RecruitingPhase 2NCT07058519

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

The Efficacy and Safety of Osimertinib-based Adaptive Treatment Guided by Circulating Tumour DNA (ctDNA) Epidermal Growth Factor Receptor Mutation-positive (EGFRm) Dynamic Monitoring in Locally Advanced or Metastatic EGFRm Non-small Cell Lung Cancer (NSCLC) Participants With ctDNA EGFRm Clearance After First-line Osimertinib Plus Chemotherapy: A Phase II, Multicentre, Prospective Study (Adaptive)

Sponsor

Shanghai Chest Hospital

Enrollment

250 participants

Start Date

Sep 23, 2025

Study Type

INTERVENTIONAL

Conditions

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

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an adaptive treatment approach for non-small cell lung cancer (NSCLC) guided by a blood test that detects cancer DNA circulating in the bloodstream (called ctDNA). Patients on osimertinib (a targeted lung cancer drug) will have their treatment adjusted based on real-time monitoring of their cancer's genetic signals. **You may be eligible if...** - You are 18 years of age or older - You have non-small cell lung cancer with EGFR mutations (a specific gene change) - You are in good overall health (ECOG performance status 0-1) - You are able to provide blood samples for ctDNA monitoring - Your life expectancy is at least 3 months **You may NOT be eligible if...** - You have poor overall health or significant organ impairment - You are unable to follow the monitoring schedule - You have active brain metastases that are unstable - You have a history of serious lung problems such as interstitial lung disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOsimertinib-based adaptive treatment

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.

DRUGOsimertinib 80 MG

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.

Locations(1)

Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

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NCT07058519