Extensive-Stage Small Cell Lung Cancer
Conditions
Interventions
Experimental group:Sacituzumab tirumotecan in combination with anlotinib
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary participation with written informed consent obtained prior to any study-specific procedures. 2. Age >= 18 years and = 1.5 × 10?/L; Platelet count >= 100 × 10?/L; Hemoglobin >= 90 g/L. 11. Adequate hepatic function: Total bilirubin (TBIL) = 50 mL/min (calculated by Cockcroft-Gault formula or other clinically validated method). 13. Adequate coagulation function: Activated partial thromboplastin time (APTT) = 50% assessed by echocardiography within 28 days prior to enrollment.New York Heart Association (NYHA) classification < 3. 15. Female patients of childbearing potential must agree to use medically effective contraception from the time of signing informed consent until 6 months after the last dose of study treatment.
Exclusion criteria
Exclusion criteria: 1. History of other primary malignancies within 5 years prior to signing informed consent, except for: radically treated malignancies with no recurrence within 5 years; adequately treated non-melanoma skin cancer, cervical carcinoma in situ, thyroid cancer, or other malignancies considered cured. 2. Prior pathological diagnosis of combined small cell lung cancer (e.g., mixed SCLC and NSCLC), transformed NSCLC (SCLC transformed to NSCLC), or transformed SCLC (NSCLC transformed to SCLC). 3. Prior anti-tumor therapy within specified washout periods before first study dose: chemotherapy, radiotherapy, biologics, endocrine therapy, immunotherapy within 4 weeks; topical anti-tumor agents within 5 half-lives; nitrosoureas or mitomycin C within 6 weeks; oral fluoropyrimidines or small-molecule targeted agents within 5 half-lives; anti-tumor traditional Chinese medicine within 2 weeks. 4. Treatment with any other investigational drug or therapy within 4 weeks prior to first study dose. 5. Prior or current use of topoisomerase I inhibitors, including antibody-drug conjugates with topoisomerase I inhibitor payloads (e.g., topotecan, irinotecan, trastuzumab deruxtecan, sacituzumab govitecan, datopotamab deruxtecan [DS-1062]). 6. Brain metastases unless asymptomatic (stable for >=4 weeks, requiring =14 days prior to first dose, and no significant peritumoral edema on imaging); leptomeningeal or brainstem metastases; spinal cord compression (radiographically confirmed, symptomatic or asymptomatic); bone marrow metastases. 7. Imaging evidence of tumor lesions located =5 mm from major blood vessels, invading major vessels, or assessed by the investigator as having high risk of major bleeding during the study. 8. History of deep vein or arterial thromboembolic events within 6 months (e.g., cerebrovascular accident including TIA, deep vein thrombosis, pulmonary embolism); DVT adequately treated or superficial vein thrombosis with low bleeding risk per investigator may be enrolled. 9. Prior treatment-related toxicities (CTCAE v5.0) >= Grade 2, except for alopecia, residual neurotoxicity, or stable hypothyroidism on hormone replacement. 10. Major surgery (excluding biopsy or vascular access) or significant trauma within 4 weeks prior to first study dose, or planned elective surgery during the study period. 11. Receipt of live or live-attenuated vaccines within 4 weeks prior to first study dose. 12. Systemic corticosteroids (prednisone >10 mg/day or equivalent) or other immunosuppressive agents within 14 days prior to first study dose, except for: topical, ocular, intra-articular, intranasal, or inhaled corticosteroids; short-term corticosteroids for prophylaxis (e.g., contrast allergy). 13. History of non-infectious interstitial lung disease/pneumonitis requiring steroid maintenance (requiring 14-day washout), current ILD, or suspected ILD not ruled out by imaging at screening. 14. Active tuberculosis; active or uncontrolled autoimmune disease; acquired or congenital immunodeficiency disorders; history of allogeneic stem cell, bone marrow, or solid organ transplantation. 15. Serious infection within 4 weeks prior to first study dose, including but not limited to infection requiring systemic antibiotics, bacteremia, or severe pneumonia. 16. Positive serology results: HIV antibody positive; untreated active hepatitis B (HBsAg positive with HBV-DNA > ULN); Note: Patients meeting certain criteria may be enrolled with a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate;duration of remission;overall survival;Clinical Benefit Rate;time to progression;Time to Treatment Failure;Overall survival;6-month PFS rate;1-year PFS rate;The incidence of adverse events and severe adverse events; | — |
Countries
China
Contacts
Public ContactJianxin Xue
West China Hospital of Sichuan University
Outcome results
None listed