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
258P - Assessment of sexual health in patients treated for ovarian cancer
Presenter: Renu Madan
Session: Poster display session
Resources:
Abstract
259P - The BOT patients fail to benefit from surgical staging procedures in prognosis and fertility outcomes: A retrospective analysis
Presenter: Li Na
Session: Poster display session
Resources:
Abstract
260P - Malignant ovarian germ cell tumours (MOGCT): Treatment results of 149 pts
Presenter: Dzhennet Chekini
Session: Poster display session
Resources:
Abstract
261P - Ovarian germ cell tumours - challenges and outcomes from a tertiary care centre in South India
Presenter: Vishnu Sreedath
Session: Poster display session
Resources:
Abstract
262P - Gestational trophoblastic tumours: Experience of the medical oncology department Hassan II University Hospital-Morocco about 29 cases
Presenter: Karima Oualla
Session: Poster display session
Resources:
Abstract
263TiP - ATHENA (GOG-3020/ENGOT-ov45): A randomised, double-blind, placebo-controlled phase III study of the poly (ADP-ribose) polymerase (PARP) inhibitor rucaparib + the PD-1 inhibitor nivolumab following frontline platinum-based chemotherapy in ovarian cancer
Presenter: Keiichi Fujiwara
Session: Poster display session
Resources:
Abstract
264TiP - ENGOT-ov43/KEYLYNK-001: A phase III trial of pembrolizumab plus chemotherapy with olaparib maintenance for first-line treatment of BRCA¬-nonmutated advanced epithelial ovarian cancer
Presenter: Keiichi Fujiwara
Session: Poster display session
Resources:
Abstract
265TiP - KEYNOTE-826: A phase III randomized study of chemotherapy with or without pembrolizumab for first-line treatment of persistent, recurrent, or metastatic cervical cancer
Presenter: Keiichi Fujiwara
Session: Poster display session
Resources:
Abstract
271P - Comparison between CHOP like regimens and DAEPOCH with or without Rituximab in adult high grade B cell lymphoma NOS; A retrospective study from a tertiary cancer hospital in South India
Presenter: LALATENDU MOHARANA
Session: Poster display session
Resources:
Abstract
272P - Melatonin increases the chemosensitivity of diffuse large Bell lymphoma cells to Epirubicin by inhibiting P-glycoprotein expression via the NF-κB pathway
Presenter: Xiuhua Sun
Session: Poster display session
Resources:
Abstract