Conditions: Metastatic Non-Small Cell Lung Cancer
Keywords: KRAS mutation metastatic NSCLC
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 96
Healthy volunteers: no

Brief 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.

Detailed description:
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 choice) single-agent chemotherapy agents including pemetrexed, docetaxel, or gemcitabine.

Arms:
arm 1: Eligible subjects will be randomly assigned to receive erlotinib plus tivantinib (ARQ 197).

Treatment will be open-label and continue until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. arm 2: Investigator's choice of single agent chemotherapy (pemetrexed, docetaxel, or gemcitabine) administered in 3-week cycles according to the approved label until disease progression or unacceptable toxicity. Subjects who discontinued chemotherapy can be switched to the crossover arm (tivantinib plus erlotinib) and continue treatment until disease progression or unacceptable toxicity.

Interventions: intervention 1: ARQ 197 plus erlotinib intervention 2: Pemetrexed, docetaxel or gemcitabine
Intervention descriptions: intervention 1: Eligible subjects will be randomly assigned to receive erlotinib plus ARQ 197. intervention 2: Investigator's choice of a single agent chemotherapy (pemetrexed, docetaxel, or gemcitabine) administered according to the approved label.

Protocol document: