drugset / Trial / NCT00409006
Chemotherapy for Patients With Non-Small Cell Lung Cancer Who Are Non-Smokers
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Subject | Gefitinib | Small molecule | 250 mg | Oral |
| Subject | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |