Table 1.
Inclusion criteria | |
---|---|
1 | Histologically or cytologically proven non-small cell lung cancer |
2 | Unresectable stage III/IV or recurrent |
3 | Received prior chemotherapy, including platinum doublet |
4 | Chronic fibrotic IP (all four items are required) (a) HRCT revealed (i) reticular shadow with basal, peripheral predominance suggestive of UIP pattern or (ii) peribronchovascular shadow suggestive of NSIP pattern(b) Without known etiology (e.g. infection, pneumoconiosis, drug, sarcoidosis, and collagen vascular disease)(c) %FVC > 70%(d) %DLCO > 35% |
6 | Age ⩾ 20 years |
7 | ECOG performance status 0–1 |
8 | With measurable or unmeasurable lesions according to RECIST Version 1.1 |
9 | Vital organ functions are preserved within 14 days prior to enrollment |
10 | Received sufficient explanations about the name and severity of the illness |
11 | Written informed consent |
Exclusion criteria | |
1 | History of acute exacerbation of pre-existing IP |
2 | Treatment history with immune checkpoint inhibitor |
3 | Systemic treatment with steroids at a daily dose of >10 mg of prednisolone or equivalent immunosuppressant |
4 | Active autoimmune disease or history of autoimmune disease requiring treatment |
5 | Symptomatic brain metastasis or spinal cord metastases |
6 | Active viral hepatitis |
7 | Local or systemic active infection requiring treatment |
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 |
DLCO, diffusing capacity of the lungs for carbon monoxide; ECOG, Eastern Cooperative Oncology Group; FVC, forced vital capacity; HRCT, high-resolution computed tomography; IP, interstitial pneumonia; NSIP, nonspecific interstitial pneumonia; RECIST, Response Evaluation Criteria in Solid Tumors; UIP, usual interstitial pneumonia.