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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)

NCT01456325 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 494

Last updated 2016-11-02

No results posted yet for this study

Summary

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.

Conditions

  • Non-Squamous Non-Small Cell Lung Cancer

Interventions

DRUG

Erlotinib

Participants will receive erlotinib 150 mg tablet orally once daily from Day 1, Cycle 1.

DRUG

Onartuzumab (MetMab)

Participants will receive onartuzumab 15 mg/kg IV infusion on Day 1 of every 3-week cycle.

DRUG

Placebo

Participants will receive onartuzumab matching placebo on Day 1 of every 3-week cycle.

Sponsors & Collaborators

Principal Investigators

  • Ivor Caro, M.D. · Genentech, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Chile
  • Croatia
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Peru
  • Poland
  • Russia
  • Serbia
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01456325 on ClinicalTrials.gov