GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Non-Small Cell Lung Cancer

Recruiting in Palo Alto (17 mi)

+500 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: GlaxoSmithKline

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this clinical trial is to demonstrate the benefit of the immunotherapeutic product GSK1572932A when given to patients with Non-Small Cell Lung Cancer, after removal of their tumor. A course of 13 injections will be administered over 27 months. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Eligibility Criteria

Inclusion Criteria

Male or female patient with completely resected, pathologically proven stage IB, II or IIIA NSCLC.

Written informed consent for MAGE-A3 expression screening on tumor biopsy has been obtained from the patient prior to shipment of the sample for expression testing (before or just after surgical resection), and written informed consent for the complete study has been obtained prior to the performance of any other protocol-specific procedure.

Patient is ≥ 18 years of age at the time of signature of the first informed consent form.

Treatment Details

Interventions

• GSK1572932A Antigen-Specific Cancer Immunotherapeutic (Cancer Vaccine)
• Placebo Control (Immunotherapy)

Participant Groups

Group I: GSK1572932 Group Experimental Treatment 1 Intervention

Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks.

Group II: Placebo Group Placebo Group 1 Intervention

Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

GSK Investigational Site Beverly Hills, CA

GSK Investigational Site Danbury, CT

GSK Investigational Site Marietta, GA

GSK Investigational Site Savannah, GA

More Trial Locations

Who Is Running the Clinical Trial?

GlaxoSmithKline Lead Sponsor

References