Cancer Immunotherapy GSK1572932A as Adjuvant Therapy for Patients With Tumor-antigen-positive Non-Small Cell Lung Cancer

Sponsor
GlaxoSmithKline
Study ID
NCT00455572
Phase
PHASE1
Status
Terminated

Conditions

  • Lung Cancer, Non-Small Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Immunotherapeutic GSK1572932A — BIOLOGICAL
    Intramuscular injection, 8 doses
  • Cisplatin (CDDP) — DRUG
    Four cycles with doses based on patient's body surface area, intravenous administration
  • Vinorelbine — DRUG
    Four cycles with doses based on patient's body surface area , intravenous administration
  • Radiotherapy — PROCEDURE
    Regimen will be based upon the site's own standard procedures

Study Details

The purpose of this clinical trial is to find out how successfully non-small-cell lung cancer patients are able to give an immune response to injections of the immunotherapeutic product GSK1572932A, and to find out more about the safety of this treatment. A course of eight injections will be administered over 21 weeks; including screening for suitability and all tests, the duration of the study for a patient will be 30-35 weeks. During this period various tests will be performed, including physical examinations and blood tests. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Key Dates

Start date
May 11, 2007
Status verified
May 2017
Primary completion
Aug 4, 2013
Completion
Aug 8, 2013

Study Design

Enrollment
71 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Patients with resected stage IB, II or IIIA tumors who are due for standard chemotherapy with cisplatin and vinorelbine. These patients will receive chemo-and immunotherapy in parallel.
  • Experimental: Cohort 2
    Patients with resected stage IB, II or IIIA tumors who are due for standard chemotherapy with cisplatin and vinorelbine. These patients will first receive chemotherapy and then immunotherapy
  • Experimental: Cohort 3
    Patients with resected stage IB, II or IIIA tumors who are not due for chemotherapy. These patients will receive immunotherapy only.
  • Experimental: Cohort 4
    Patients with unresectable stage III tumors, following standard chemotherapy and/or radiotherapy. These patients will receive immunotherapy only.

Primary Outcome Measure

The anti-MAGE-A3 seroconversion [ Time Frame: After the fourth dose of ASCI and at the end of treatment ]

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