Preoperative Nivolumab to Evaluate Pathological Response in Patients with Stage I Non-small Cell Lung Cancer: a Study Protocol of Phase II Trial (POTENTIAL)

Overview

Journal BMJ Open

Specialty General Medicine

Date 2021 Mar 19

PMID 33737428

Citations 3

Authors

Atsushi Kagimoto

Yasuhiro Tsutani

Takahiro Mimae

Yoshihiro Miyata

Norihiko Ikeda

Hiroyuki Ito

Yoshimasa Maniwa

Kenji Suzuki

Masahiro Tsuboi

Kenichi Yoshimura

Seiji Umemoto

Morihito Okada

Affiliations

Soon will be listed here.

Abstract

Introduction: Recently, inhibition of programmed cell death 1 or its ligand has shown therapeutic effects on non-small cell lung cancer (NSCLC). However, the effectiveness of preoperative nivolumab monotherapy for stage I NSCLC remains unknown. The present study aimed to investigate the pathological response of preoperative treatment with nivolumab for clinically node negative but having a high risk of NSCLC recurrence.

Methods And Analysis: The Preoperative Nivolumab (Opdivo) to evaluate pathologic response in patients with stage I non-small cell lung cancer: a phase 2 trial (POTENTIAL) study is a multicentre phase II trial investigating efficacy of preoperative nivolumab for clinical stage I patients at high risk of recurrence. This study includes histologically or cytologically confirmed NSCLC patients with clinical N0 who were found on preoperative high-resolution CT to have a pure solid tumour without a ground-glass opacity component (clinical T1b, T1c or T2a) or a solid component measuring 2-4 cm in size (clinical T1c or T2a). Patients with epidermal growth factor receptor (EGFR) mutation (deletion of exon 19 or point mutation on exon21, L858R), anaplastic lymphoma kinase (ALK) translocation or c-ros oncogene 1 (ROS-1) translocation are excluded from this study. Nivolumab (240 mg/body) is administrated intravenously as preoperative therapy every 2 weeks for three cycles. Afterward, lobectomy and mediastinal lymph node dissection (ND 2a-1 or ND 2a-2) are performed. The primary endpoint is a pathological complete response in the resected specimens. The secondary endpoints are safety, response rates and major pathological response. The planed sample size is 50 patients. Patients have been enrolled since April 2019.

Ethics And Dissemination: This trial was approved by the Institutional Review Board of Hiroshima University Hospital and other participating institutions. This trial will help examine the efficacy of preoperative nivolumab therapy for clinical stage I NSCLC.

Trial Registration Number: jRCT2061180016.

Citing Articles

Clinical factors associated with high PD-L1 expression in patients with early-stage non-small cell lung cancer.

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Recent Advances in Perioperative Immunotherapies in Lung Cancer.

Fukuda S, Suda K, Hamada A, Tsutani Y Biomolecules. 2023; 13(9).

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Identification of High-Risk of Recurrence in Clinical Stage I Non-Small Cell Lung Cancer.

Tsutani Y, Shimada Y, Ito H, Miyata Y, Ikeda N, Nakayama H Front Oncol. 2021; 11:622742.

PMID: 34164334 PMC: 8215653. DOI: 10.3389/fonc.2021.622742.

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