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A Randomized Phase 2, Double-blind, Placebo-controlled, Multi-center Study Comparing Pemetrexed in Combination With TH-302 vs. Pemetrexed in Combination With Placebo as Second-line Chemotherapy for Advanced Non-Squamous, Non-Small Cell Lung Cancer
The purpose of this study is to determine whether TH-302 in combination with pemetrexed is safe and effective in the treatment of non-squamous non-small cell lung cancer.
Details
| Lead sponsor | ImmunoGenesis |
|---|---|
| Phase | Phase 2 |
| Status | TERMINATED |
| Enrolment | 265 |
| Start date | 2014-06 |
| Completion | 2016-05 |
Conditions
- Non-small Cell Lung Cancer
Interventions
- TH-302 combination with pemetrexed
- Matched placebo in combination with pemetrexed
Primary outcomes
- Overall Survival — 2 years
To assess the efficacy of pemetrexed in combination with TH-302 as determined by overall survival in patients with advanced non-squamous NSCLC in the second-line chemotherapy setting compared with pemetrexed in combination with placebo
Countries
United States, Czechia, Germany, Greece, Hungary, Italy, Poland, Romania, Russia, Spain