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.
This is an open, four-arm, parallel-group study, to be conducted at approximately 20 centers in Europe and Canada. All patients will receive the same immunotherapeutic treatment with GSK1572932A, but they will be recruited into four cohorts according to the details of their disease. 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. 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. Cohort 3: Patients with resected stage IB, II or IIIA tumors who are not due for chemotherapy. These patients will receive immunotherapy only. Cohort 4: Patients with unresectable stage III tumors, following standard chemotherapy and/or radiotherapy. These patients will receive immunotherapy only. Immunotherapeutic treatment will comprise eight doses of GSK1572932A. Doses will be administered at three-week intervals; in Cohort 1 this may be adapted to fit in with the patient's chemotherapy. During the study, adjuvant radiotherapy is allowed in Cohorts 1, 2 and 3 for patients in stage III only and is prohibited in Cohort 4. Chemotherapy during the study is allowed in Cohort 1 only as described above, and is prohibited in Cohorts 2-4. The total maximum duration of the study for a patient will be 30-35 weeks.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
71
Intramuscular injection, 8 doses
Four cycles with doses based on patient's body surface area, intravenous administration
Four cycles with doses based on patient's body surface area , intravenous administration
Regimen will be based upon the site's own standard procedures
GSK Investigational Site
Genk, Belgium
GSK Investigational Site
Leuven, Belgium
GSK Investigational Site
Liège, Belgium
GSK Investigational Site
Edmonton, Alberta, Canada
GSK Investigational Site
Greenfield Park, Quebec, Canada
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Montpellier, France
GSK Investigational Site
Pierre-Bénite, France
GSK Investigational Site
Saint-Herblain, France
GSK Investigational Site
Strasbourg, France
...and 16 more locations
The anti-MAGE-A3 seroconversion
Time frame: After the fourth dose of ASCI and at the end of treatment
The anti-protein D seroconversion
Time frame: After the fourth dose of ASCI and at the end of treatment
The anti-CpG seroconversion
Time frame: After the fourth dose of ASCI and at the end of treatment
The MAGE-A3 cellular (T cell) response
Time frame: After the fourth dose of ASCI and at the end of treatment
Occurrence of adverse events, including abnormal hematological and biochemical laboratory values
Time frame: During the study
Occurrence of serious adverse events
Time frame: During the study
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