TORG1936 / AMBITIOUS study

JRCT ID: jRCTs031190084

Registered date:27/08/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Advanced / recurrent Non-small cell lung cancer with idiopathic interstitial pneumonia
• Date of first enrollment: 05/09/2019
• Target sample size: 38
• Study type: Interventional
• Intervention(s): Atezolizumab 1200mg, every 3 weeks

Outcome(s)

• Primary Outcome: 1 year-survival rate
• Secondary Outcome: The incidence of acute exacerbation of IP within 1 year after treatment initiation, overall survival, progression free survival, objective response rate, time to treatment failure, mortality rate due to acute exacerbation of IP or pneumonitis during observation period, safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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%FVC>70%
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

Exclude criteria

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

Related Information

• Primary Sponsor: KATO Terufumi
• Secondary Sponsor: IKEDA Satoshi
• Source(s) of Monetary Support: Thoracic Oncology Research Group