TORG1936 / AMBITIOUS study

Phase 2

• Conditions: Advanced / recurrent Non-small cell lung cancer with idiopathic interstitial pneumonia

• Registration Number: JPRN-jRCTs031190084
• Lead Sponsor: KATO Terufumi

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-27
• Study Completion: 2021-01-22
• Results First Posted: 2022-06-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 17

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified