drugset / Trial / NCT00527735
Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC)
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of the study is to determine whether ipilimumab given with paclitaxel/carboplatin has clinical benefit when compared with paclitaxel/carboplatin alone in patients with previously untreated lung cancer.
Timeline
- Start
- 2008-02
- Primary completion
- 2009-10
- Completion
- 2011-12
Outcome
Mixed primary results
registry p = 0.1302; Hazard Ratio (HR) 0.806 (95% CI 0.553 to 1.174); 1-sided log rank NCT00527735 ↗
registry p = 0.0473; Hazard Ratio (HR) 0.724 (95% CI 0.495 to 1.059); 1-sided log rank NCT00527735 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Background | Carboplatin | Small molecule | 6 unknown | Intravenous |
| Background | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |