Phase II Study Evaluating The Safety And Response To Neoadjuvant Dasatinib In Early Stage Non-Small Cell Lung Cancer

PHASE2TerminatedINTERVENTIONAL
Enrollment

2

Participants

Timeline

Start Date

November 30, 2007

Primary Completion Date

September 30, 2009

Study Completion Date

September 30, 2009

Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
DRUG

Dasatinib

Fresh frozen tumor tissue must be available prior to initiating dasatinib. Eligible patients will receive neoadjuvant dasatinib 70 mg PO twice daily for 3 weeks followed by surgery. The surgical specimen will be evaluated for pathologic response. The second tumor sample will be obtained after 3 weeks of dasatinib therapy at the time of definitive surgical resection which will be evaluated for changes in genomic expression profiles. Patients with at least a 15% decrease or better objective response, without evidence of progression (per tumor evaluation pre-surgery) or pathologic response (as defined as ≥30% tumor necrosis or cell death) to neoadjuvant dasatinib therapy will be eligible to receive dasatinib 70 mg twice daily for 90 days after the completion of standard adjuvant therapy.

Trial Locations (1)

27710

Duke University Medical Center, Durham

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Duke University

OTHER