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A Study of Onartuzumab (MetMAb) Versus Placebo in Combination With Paclitaxel Plus Platinum in Patients With Squamous Non-Small Cell Lung Cancer

NCT01519804 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2016-09-02

No results posted yet for this study

Summary

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with paclitaxel plus platinum in patients with incurable Stage IIIB or Stage IV squamous non-small cell lung cancer (NSCLC). Patients will be randomized to receive either onartuzumab (MetMAb) 15 mg/kg iv or placebo on Day 1 of each 21-day cycle in combination with 4 cycles of paclitaxel 200 mg/m2 iv and platinum (carboplatin/cisplatin) iv on Day 1 of each 21-day cycle. Patients who have not progressed after 4 cycles will continue with either onartuzumab (MetMAb) or placebo as maintenance therapy until disease progression or unacceptable toxicity occurs.

Conditions

  • Non-Squamous Non-Small Cell Lung Cancer

Interventions

DRUG

Placebo

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

DRUG

cisplatin/carboplatin

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

DRUG

onartuzumab

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

DRUG

paclitaxel

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

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
2014-01-31
Completion
2015-09-30

Countries

  • United States
  • Argentina
  • France
  • Germany
  • Israel
  • Italy
  • Latvia
  • Spain
  • 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 NCT01519804 on ClinicalTrials.gov