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



Status:Completed
Conditions:Lung Cancer, Cancer, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2009
End Date:January 2016

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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

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.


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
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3181 Southwest Sam Jackson Park Road
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825 Eastlake Ave E
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12902 USF Magnolia Dr
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550 Peachtree St NE
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450 Brookline Ave
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1653 W. Congress Parkway
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1 Ingalls Dr
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535 Barnhill Dr
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1 Medical Center Dr
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