NCT07058519 - A Study of Osimertinib-based Adaptive Treatment Guided by ctDNA EGFRm+ Monitoring in NSCLC | Biotech Hunter

Enrollment

250

Participants

Timeline

Start Date

September 23, 2025

Primary Completion Date

January 24, 2029

Study Completion Date

January 24, 2029

Conditions

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

Interventions

DRUG

Osimertinib-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.

DRUG

Osimertinib 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.

Trial Locations (1)

200030

RECRUITING

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