Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III | Biomarker/Laboratory analysis, Treatment | Completed | 18 and over | Pharmaceutical / Industry | BO18602 NCT00556322 |
Summary
This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva and that of standard of care chemotherapy in patients with advanced, recurrent, or metastatic NSCLC experiencing disease progression after failure of platinum-based chemotherapy.Eligible patients will be randomized to receive either Tarceva 150mg po daily, or comparator (either Alimta 500mg/m2 every 3 weeks, or Taxotere 75mg/m2 every 3 weeks). The anticipated time on study treatment is until disease progression ,and the target sample size is 500+ individuals.
Eligibility Criteria
Inclusion Criteria:
- adult patients >=18 years of age;
- histologically documented, locally advanced or recurrent or metastatic NSCLC;
- measurable disease;
- disease progression during 1-4 cycles of platinum-based chemotherapy.
Exclusion Criteria:
- any other malignancies within the last 5 years;
- unstable systemic disease.
Trial Lead Organizations/Sponsors
F. Hoffmann - La Roche, Limited
| Clinical Trials |  | Study Director |
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00556322
Information obtained from ClinicalTrials.gov on June 10, 2013
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