A Phase 2 Randomized Open-label Study of Erlotinib Plus Tivantinib (ARQ 197) Versus Single Agent Chemotherapy in Previously Treated KRAS Mutation Positive Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Status
Active
Cancer Type
Lung Cancer
Trial Phase
Phase II
Eligibility
18 and over, Male and Female
Study Type
Treatment
NCD ID
NCT01395758
Protocol IDs
ARQ 197-218 (primary)
Study Sponsor
ArQule, Incorporated

Summary

The purpose of this study is to evaluate progression-free survival among subjects with KRAS mutation positive Non-Small Cell Lung Cancer (NSCLC) treated with erlotinib plus tivantinib (ARQ 197) compared to single agent chemotherapy.

Objectives

This is a randomized, open-label Phase 2 study designed to compare treatment with erlotinib plus tivantinib (ARQ 197) versus single agent chemotherapy in subjects with previously treated KRAS mutation positive NSCLC. Eligible subjects are randomly assigned to receive erlotinib plus tivantinib or one of three (based on Investigator's decision) single-agent chemotherapy agents including pemetrexed, docetaxel, or gemcitabine.