Extensive-Stage Small Cell Lung Cancer
Conditions
Interventions
Single Arm:Bemotuzumab Vedotin Injection 1200mg intravenous infusion every 3 weeks + Anlotinib Hydrochloride Capsules 12mg oral once daily (continuous 2 weeks, then 1 week off) + Carboplatin AUC 5 mg/
followed by sequential thoracic radiotherapy 2 Gy per session, once daily, total 25-30 sessions (consolidation phase)
followed by maintenance therapy with bemotuzumab and anlotinib until disease progression or intolerable toxicity (maintenance phase)
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed unresectable extensive-stage SCLC (VALG staging); 2. No prior systemic therapy for extensive-stage SCLC; 3. Measurable lesions per RECIST 1.1. Previously irradiated lesions are considered measurable only if there is clear progression post-radiotherapy and they are not the sole lesion; 4. Age 18–75 years; 5. ECOG performance status 0–1; 6. Life expectancy >=3 months; 7. =1.5 ×10^9/L; 2) Platelet count (PLT) >=100 ×10^9/L; 3) Hemoglobin (HB) >=80 g/L. (2) Renal: 1) Calculated creatinine clearance (CrCl) >=50 mL/min; 2) Urine protein =28 g/L. (4) Coagulation: INR and APTT =50%. (6) Other: 1) Lipase 1.5× ULN without clinical/imaging evidence of pancreatitis); 2) Amylase 1.5× ULN without clinical/imaging evidence of pancreatitis); 3) Alkaline phosphatase (ALP) <=2.5× ULN (<=5× ULN if bone metastases present). 9. Voluntary participation with signed informed consent, good compliance, and cooperation with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with symptomatic brain metastases. Patients whose brain metastases have been treated and remain clinically stable for at least 1 month, with no use of steroids or anticonvulsants for at least 1 month prior to study enrollment, are eligible; 2. Prior use of anti-angiogenic agents such as anlotinib, apatinib, bevacizumab, or immune checkpoint inhibitors targeting PD-1, PD-L1, etc; 3. Patients with conditions that affect oral drug administration (e.g., dysphagia, post-gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.); 4. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; 5. Patients with radiological evidence of tumor invasion around major blood vessels, or those judged by the investigator to be at high risk of fatal massive hemorrhage due to potential tumor invasion of major blood vessels during the study; 6. History of severe bleeding tendency or coagulation disorders, including but not limited to: clinically significant hemoptysis (>= 1 tablespoon per day) within 3 months prior to enrollment; or clinically significant bleeding symptoms or tendency within 4 weeks prior to group assignment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer (including gastrointestinal perforation and/or fistula; patients with gastrointestinal perforation or fistula that has been surgically resected are eligible), unhealed wounds, ulcers, or fractures, etc; 7. Receipt of major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to group assignment; 8. History of arterial/venous thrombotic events (e.g., cerebrovascular accident including transient ischemic attack, deep vein thrombosis, pulmonary embolism) within 6 months prior to group assignment; 9. Active autoimmune disease requiring systemic treatment (e.g., disease-modifying antirheumatic drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose of study drug; 10. Other conditions that increase the risk associated with study participation or study drugs and, in the investigator’s judgment, render the patient unsuitable for enrollment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigator-Assessed Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);6-Month Progression-Free Survival Rate;Serious Adverse Event (SAE);Adverse Event (AE);18-Month Overall Survival Rate;Progression-Free Survival (PFS);Duration of Response (DOR);12-Month Progression-Free Survival Rate;12-Month Overall Survival Rate;Disease Control Rate (DCR);Immune-Related Adverse Event (irAE); | — |
Countries
China
Contacts
Public ContactHe Yaye
Shanghai Pulmonary Hospital
Outcome results
None listed