Treatment Rationale and Design for J-SONIC: A Randomized Study of Carboplatin Plus Nab-paclitaxel With or Without Nintedanib for Advanced Non–Small-cell Lung Cancer With Idiopathic Pulmonary Fibrosis

Kohei Otsubo, Junji Kishimoto, Hirotsugu Kenmotsu, Yuji Minegishi, Eiki Ichihara, Akira Shiraki, Terufumi Kato, Shinji Atagi, Hidehito Horinouchi, Masahiko Ando, Yasuhiro Kondoh, Masahiko Kusumoto, Kazuya Ichikado, Nobuyuki Yamamoto, Yoichi Nakanishi, Isamu Okamoto

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Abstract

We describe the treatment rationale and procedure for a randomized study (J-SONIC; University Hospital Medical Information Network Clinical Trials Registry identification no., UMIN000026799) of carboplatin plus nanoparticle albumin-bound paclitaxel (nab-paclitaxel) with or without nintedanib for patients with advanced non–small cell lung cancer (NSCLC) and idiopathic pulmonary fibrosis (IPF). The study was designed to examine the efficacy and safety of nintedanib administered with carboplatin plus nab-paclitaxel versus carboplatin plus nab-paclitaxel alone in chemotherapy-naive patients with advanced NSCLC associated with IPF. Eligible patients (enrollment target, n = 170) will be randomized at a 1:1 ratio to receive 4 cycles of carboplatin (area under the curve, 6 on day 1) plus nab-paclitaxel (100 mg/m 2 on days 1, 8, and 15) administered every 3 weeks either without (arm A) or with (arm B) nintedanib (150 mg twice daily), to be followed in arm B by single-agent administration of nintedanib (150 mg twice daily). The present trial is the first randomized controlled study for the treatment of NSCLC associated with IPF. The goal of the study is to demonstrate that nintedanib combined with carboplatin plus nab-paclitaxel prolongs the interval to acute exacerbation of IPF compared with carboplatin plus nab-paclitaxel alone.

Original languageEnglish
Pages (from-to)e5-e9
JournalClinical Lung Cancer
Volume19
Issue number1
DOIs
Publication statusPublished - Jan 1 2018

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Idiopathic Pulmonary Fibrosis
Carboplatin
Non-Small Cell Lung Carcinoma
Nanoparticles
Therapeutics
Information Services
Area Under Curve
Registries
nintedanib
130-nm albumin-bound paclitaxel
Albumin-Bound Paclitaxel
Clinical Trials
Safety
Drug Therapy

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

Cite this

Treatment Rationale and Design for J-SONIC : A Randomized Study of Carboplatin Plus Nab-paclitaxel With or Without Nintedanib for Advanced Non–Small-cell Lung Cancer With Idiopathic Pulmonary Fibrosis. / Otsubo, Kohei; Kishimoto, Junji; Kenmotsu, Hirotsugu; Minegishi, Yuji; Ichihara, Eiki; Shiraki, Akira; Kato, Terufumi; Atagi, Shinji; Horinouchi, Hidehito; Ando, Masahiko; Kondoh, Yasuhiro; Kusumoto, Masahiko; Ichikado, Kazuya; Yamamoto, Nobuyuki; Nakanishi, Yoichi; Okamoto, Isamu.

In: Clinical Lung Cancer, Vol. 19, No. 1, 01.01.2018, p. e5-e9.

Research output: Contribution to journalArticle

Otsubo, K, Kishimoto, J, Kenmotsu, H, Minegishi, Y, Ichihara, E, Shiraki, A, Kato, T, Atagi, S, Horinouchi, H, Ando, M, Kondoh, Y, Kusumoto, M, Ichikado, K, Yamamoto, N, Nakanishi, Y & Okamoto, I 2018, 'Treatment Rationale and Design for J-SONIC: A Randomized Study of Carboplatin Plus Nab-paclitaxel With or Without Nintedanib for Advanced Non–Small-cell Lung Cancer With Idiopathic Pulmonary Fibrosis', Clinical Lung Cancer, vol. 19, no. 1, pp. e5-e9. https://doi.org/10.1016/j.cllc.2017.06.003
Otsubo, Kohei ; Kishimoto, Junji ; Kenmotsu, Hirotsugu ; Minegishi, Yuji ; Ichihara, Eiki ; Shiraki, Akira ; Kato, Terufumi ; Atagi, Shinji ; Horinouchi, Hidehito ; Ando, Masahiko ; Kondoh, Yasuhiro ; Kusumoto, Masahiko ; Ichikado, Kazuya ; Yamamoto, Nobuyuki ; Nakanishi, Yoichi ; Okamoto, Isamu. / Treatment Rationale and Design for J-SONIC : A Randomized Study of Carboplatin Plus Nab-paclitaxel With or Without Nintedanib for Advanced Non–Small-cell Lung Cancer With Idiopathic Pulmonary Fibrosis. In: Clinical Lung Cancer. 2018 ; Vol. 19, No. 1. pp. e5-e9.
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AU - Minegishi, Yuji

AU - Ichihara, Eiki

AU - Shiraki, Akira

AU - Kato, Terufumi

AU - Atagi, Shinji

AU - Horinouchi, Hidehito

AU - Ando, Masahiko

AU - Kondoh, Yasuhiro

AU - Kusumoto, Masahiko

AU - Ichikado, Kazuya

AU - Yamamoto, Nobuyuki

AU - Nakanishi, Yoichi

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