A randomized phase II study of S-1 monotherapy versus cisplatin with vinorelbine for completely resected stage II/IIIA non-small cell lung cancer: rationale and study protocol design for the LOGIK1702 study

Tomoshi Tsuchiya,Shoji Tokunaga,Ryoichiro Doi,Koichi Tomoshige,Hironosuke Watanabe,Kenji Sugio,Keitaro Matsumoto,Hiroyuki Yamaguchi,Takeshi Nagayasu,Takuro Miyazaki

doi:10.1186/s12885-021-07945-y

Abstract

BackgroundThe current standard postoperative treatment for stage II-IIIA non-small cell lung cancer (NSCLC) is a regimen of platinum doublet adjuvant chemotherapy. These regimens, which are the same as for solid NSCLC tumors, often cause severe adverse reactions in the treated patients. Therefore, an effective treatment regimen with fewer side effects is needed.Methods/designThe purpose of this study is to evaluate the effectiveness and safety of S-1 monotherapy (80 mg/m2 orally administrated twice daily, at day 1–14, 16 cycles) and cisplatin with vinorelbine combination therapy (cisplatin 80 mg/m2 at day 1,vinorelbine 25 mg/m2 at day 1, 8, 4 cycles) in patients with II/IIIA stage non-small-cell lung cancer who underwent a total resection. In addition, we will also evaluate the level of treatment side effects by assessing quality of life (QOL), work productivity and activity performance. The primary endpoint is a 2-year relapse free survival (RFS) and the second primary endpoints are 2-year overall survival (OS), rate of treatment completion, safety, work productivity and activity, and quality of adjusted life years (QALY). At the same time, we aim to obtain precise information required to perform future phase 3 randomized controlled trials. The study is designed to estimate the primary endpoint with accuracy determined as the width of its 95% confidence interval to be less than 20%. Recruitment started in May 2017 and is ongoing.DiscussionThis study has been conceived to establish a superior regimen for completely resected NSCLC based on efficacy, safety and QOL.Trial registrationRegistry number: UMIN000027435. Registered May 22, 2017.

Highlights

The current standard postoperative treatment for stage II-IIIA non-small cell lung cancer (NSCLC) is a regimen of platinum doublet adjuvant chemotherapy
Since 2004, cisplatin with vinorelbine has been the preferred treatment for patients who have undergone complete resection of stage II to IIIA NSCLC and the recommended regimen has not been changed in more than 16 years
Because the adverse reactions are severe in the cisplatin with vinorelbine regime, the Lung Cancer Group in Kyusyu (LOGIK) is conducting the LOGIK1702 study in order to compare the efficacy of milder chemotherapy using S-1 compared to the standard regimen of cisplatin with vinorelbine

Summary

Introduction

The current standard postoperative treatment for stage II-IIIA non-small cell lung cancer (NSCLC) is a regimen of platinum doublet adjuvant chemotherapy. These regimens, which are the same as for solid NSCLC tumors, often cause severe adverse reactions in the treated patients. Lung cancer remains the leading cause of cancer-related deaths worldwide. In order to prevent lung cancer recurrence, adjuvant chemotherapy in post-operative patients with stage IB-IIIA non-small cell lung cancer (NSCLC) has been established as the standard treatment [1–3]. Given the severe adverse reactions to this standard adjuvant chemotherapy and the fact that there are few remnant malignant cells in the postoperative patients, milder treatment options have been considered

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