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

Sponsor
Shanghai Chest Hospital
Study ID
NCT07058519
Phase
PHASE2
Status
Recruiting
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Conditions

  • Locally Advanced or Metastatic EGFRm Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Osimertinib-based adaptive treatment — DRUG
    Participants in Cohort 1 will receive Osimertinib-based adaptive treatment (either Osimertinib monotherapy or Osimertinib plus chemotherapy) depending on ctDNA EGFRm clearance or relapse by ctDNA EGFRm dynamic monitoring, until radiological disease progression (PD) as per RECIST v1.1 or other withdrawal criteria are met.
  • Osimertinib 80 MG — DRUG
    Participants in Cohort 2 will receive Osimertinib 80 mg once daily (QD) plus pemetrexed maintenance every 3 weeks (Q3W) until radiological PD as per RECIST v1.1 or other withdrawal criteria are met.

Study Details

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

Key Dates

Start date
Sep 23, 2025
Status verified
Sep 2025
Primary completion
Jan 24, 2029
Completion
Jan 24, 2029

Study Design

Enrollment
250 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 (EGFRm ctDNA Clearance Group)
    EGFRm ctDNA Clearance Group
  • Experimental: Cohort 2 (ctDNA EGFRm non-clearance group)

Primary Outcome Measure

Progression-Free Survival (PFS) in Cohort 1 [ Time Frame: From initiation of osimertinib in the adaptive therapy period until radiological disease progression or death (up to 33 months). ]

Central Contacts