Clinical Trial

A Study of Osimertinib-based Adaptive Treatment Guided by ctDNA EGFRm+ Monitoring in NSCLC

Recruiting Phase 2
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Summary
The goal of this adaptive, interventional study is to assess the efficacy and safety of osimertinib-based adaptive treatment based on ctDNA dynamic monitoring in locally advanced or metastatic EGFRm NSCLC participants with ctDNA EGFRm clearance after osimertinib plus chemotherapy. The main questions it aims to answer are: 1) PFS during adaptive treatment period in Cohort 1 defined as from initiation of Osimertinib in adaptive period to progression per investigator assessment; 2) Time from initiation of osimertinib in adaptive period to first ctDNA EGFRm relapse or death
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-06-30; most recent amendment 2025-11-24.
Status change: Not Yet Recruiting → Recruiting 2025-09-24
Trial Details
NCT Number NCT07058519
Lead Sponsor Shanghai Chest Hospital
Collaborators: AstraZeneca
Conditions Locally Advanced or Metastatic EGFRm Non-small Cell Lung Cancer (NSCLC)
Enrollment 250 participants
Start Date 2025-09-23
Primary Completion 2029-01-24 (estimated)
Study Completion 2029-01-24 (estimated)
Updated on ClinicalTrials.gov 2025-11-26