A phase II study of Atezolizumab for advanced / recurrent Non-Small Cell Lung Cancer with Idiopathic Interstitial Pneumonias - TORG1936 / AMBITIOUS study

KATO Terufumi0 个研究点目标入组 17 人开始时间: 2019年8月27日最近更新: 2023年10月17日

试验速览

Atezolizumab for NSCLC with comorbid interstitial pneumonia may provide survival benefit, despite the high risk of developing pneumonitis.

•1)Histologically or cytologically proven non-small cell lung cancer
•2)Unresectable stage 3/4 or recurrent
•3)Received prior chemotherapy including platinum doublet
•4)Chronic fibrotic IP
•HRCT revealed (1) reticular shadow with basal and peripheral predominance suggestive of UIP pattern,or(2) peri-bronchovascular shadow suggestive of NSIP pattern
•lOther interstitial lung disease of known etiology(infection, pneumoconiosis, drug, sarcoidosis, and collagen vascular disease)
•l%DLCO>35%
•5)Age>=20 years
•6)ECOG Performance Status 0-1
•7)With measurable or evaluable lesions according to RECIST Version1.1
•8)Vital organ functions are preserved
•9)Received sufficient explanations about the name and severity of the illness
•10) Written informed consent

•1)History of acute exacerbation of IPF
•2)Treatment history with immune-checkpoint inhibitor
•3)Systemic treatment with steroids at a daily dose>10mg of prednisolone equivalent or immunosupressants
•4)Active autoimmune disease or history of autoimmune disease requiring treatment
•5)Symptomatic brain metastasis or spinal cord metastases
•6)Active viral hepatitis
•7)Active infection
•8)Synchronous or metachronous active double malignancies
•9)Pregnant or breastfeeding
•10) Disapprove of contraception during the protocol treatment period
•11) Treatment history with thoracic radiotherapy
•12) History of serious drug allergies
•13) Other conditions not suitable for the study

发起方

KATO Terufumi