Conditions: Non Squamous, Non-small-cell Lung Cancer
Keywords: Non squamous, non-small-cell lung cancer Epidermal growth factor receptor c-Met inhibitor
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1048
Healthy volunteers: no

Brief summary:
This study is to determine if the combination regimen of tivantinib with erlotinib will improve overall survival relative to erlotinib alone in subjects with locally advanced or metastatic non-squamous, non-small cell lung cancer who have received 1 or 2 prior systemic anti-cancer therapies.

Detailed description:

Arms:
arm 1: Tivantinib 720 mg daily (360 mg twice a day) in combination with 150 mg of erlotinib, given once a day arm 2: Tivantinib placebo given twice a day in combination with 150 mg of erlotinib, given once a day

Interventions: intervention 1: Tivantinib intervention 2: Placebo intervention 3: Erlotinib
Intervention descriptions: intervention 1: Tivantinib 720 mg daily as 3 x 120 mg oral tablets given twice a day intervention 2: Tivantinib Placebo tablets given twice a day intervention 3: Erlotinib 150 mg oral tablets, given once a day

Protocol document: