Nintedanib plus chemotherapy for nonsmall cell lung cancer with idiopathic pulmonary fibrosis: a randomised phase 3 trial

Kohei Otsubo, Junji Kishimoto, Masahiko Ando, Hirotsugu Kenmotsu, Yuji Minegishi, Hidehito Horinouchi, Terufumi Kato, Eiki Ichihara, Masashi Kondo, Shinji Atagi, Motohiro Tamiya, Satoshi Ikeda, Toshiyuki Harada, Shinnosuke Takemoto, Hidetoshi Hayashi, Keita Nakatomi, Yuichiro Kimura, Yasuhiro Kondoh, Masahiko Kusumoto, Kazuya IchikadoNobuyuki Yamamoto, Kazuhiko Nakagawa, Yoichi Nakanishi, Isamu Okamoto

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39 Citations (Scopus)


Background Idiopathic pulmonary fibrosis (IPF) is a fatal lung disease implicated as an independent risk factor for lung cancer. However, optimal treatment for advanced lung cancer with IPF remains to be established. We performed a randomised phase 3 trial (J-SONIC) to assess the efficacy and safety of nintedanib plus chemotherapy (experimental arm) compared with chemotherapy alone (standard-of-care arm) for advanced nonsmall cell lung cancer (NSCLC) with IPF. Methods Chemotherapy-naïve advanced NSCLC patients with IPF were allocated to receive carboplatin (area under the curve of 6 on day 1) plus nanoparticle albumin-bound paclitaxel (nab-paclitaxel) (100 mg·m−2 on days 1, 8 and 15) every 3 weeks with or without nintedanib (150 mg twice daily, daily). The primary end-point was exacerbation-free survival (EFS). Results Between May 2017 and February 2020, 243 patients were enrolled. Median EFS was 14.6 months in the nintedanib plus chemotherapy group and 11.8 months in the chemotherapy group (hazard ratio (HR) 0.89, 90% CI 0.67–1.17; p=0.24), whereas median progression-free survival was 6.2 and 5.5 months, respectively (HR 0.68, 95% CI 0.50–0.92). Overall survival was improved by nintedanib in patients with nonsquamous histology (HR 0.61, 95% CI 0.40–0.93) and in those at GAP (gender–age–physiology) stage I (HR 0.61, 95% CI 0.38–0.98). Seven (2.9%) out of 240 patients experienced acute exacerbation during study treatment. Conclusions The primary end-point of the study was not met. However, carboplatin plus nab-paclitaxel was found to be effective and tolerable in advanced NSCLC patients with IPF. Moreover, nintedanib in combination with such chemotherapy improved overall survival in patients with nonsquamous histology.

Original languageEnglish
Article number2200380
JournalEuropean Respiratory Journal
Issue number6
Publication statusPublished - 01-12-2022

All Science Journal Classification (ASJC) codes

  • Pulmonary and Respiratory Medicine


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