Tivantinib Plus Erlotinib Versus Placebo Plus Erlotinib for the Treatment of Non-squamous, Non-small-cell Lung Cancer

Conditions

• Non Squamous, Non-small-cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Tivantinib — DRUG
  Tivantinib 720 mg daily as 3 x 120 mg oral tablets given twice a day
• Placebo — DRUG
  Tivantinib Placebo tablets given twice a day
• Erlotinib — DRUG
  Erlotinib 150 mg oral tablets, given once a day

Study Details

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.

Key Dates

First listed

Nov 19, 2010

Start date

Jan 11, 2011

Status verified

Mar 2021

Primary completion

Dec 15, 2012

Completion

Dec 15, 2012

Study Design

Enrollment

1,048 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Tivantinib and erlotinib
  Tivantinib 720 mg daily (360 mg twice a day) in combination with 150 mg of erlotinib, given once a day
• Active Comparator: Placebo and erlotinib
  Tivantinib placebo given twice a day in combination with 150 mg of erlotinib, given once a day

Primary Outcome Measure

Overall Survival Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer [ Time Frame: Date of randomization up to date of death, up to approximately 1 year 11 months postdose ]

Locations (111)