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TORG1936 / AMBITIOUS study

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031190084
Enrollment
38
Registered
2019-08-27
Start date
2019-09-05
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Atezolizumab 1200mg, every 3 weeks

Sponsors

KATO Terufumi
Lead Sponsor
IKEDA Satoshi
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
1 year-survival rate

Secondary

MeasureTime frame
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

Contacts

Public ContactSatoshi IKEDA

Kanagawa Cardiovascular and Respiratory Center

isatoshi0112@gmail.com+81-45-701-9581

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026