Last updated: 11/07/2018 01:56:29
Cancer immunotherapy GSK1572932A as adjuvant therapy for patients with tumor-antigen-positive Non-Small Cell Lung cancer
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Terminated (halted prematurely)
Terminated (halted prematurely)
Trial overview
Official title: Cancer immunotherapeutic GSK1572932A as adjuvant therapy for patients with MAGE-A3-positive Non-Small Cell Lung cancer
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
The anti-MAGE-A3 seroconversion
Timeframe: After the fourth dose of ASCI and at the end of treatment
The anti-protein D seroconversion
Timeframe: After the fourth dose of ASCI and at the end of treatment
The anti-CpG seroconversion
Timeframe: After the fourth dose of ASCI and at the end of treatment
The MAGE-A3 cellular (T cell) response
Timeframe: After the fourth dose of ASCI and at the end of treatment
Occurrence of adverse events, including abnormal hematological and biochemical laboratory values
Timeframe: During the study
Occurrence of serious adverse events
Timeframe: During the study
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Immunotherapeutic GSK1572932A
Drug: Cisplatin (CDDP)
Drug: Vinorelbine
Procedure/surgery: Radiotherapy
Enrollment:
71
Observational study model:
Not applicable
Primary completion date:
2013-04-08
Time perspective:
Not applicable
Clinical publications:
Pujol JL et al. (2015) Safety and immunogenicity of MAGE-A3 cancer immunotherapy in patients with resected stage IB to III NSCLC and undergoing chemotherapy. J Thorac Oncol. 10(10):1458-1467.
Medical condition
Lung Cancer, Non-Small Cell
Product
GSK1572932A
Collaborators
Not applicable
Study date(s)
May 2007 to August 2013
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Written informed consent obtained,
- Aged 18 or more,
- Previous or concomitant other malignancies, except if effectively treated and considered by the investigator highly likely to have been cured
- Pregnant or lactating
Inclusion and exclusion criteria
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: a) Completely resected stage IB, II or IIIA NSCLC, b) Anatomical tumor resection, involving at least a lobectomy, and nodal sampling as per center standard c) ECOG performance status = 0 or 1 d) Due to receive adjuvant chemotherapy as permitted in the protocol e) Not received, not receiving, and not due to receive adjuvant radiotherapy (except stage III patients) f) First administration of chemotherapy can be scheduled within 4–12 weeks after surgery
- For Cohort 2, all of the following: a) Resected stage IB, II or IIIA NSCLC, b) Anatomical tumor resection, involving at least a lobectomy, and nodal sampling as per center standard c) ECOG PS = 0 or 1 d) Due to receive, or receiving, adjuvant chemotherapy as permitted in the protocol e) Not received, not receiving, and not due to receive, adjuvant radiotherapy (except stage III patients) f) First administration of ASCI treatment can be scheduled within 2–4 weeks after the last administration of chemotherapy g) 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: a) Resected stage IB, II or IIIA NSCLC b) Anatomical tumor resection, involving at least a lobectomy, and nodal sampling as per center standard c) ECOG PS = 0 or 1 or 2 d) Not received, not receiving, and not due to receive, adjuvant chemotherapy e) Not received, not receiving, and not due to receive, adjuvant radiotherapy (this does not apply to patients in stage III) f) First administration of ASCI treatment can be scheduled within 4–8 weeks after surgery
- For Cohort 4, all of the following: a) Unresectable stage III NSCLC b) ECOG PS = 0 or 1 or 2 c) Due to receive, or receiving, chemo- and radiotherapy according to institution standard d) Received at least 2 cycles of standard chemotherapy before the initiation of ASCI treatment, whereafter no further chemo-/radiotherapy is planned e) Stable disease or objective response (confirmed by CT scan) after standard chemo-/radiotherapy f) 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
Trial location(s)
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Study Complete
Location
GSK Investigational Site
Wythenshawe, Greater Manchester, United Kingdom, M23 9LT
Status
Study Complete
Location
GSK Investigational Site
Udine, Friuli-Venezia-Giulia, Italy, 33100
Status
Study Complete
Location
GSK Investigational Site
Grosshansdorf, Schleswig-Holstein, Germany, 22927
Status
Study Complete
Location
GSK Investigational Site
Bebington, Wirral, United Kingdom, CH63 4JY
Status
Study Complete
Location
GSK Investigational Site
Greenfield Park, Québec, Canada, J4V 2H1
Status
Study Complete
Location
GSK Investigational Site
Hemer, Nordrhein-Westfalen, Germany, 58675
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Terminated (halted prematurely)
Actual primary completion date
2013-04-08
Actual study completion date
2013-08-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 107240 can be found on the GSK Clinical Study Register
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