A randomized phse 3 study of carboplatin plus nab-paclitaxel with or without nintedanib for advanced non-small-cell lung cancer with idiopathic pulmonary fibrosis
Phase 3
- Conditions
- on-small-cell lung cancer with idiopathic pulmonary fibrosis
- Registration Number
- JPRN-UMIN000026799
- Lead Sponsor
- Research Institute for Diseases of the Chest, Kyushu University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 243
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to acute exacerbation of IPF (Initiation of 2nd line chemotherapy for non-small cell lung cancer is not treated as censored)
- Secondary Outcome Measures
Name Time Method 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