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A Study of Onartuzumab (MetMAb) in Combination With Bevacizumab (Avastin) Plus Platinum And Paclitaxel or With Pemetrexed Plus Platinum in Patients With Non-Squamous Non-Small Cell Lung Cancer

NCT01496742 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 259

Last updated 2016-09-23

No results posted yet for this study

Summary

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of RO5490258 (MetMab) in combination with either of two backbone chemotherapy regimens in the first-line setting in patients with incurable Stage IIIB or IV non-squamous non-small cell lung cancer. In Cohort 1, patients will be randomized to receive 4 cycles of bevacizumab (Avastin) 15 mg/kg iv, paclitaxel 200 mg/m2 iv, platinum (cisplatin/carboplatin) iv plus either MetMab 15 mg/kg iv or placebo on Day 1 of each 21-day cycle. In Cohort 2, patients will be randomized to receive pemetrexed 500 mg/m2 iv, platinum (cisplatin/carboplatin) iv plus either MetMAb 15 mg/m2 iv or placebo on Day 1 of each 21-day cycle. Patients who have not progressed after 4 cycles will be offered maintenance therapy with their assigned treatment of bevacizumab plus either MetMAb or placebo (Cohort 1) or pemetrexed plus either MetMAb or placebo (Cohort 2). Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Conditions

  • Non-Squamous Non-Small Cell Lung Cancer

Interventions

DRUG

Placebo

Matching RO5490258 (MetMAb) placebo iv, Day 1 of each 21-day cycle

DRUG

RO5490258

15 mg/kg iv, Day 1 of each 21-day cycle

DRUG

bevacizumab [Avastin]

15 mg/kg iv, Day 1 of each 21-day cycle

DRUG

cisplatin/carboplatin

standard dose iv, Day 1 of each 21-day cycle, 4 cycles

DRUG

paclitaxel

200 mg/m2 iv, Day 1 of each 21-day cycle, 4 cycles

DRUG

pemetrexed

500 mg/m2, Day 1 of each 21-day cycle

Sponsors & Collaborators

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Genentech, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • United States
  • Argentina
  • France
  • Germany
  • Israel
  • Italy
  • Latvia
  • Malaysia
  • Mexico
  • Philippines
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT01496742 on ClinicalTrials.gov