Actively Recruiting
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
Led by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Updated on 2026-05-11
60
Participants Needed
1
Research Sites
343 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, aged 18 to 75 years at consent
- Confirmed diagnosis of Non-Small Cell Lung Cancer by tissue or cell analysis
- No previous systemic anti-tumor therapy
- No previous local treatment for NSCLC
- Presence of EGFR sensitizing mutations confirmed by tumor analysis
- ECOG performance status of 0 or 1 within 7 days before randomization
- At least one measurable target lesion per RECIST v1.1
- Life expectancy of at least 24 weeks
- Adequate organ and bone marrow function
- Agreement to use effective contraception from consent until 6 months after last dose for those of childbearing potential
- Ability to voluntarily join and comply with study visits and procedures
You will not qualify if you...
- Tumors with more than 10% combined small cell lung cancer, neuroendocrine carcinoma, carcinosarcoma, or squamous cell carcinoma components
- Other malignant tumors within 3 years before randomization
- Abnormal resting ECG results considered clinically significant
- Presence of cardiovascular or cerebrovascular diseases or risk factors
- Uncontrolled systemic diseases as judged by investigator
- History or current interstitial lung disease, drug-induced ILD, or non-infectious pneumonitis
- Severe lung damage from lung disorders
- Systemic corticosteroids over 10 mg/day prednisone or immunosuppressive drugs within 2 weeks before randomization
- Active pulmonary tuberculosis
- History of allogeneic organ or hematopoietic stem cell transplant
- Active hepatitis B infection
- Positive HIV test or history of AIDS; active syphilis infection
- Known severe allergies to osimertinib, sacituzumab tirumotecan, or related components
- Receipt of live vaccine within 30 days before randomization or planned during study
- Pregnant or breastfeeding women
- Any condition interfering with safety, study drug evaluation, or result interpretation as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
Research Team
Y
Yina Diao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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