CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 137 enrolled
Drug / intervention
Erlotinib HCl +2 moredrug
Likely dose
Erlotinib HCl 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00854308
NCT00854308Phase 2Completed
CompareCT.gov

A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Activity of MetMAb, a Monovalent Antagonist Antibody to the Receptor Met, Administered to Patients With Advanced Non-Small Cell Lung Cancer, in Combination With Tarceva (Erlotinib)

Genentech, Inc.·interventional·Posted Mar 3, 2009·Updated Mar 31, 2017

In Brief

A Phase 2 clinical trial evaluating Erlotinib HCl, MetMAb, and 1 other intervention for Non-Small Cell Lung Cancer. Completed, enrolled 137 participants.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small Cell Lung Cancer
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 3, 2009
Enrollment StartApr 1, 2009
Primary CompletionNov 1, 2010
Study CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 17.3 years ago

Interventions

Erlotinib HCldrug

Erlotinib 150 mg oral dose once daily.

MetMAbdrug

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.