out every 6 weeks from randomization until documented progression, withdrawal of consent, loss to follow up, death or the primary data cut off (DCO) for the analysis, assessed up to 50 weeks
PFS is the time from randomisation until the date of objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) or death (by any cause in the absence of progression). Progression is defined using RECIST (v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.
Group
Value
95% CI
Gefitinib
5.4
4.5 – 5.7
Placebo
5.4
4.6 – 5.5
Overall Survival (OS)Secondary· Following progression survival data was collected every 8 weeks until documentation of death, withdrawal of consent, loss to follow-up or the final data cut-off, whichever occurs first.
OS is the time from the date of randomisation until death due to any cause. Any subject not known to have died at the time of analysis will be censored based on the last recorded date on which the subject was known to be alive.
Group
Value
95% CI
Gefitinib
50
10.4 – 19.0
Placebo
37
15.6 – NA
Median Overall Survival (OS) at Time of PFS AnalysisSecondary· Baseline and then every 6 weeks after randomization until objective disease progression. OS is then assessed 8 weekly following PFS progression up to PFS analysis data cut off.
Group
Value
95% CI
Gefitinib
14.8
10.4 – 19.0
Placebo
17.2
15.6 – NA
Objective Response Rate (ORR) (Site Read Data)Secondary· Radiologic evaluations were carried out every 6 weeks from randomization until documented progression, withdrawal of consent, loss to follow up, death or the primary data cut off (DCO) for the analysis.
ORR rate is defined as the number (%) of subjects with at least one visit response of Complete Response (CR) or Partial Response (PR) , as defined by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions and assessed by CT or MRI. CR, Disappearance of all target lesions; PR, ≥30% decrease in the sum of the longest diameter of target lesions. Data obtained up until progression, or last evaluable assessment in the absence of progression, was included in the assessment of ORR.
Group
Value
95% CI
Gefitinib
31.6
0.55 – 1.55
Placebo
34.1
0.55 – 1.55
Disease Control Rate (DCR)Secondary· Radiologic evaluations were carried out every 6 weeks from randomization until documented progression, withdrawal of consent, loss to follow up, death or the primary data cut off (DCO) for the analysis.
DCR is the percentage of patients who achieve disease control at 6 weeks following randomisation. DCR is defined as a Best Objective Response (BOR) of Complete Response, Partial Response or Stable Disease, as defined by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions and assessed by CT or MRI. CR, Disappearance of all target lesions; PR, ≥30% decrease in the sum of the longest diameter of target lesions; SD, neither sufficient shrinkage to qualify for PR not sufficient increase to qualify for Progressive Disease (PD); PD, ≥20% increase in the sum of diameters of
Group
Value
95% CI
Gefitinib
84.2
0.74 – 2.62
Placebo
78.8
0.74 – 2.62
Improvement in Trial Outcome IndexSecondary· At visits 2-8, then every 6 weeks until progression, at progression or treatment discontinuation, and every 8 weeks after progression until PFS analysis data cut off.
An improvement is defined as a change from baseline of ≥ +6 (0-84 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire.
Group
Value
95% CI
Gefitinib
36
0.74 – 2.62
Placebo
39
0.74 – 2.62
Time to Worsening in Trial Outcome IndexSecondary· At visits 2-8, then every 6 weeks until progression, at progression or treatment discontinuation, and every 8 weeks after progression until PFS analysis data cut off.
A worsening is defined as a change from baseline of ≤ -6 (0-84 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire
Group
Value
95% CI
Gefitinib
12.1
8.7 – 18.1
Placebo
9.4
7.7 – 13.4
Improvement in FACT-L Total ScoreSecondary· At visits 2-8, then every 6 weeks until progression, at progression or treatment discontinuation, and every 8 weeks after progression until PFS analysis data cut off.
An improvement is defined as a change from baseline of ≥ +6 (0-136 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire
Group
Value
95% CI
Gefitinib
44
0.74 – 2.62
Placebo
49
0.74 – 2.62
Time to Worsening in FACT-L Total ScoreSecondary· At visits 2-8, then every 6 weeks until progression, at progression or treatment discontinuation, and every 8 weeks after progression until PFS analysis data cut off.
A worsening is defined as a change from baseline of ≤ -6 (0-136 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire
Group
Value
95% CI
Gefitinib
12.0
6.0 – 15.0
Placebo
8.9
6.0 – 9.9
Improvement in Lung Cancer SubscaleSecondary· At visits 2-8, then every 6 weeks until progression, at progression or treatment discontinuation, and every 8 weeks after progression until PFS analysis data cut off.
An improvement is defined as a change from baseline of ≥ +2 (0-28 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire
Group
Value
95% CI
Gefitinib
54
Placebo
55
Time to Worsening in Lung Cancer SubscaleSecondary· At visits 2-8, then every 6 weeks until progression, at progression or treatment discontinuation, and every 8 weeks after progression until PFS analysis data cut off.
A worsening is defined as a change from baseline of ≤ -2 (0-28 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire
Group
Value
95% CI
Gefitinib
14.6
9.1 – 24.3
Placebo
9.1
6.1 – 23.9
Adverse events — posted to ClinicalTrials.gov
Time frame: AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Gefitinib 250 mg
Serious: 38/132 (29%)
Deaths: —
Placebo
Serious: 28/132 (21%)
Deaths: —
Serious adverse events (65 terms)
Reaction
System
Gefitinib 250 mg
Placebo
Pneumonia
Infections and infestations
—
—
Dyspnoea
Respiratory, thoracic and mediastinal disorders
—
—
Respiratory failure
Respiratory, thoracic and mediastinal disorders
—
—
Anaemia
Blood and lymphatic system disorders
—
—
Diarrhoea
Gastrointestinal disorders
—
—
Nausea
Gastrointestinal disorders
—
—
Pyrexia
General disorders
—
—
Cellulitis
Infections and infestations
—
—
Urinary tract infection
Infections and infestations
—
—
Hypokalaemia
Metabolism and nutrition disorders
—
—
Back pain
Musculoskeletal and connective tissue disorders
—
—
Cognitive disorder
Nervous system disorders
—
—
Pleural effusion
Respiratory, thoracic and mediastinal disorders
—
—
Bone marrow failure
Blood and lymphatic system disorders
—
—
Febrile bone marrow aplasia
Blood and lymphatic system disorders
—
—
Cardiac failure
Cardiac disorders
—
—
Myocardial infarction
Cardiac disorders
—
—
Pericardial effusion
Cardiac disorders
—
—
Wolff-Parkinson-White syndrome
Cardiac disorders
—
—
Inappropriate antidiuretic hormone secretion
Endocrine disorders
—
—
Abdominal discomfort
Gastrointestinal disorders
—
—
Abdominal pain upper
Gastrointestinal disorders
—
—
Dysphagia
Gastrointestinal disorders
—
—
Enteritis
Gastrointestinal disorders
—
—
Gastric perforation
Gastrointestinal disorders
—
—
Other adverse events (327 terms — click to expand)
The purpose of this study is to assess the efficacy and safety of gefitinib in patients who have progressed on first line gefitinib, comparing continuing gefitinib in addition to cisplatin plus pemetrexed combination chemotherapy versus cisplatin plus pemetrexed combination chemotherapy alone.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03866499 — A Study of BPI-7711 Capsule in Non-small Cell Lung Cancer Patients
· Phase 3
· active not recruiting
NCT04425187 — Bevacizumab Combined With Gefitinib in the Treatment of Advanced NSCLC
· Phase 2
· unknown
NCT04358562 — Gefitinib With Anlotinib in Advanced Non-squamous NSCLC Patients With Uncleared Plasma ctDNA EGFRm After First-line Trea
· Phase 2
· unknown
NCT04239833 — A Study of SH-1028 Tablets Versus Gefitinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
· Phase 3
· unknown
NCT04143607 — ASK120067 Versus Gefitinib as First-line Treatment for EGFRm Locally Advanced or Metastatic NSCLC
· Phase 3
· active not recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 25 September 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01544179.