A Phase 2 Study of atezolizumab + carboplatin + paclitaxel + bevacizumab for previously-treated patients with NSCLC harboring EGFR mutations. - NEJ043

Kikuchi Toshiaki0 个研究点目标入组 60 人开始时间: 2019年8月1日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) Stage III or IV Non-Squamous, non-small cell lung cancer proven by histology and/or cytology without indication of curative surgery or curative radiotherapy, 2) Sensitizing EGFR mutations (19 deletion, L858R, G719X, S768I, L861Q, T790M), 3) Prior therapy with EGFR-TKIs, 4) Measurable disease, as defined by RECIST ver 1.1, 5) No prior cytotoxic chemotherapy or immunotherapy, 6) 20 years or older, 7) ECOG PS 0 or 1, 8) adequate hematologic and end organ function, 9) Written informed consent form.

•1) History of interstitial lung disease or radiation pneumonitis, 2) Symptomatic CNS metastases, CNS metastases treated with corticosteroids, leptomeningeal disease, 3) Irradiation for primary tumor or target lesion defined by RECIST ver 1.1, 4) Uncontrolled heart, lung, liver, renal diseases, 5) History of autoimmune diseases, 6) Known hypersensitivity or allergy to paclitaxel or polyoxyethylene castor oil containing formulations, 7) History of hemoptysis, 8)Invasion to major vessels or heart, 9) Treatment with systemic corticosteroid or immunosuppressant, 10) Patients with active hepatitis B or hepatitis C or positive for HIV test, 11) Women who are pregnant, lactating, or intending to become pregnant during the study, 12) Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures, 13) Malignancies other than NSCLC within 5 years, 14) History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins, 15) Plan for major surgical procedure during the course of the study.

发起方

Kikuchi Toshiaki