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

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.

Trial Details

NCT ID
NCT07375316
Phase
PHASE2
Sponsor
Guangdong Association of Clinical Trials
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Osimertinib + Sacituzumab Tirumotecan
  • Osimertinib
Locations (sample)
  • Guangzhou, Guangdong, China|23.11667,113.25
  • Meizhou, Guangdong, China|24.28859,116.11768
  • Shantou, Guangdong, China|23.35489,116.67876
  • Shenzhen, Guangdong, China|22.54554,114.0683

Key Eligibility Criteria

  • Age ≥18 years at the time of signing the Informed Consent Form (ICF), regardless of gender;
  • Histologically or cytologically confirmed locally advanced (stage IIIB/IIIC) or metastatic (Stage IV) non-squamous NSCLC not amenable to radical su…
  • Presence of sensitizing EGFR mutation (exon 19 deletion and/or L858R);
  • Completion of 3\~5-week first-line treatment with osimertinib monotherapy. Non-PD as assessed by investigator per RECIST v1.1, and willing to under…

For full eligibility, visit ClinicalTrials.gov.

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