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

Part of paid clinical trials in Bakersfield, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT01887886
Phase
PHASE3
Status
Completed

Conditions

  • Non-Squamous Non-Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • erlotinib — DRUG
    150 mg orally daily
  • onartuzumab — DRUG
    15 mg/kg IV every 3 weeks
  • placebo — DRUG
    IV every 3 weeks

Study Details

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.

Key Dates

First listed
Jun 27, 2013
Start date
Dec 31, 2013
Status verified
Nov 2016
Primary completion
Feb 28, 2015
Completion
Feb 28, 2015

Study Design

Enrollment
10 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Onartuzumab + Erlotinib
  • Active Comparator: Placebo + Erlotinib

Primary Outcome Measure

Progression-free survival (investigator-assessed according to RECIST v1.1) [ Time Frame: approximately 3 years ]

Locations (15)

FacilityCityStateZIPSite coordinators
-BakersfieldCalifornia93309-
-FullertonCalifornia92835-
-Long BeachCalifornia90813-
-Los AngelesCalifornia90095-1772-
-Los AngelesCalifornia90095-
-San Luis ObispoCalifornia93454-
-Fort MyersFlorida33905-
-OrlandoFlorida32803-
-St. PetersburgFlorida33705-
-ChicagoIllinois60637-
-MarreroLouisiana70072-
-MetairieLouisiana70006-
-St LouisMissouri63110-
-CantonOhio44718-
-NashvilleTennessee37203-

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