Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva, compared with placebo, following platinum-based chemotherapy in patients with advanced, recurrent, or metastatic NSCLC who have not had disease progression or unacceptable toxicity during chemotherapy. Following 4 cycles of platinum-based chemotherapy, eligible patients will be randomized to receive either Tarceva 150mg po daily, or placebo daily. The anticipated time on study treatment is until disease progression; the target sample size is 500+ individuals.

Eligibility Criteria

Inclusion Criteria:

• adult patients >=18 years of age;

• histologically documented, locally advanced , recurrent or metastatic NSCLC;

• measurable disease;

• no disease progression after 4 cycles of platinum-based chemotherapy.

Exclusion Criteria:

• unstable systemic disease;

• any other malignancies in the last 5 years.

Trial Contact Information

Trial Lead Organizations/Sponsors

F. Hoffmann - La Roche, Limited

Clinical Trials

Study Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00556712
Information obtained from ClinicalTrials.gov on November 20, 2012

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