Phase II study of Platinum-Based Doublet Chemotherapy plus Atezolizumab, in completely resected, p-stage II-IIIA NSCLC patients harboring EGFR mutation. (WJOG11719L Investigator-Initiated Clinical Trial)

obuyuki Yamamoto (Coordinating Investigator)0 个研究点目标入组 18 人开始时间: 2019年7月8日最近更新: 2023年10月17日

试验速览

暂无简介。

•1.ECOG PS 0 or 1
•2.Patients with a histologically or cytologically confirmed diagnosis of NSCLC
•3.Pathologic stage II or IIIA (UICC TNM Classification 8th edition)
•4.Proven EGFR gene mutation status (Exon19 deletion/ Exon21 L858R)
•5.Twenty-one or more days after surgery but within 56 days after surgery, confirmed completely resection as negative margins, and post-operative recovery
•6.Patients with mediastinal lymph node dissection or lymph node sampling
•7.Patients who were not previously treated with chemotherapy nor EGFR TKI
•8.The functions of the hematopoiesis and main organs are maintained, and all the criteria are satisfied.

•1.Patients with other cancers except for NSCLC within 5 years
•2.Patients with a history of autoimmune disease
•3.Patients with active hepatitis B and/or C
•4.Patients with a history of other surgeries except lung cancer resection, vaccination with a live-attenuated vaccine, or possibility of these therapy during the trial
•5.Patients with a history of other study drug administration within 28 days
•6.Patients with hypersensitivity to the ingredients or additives of cisplatin, vinorelbine, atezolizumab or mannitol
•7.Pregnant women, lactating women, or patients not intending to practice contraception

发起方

obuyuki Yamamoto (Coordinating Investigator)