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An Open-label, Multicentre, Randomised Phase II Study of Pazopanib in Combination With Pemetrexed in First-line Treatment of Subjects With Predominantly Non-squamous Cell Stage IIIBwet/IV Non-small Cell Lung Cancer
The main purpose of this study is to determine whether the combination of pazopanib and pemetrexed is safe and effective in the treatment of advanced non-small cell lung cancer (NSCLC).
Details
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 107 |
| Start date | 2009-07 |
| Completion | 2011-03 |
Conditions
- Lung Cancer, Non-Small Cell
Interventions
- pazopanib and pemetrexed
- pemetrexed and cisplatin
Primary outcomes
- Progression-free Survival (PFS) — Randomization until progression or death (up to 85 weeks)
PFS is defined as the interval between the date of randomization (date on which the investigator evaluated the participant and first determined he/she had disease progression) and the first occurrence of progressive disease (PD) or death from any cause. Per Response Evaluation Criteria in Solid Tumors (RECIST), version 1, PD is defined as a \>=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of \>=1 new lesion).
Countries
Denmark, United Kingdom