|Phase III||Biomarker/Laboratory analysis, Treatment||Completed||18 and over||Pharmaceutical / Industry||BO18192|
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.
- 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.
- unstable systemic disease;
- any other malignancies in the last 5 years.
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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