Phase I/II study of biweekly nab-paclitaxel in patients with platinum-pretreated non-small cell lung cancer: NJLCG1402

Eisaku Miyauchi, Hisashi Tanaka, Atsushi Nakamura, Toshiyuki Harada, Taku Nakagawa, Mami Morita, Daisuke Jingu, Tomoya Kuda, Shunichi Gamou, Ryota Saito, Akira Inoue

Research output: Contribution to journalArticlepeer-review

Abstract

Background: NJLCG1402 was a phase I/II trial investigating biweekly nanoparticle albumin-bound paclitaxel (nab-PTX) in patients with advanced non-small cell lung cancer (NSCLC). Methods: The study included patients aged ≥20 years with previously treated NSCLC. Nab-PTX (100–150 mg/m2) was administered biweekly in a 28-day cycle. The phase I portion was performed to determine the recommended phase II dose of nab-PTX. In the phase II portion, the primary endpoint was the objective response rate. Secondary endpoints were disease control rate, progression-free survival, overall survival, and safety. Results: A total of 15 patients received biweekly nab-PTX (100–150 mg/m2) and 12 patients in phase II were treated with 150 mg/m2. In the phase I portion, 150 mg/m2 was determined as the recommended dose. Among those treated with 150 mg/m2, the objective response rate was 22%, and the median progression-free and overall survival was 3.6 and 11.2 months, respectively. Adverse events grade ≥3 were observed in 39% of patients. Conclusions: Biweekly nab-PTX monotherapy was well tolerated and exhibited favorable antitumor activity in patients with previously treated NSCLC.

Original languageEnglish
Pages (from-to)2886-2893
Number of pages8
JournalThoracic Cancer
Volume12
Issue number21
DOIs
Publication statusPublished - 2021 Nov

Keywords

  • nab-PTX monotherapy
  • non-small cell lung cancer
  • phase I/II trial

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine

Fingerprint

Dive into the research topics of 'Phase I/II study of biweekly nab-paclitaxel in patients with platinum-pretreated non-small cell lung cancer: NJLCG1402'. Together they form a unique fingerprint.

Cite this