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Minimal Residual Disease Guiding Adjuvant Therapy in Stage I NSCLC

NCT06709274 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 342

Last updated 2024-11-29

No results posted yet for this study

Summary

This investigator-initiated study aims to evaluate the effectiveness of minimal residual disease (MRD) as a biomarker for guiding adjuvant therapy decisions in patients with Stage I non-small-cell lung cancer (NSCLC). The study will compare outcomes between an MRD-guided management group and a standard-of-care group, focusing on whether the use of MRD information can improve the 3-year disease-free survival rate compared to existing treatment protocols. Participants in the MRD-guided management group will receive targeted therapy, immunotherapy, or observation based on their postoperative MRD status, while those in the standard-of-care group will receive treatments or observation according to current clinical guidelines.

Conditions

Interventions

DRUG

Osimertinib

80mg daily, for EGFR-positive patients

DRUG

Alectinib

600mg BID, for ALK-rearranged patients

DRUG

TORIPALIMAB INJECTION (JS001 ) combine with chemotherapy

Toripalimab 240mg + Platinum-based chemotherapy (Q3W for 4 cycles), followed by Toripalimab maintenance therapy (240mg Q3W for one year), for EGFR/ALK wildtype patients

Sponsors & Collaborators

  • Nanjing Geneseeq Technology Inc.

    collaborator INDUSTRY

  • Guangdong Association of Clinical Trials

    lead OTHER

Principal Investigators

  • Yi-Long Wu, M.D. · Guangdong Provincial People's Hospital

  • Xue-Ning Yang, M.D. · Guangdong Provincial People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-30
Primary Completion
2029-01-31
Completion
2032-01-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06709274 on ClinicalTrials.gov