Non-small-cell lung cancer with idiopathic pulmonary fibrosis
Conditions
Interventions
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)
Sponsors
Research Institute for Diseases of the Chest, Kyushu University
Eligibility
Sex/Gender
All
Inclusion criteria
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 with pirfenidone, cyclophosphamide, cyclosporine within 56 days before registration 15) No history of systemic treatment with steroid at a daily dose of more than 15mg in prednisolone equivalent. 16) Definite honeycomb lung destruction with basal and peripheral predominance or presence of reticular abnormality and traction bronchiectasis consistent with fibrosis with basal and peripheral predominance. 17) DLCO 36% to 79% predicted of normal 18) FVC >= 50% predicted of normal 19) SpO2 >= 90% or PaO2 >= 60 torr under room air conditions 20) ECOG performance status of 0 or 1 21) Correspond to the following values in laboratory tests performed within 14 days before registration a. Neutrophil count >= 1,500 /mm3 b. Hemoglobin >= 9.0 g/dL c. Platelet count >= 100,000 /mm3 d. Total bilirubin <= 1.5 mg/dL e. AST <= 100 IU/L f. ALT <= 100 IU/L g. Creatinine <= 2.0 mg/dL h. PT-INR <= 2 i. Proteinuria <= Grade1 (CTCAE ver 4.0)
Exclusion criteria
Exclusion criteria: 1) Ground glass opacity is less extensive than reticular opacity pattern 2) History of acute exacerbation of IPF 3) Other interstitial lung disease of known etiology including infection, pneumoconiosis, drug-induced pneumonitis, sarcoidosis, and collagen vascular disease 4) Synchronous or metachronous active double malignancies 5) With serious complications 6) With high bleeding risks 7) Local or systemic active infection that requires treatment 8) Pregnant, possibly pregnant or breastfeeding, or unwilling to practice contraception during the study 9) Severe psychiatric diseases 10) History of serious drug allergies 11) Other conditions not suitable for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to acute exacerbation of IPF (Initiation of 2nd line chemotherapy for non-small cell lung cancer is not treated as censored) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactShinichiro Nakamura
West Japan Oncology Group WJOG datacenter
Outcome results
None listed