Phase II Study of Sacituzumab Tirumotecan in Combination With Osimertinib or Sacituzumab Tirumote… (NCT07329322) | Clinical Trial Compass
RecruitingPhase 2
Phase II Study of Sacituzumab Tirumotecan in Combination With Osimertinib or Sacituzumab Tirumotecan for Neoadjuvant Treatment in Patients With Resectable Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
China60 participantsStarted 2026-03-30
Plain-language summary
The aim of the study to evaluate the safety and efficacy of Sacituzumab Tirumotecan in combination with osimertinib or as monotherapy for neoadjuvant treatment in patients with resectable Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Male or female, ≥ 18 and ≤ 75 years at the time of signing the informed consent form (ICF).
✓. Histologically or cytologically confirmed NSCLC.
✓. No prior systemic anti-tumor therapy.
✓. No prior local therapy for NSCLC.
✓. Confirmed by tumor histology, or cytology to have EGFR sensitizing mutations.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.
✓. At least one target lesion as assessed by the investigator according to RECIST v1.1.
✓. Life expectancy ≥ 24 weeks.
Exclusion criteria
✕. Tumor histology or cytology confirming combined small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma or squamous cell carcinoma components of more than 10%.
✕. Participants with other malignant tumors within 3 years prior to randomization.
. Uncontrolled systemic diseases in the investigator's judgment.
✕. History of interstitial lung disease (ILD), drug-induced ILD, or non-infectious pneumonitis, have current ILD or non-infectious pneumonitis.
✕. Clinically severe lung damage due to complications of lung disorder.
✕. Participants who have received systemic corticosteroids therapy with \> 10 mg/day of prednisone or other immunosuppressive drugs within 2 weeks before randomization.