MAGRIT肿瘤的免疫治疗在近期也是研究热点，在NSCLC的术后辅助治疗中的作用也初见端倪。它也是一项正在进行中的免疫治疗相关试验，入组完全手术切除同时MAGE-A3阳性的Ⅰ、Ⅱ、ⅢA期NSCLC患者，研究表明大约有35%～50%早期的NSCLC MAGE-A3表达阳性。此试验拟入组2 270例患者，随机分为治疗组及安慰剂组，治疗组术后6周内给予MAGE-A3疫苗，每3周1次，共5次，以后每3个月1次，共8次。试验以DFS为评价终点，同时根据是否行辅助化疗对入组患者进行分层分析。
Phase III study – MAGRIT MAGE-A3 as Adjuvant Non-Small Cell LunG CanceR ImmunoTherapy
the Phase III trial will incorporate 3 changes to the design of the Phase II trial. These are:
The inclusion of patients with stage IIIA NSCLC because the treatment approach used for these patients is similar to the one used for stage IB and II patients, especially these patients will undergo surgical resection of their tumor,
The inclusion of chemotherapy in the study design in order to offer the MAGE-A3 treatment to all patients with MAGE-A3 positive lung cancer.
The use of an improved immunological Adjuvant System.
Therefore, this Phase III trial will evaluate the MAGE-A3 treatment:
in patient receiving adjuvant chemotherapy; these patients will receive sequential administrations: first chemotherapy then immunotherapy
in patient not receiving chemotherapy (due to refusal, contra-indication or stage IB); the administration of the ASCI will begin directly after surgery and an adequate recovery time (4-12 weeks).
The MAGRIT trial is powered to assess the efficacy of the MAGE-A3 ASCI separately in:
The global population,
The population of patients who did not receive chemotherapy.
