Carboplatin/Cisplatin + Etoposide + Benmelstobart Sequential Benmelstobart Combined With Anlotinib Versus Carboplatin/Cisplatin + Etoposide + Tislelizumab Sequential Tislelizumab in the Treatment of Extensive Stage Small Cell Lung Cancer
Stopped: This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.
China40 participantsStarted 2025-04-07
Plain-language summary
This is a randomized, controlled, open-label, multicenter clinical study to evaluate the efficacy and safety of carboplatin/cisplatin + etoposide + benmelstobart sequential benmelstobart combined with anlotinib versus carboplatin/cisplatin + etoposide + Tislelizumab sequential Tislelizumab in the first-line treatment of extensive stage small cell lung cancer.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Hemoglobin (HGB) ≥ 90g/L;
✓. Neutrophil absolute value (NEUT) ≥ 1.5× 10 9 /L;
✓. Platelet count (PLT) ≥ 90× 10 9 /L;
✓. Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN);
✓. Alanine transferase (ALT) and aspartate transferase (AST) ≤ 2.5×ULN. ALT and AST≤ 5×ULN if accompanied by liver metastasis;
✓. Serum creatinine (CR) ≤ 1.5×ULN or creatinine clearance (CCR) ≥60 mL /min;
✓. Prothrombin time (PT), activated partial thromboplastin time (APTT), International standardized ratio (INR) ≤ 1.5×ULN (no anticoagulant therapy).
Exclusion criteria
✕. According to the New York Heart Association (NYHA) standards of grade II or higher cardiac insufficiency or heart color ultrasound: left ventricular ejection fraction (LVEF) \<50%;
✕. There is a history of clinically significant ventricular arrhythmias (such as persistent ventricular tachycardia, ventricular fibrillation, tip torsion ventricular tachycardia) or arrhythmias requiring continuous antiarrhythmic drug treatment;
What they're measuring
1
Progression free survival (PFS)
Timeframe: From enrollment until the first onset of disease progression or death from any cause, evaluation is expected to take 2 years
Trial details
NCT IDNCT06897579
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.
✕. Myocardial infarction occurred within 12 months;
✕. Fridericia- modified QT interval (QTcF) \> 450 ms (msec) for men and \>470 msec for women (if QTc is abnormal, it can be tested three times at intervals of more than 2 minutes, and its average value is taken);
✕. Congenital long QT syndrome history or family history;
✕. A history of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolism within the 3 months prior to randomization (implantable venous port or catheter-derived thrombosis, or superficial venous thrombosis is not considered "severe" thromboembolism);
✕. Currently receiving or having recently received (within 7 days before the start of study treatment) aspirin (\>325mg/ day (maximum antiplatelet dose) or dipyridamole, ticlopidine, clopidogrel, and cilostazol.