A multi-institutional randomized phase III study comparing weekly carboplatin plus nab-paclitaxel and daily low-dose carboplatin as regimens for concurrent chemoradiotherapy in elderly patients with unresectable locally advanced non-small cell lung cancer: Japan Clinical Oncology Group Study JCOG1914

Jpn J Clin Oncol. 2021 Apr 30;51(5):836-841. doi: 10.1093/jjco/hyab025.


Daily low-dose carboplatin plus concurrent thoracic radiotherapy is the standard treatment for elderly patients with unresectable clinical stage (c-Stage) III non-small cell lung cancer (NSCLC) in Japan. However, a phase I study by Omori et al. suggests that weekly carboplatin and nab-paclitaxel plus concurrent thoracic radiotherapy have comparable efficacy outcomes with more manageable adverse events. In December 2020, we initiated a randomized controlled trial in Japan to confirm whether the weekly carboplatin plus nab-paclitaxel regimen is noninferior to the daily low-dose carboplatin regimen for concurrent chemoradiotherapy in elderly patients with unresectable c-Stage III NSCLC. We plan to enroll 166 patients from 50 institutions in 3.5 years. The primary endpoint is overall survival. The secondary endpoints are progression-free survival, response rate, proportion of patients starting maintenance durvalumab therapy, adverse events, site of progression, Functional Assessment of Cancer Therapy-Trial Outcome Index deterioration and Instrumental Activities of Daily Living deterioration.

Keywords: carboplatin; nab-paclitaxel; non-small cell lung cancer; radiotherapy; randomized controlled trial.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Albumins / pharmacology
  • Albumins / therapeutic use*
  • Antineoplastic Combined Chemotherapy Protocols / pharmacology
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Carboplatin / administration & dosage
  • Carboplatin / pharmacology
  • Carboplatin / therapeutic use*
  • Carcinoma, Non-Small-Cell Lung / drug therapy*
  • Carcinoma, Non-Small-Cell Lung / pathology
  • Chemoradiotherapy / methods*
  • Female
  • Humans
  • Japan
  • Lung Neoplasms / drug therapy*
  • Lung Neoplasms / pathology
  • Male
  • Paclitaxel / pharmacology
  • Paclitaxel / therapeutic use*


  • 130-nm albumin-bound paclitaxel
  • Albumins
  • Carboplatin
  • Paclitaxel