A ctDNA-guided Phase II Trial of Osimertinib in Combination With Sacituzumab Tirumotecan in EGFR-mutated Advanced NSCLC Patients With Positive ctDNA After lead-in Osimertinib Monotherapy

Sponsor
Guangdong Association of Clinical Trials
Study ID
NCT07375316
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

Study Details

EGFR-mutated advanced NSCLC patients without ctDNA clearance after lead-in osimertinib monotherapy have inferior PFS compared with those with ctDNA clearance. Consequently, these patients might need an intensified therapeutic strategy, such as osimertinib combined with chemotherapy or ADC. This study aims to explore the efficacy and safety of osimertinib in combination with sacituzumab tirumotecan adaptively in EGFR-mutated advanced NSCLC patients with positive ctDNA after lead-in osimertinib monotherapy.

Key Dates

Start date
Dec 15, 2025
Status verified
Apr 2026
Primary completion
Jun 30, 2028
Completion
Dec 30, 2028

Study Design

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

Arms

  • Experimental: Cohort 1: （experimental cohort）Osimertinib + Sacituzumab Tirumotecan
    Drug: Osimertinib/Sacituzumab Tirumotecan. Osimertinib (80mg QD) + Sacituzumab Tirumotecan (4 mg/m2) on Day 1 and Day 8 of 28-day cycles (4 mg/m2 Q2W).
  • Active Comparator: Cohort 2: （observational cohort）Osimertinib monotherapy
    Drug: Osimertinib •Osimertinib (80mg QD).

Primary Outcome Measure

Progression-free Survival (PFS) in Cohort 1, Assessed by Investigator [ Time Frame: From date of start of combinational treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months. ]

Central Contacts

Related Studies