A Study of the Efficacy and Safety of MetMAb Combined With Tarceva in Patients With Met-Positive Non-Small Cell Lung Cancer

Sponsor
Hoffmann-La Roche
Study ID
NCT02031744
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • erlotinib [Tarceva] — DRUG
    150 mg oral administration once daily
  • Placebo — DRUG
    15 mg/kg intravenous administration every 3 weeks
  • Onartuzumab [MetMAb] — DRUG
    15 mg/kg intravenous administration every 3 weeks

Study Details

This randomized, Phase III, double-blind, placebo-controlled study will evaluate the safety and efficacy of MetMAb (onartuzumab) in combination with Tarceva (erlotinib) compared with treatment with Tarceva alone in patients with incurable Met-positive non-small cell lung cancer (NSCLC). Patients will be randomized in a 2:1 ratio to receive either MetMAb + Tarceva or placebo + Tarceva. Tarceva (150 mg) will be given orally once daily, and MetMAb (15 mg/kg) will be given intravenously every 3 weeks. Treatment will continue until disease progression, unacceptable toxicity, a decision to discontinue, or death occurs. Total study length is expected to be around 36 months.

Key Dates

First listed
Jan 9, 2014
Start date
Jan 22, 2014
Status verified
Mar 2017
Primary completion
Jan 6, 2016
Completion
Jan 6, 2016

Study Design

Enrollment
530 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: erlotinib [Tarceva] + placebo
  • Experimental: erlotinib [Tarceva] + onartuzumab [MetMAb]

Primary Outcome Measure

Overall survival (OS) [ Time Frame: Up to 36 months ]

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