A Study of Tarceva (Erlotinib) Following Platinum-Based Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Basic Trial Information
|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 Contact Information
Trial Lead Organizations/Sponsors
F. Hoffmann - La Roche, Limited
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00556712
ClinicalTrials.gov processed this data on May 26, 2015
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.