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

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 - LC-SCRUM-Advantage/MRD

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000048977

Enrollment

10680

Registered

2022-09-23

Start date

2022-08-29

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Not applicable

Design outcomes

Primary

Measure	Time frame
To characterize the clinicopathological and molecular biological features of early-stage NSCLC with genetic alterations identified in the genomic screening.	—

Secondary

Measure	Time frame
To assess the utility of monitoring of MRD as a biomarker to predict recurrence and treatment response in patients with lung cancer.	—

Countries

Japan

Contacts

Public ContactKiyotaka Yoh

National Cancer Center Hospital East Department of Thoracic Oncology

kyoh@east.ncc.go.jp04-7133-1111

Outcome results