drugset / Trial / NCT00257608

A Study Comparing Bevacizumab Therapy With or Without Erlotinib for First-Line Treatment of Non-Small Cell Lung Cancer (ATLAS)

NCT00257608 ↗

Phase 3 Completed 1145 enrolled Genentech, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a Phase IIIb, multicenter, randomized, placebo-controlled trial to evaluate the safety and efficacy of chemotherapy+bevacizumab followed by bevacizumab+erlotinib versus bevacizumab+erlotinib placebo in subjects with locally advanced or metastatic NSCLC.

Timeline

Start
2006-01
Primary completion
2014-11
Completion
2014-11

Outcome

Met primary endpoint

paper 3.7 months with bevacizumab/placebo and 4.8 months with bevacizumab/erlotinib (hazard ratio [HR], 0.71; 95% CI, 0.58 to 0.86; P < .001). PMID 24101054 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Erlotinib Small molecule 150 mg Oral
Background Bevacizumab Monoclonal antibody 15 mg/kg Intravenous