Abstract 534TiP
Background
Idiopathic pulmonary fibrosis (IPF) is a fatal lung disease characterized by worsening dyspnea and progressive loss of lung function. Acute exacerbation of IPF is associated with high morbidity and mortality. Several studies have provided evidence of an association between lung cancer and IPF, with a prevalence of lung cancer in IPF patients ranging from 9.8% to 38%. Although the efficacy of nintedanib for IPF has been demonstrated, it has remained unknown whether this agent also reduces the risk of chemotherapy-induced acute exacerbation of IPF. Patients with interstitial pneumonia have been excluded from most prospective clinical trials for NSCLC because of the risk of acute exacerbation, with a few prospective single-arm phase II studies having been reported. In addition, it has been difficult to perform a randomized prospective clinical trial for patients with advanced NSCLC and IPF because of their rarity. Therefore, the optimal chemotherapy regimen for advanced NSCLC with IPF has thus remained unclear.
Trial design
Chemotherapy-naïve patients with advanced NSCLC associated with IPF (enrolment target of n = 240) are randomized at a 1:1 ratio to receive four cycles of carboplatin (AUC 6 on day 1) plus nab-paclitaxel (100 mg/m2 on days 1, 8, and 15) administered every 3 weeks either without (arm A) or with (arm B) nintedanib (150 mg b.i.d., daily), to be followed in arm B by single-agent administration of nintedanib (150 mg b.i.d., daily). The primary end point of the study is time to acute exacerbation of IPF. Study enrolment began in May 2017 and is to continue for 3 years.
Clinical trial identification
Legal entity responsible for the study
Isamu Okamoto.
Funding
Nippon Boehringer Ingelheim and Japan Agency for Medical Research and Development.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
205P - Treatment pattern and outcomes of radium-223 (Ra223) in metastatic castration resistant prostate cancer (mCRPC): Retrospective cohort analysis from Hong Kong
Presenter: Darren Poon
Session: Poster display session
Resources:
Abstract
206P - Population-based validation of the risk stratification among prostate cancer patients
Presenter: Mu Xie
Session: Poster display session
Resources:
Abstract
211P - Adjuvant axitinib in Asian vs non-Asian patients with metastatic renal cell carcinoma (mRCC): ATLAS trial subgroup analysis
Presenter: Chi Fai Ng
Session: Poster display session
Resources:
Abstract
212P - Immunotherapy with nivolumab in metastatic renal cell carcinoma patients in India: Bringing a change in clinical practice
Presenter: Amit Rauthan
Session: Poster display session
Resources:
Abstract
213P - An observational retrospective real-world study of sarcomatoid renal cell carcinoma (sRCC) patients in an Asian cancer centre
Presenter: Ravindran Kanesvaran
Session: Poster display session
Resources:
Abstract
214P - Targeting epithelial-mesenchymal transition (EMT), novel strategy to delay resistance or re-sensitize renal cancer to Sunitinib
Presenter: Revati Sharma
Session: Poster display session
Resources:
Abstract
215P - Radiologic and pathologic tumour size variation in localized renal cell carcinoma and its implications
Presenter: Shanky Singh
Session: Poster display session
Resources:
Abstract
216P - Partial versus radical nephrectomy: 10- year long-term survival among patients with Wilms tumour
Presenter: Mira Mostafa
Session: Poster display session
Resources:
Abstract
217P - Neutrophil-to-lymphocyte ratio is a useful biomarker for predicting worse clinical outcome in chemo-resistant urothelial carcinoma patients treated with pembrolizumab
Presenter: Koichiro Ogihara
Session: Poster display session
Resources:
Abstract
219P - Long-term outcomes of bladder preservation in muscle-invasive bladder cancer patients
Presenter: Amanda Dania Satiti
Session: Poster display session
Resources:
Abstract