A Phase I/II study to assess the safety and immunogenicity of recMAGE-A3+AS15 cancer immunotherapeutic given as adjuvant therapy, with or without standard adjuvant chemo(-radio)therapy, to patients with MAGE A3-positive Non-Small Cell Lung Cancer (stage IB, II or III) - MAGE3-AS15-NSC-001 (ADJ-Chemo)

GlaxoSmithKline Biologicals0 sites72 target enrollmentJanuary 22, 2007

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: GlaxoSmithKline Biologicals
Enrollment: 72
Status: Active, Not Recruiting
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 22, 2007

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GlaxoSmithKline Biologicals

Eligibility Criteria

Inclusion Criteria

•1\.Written informed consent has been obtained before performance of any protocol\-specific procedure. 2\. Patient is at least 18 years of age at the time when informed consent is signed. 3\. Pathologically proven stage IB, II or III NSCLC. 4\. The patient's tumor shows expression of MAGE\-A3 antigen, detected by RT\-PCR or any updated technique at the time of sample analysis. 5\.The patient is free of any distant metastasis, as shown by standard procedures at the site. 6\.For patients to be included in Cohort 1, all of the following. 6a. Completely resected stage IB, II or III NSCLC. Stage III N2 and N3 are not eligible for this study. 6b. 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. 6c. ECOG performance status \= 0 or 1 at the time of screening. 6d. The patient is due to receive adjuvant chemotherapy as permitted in this protocol. 6e. 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). 6f. First administration of chemotherapy can be scheduled to take place within the time\-window of 4–12 weeks after surgery. 7\.For patients to be included in Cohort 2, all of the following. 7a. Completely resected stage IB, II or III NSCLC. Stage III N2 and N3 are not eligible for this study. 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. Completely resected stage IB, II or III NSCLC. Stage III N2 and N3 are not eligible. 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 stand

Exclusion Criteria

•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.