A randomized phse II study of carboplatin plus nab-paclitaxel with or without nintedanib for advanced non-small-cell lung cancer with idiopathic pulmonary fibrosis

INTERVENTION: A: 4 cycles of Carboplatin (AUC 6, day 1) plus nab‐Paclitaxel (100 mg/m2, day 1, 8, 15) repeated every 3 weeks B: 4 cycles of Carboplatin (AUC 6, day 1) plus nab‐Paclitaxel (100 mg/m2, day 1, 8, 15) in combination with nintedanib (150 mg B.I.D, daily) repeated every 3 weeks followed by single‐agent administration of nintedanib (150 mg B.I.D, daily) CONDITION: Non‐small‐cell lung cancer with idiopathic pulmonary fibrosis PRIMARY OUTCOME: Time to acute exacerbation of IPF (Initiation of 2nd line chemotherapy for non‐small cell lung cancer is not treated as censored) SECONDARY OUTCOME: Time to acute exacerbation of IPF (Initiation of 2nd line chemotherapy for non‐small cell lung cancer is treated as censored), Exacerbation‐free survival of IPF, Frequency of patients with acute exacerbation of IPF, Rate of decline in FVC (expressed in mL over 12 weeks), Quality of life (QOL), Overall response rate (ORR), Progression‐free survival (PFS) of non‐small cell lung cancer, Time to treatment failure (TTF), Overall survival (OS), toxicity INCLUSION CRITERIA: 1) Written informed consent 2) 20 years of age or older 3) Histologically or cytologically proven non‐small cell lung carcinoma 4) Clinical stage III, IV or recurrent disease after surgery 5) With or without measurable lesions 6) Without symptomatic central nervous system metastases 7) Without uncontrollable cardiac effusion, pleural effusion, ascites, superior vena cava syndrome or spinal cord compression 8) No prior chemotherapy 9) No history of treatment with nintedanib, nab‐paclitaxel or immune checkpoint inhibitor 10) No prior operation under general anesthesia within 14 days before registration 11) No prior palliative radiotherapy within 14 days before registration 12) No prior biopsy under incision, thoracoscopic biopsy, or treatment for wound occurred within 7 days before registration 13) No prior blood transfusion or hematopoietic factor administration within 7 days before registration 14) No history of treatment wi