Study identifier:D791LC00001
ClinicalTrials.gov identifier:NCT01544179
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase III Randomised, Double blind, Placebo controlled, Parallel, Multicentre Study to Assess the Efficacy and Safety of continuing IRESSA 250 mg in addition to Chemotherapy versus Chemotherapy alone in Patients who have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) and have progressed on First Line IRESSA
Non-small Cell Lung Cancer
Phase 3
No
Gefitinib, Placebo, Pemetrexed, Cisplatin
All
265
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Dec 2019 by AstraZeneca
AstraZeneca
-
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.
A Phase III Randomised, Double blind, Placebo controlled, Parallel, Multicentre Study to Assess the Efficacy and Safety of continuing IRESSA 250 mg in addition to Chemotherapy versus Chemotherapy alone in Patients who have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) and have progressed on First Line IRESSA.
Location
Location
Shanghai, China, 200030
Location
Beijing, China, 100021
Location
Shanghai, China, 200032
Location
Guangzhou, China, 510000
Location
Hangzhou, China, 310003
Location
Beijing, China, 100730
Location
Beijing, China, 100853
Location
nanjing, China, 210002
Arms | Assigned Interventions |
---|---|
Experimental: Gefitinib Gefitinib and cisplatin plus pemetrexed combination chemotherapy | Drug: Gefitinib Investigational Drug Drug: Pemetrexed Chemotherapy (concomitant therapy) Drug: Cisplatin Chemotherapy (concomitant therapy) |
Placebo Comparator: Placebo Placebo and cisplatin plus pemetrexed combination chemotherapy. | Drug: Placebo Matching placebo as comparator Drug: Pemetrexed Chemotherapy (concomitant therapy) Drug: Cisplatin Chemotherapy (concomitant therapy) |
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