A Study of Onartuzumab (MetMAb) in Combination With Tarceva (Erlotinib) in Participants With Met Diagnostic-Positive Non-Small Cell Lung Cancer Who Have Received Chemotherapy For Advanced or Metastatic Disease (MetLung)

Conditions

• Non-Squamous Non-Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Erlotinib — DRUG
  Participants will receive erlotinib 150 mg tablet orally once daily from Day 1, Cycle 1.
• Onartuzumab (MetMab) — DRUG
  Participants will receive onartuzumab 15 mg/kg IV infusion on Day 1 of every 3-week cycle.
• Placebo — DRUG
  Participants will receive onartuzumab matching placebo on Day 1 of every 3-week cycle.

Study Details

This randomized, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with Tarceva (erlotinib) in participants with incurable non-small cell lung cancer identified to be Met diagnostic-positive. Participants will be randomized to receive either onartuzumab (MetMAb) or placebo in combination with erlotinib. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Key Dates

First listed

Oct 20, 2011

Start date

Jan 31, 2012

Status verified

Nov 2016

Primary completion

Jan 31, 2016

Completion

Jan 31, 2016

Study Design

Enrollment

494 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Onartuzumab+Erlotinib
  Participants will receive onartuzumab 15 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 of every cycle of 3 weeks along with erlotinib 150 mg tablet orally once daily (QD) from Day 1, Cycle 1 until there is evidence of disease progression, death, or unacceptable toxicity, whichever occurred first.
• Placebo Comparator: Placebo+Erlotinib
  Participants will receive onartuzumab matching placebo on Day 1 of every cycle of 3 weeks along with erlotinib 150 mg tablet orally QD from Day 1, Cycle 1 until there is evidence of disease progression, death, or unacceptable toxicity, whichever occurred first.

Primary Outcome Measure

Overall Survival [ Time Frame: Randomization until death (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice) ]

Locations (56)

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