236TiP - Large-scale prospective observational study to develop a liquid-based detection system of minimal residual disease (MRD): LC-SCRUM-MRD

Background

MRD is a potential biomarker for predicting disease relapse or therapeutic response for lung cancer, and it is expected to establish a precise detection system by liquid biopsy. We have been conducting a prospective observational study to evaluate the clinical utility of MRD detection in lung cancer (LC-SCRUM-MRD) since August 2022, in parallel with a multicenter prospective genomic screening project in Japan (LC-SCRUM-Advantage).

Trial design

The main inclusion criteria are pathologically diagnosed treatment-naive lung cancer, 16 years of age or older, performance status 0-1, and normal organ function. A total of 10,680 patients in LC-SCRUM-Advantage/MRD will be enrolled over five years and assigned to one of six cohorts (A1 to B2) according to their histology, stage, and treatment (Table). In the MRD monitoring cohorts A2-B2 of 680 patients, we will analyze MRD every 1-6 months for up to 2 years, and computed tomography scans and serum tumor markers measurement will be performed at each time point. As for MRD analysis, we will perform tissue-based MRD detection systems that require sequencing of tumor tissue to create personalized plasma circulating tumor DNA (ctDNA) assay and liquid-based MRD detection systems that analyze plasma ctDNA by methylation profiling or urinary exosomal microRNA. The performance of these liquid-based MRD detection systems will be compared with tissue-based MRD detection systems to establish the optimal MRD detection system for lung cancer. As of April 2023, a total of 154 patients have been enrolled in LC-SCRUM-MRD across 40 institutions, and preliminary results will be presented at this meeting. Table: 236TiP

LC-SCRUM-advantage/MRD

Clinical trial identification

UMIN000048977.

Editorial acknowledgement

The authors thank all patients and their families and the staff and investigators at all study sites.

Legal entity responsible for the study

National cancer center.

Funding

Institutional funding.

Disclosure

Y. Zenke: Financial Interests, Personal, Invited Speaker: AstraZeneca, Lilly, chugai, Boheringer-ingelheim, Ono Pharmaceutical, Bristol-Meyers Squibb, Takeda Pharmaceutical, Taiho pharmaceutical, MSD, Novartis, Nippon-kayaku, Amgen, Kyowa-Hakko Kirin; Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Financial Interests, Institutional, Research Grant: AstraZeneca, MSD, Merck, Daiichi Sankyo, Amgen. K. Yoh: Financial Interests, Personal, Invited Speaker: AstraZeneca, Bristol Myers Squibb, Chugai, Daiichi sankyo, Lilly, Boehringer Ingelheim, Amgen, Takeda; Financial Interests, Institutional, Local PI: AstraZeneca, Lilly, Daiichi Sankyo, AbbVie, Taiho, MSD, Takeda, Amgen, Boehringer Ingelheim, Chugai; Financial Interests, Personal, Steering Committee Member: AstraZeneca. J. Samejima: Financial Interests, Personal, Writing Engagement: Taiho Pharmaceutical Co., Ltd, Shizenkagakusha, Stryker, Ziosoft; Financial Interests, Personal, Invited Speaker: B. Braun, Ziosoft, Johnson & Johnson, MiRXES, Taiho Pharmaceutical Co., Ltd; Financial Interests, Personal, Other, Providing surgical videos: Olympus, Johnson & Johnson. K. Kunimasa: Financial Interests, Institutional, Research Grant: Taiho Pharmaceutical Co., Ltd., AbbVie; Financial Interests, Personal, Invited Speaker: AstraZeneca, Chugai pharmaceutical, Nippon Boehringer Ingelheim, Eli Lilly Japan, Roche Diagnostics, Daiichi Sankyo, Novartis, Pfizer, Merk, Bristol Myers Squibb, Nippon Kayaku. R. Toyozawa: Financial Interests, Personal, Other, Honoraria: Chugai Pharmaceutical, Eli Lilly Japan, Taiho Pharmaceutical, Ono Pharmaceutical; Financial Interests, Personal, Other, honoraria: AstraZeneca, Takeda Pharmaceutical, MSD, Pfizer Japan; Financial Interests, Institutional, Local PI: AbbVie, Amgen, Takeda Pharmaceutical, Pfizer Japan, Daiichi Sankyo, Eli Lilly Japan, Novartis Pharma, AnHeart Therapeutics. M. Tachihara: Financial Interests, Personal, Invited Speaker: Eli Lilly Japan K.K., Chugai Pharmaceutical Co.,Ltd, AstraZeneca K.K, MSD K.K., Ono Pharmaceutical Co.,Ltd., Bristol Myers Squibb Co. Ltd.; Financial Interests, Personal and Institutional, Research Grant: AstraZeneca K.K. S. Niho: Financial Interests, Personal, Invited Speaker: AstraZeneca, Pfizer, Ono, Chugai, Eli Lilly, Takeda, Merck Biopharma, Eisai, Novartis, Kyorin, Boehringer Ingelheim, Kyowa Kirin, MSD, Nippon Kayaku, Daiichi Sankyo, Amgen; Financial Interests, Institutional, Funding: Taiho, GSK, Daiichi Sankyo, Chugai, Teijin, Eli Lilly, Kyowa Kirin, Shionogi, Boehringer Ingelheim, Kyorin, Nippon Kayaku. K. Nosaki: Financial Interests, Personal, Invited Speaker: AstraZeneca, Chugai Pharma, Lilly, MSD, Pfizer, Taiho Pharmaceutical, Jansen, Ono, Takeda, Novartis, Merck; Financial Interests, Personal, Advisory Board: Daiichi Sankyo, AbbVie; Financial Interests, Institutional, Local PI: Takeda, AstraZeneca, MSD, AbbVie, Chugai Pharma, Daiichi Sankyo/UCB Japan, Anheart Therapeutics. H. Izumi: Financial Interests, Institutional, Local PI: Amgen Inc, Eisai, AbbVie; Financial Interests, Personal and Institutional, Local PI, Invited Speaker: Ono Pharmaceutical Company, AstraZeneca; Financial Interests, Personal, Other, Invited Speaker: Chugai Pharmaceutical Co., Merck Biopharma Co., Takeda Pharmaceutical Co.; Financial Interests, Personal, Other, Advisory board: Amgen. T. Sakai: Financial Interests, Institutional, Research Grant: Amgen, Daiichi-Sankyo; Financial Interests, Personal, Invited Speaker: AstraZeneca, Chugai, Novartis, MSD, Thermo Fisher Scientific, Merck. S. Umemura: Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical. S. Matsumoto: Financial Interests, Personal, Invited Speaker: Merck Biopharma, Eli Lilly, AstraZeneca, Chugai, Nvartis, Guardant Health, Amgen, Takeda; Financial Interests, Institutional, Local PI: Merck Biopharma, Janssen Pharmaceutical K.K., MSD. M. Tsuboi: Financial Interests, Personal, Invited Speaker, Lecture: Johnson & Johnson Japan; Financial Interests, Personal, Advisory Board, Lectures, Advisory boards: AstraZeneca KK, Chugai Pharmaceutical Co.,Ltd, MSD; Financial Interests, Personal, Invited Speaker, Lectures: Eli Lilly Japan, Bristol Myers Squibb KK, Taiho Pharma, Medtronic Japan, ONO Pharmaceutical Co.,Ltd; Financial Interests, Personal, Advisory Board, Advisory boards: Novartis; Financial Interests, Personal, Invited Speaker: Daiichi Sankyo company limited; Financial Interests, Institutional, Research Grant: Boehringer Ingelheim Japan, MSD, AstraZeneca KK, Ono Pharmaceutical CO.,LTD, Bristol Myers Squibb KK, Novartis, MiRXES; Financial Interests, Personal, Steering Committee Member: MSD, AstraZeneca, Novartis; Financial Interests, Institutional, Steering Committee Member: Eli Lilly Japan. K. Goto: Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical Co., Ltd., Amgen K.K., Takeda Pharmaceutical Co., Ltd., Eli Lilly Japan K.K., Amgen Inc., Amoy Diagnosties Co.,Ltd., AstraZeneca K.K., Bayer HealthCare Pharmaceuticals Inc., Boehringer Ingelheim Japan, Inc., Bristol Myers Squibb K.K., Daiichi Sankyo Co., Ltd., Eisai Co., Ltd., Guardant Health Inc., Merck Biopharma Co., Ltd., Novartis Pharma K.K., Ono Pharmaceutical Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Thermo Fisher Scientific K.K., Taiho Pharmaceutical Co., Ltd., Syneos Health Clinical K.K., Life Technologies Japan Ltd.; Financial Interests, Personal, Advisory Board: Janssen Pharmaceutical K.K., Medpace Japan K.K., Haihe Biopharma Co., Ltd.; Financial Interests, Personal and Institutional, Funding: Amgen Inc., Amgen K.K., AstraZeneca K.K., Boehringer Ingelheim Japan, Inc., Bristol Myers Squibb K.K., Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Eisai Co., Ltd., Eli Lilly Japan K.K., Haihe Biopharma Co., Ltd., Ignyta,Inc., Janssen Pharmaceutical K.K., Kissei Pharmaceutical Co., Ltd., Kyowa Kirin Co., Ltd., Loxo Oncology, Inc., Medical ＆ Biological Laboratories Co., Ltd., Merck Biopharma Co., Ltd., Merus N.V., MSD K.K., Ono Pharmaceutical Co., Ltd., Pfizer Japan Inc., Sysmex Corporation., Taiho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Turning Point Therapeutics,Inc., Amgen Astellas BioPharma K.K., Bayer Yakuhin, Ltd., Blueprint Medicines Corporation., Life Technologies Japan Ltd., NEC Corporation., Novartis Pharma K.K., Craif Inc., Pfizer R&D Japan G.K., Turning Point Therapeutics,Inc.; Non-Financial Interests, Member: American Society of Clinical Oncology, The Japan Lung Cancer Society, Japanese Society of Medical Oncology, The Japanese Cancer Association. All other authors have declared no conflicts of interest.