Papers

International journal
Apr 27, 2021

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).

Clinical lung cancer
  • Akira Hamada
  • Junichi Soh
  • 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
  • Display all

Volume
22
Number
6
First page
596
Last page
600
Language
English
Publishing type
Research paper (scientific journal)
DOI
10.1016/j.cllc.2021.04.006

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.

Link information
DOI
https://doi.org/10.1016/j.cllc.2021.04.006
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/34034990
ID information
  • DOI : 10.1016/j.cllc.2021.04.006
  • Pubmed ID : 34034990

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