drugset / Trial / NCT00409006

Chemotherapy for Patients With Non-Small Cell Lung Cancer Who Are Non-Smokers

NCT00409006 ↗

Phase 2 Completed 70 enrolled Eli Lilly and Company
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the efficacy and safety of chemotherapy followed sequentially by gefitinib versus chemotherapy alone in the first line treatment of non-small cell lung cancer (NSCLC). This study will be conducted in Asian patients who are classified as 'never smoker' since it is suggested that these patients are more likely to respond favorably to treatment with gefitinib.

Timeline

Start
2007-02
Primary completion
2009-08
Completion
2010-05

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Pemetrexed/Cisplatin/Gefitinib vs Pemetrexed/Cisplatin; p = 0.0618; Log Rank NCT00409006 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 75 mg/m2 Intravenous
Subject Gefitinib Small molecule 250 mg Oral
Subject Pemetrexed Small molecule 500 mg/m2 Intravenous