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

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

Trial Details

NCT ID
NCT07058519
Phase
PHASE2
Sponsor
Shanghai Chest Hospital
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Osimertinib-based adaptive treatment
  • Osimertinib 80 MG
Locations (sample)
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806

Key Eligibility Criteria

  • Provision of signed and dated, written informed consent form (ICF) prior to any study specific procedures.
  • Male or female participants aged 18 years old and above.
  • ECOG PS of 0-1.
  • Life expectancy of at least 3 months at recruitment.

For full eligibility, visit ClinicalTrials.gov.

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