Minimal Residual Disease (MRD)-Guided Adjuvant Therapy in Stage I Non-Small Cell Lung Cancer: A Prospective, Multicenter, Randomized Controlled Study
Overview
- Phase
- Not Applicable
- Intervention
- Osimertinib
- Conditions
- Non-Small Cell Lung Cancer
- Sponsor
- Guangdong Association of Clinical Trials
- Enrollment
- 342
- Locations
- 15
- Primary Endpoint
- 3-Year disease-free survival (DFS) Rate
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief 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.
Investigators
Xue-Ning Yang
Principal Investigator
Guangdong Association of Clinical Trials
Eligibility Criteria
Inclusion Criteria
- •Non-small cell lung cancer (NSCLC) confirmed by histological and/or cytological examination. Invasive subtypes are required for adenocarcinomas.
- •Stage IA or IB after surgery based on pathological TNM8 staging criteria established by the International Union Against Cancer/American Joint Committee on Cancer (8th Edition).
- •Completely surgical resection (R0) of the primary NSCLC via lobectomy, segmentectomy, or sleeve lobectomy. The gross tumor must be entirely removed, and all surgical margins of the excised tumor must be negative.
- •Complete recovery from surgery with no evidence of disease progression within 2 weeks prior to the first treatment decision.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-
- •Minimum life expectancy of ≥12 weeks.
- •Demonstrate adequate organ function, including:
- •Hematological parameters:
- •Absolute neutrophil count ≥1.5×10\^9/L
- •Platelet count ≥100×10\^9/L
Exclusion Criteria
- •Histopathologically confirmed small cell carcinoma components.
- •Presence of multiple pulmonary nodules.
- •Incomplete resections (R1/R2) or resections via bilateral lobectomy, pneumonectomy, or wedge resection.
- •A history of any systemic anti-tumor treatment, including but not limited to surgery, neoadjuvant chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
- •Significant allergies to any targeted drugs, immunotherapies, or chemotherapy agents used in the study.
- •Previous use of any traditional Chinese medicine with anti-tumor properties, or use of such medicine within 2 weeks prior to surgery.
- •History of other malignancies within the past 5 years, with the exception of the following:
- •Other malignancies fully cured by surgery with a disease-free survival of more than 10 years
- •Curable basal cell carcinoma of the skin
- •Bladder carcinoma in situ
Arms & Interventions
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.
Intervention: Osimertinib
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.
Intervention: Alectinib
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.
Intervention: TORIPALIMAB INJECTION (JS001 ) combine with chemotherapy
Outcomes
Primary Outcomes
3-Year disease-free survival (DFS) Rate
Time Frame: 3 years post randomization
The proportion of patients remain disease-free at the 3-year mark starting from the day of randomization
Secondary Outcomes
- 5-Year disease-free survival (DFS) Rate(5 years post randomization)
- 5-Year overall survival (OS) rate(5 years post randomization)
- Disease-free survival (DFS)(Up to 8 years post randomization)
- Overall survival(Up to 8 years post randomization)
- Quality of Life (QoL) Assessed using the EORTC QLQ-C30 (Version 3.0)(Up to 8 years post randomization)
- Quality of Life (QoL) Assessed using the EORTC QLQ-LC13(Up to 8 years post randomization)