A Study Comparing of Two Different Chemotherapy Regimens, in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
Summary
This is a multicenter, open-label, randomized, two-arm Phase 2 study comparing pemetrexed plus best supportive care with best supportive care alone as maintenance therapy following first-line treatment with a pemetrexed-cisplatin combination in patients with advanced non-squamous non-small cell lung cancer. A total of approximately 100 patients are planned to be enrolled, and following completion of four cycles of pemetrexed-cisplatin (Induction Phase) those patients in which disease progression has not occurred will be randomized in a 2:1 ratio to one of two treatment arms (Maintenance Phase): Arm A (pemetrexed plus best supportive care) or Arm B (best supportive care alone).
Timeline
- Start
- 2008-01
- Primary completion
- 2010-12
- Completion
- 2010-12
Outcome
Met primary endpoint
registry Pemetrexed Plus Best Supportive Care (Maintenance Phase) vs Best Supportive Care (Maintenance Phase); p = 0.1815; Hazard Ratio (HR) 0.76 NCT00606021 ↗
paper the one-sided p-value for the PFS HR comparison was less than the prespecified limit of 0.2 PMID 23006447 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |