A Study of MetMAb Administered to Patients With Advanced Non-Small Cell Lung Cancer, in Combination With Tarceva (Erlotinib)

Sponsor
Genentech, Inc.
Study ID
NCT00854308
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Erlotinib HCl — DRUG
    Erlotinib 150 mg oral dose once daily.
  • MetMAb — DRUG
    MetMab (a monovalent antagonist antibody to the receptor MET) 15 mg/kg in 250 CC 0.9% saline intravenous infusion every 3 weeks.
  • placebo (0.9 % saline) — DRUG
    Placebo Intravenous infusion every 3 weeks.

Study Details

This is a Phase II, double-blind, randomized, multicenter trial designed to preliminarily evaluate the activity and safety of treatment with MetMAb + erlotinib versus erlotinib + placebo in second- and third-line Non-Small Cell Lung Cancer (NSCLC). Up to 180 patients will be randomized in a 1:1 ratio to one of the two treatment arms.

Key Dates

First listed
Mar 3, 2009
Start date
Apr 30, 2009
Status verified
Nov 2012
Primary completion
Nov 30, 2010
Completion
Jan 31, 2012

Study Design

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

Arms

  • Experimental: MetMAb + Erlotinib
    MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
  • Placebo Comparator: Placebo + Erlotinib
    Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.

Primary Outcome Measure

Progression-free Survival [ Time Frame: Time from randomization to the first occurrence of progression/relapse or death on study. (Up to 20 months) ]

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