Status:
TERMINATED
Cancer Immunotherapy GSK1572932A as Adjuvant Therapy for Patients With Tumor-antigen-positive Non-Small Cell Lung Cancer
Lead Sponsor:
GlaxoSmithKline
Conditions:
Lung Cancer, Non-Small Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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, a...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Written informed consent obtained,
- Aged 18 or more,
- Pathologically proven stage IB, II or III NSCLC,
- Tumor expresses MAGE-A3,
- Free of distant metastasis,
- For Cohort 1, all of the following:
- Completely resected stage IB, II or IIIA NSCLC,
- Anatomical tumor resection, involving at least a lobectomy, and nodal sampling as per center standard
- ECOG performance status = 0 or 1
- Due to receive adjuvant chemotherapy as permitted in the protocol
- Not received, not receiving, and not due to receive adjuvant radiotherapy (except stage III patients)
- First administration of chemotherapy can be scheduled within 4-12 weeks after surgery
- For Cohort 2, all of the following:
- Resected stage IB, II or IIIA NSCLC,
- Anatomical tumor resection, involving at least a lobectomy, and nodal sampling as per center standard
- ECOG PS = 0 or 1
- Due to receive, or receiving, adjuvant chemotherapy as permitted in the protocol
- Not received, not receiving, and not due to receive, adjuvant radiotherapy (except stage III patients)
- First administration of ASCI treatment can be scheduled within 2-4 weeks after the last administration of chemotherapy
- Received at least 2 cycles of standard chemotherapy before ASCI treatment is initiated, whereafter no further chemotherapy is planned
- For Cohort 3, all of the following:
- Resected stage IB, II or IIIA NSCLC
- Anatomical tumor resection, involving at least a lobectomy, and nodal sampling as per center standard
- ECOG PS = 0 or 1 or 2
- Not received, not receiving, and not due to receive, adjuvant chemotherapy
- Not received, not receiving, and not due to receive, adjuvant radiotherapy (this does not apply to patients in stage III)
- First administration of ASCI treatment can be scheduled within 4-8 weeks after surgery
- For Cohort 4, all of the following:
- Unresectable stage III NSCLC
- ECOG PS = 0 or 1 or 2
- Due to receive, or receiving, chemo- and radiotherapy according to institution standard
- Received at least 2 cycles of standard chemotherapy before the initiation of ASCI treatment, whereafter no further chemo-/radiotherapy is planned
- Stable disease or objective response (confirmed by CT scan) after standard chemo-/radiotherapy
- Administration of ASCI treatment can be scheduled within 2-6 weeks after the last administration of chemo-/radiotherapy
- Laboratory criteria: adequate bone-marrow reserve, adequate renal function, adequate hepatic function.
- For females: EITHER not of child-bearing potential, OR sexually abstinent, OR negative urine pregnancy test + use of adequate contraceptive precautions from 30 days before first study treatment till 2 months after completion of study treatment course
- In the view of the investigator, the patient can and will comply with the requirements of the protocol
- Exclusion criteria:
- Previous or concomitant other malignancies, except if effectively treated and considered by the investigator highly likely to have been cured
- Pregnant or lactating
- History of anaphylaxis or severe allergic reaction
- Concurrent severe medical problems, unrelated to the malignancy, limiting full compliance with the study or exposing the patient to unacceptable risk
- Psychiatric or addictive disorders compromising the ability to give informed consent, or to comply with the trial procedures
- HIV-positive
- Require treatment with systemic corticosteroids, or other immunosuppressive agents
- Need home oxygenation
- Received or plan to receive investigational or non-registered product other than the study medication from 30 days before first dose of study medication and during whole study period
- History of chronic alcohol consumption and/or drug abuse
Exclusion
Key Trial Info
Start Date :
May 11 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2013
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00455572
Start Date
May 11 2007
End Date
August 8 2013
Last Update
May 15 2017
Active Locations (26)
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1
GSK Investigational Site
Genk, Belgium, 3600
2
GSK Investigational Site
Leuven, Belgium, 3000
3
GSK Investigational Site
Liège, Belgium, 4000
4
GSK Investigational Site
Edmonton, Alberta, Canada, T6G 1Z2