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
520P - A phase II study to evaluate abscopal effect by palliative radiation therapy in nivolumab treatment for pretreated non-small cell lung cancer (HANSHIN 0116)
Presenter: Akito Hata
Session: Poster display session
Resources:
Abstract
504P - A single center report for safety and efficacy of CT-707 in Chinese patients with advanced, anaplastic lymphoma kinase-rearranged non-small cell lung cancer or other tumours
Presenter: Peng Song
Session: Poster display session
Resources:
Abstract
519P - Initial results of lung cancer genomic screening project for individualized medicine in Asia: LC-SCRUM-Asia
Presenter: Chih-Hsi Kuo
Session: Poster display session
Resources:
Abstract
521P - A randomized, phase II study comparing irinotecan versus amrubicin as maintenance therapy after first-line induction therapy for extensive disease small cell lung cancer (HOT1401/NJLCG1401)
Presenter: Keisuke Baba
Session: Poster display session
Resources:
Abstract
526P - A phase II study of apatinib in patients with recurrent/metastatic esophageal squamous cell carcinoma (ESCC)
Presenter: Li Chu
Session: Poster display session
Resources:
Abstract
499P - Prevalence of uncommon epidermal growth factor receptor (EGFR) alterations detected by circulating tumour DNA (ctDNA) in non-small cell lung cancer (NSCLC) patients in Hong Kong
Presenter: Oscar Siu Hong Chan
Session: Poster display session
Resources:
Abstract
489P - Overall survival in patients with EGFRm+ NSCLC receiving sequential afatinib and osimertinib: Updated analysis of the GioTag study
Presenter: Maximilian J. Hochmair
Session: Poster display session
Resources:
Abstract
509P - Second-line treatment after first-line vinorelbine in advanced platinum unfit NSCLC patients: An exploratory analysis of randomized Tempo-Lung trial
Presenter: Andrea Camerini
Session: Poster display session
Resources:
Abstract
500P - Clinico-molecular characteristics of Chinese primary non-small cell lung cancer patients with compound EGFR mutations
Presenter: Jianchun Duan
Session: Poster display session
Resources:
Abstract
527P - A multicenter study of NRG1 fusions in Chinese non-small cell lung cancer patients and response to afatinib using next generation sequencing
Presenter: Xingliang Li
Session: Poster display session
Resources:
Abstract