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

NCT02031744 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 530

Last updated 2017-03-14

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

erlotinib [Tarceva]

150 mg oral administration once daily

DRUG

Placebo

15 mg/kg intravenous administration every 3 weeks

DRUG

Onartuzumab [MetMAb]

15 mg/kg intravenous administration 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
2014-01-22
Primary Completion
2016-01-06
Completion
2016-01-06

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT02031744 on ClinicalTrials.gov