Minimal Residual Disease Guiding Adjuvant Therapy in Stage I NSCLC

Sponsor
Guangdong Association of Clinical Trials
Study ID
NCT06709274
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Osimertinib — DRUG
    80mg daily, for EGFR-positive patients
  • Alectinib — DRUG
    600mg BID, for ALK-rearranged patients
  • TORIPALIMAB INJECTION (JS001 ) combine with chemotherapy — DRUG
    Toripalimab 240mg + Platinum-based chemotherapy (Q3W for 4 cycles), followed by Toripalimab maintenance therapy (240mg Q3W for one year), for EGFR/ALK wildtype patients

Study Details

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.

Key Dates

Start date
Nov 30, 2024
Status verified
Nov 2024
Primary completion
Jan 31, 2029
Completion
Jan 31, 2032

Study Design

Enrollment
342 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MRD-guided management
    Patients who are MRD-positive after surgery in the MRD-guided management group receive adjuvant therapy. Patients who are MRD-negative in the MRD-guided management group are monitored through observation.
  • No Intervention: Standard of care
    Adjuvant therapy is not recommended. However, if the physician and patient decide on adjuvant therapy, the treatment regimen and cycle must be documented. Researchers are strongly advised to follow the medication guidelines laid out in the Chinese Society of Clinical Oncology (CSCO) Clinical Practice Guidelines.

Primary Outcome Measure

3-Year disease-free survival (DFS) Rate [ Time Frame: 3 years post randomization ]

Central Contacts

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