Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Antineoplastic Agents

Amino Acids

Antibodies

Immunoglobulins

Erlotinib Hydrochloride

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

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

Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.

Erlotinib HCl

MetMab (a monovalent antagonist antibody to the receptor MET) 15 mg/kg in 250 CC 0.9% saline intravenous infusion every 3 weeks.

MetMAb

Placebo Intravenous infusion every 3 weeks.

placebo (0.9 % saline)

Premal Patel, M.D., Ph.D.

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.

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

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)

Progression-free survival was defined as the time from randomization to the first occurrence of progression or relapse (as per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) and assessed by the site radiologist or investigator) or death on study from any cause (within 30 days of last treatment).

Progression-free survival (PFS) in participants with Met Diagnostic-Positive tumors as determined by immunohistochemistry.

PFS was defined as the time from randomization to the first occurrence of progression or relapse (as per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) and assessed by the site radiologist or investigator) or death on study from any cause (within 30 days of last treatment).

Objective response (partial and complete response as determined using RECIST 1.0).

Partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter.

Complete response was defined as disappearance of all target lesions.

Objective response (OR); partial and complete response as determined using RECIST 1.0 in patients with Met Diagnostic-Positive Tumors as determined by immunohistochemistry.

Partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter.

Complete response was defined as disappearance of all target lesions.

Genentech, Inc.

MetMAb + Erlotinib

Placebo + Erlotinib

Total

Age, Continuous

Sex: Female, Male

Medical Communications

The null hypothesis is that there is no difference in PFS between MetMab + Erlotinib and Placebo + Erlotinib. The alternate hypothesis is that MetMab + Erlotinib would have prolonged PFS compared with Placebo + Erlotinib.

Progression-free Survival

The null hypothesis is that there is no difference in Objective Response between MetMab + Erlotinib and Placebo + Erlotinib. The alternate hypothesis is that MetMab + Erlotinib would have better Objective Response compared with Placebo + Erlotinib.

Percentage of Participants With Objective Response

The null hypothesis is that there is no difference in Objective Response between MetMab + Erlotinib and Placebo + Erlotinib. The alternate hypothesis is that MetMab + Erlotinib would have better Objective Response compared with Placebo + Erlotinib

All randomized intent-to-treat patients with Met Diagnostic-positive tumors.

Percentage of Participants With Objective Response in Patients With Met Diagnostic-Positive Tumors

All randomized intent-to-treat patients with Met Diagnostic-Positive tumors.

Progression-free Survival in Patients With Met Diagnostic-Positive Tumors

All randomized intent-to-treat patients. Analyses of duration of response were not performed because of the small number of patients with objective responses.

Duration of Overall Response

MetMab (a monovalent antagonist antibody to the receptor MET) 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.

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

Trial Identification

Conditions

Interventions

Study Description

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Eligibility

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Contact Details

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