A Phase I/II study to assess the safety and immunogenicity of recMAGE-A3+AS15 cancer immunotherapeutic given as adjuvant therapy, with or without adjuvant chemo(-radio)therapy, to patients with MAGE-A3-positive Non-Small Cell Lung cancer (stage IB, II or III) - MAGE3-AS15-NSC-001
- Conditions
- on-Small Cell Lung CancerMedDRA version: 6.1Level: PTClassification code 10061873
- Registration Number
- EUCTR2006-004777-10-IT
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 70
1.Written informed consent obtained before performance of any protocol-specific procedure. 2.Patient is at least 18 years of age . 3.Pathologically proven stage IB, II or III NSCLC. 4.Patient's tumor shows expression of MAGE-A3 antigen, detected by RT-PCR. 5.Patient is free of any distant metastasis, as shown by standard procedures at the site. 6.Patients to be included in Cohort 1, all of the following. 6a.Resected stage IB, II or IIIA NSCLC. 6b.Operative technique for resection of the patient's tumor is anatomical, involving at least a lobectomy, and with a level of nodal sampling corresponding to the standard procedures at the center. 6c.ECOG performance status = 0 or 1 at the time of screening. 6d.Patient is due to receive adjuvant chemotherapy as permitted in this protocol. 6e.Patient has not received, is not receiving, and is not due to receive, adjuvant radiotherapy (this does not apply to patients in stage III). 6f.First administration of chemotherapy can be scheduled to take place within the time-window of 4?8 weeks after surgery. 7.For patients to be included in Cohort 2, all of the following. 7a.Resected stage IB, II or IIIA NSCLC. 7b.The operative technique for resection of the patient's tumor is anatomical, involving at least a lobectomy, and with a level of nodal sampling corresponding to the standard procedures at the center. 7c.ECOG performance status = 0 or 1 at the time of screening. 7d.The patient is due to receive, or is already receiving, adjuvant chemotherapy as permitted in this protocol. 7e.The patient has not received, is not receiving, and is not due to receive, adjuvant radiotherapy (this does not apply to patients in stage III). 7f. First administration of recMAGE A3+AS15 ASCI study treatment can be scheduled to take place within the time-window of 2?4 weeks after the last administration of chemotherapy 7g.The patient has received at least two cycles of standard chemotherapy before study treatment with recMAGE A3 ASCI is initiated, whereafter no further chemotherapy is planned. 8.For patients to be included in Cohort 3, all of the following. 8a.Resected stage IB, II or IIIA NSCLC. 8b.The operative technique for resection of the patient's tumor is anatomical, involving at least a lobectomy, and with a level of nodal sampling corresponding to the standard procedures at the center. 8c.ECOG performance status = 0 or 1 or 2 at the time of screening. 8d.The patient has not received, is not receiving, and is not due to receive, adjuvant chemotherapy. 8e.The patient has not received, is not receiving, and is not due to receive, adjuvant radiotherapy (this does not apply to patients in stage III). 8f.First administration of recMAGE A3+AS15 ASCI study treatment can be scheduled to take place within the time-window of 4?8 weeks after surgery. 9.For patients to be included in Cohort 4, all of the following. 9a.Unresectable stage III NSCLC. 9b.ECOG performance status = 0 or 1 or 2 at the time of screening. 9c.The patient is due to receive, or is already receiving, chemo- and radiotherapy according to standard practice at the institution. 9d.The patient has received at least two cycles of standard chemotherapy before the initiation of study treatment with recMAGE A3+AS15 ASCI, whereafter no further chemo-/radiotherapy is planned. 9e.The patient has stable disease or objective response (confirmed by CT scan) after standard chemo-/radiotherapy. 9f.Administration of recMAGE A3+AS
1. The patient has (or has had) previous or concomitant malignancies at other sites, except effectively treated malignancy that is considered by the investigator highly likely to have been cured. 2. The patient is pregnant or lactating. 3. The patient has a history of anaphylaxis or severe allergic reaction. 4. The patient has concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk. 5. The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the trial procedures. 6. The patient is known to be HIV-positive. 7. The patient requires concomitant treatment with systemic corticosteroids, or any other immunosuppressive agents. [Notes: 1. The use of prednisone, or equivalent, <0.5 mg/kg/day (absolute maximum 40 mg/day), or inhaled corticosteroids for COPD or topical steroids is permitted. 2. The use of corticosteroids as anti-emetic treatment is permitted.] 8. The patient needs home oxygenation. 9. The patient has received any investigational or non-registered drug or vaccine other than the study medication within the 30 days preceding the first dose of study medication, or plans to receive such a drug during the study period. 10. The patient has a history of chronic alcohol consumption and/or drug abuse.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - To assess the specific humoral and cellular immune response induced by the cancer immunotherapeutic recMAGE-A3+AS15 in patients with MAGE-A3-positive NSCLC. - To evaluate the safety of recMAGE-A3+AS15 in patients with MAGE-A3-positive NSCLC.;Secondary Objective: N/A;Primary end point(s): Immunogenicity Immunogenicity will be judged primarily after the fourth dose of ASCI, on the basis of: The anti-MAGE-A3 seroconversion. The anti-protein D seroconversion. The MAGE-A3 cellular (T-cell) response. Additionally, these antibody and cellular T-cell responses will be evaluated at the end of treatment. Safety The safety of the cancer immunotherapeutic recMAGE-A3+AS15, combined or not with standard chemotherapy, will be judged on the basis of: Occurrence of adverse events during the study, including abnormal hematological and biochemical laboratory values. Occurrence of serious adverse events during the study.
- Secondary Outcome Measures
Name Time Method