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This study evaluates the investigational drug PF-02341066 in patients with advanced non-small cell lung cancer that is positive for the ALK fusion gene. It enrolled patients with histologically or cytologically confirmed cancer whose tumors tested positive for the ALK fusion gene. The study was conducted in Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
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Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * histologically or cytologically proven diagnosis of non-small cell lung cancer * positive for the ALK fusion gene (test provided by either a central laboratory. Local laboratory may be used for certain cases) * may have received pemetrexed or docetaxel from previous Phase 3 trial (A8081007) and discontinued treatment due to Response Evaluation Criterion in Solid Tumors (RECIST)-defined progression. or, once the primary endpoint of Study A8081007 has been analyzed and the results made available, at any time without RECIST-defined progression. * Tumors can be measurable or non measurable Exclusion Criteria: * prior treatment with PF-02341066 * received no prior systemic treatment, chemotherapy or EGFR tyrosine kinase inhibitor, for advanced non-small cell lung cancer * current enrollment in another therapeutic clinical trial