Clinical Trial

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

Recruiting Phase 2
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Summary
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2026-01-21; most recent amendment 2026-05-21.
Trial Details
NCT Number NCT07375316
Lead Sponsor Guangdong Association of Clinical Trials
Conditions Non Small Cell Lung Cancer
Enrollment 120 participants
Start Date 2025-12-15
Primary Completion 2028-06-30 (estimated)
Study Completion 2028-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-26