drugset / Trial / NCT00777309

A Randomized Phase 2 Study of Erlotinib + ARQ 197 Versus Erlotinib + Placebo in Previously Treated Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

NCT00777309

Phase 2 Completed 167 enrolled ArQule, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a randomized, placebo-controlled, double blind phase 2 study designed to compare treatment with ARQ 197 plus erlotinib to erlotinib plus placebo in patients with non-small cell lung cancer. The study will enroll patients who have had one prior chemotherapy regimen (other than erlotinib) for NSCLC.

Timeline

Start
2008-09
Primary completion
2011-05
Completion
2011-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Tivantinib Small molecule 360 mg
Background Erlotinib Small molecule 150 mg