An Investigational Drug, PF-02341066, Is Being Studied In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene

Not Recruiting

Trial ID: NCT00932451


This is a Phase 2 trial that will evaluate the safety and efficacy of PF-02341066 in patients with advanced non-small cell lung cancer with a specific gene profile involving the ALK gene. This trial will also allow patients from a Phase 3 trial who received standard of care chemotherapy (Study A8081007) to receive PF-02341066.

Official Title

Phase 2, Open-label Single Arm Study Of The Efficacy And Safety Of Pf-02341066 In Patients With Advanced Non-small Cell Lung Cancer (Nsclc) Harboring A Translocation Or Inversion Involving The Anaplastic Lymphoma Kinase (Alk) Gene Locus

Stanford Investigator(s)

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor

Joel Neal, MD, PhD
Joel Neal, MD, PhD

Associate Professor of Medicine (Oncology)

A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD

Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)

George A. Fisher Jr.
George A. Fisher Jr.

Colleen Haas Chair in the School of Medicine


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

   - 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


drug: PF-02341066

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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