Last reviewed · How we verify

NCT07058519

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

Recruiting now Phase 2 Last updated 26 November 2025
What this trial tests

Phase 2 trial testing Osimertinib-based adaptive treatment in Locally Advanced or Metastatic EGFRm Non-small Cell Lung Cancer (NSCLC) in 250 participants. Currently enrolling.

Timeline
23 September 2025
Primary endpoint
24 January 2029
24 January 2029

Quick facts

Lead sponsorShanghai Chest Hospital
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment250
Start date23 September 2025
Primary completion24 January 2029
Estimated completion24 January 2029
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Shanghai Chest Hospital

Who can join

18 and older, any sex, with Locally Advanced or Metastatic EGFRm Non-small Cell Lung Cancer (NSCLC). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other Shanghai Chest Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07058519.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing