Advanced / recurrent Non-small cell lung cancer with idiopathic interstitial pneumonia
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| 1 year-survival rate | — |
Secondary
| Measure | Time 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
Kanagawa Cardiovascular and Respiratory Center