Cancer Immunotherapeutic GSK1572932A as Adjuvant Therapy for Patients With MAGE-A3-positive Non-Small Cell Lung Cancer
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The anti-MAGE-A3 seroconversion
After the fourth dose of ASCI and at the end of treatment
No
GSK Clinical Trials
Study Director
GlaxoSmithKline
United Kingdom: Medicines and Healthcare Products Regulatory Agency
107240
NCT00455572
May 2007
November 2013
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