UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048977
Receipt number R000055775
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
Date of disclosure of the study information 2022/09/23
Last modified on 2022/09/20 17:00:29

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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 or person

Institute

National Cancer Center

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055775


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name