Phase II Study of Neoadjuvant Concurrent Chemo-immuno-radiation Therapy Followed by Surgery and Adjuvant Immunotherapy for Resectable Stage IIIA-B (Discrete N2) Non–small-cell Lung Cancer: SQUAT trial (WJOG 12119L)

Akira Hamada, Junichi Sou, Akito Hata, Kiyoshi Nakamatsu, Mototsugu Shimokawa, Yasushi Yatabe, Hiroyuki Oizumi, Masahiro Tsuboi, Hidehito Horinouchi, Ichiro Yoshino, Masayuki Tanahashi, Shinichi Toyooka, Morihito Okada, Hiroyasu Yokomise, Motohiro Yamashita, Yasumasa Nishimura, Nobuyuki Yamamoto, Kazuhiko Nakagawa, Tetsuya Mitsudomi

Research output: Contribution to journalComment/debatepeer-review

2 Citations (Scopus)

Abstract

Introduction: We describe our ongoing multicenter, prospective, single-arm, phase II trial of neoadjuvant concurrent chemo-immuno-radiation therapy followed by surgical resection and adjuvant immunotherapy for resectable stage IIIA-B (discrete N2) non–small-cell lung cancer (NSCLC) (registered at the Japan Pharmaceutical Information Center, Clinical Trials Information-195069). Patients and Methods: Key inclusion criteria include (1) clinical T1-3/T4 (tumor size) N2 stage IIIA-B NSCLC, and (2) pathologically confirmed N2 without extranodal invasion (based on diagnostic imaging). Patients will receive concurrent chemoradiotherapy (carboplatin [area under the curve = 2] and paclitaxel [40 mg/m2] on days 1, 8, 15, 22, and 29, with involved-field radiation therapy [RT] [dose 50 Gy] on days 1-25) and neoadjuvant immunotherapy (durvalumab [1500 mg] on days 1 and 29). Surgical resection with mediastinal lymph node dissection is performed within 2 to 6 weeks after RT. Consolidation therapy with durvalumab is administered for up to 1 year after surgery. The primary endpoint is major pathologic response (MPR) (≤10% residual viable tumor) according to the central pathological assessment. Secondary endpoints are progression-free survival, overall survival, and safety. The sample size is planned to be 31 patients based on the exact binomial distribution with a 1-sided significance level of 5% and a power of 80%, and assuming a threshold MPR rate of 40% and an expected MPR rate of 65%. Conclusion: This trial will help establish a novel treatment strategy for resectable N2-positive NSCLC.

Original languageEnglish
JournalClinical Lung Cancer
DOIs
Publication statusAccepted/In press - 2021

Keywords

  • Chemoradiotherapy
  • Immune checkpoint inhibitors
  • Major pathologic response
  • Neoadjuvant therapy
  • Quadruple-modality therapy

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

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