Study of Erlotinib With or Without Investigational Drug (U3-1287) in Subjects With Advanced Non-small Cell Lung Cancer
Summary
This is a Phase 1b/2 study. In Phase 1b, subjects will know the treatment they are receiving. Subjects will receive Erlotinib + U3-1287. The Phase 1b portion will determine if adding U3-1287 to Erlotinib will be safe in subjects with advanced non-small cell lung cancer who fail prior treatment. In the Phase 2 portion, subjects will be blinded to the treatments they are receiving. Subjects will receive either Erlotinib alone or Erlotinib + U3-1287. The Phase 2 portion will determine if adding U3-1287 to Erlotinib will be safe and improve survival in subjects with advanced non-small cell lung cancer who failed the first treatment.
Timeline
- Start
- 2010-09
- Primary completion
- 2013-10
- Completion
- 2013-11-23
Outcome
Mixed primary results
registry Hazard Ratio (HR) 0.978 (95% CI 0.674 to 1.420) NCT01211483 ↗
registry p = 0.0185; Hazard Ratio (HR) 0.369 (95% CI 0.161 to 0.846) NCT01211483 ↗
registry p = 0.9879; Hazard Ratio (HR) 1.006 (95% CI 0.458 to 2.212) NCT01211483 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Patritumab | Monoclonal antibody | 70 mg/ml | Intravenous |
| Background | Erlotinib | Small molecule | 150 mg | Oral |