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A Study of Onartuzumab in Combination With Erlotinib in Patients With MET-Positive Stage IIIB or IV Non-Small Cell Lung Cancer Carrying an Activating Epidermal Growth Factor Receptor (EGFR) Mutation

NCT01887886 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2016-11-02

No results posted yet for this study

Summary

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of onartuzumab in combination with erlotinib in patients with previously untreated, unresectable stage IIIB or IV non-small cell lung cancer identified to carry and activating EGFR mutation and MET-positive. Patients will be randomized to receive either onartuzumab 15 mg/kg intravenously every 3 weeks in combination with erlotinib 150 mg orally daily 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

150 mg orally daily

DRUG

onartuzumab

15 mg/kg IV every 3 weeks

DRUG

placebo

IV every 3 weeks

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United States
  • France
  • Germany
  • Japan
  • Malaysia
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

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 NCT01887886 on ClinicalTrials.gov