Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT05536505
Brief Summary:
A prospective, multicenter clinical study designed to explore the efficacy of postoperative adjuvant EGFR-TKIs therapy based on MRD status in patients with stage IB-IIIB EGFR-mutant non-squamous non-small cell lung cancer (non-squamous NSCLC). Primary endpoints include 3-year Disease-Free Survival rate (3y-DFS) and median disease-free survival (mDFS).
Detailed Description:
All subjects enrolled in this clinical trial will receive peripheral blood MRD status assessment within 1 week and 1 month after surgery, and will be divided into MRD positive group (+) and MRD negative group (-) according to their results , followed by MRD status assessment every 12 weeks.
The MRD positive group would receive icotinib as adjuvant treatment. When the peripheral blood MRD turned negative, the subjects entered the drug withdrawal observation period. When the MRD turned positive again, the subjects resumed icotinib treatment. If EGFR T790M mutation was found, researchers would resume medication and choose osimertinib therapy.
The MRD negative group (-) directly entered the follow-up observation period. When the MRD status of peripheral blood turned positive, the subjects received osimertinib treatment. When the MRD turned negative again, the subjects entered the drug withdrawal observation period.
Study:
NCT05536505
Study Brief:
Protocol Section:
NCT05536505