Unresectable limited or extensive disease small cell lung cancer with idiopathic pulmonary fibrosis
Conditions
Interventions
The patients receive carboplatin(area under the curve 5 mg/mL, intravenously, day 1), etoposide (=75years old:80mg/m2
intravenously,days 1-3), and nintedanib (150mg twice a day, orally). The patients receive combination chemotherapy every3 weeks for 4 cycles until disease progression or unacceptable toxicity occurs.
Sponsors
IKEDA Satoshi
OGURA Takashi
Thoracic Oncology Research Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically proven small cell lung cancer 2. Unresectable limited disease or extensive disease 3. No previous chemotherapy for small cell lung cancer 4. HRCT reveal (1) Definite honeycomb lung destruction with basal and peripheral predominance : or (2) Presence of reticular abnormality and traction bronchiectasis consistent with fibrosis with basal and peripheral predominance 5. % FVC >= 50 , % DLCO >= 30 % 6. Age >= 20 years 7. ECOG Performance Status 0-2 8. With measurable lesions according to RECIST Version1.1 9. Vital organ functions are preserved 10.Received sufficient explanations about the name and severity of the illness 11. Written informed consent
Exclusion criteria
Exclusion criteria: 1.Ground glass opacity pattern less extensive than reticular opacity pattern 2.Other interstitial lung disease of known etiology (including infection, pneumoconiosis, drug-induced pneumonitis, sarcoidosis, and collagen vascular disease) 3.History of acute exacerbation of IPF 4.Synchronous or metachronous active double malignancies 5.Symptomatic brain metastasis or spinal cord metastases 6.Treatment history with pirfenidone, immunosuppressants, and N-acetylcysteine within 56 days before registration 7.Treatment history with nintedanib, cytotoxic chemotherapy, and immune checkpoint inhibitors 8.High hemorrhage risk 9.Serious complications 10.Local or systemic active infection requiring treatment 11.Pregnant, possibly pregnant, breastfeeding 12.History of serious drug allergies 13.Systemic treatment with steroids at a daily dose >10 mg of prednisolone equivalent 14.Other conditions not suitable for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the incidence of acute exacerbation of IPF at 28 days after last administration of cytotoxic anti-cancer agents (carboplatin and etoposide) | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first acute exacerbation of IPF, ORR, PFS, OS, and toxicities | — |
Contacts
Public ContactSatoshi IKEDA
Kanagawa Cardiovascular and Respiratory Center
Outcome results
None listed