drugset / Trial / NCT01211483

Study of Erlotinib With or Without Investigational Drug (U3-1287) in Subjects With Advanced Non-small Cell Lung Cancer

NCT01211483

Phase 1/2 Completed 222 enrolled Daiichi Sankyo
RandomizedParallel-groupQuadruple-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Patritumab Monoclonal antibody 70 mg/ml Intravenous
Background Erlotinib Small molecule 150 mg Oral