Conditions: Non-Small Cell Lung Cancer
Keywords: Non Small Cell Lung Cancer Gefitinib Pemetrexed Treatment Beyond Progression
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 265
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Gefitinib and cisplatin plus pemetrexed combination chemotherapy arm 2: Placebo and cisplatin plus pemetrexed combination chemotherapy.

Interventions: intervention 1: Gefitinib intervention 2: Placebo intervention 3: Pemetrexed intervention 4: Cisplatin
Intervention descriptions: intervention 1: Investigational Drug intervention 2: Matching placebo as comparator intervention 3: Chemotherapy (concomitant therapy) intervention 4: Chemotherapy (concomitant therapy)

Protocol document: