An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care 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: NCT00932893

Purpose

This is a Phase 3 trial comparing the safety and anti-tumor activity of PF-02341066 versus pemetrexed or docetaxel in patients with advanced non-small cell lung cancer with specific gene profile involving the ALK gene after failure of one previous chemotherapy regimen that included one platinum drug.

Official Title

Phase 3, Randomized, Open-label Study Of The Efficacy And Safety Of Pf-02341066 Versus Standard Of Care Chemotherapy (Pemetrexed Or Docetaxel) In Patients With Advanced Non-small Cell Lung Cancer (Nsclc) Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (Alk) Gene Locus

Stanford Investigator(s)

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)

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor

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

Colleen Haas Chair in the School of Medicine

Eligibility


Inclusion Criteria:

   - histologically or cytologically proven diagnosis of non-small cell lung cancer

   - positive for the ALK fusion gene (test provided by a central laboratory)

   - must have had disease progression after only one prior chemotherapy and that regimen
   but must have included one platinum drug

   - tumors must be measurable

Exclusion Criteria:

   - prior treatment with PF-02341066

   - current treatment in another clinical trial

Intervention(s):

drug: PF-02341066

drug: Pemetrexed

drug: Docetaxel

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061

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