Study of Post-Surgery Adjuvant Treatment Using EGFR-TKI Therapy Based on Minimal Residual Disease in Patients With Resectable Stage IB-IIIB EGFR-Mutant Non-Squamous Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the effectiveness of postoperative adjuvant therapy with EGFR-TKIs based on minimal residual disease MRD status in patients with stage IB-IIIB EGFR-mutant non-squamous non-small cell lung cancer NSCLC. This multicenter, prospective clinical study aims to explore whether MRD-guided treatment improves disease-free survival, with primary endpoints including the 3-year disease-free survival rate and median disease-free survival time. All participants will have their peripheral blood tested for MRD within one week and one month after surgery. Those with positive MRD results will receive icotinib as adjuvant treatment until their MRD turns negative, after which they enter a drug withdrawal observation period. If MRD becomes positive again, icotinib treatment resumes. Detection of the EGFR T790M mutation will lead to switching treatment to osimertinib. Participants with negative MRD results initially will be monitored regularly and start osimertinib treatment if MRD turns positive, followed by drug withdrawal once MRD is negative again. Participants will undergo MRD assessments at specified intervals, including every 12 weeks after surgery. Researchers will track disease progression, survival rates, and overall survival up to 100 months. The study includes careful monitoring of participants health status, laboratory tests, and treatment adherence. This approach aims to personalize treatment based on MRD status and provide close follow-up to assess outcomes and safety over an extended period.

Adjuvant Treatment Based on MRD for EGFR Mutant NSCLC