EUCTR2006-004777-10-BE进行中（未招募）1 期
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)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 receiv
排除标准
- •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.
研究者
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