NCT00290355

Study to Test the Efficacy of the Vaccine GSK 249553 in Treating Non-small-cell Lung Cancer After Tumour Removal by Surgery

A Phase IIB Study to Assess the Efficacy of GSK 249553 as Adjuvant Therapy Given to MAGE-3-Positive Patients With Non-Small-Cell Lung Cancer in Stage IB (T2/N0) or II (T1/N1 or T2/N1 or T3/N0), Who Have Had Complete Surgical Resection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients will receive injections of GSK 249553 vaccine . Appropriate tests will be performed to assess the safety of the treatment and its ability to induce an immune response.

Detailed description

This Phase IIb study will be conducted at centres in several European countries according to a multicentre, international, randomised, double-blind design. It will provide information about the clinical and immunological efficacy and the tolerability of GSK 249553 when this is administered to patients with stage IB, II NSCLC. The study treatment will be administered by intramuscular injection; first administration will take place 4-6 weeks after surgery. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

• Lung Cancer, Non-Small Cell

Interventions

Type	Name	Description
BIOLOGICAL	GSK 249553 vaccine	Intramuscular injection, 13 doses
BIOLOGICAL	Placebo	Intramuscular administration, 13 doses

Timeline

• Start date: 2002-05-28
• Primary completion: 2011-07-19
• Completion: 2011-07-19
• First posted: 2006-02-13
• Last updated: 2020-01-02
• Results posted: 2019-02-25

Locations

62 sites across 14 countries: Belgium, Estonia, Finland, France, Germany, Greece, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Spain, United Kingdom