UMIN-CTR Clinical Trial

Basic information
Public title	Lung Cancer Genomic Screening Project for Neoadjuvant and Adjuvant setting Molecular Targeted Therapy in Early-Stage Non-Small Cell Lung Cancer and the Assessment of monitoring Minimal Residual Disease
Acronym	LC-SCRUM-Advantage/MRD
Scientific Title	Lung Cancer Genomic Screening Project for Neoadjuvant and Adjuvant setting Molecular Targeted Therapy in Early-Stage Non-Small Cell Lung Cancer and the Assessment of monitoring Minimal Residual Disease
Scientific Title:Acronym	LC-SCRUM-Advantage/MRD
Region	Japan

Condition
Condition	Lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To screen any actionable oncogenic drivers in patients with early-stage non-small cell lung cancer (NSCLC) who are candidates for targeted therapy.
Basic objectives2	Others
Basic objectives -Others	To assess the utility of monitoring of Minimal Residual Disease (MRD) as a biomarker to predict recurrence and treatment response in patients with lung cancer.
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	To characterize the clinicopathological and molecular biological features of early-stage NSCLC with genetic alterations identified in the genomic screening.
Key secondary outcomes	To assess the utility of monitoring of MRD as a biomarker to predict recurrence and treatment response in patients with lung cancer.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Advantage-cohorts (Cohort A1) 1) Patients with pathologically (histology or cytology) confirmed NSCLC, clinical stage I, II and III. 2) Treatment-naive and scheduled for surgery for lung cancer MRD-cohorts (Cohort A2, A3, A4, B1 and B2) NCCLC (Cohort A2, A3 and A4) 3) Stage I, II and III, scheduled for surgery. (Cohort A2) 4) Stage III, scheduled for CRT. (Cohort A3) 5) Advanced NSCLC, scheduled for Chemotherapy (Cohort A4) SCLC (B1, B2) 6) LD-SCLC, scheduled for CRT (Cohort B1) 7) ED-SCLC, scheduled for Chemotherapy and enrolled into JCOG2002. (Cohort B2) The following is common to all cohorts. 8) Patients aged 16 years or older 9) Patients with pathologically (histology or cytology) confirmed lung cancer 10) Eastern Cooperative Oncology Group performance status (PS) of 0 or 1. However, Cohort B2 is also eligible for PS 2. 11) Patients who meet the following criteria for major organ function (assessed by a test performed within 2 weeks prior to study enrollment): - (1) Neutrophil count: >=1500/mm 3 - (2) Hemoglobin: >=8.0 g/dl - (3) Platelet count: >=7.5 x 10 4/mm 3 - (4) AST, ALT: <=ULN (upper limit of normal) x 3 (x 5 in patients with liver metastasis) - (5) Total bilirubin: <=ULN x 1.5 - (6) SpO2: >=90% 12) Patients without serious complications (e.g., interstitial pneumonitis, poorly controlled diabetes mellitus, cardiac disease, infection, etc.) 13) Patients who are expected to live for at least 3 months from the date of study enrollment 14) Patients who are able to submit samples that can be used for genetic analyses. The samples must be ones collected before the initial drug treatment 15) Patients who wish to enroll in genotype-directed clinical trials if the target gene alterations are identified in this study 16) Patients who have provided written consent to enroll in this study
Key exclusion criteria	Not applicable
Target sample size	10680

Research contact person
Name of lead principal investigator	1st name Koichi Middle name Last name Goto
Organization	National Cancer Center Hospital East
Division name	Department of Thoracic Oncology
Zip code	277-8577
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL	04-7133-1111
Email	kgoto@east.ncc.go.jp

Public contact
Name of contact person	1st name Kiyotaka Middle name Last name Yoh
Organization	National Cancer Center Hospital East
Division name	Department of Thoracic Oncology
Zip code	277-8577
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL	04-7133-1111
Homepage URL
Email	kyoh@east.ncc.go.jp

Sponsor
Institute	National Cancer Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Cancer Center Hospital East
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba
Tel	04-7133-1111
Email	irst@ml.res.ncc.go.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 09 Month 23 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2022 Year 06 Month 16 Day
Date of IRB	2022 Year 08 Month 02 Day
Anticipated trial start date	2022 Year 08 Month 29 Day
Last follow-up date	2027 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study is a prospective observational study.

Management information
Registered date	2022 Year 09 Month 20 Day
Last modified on	2022 Year 09 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055775