SCLC
Conditions
Interventions
Intervention group:Bemosumab injection is administered at a dose of 1200 mg per infusion intravenously on Day 1 of every 3-week cycle (Q3W).Anlotinib hydrochloride capsules are taken orally at a dose
Sponsors
Shandong First Medical University Affiliated Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients must meet all the following criteria to be eligible for this study: 1.Voluntary Participation: Subjects voluntarily enrolled in this study, signed the informed consent form, and demonstrated good compliance. 2.Age: 18–75 years (at the time of signing informed consent);ECOG Performance Status (PS): 0–1;Expected survival: >6 months;Body weight: >40 kg;Pathological Confirmation: 3.Definitive histologically or cytologically confirmed limited-stage small cell lung cancer (LS-SCLC) (staged according to the Veterans Administration Lung Study Group [VALG] criteria). 4.Radiological Exclusion of Metastasis:Diagnostic-quality contrast-enhanced CT (neck, chest, abdomen, pelvis) and brain MRI (non-contrast + contrast) demonstrating no evidence of metastatic disease.PET-CT is recommended prior to chemoradiotherapy (CRT). If PET-CT was not performed pre-CRT, bone scintigraphy is mandatory.Post-CRT screening PET-CT is required to rule out metastasis. 5.Surgical Patients:Underwent curative-intent surgery with completion of 4–6 cycles of adjuvant chemotherapy. Postoperative lymph node-positive patients must have completed adjuvant radiotherapy. 6.Chemoradiotherapy-Treated Patients: Must have completed the following first-line CRT: 4–6 cycles of platinum-based chemotherapy (concurrent/sequential with radiotherapy), completed 1–56 days prior to first study drug administration. Chemotherapy regimen: Must include cisplatin/carboplatin + intravenous etoposide. Radiotherapy: Standard QD regimen: Total dose of 60 Gy +/-10% (6-week scheme). Hyperfractionated BID regimen: Total dose of 45 Gy (3-week scheme). Dose calculation: Based on planned target volume (PTV). Recommended organ-at-risk constraints: Lung: Mean lung dose =1 cycle of chemotherapy during radiotherapy. Sequential CRT: =1 RECIST v1.1-defined measurable lesion before CRT. 11.Adequate Organ Function (within 7 days prior to screening, no blood transfusion/growth factor support): Hematology: Hemoglobin (HGB): >=90 g/L Absolute neutrophil count (ANC): >=1.0×10^9/L Platelets (PLT): >=80×10^9/L Biochemistry: Total bilirubin (TBIL): =60 mL/min Albumin (ALB): >=30 g/L Urinalysis: Urine protein: =++). Coagulation: PT, APTT, INR: =50%. 12.Contraception: Women of childbearing potential (WOCBP) must use effective contraception (IUD/condoms) during and for 6 months post-study.Negative serum pregnancy test within 7 days prior to enrollment. Non-lactating.
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study if they meet any of the following criteria: 1.Tumor-Related Conditions & Medical History Other malignancies within the past 3 years or concurrent except: Malignancies treated with surgery alone and disease-free survival (DFS) >=3 years. Cured carcinoma in situ of the cervix, non-melanoma skin cancer, and superficial bladder tumors (Ta [non-invasive], Tis [in situ], T1 [invading lamina propria]). Histologically or cytologically confirmed composite small cell lung cancer. Known central nervous system (CNS) metastases and/or carcinomatous meningitis. Malignant pleural effusion or pericardial effusion. Radiological (CT/MRI) evidence of tumor encasement of major blood vessels or investigator-judged high risk of fatal hemorrhage due to vascular invasion. 2.Prior Antitumor Therapy Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 drugs, or agents targeting stimulatory/coinhibitory T-cell receptors (e.g., CTLA-4, OX 40, CD137). Prior antiangiogenic therapy (e.g., bevacizumab, anlotinib, apatinib). Received >6 cycles of chemotherapy. Only etoposide + platinum-based regimens permitted; no other regimens allowed. Radiation pneumonitis =Grade 3 post-CRT. Grade 2 pneumonitis allowed if resolved to Grade 1 with treatment. 3.Comorbidities & Medical History Liver cirrhosis or active hepatitis*: Active hepatitis definition: HBV: HBsAg-positive + HBV DNA > upper limit of normal (ULN). HCV: HCV antibody-positive + HCV RNA > ULN. Note: Patients with HBsAg+/anti-HBc+ or HCV+ must receive continuous antiviral prophylaxis to prevent reactivation. Renal failure requiring dialysis (hemodialysis/peritoneal) or history of nephrotic syndrome/chronic nephritis. Cardiovascular abnormalities: >=Grade 2 myocardial ischemia, myocardial infarction, arrhythmias, or congestive heart failure (NYHA Class >=2). Major arterial/venous thromboembolism within 6 months (e.g., cerebrovascular accident [TIA, hemorrhage, infarction], DVT, pulmonary embolism). Uncontrolled hypertension ( >=150/90 mmHg) despite >=2 antihypertensive agents. Factors impairing oral drug intake (e.g., dysphagia, chronic diarrhea, intestinal obstruction). Bleeding risk: Bleeding disorders or use of warfarin/antiplatelet agents (except aspirin =100 mg/day for prophylaxis) within 28 days before treatment. Major surgery, open biopsy, or significant trauma within 28 days before first dose. Non-healing wounds/fractures (excluding pathological fractures). History of hemorrhage or coagulation dysfunction (any severity). Immunodeficiency: HIV+, congenital/acquired immunodeficiency, or organ transplant history. Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, immunosuppressants) within 2 years before treatment initiation. Excludes: Hormonal replacement (thyroxine, insulin, physiologic corticosteroids for adrenal/pituitary insufficiency). Excludes: Non-systemic treatments (e.g., bronchodilators for asthma). Immunosuppressive therapy (>10 mg/day prednisone or equivalent) within 2 weeks before first dose. Poorly controlled diabetes (fasting blood glucose >10 mmol/L). Active or uncontrolled severe infection ( >=CTCAE Grade 2). Active tuberculosis (TB) within 1 year. History of TB >1 year prior: Must provide documented cure proof.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median Progression-Free Survival (mPFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate;Duration of Response;Median Overall Survival;Safety; | — |
Countries
China
Contacts
Public ContactXiangjiao Meng
Shandong First Medical University Affiliated Cancer Hospital (Shandong Cancer Hospital)
Outcome results
None listed