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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: PF-02341066

Study type: Interventional

Funder types: Industry

Identifiers

NCT00932451

A8081005

2009-012504-13 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 1,069 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,069 participants in 1 patient group

PF-0231066

Experimental group

Treatment:

Drug: PF-02341066