An Exploratory Phase II Study of Bemotuzumab Combined With Chemotherapy and Anlotinib as Induction Therapy, Followed by Bemotuzumab, Anlotinib, and Consolidative Thoracic Radiotherapy in Patients With Extensive-Stage Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
This is a phase II study evaluating a new combination therapy for untreated extensive-stage small cell lung cancer. The treatment involves an initial phase with the drug Bemotuzumab plus standard chemotherapy and anlotinib, followed by a phase combining Bemotuzumab, anlotinib, and chest radiation. The primary objectives are to assess the efficacy of this approach in delaying cancer growth (progression-free survival) and to evaluate its safety in approximately 25 patients.
详细描述
This is an exploratory Phase II clinical trial for previously untreated extensive-stage small cell lung cancer (ES-SCLC). The study evaluates a novel three-phase sequential treatment strategy: patients first receive induction therapy with Bemotuzumab combined with standard chemotherapy and Anlotinib; those achieving disease control then proceed to consolidation therapy with Bemotuzumab, Anlotinib, and concurrent thoracic radiotherapy; followed by a maintenance phase with Bemotuzumab plus Anlotinib. The primary objectives are to assess the regimen's efficacy in prolonging progression-free survival (PFS) and to observe its safety profile. The study plans to enroll approximately 25 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study. No masking (blinding) is used.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •**Inclusion Criteria:**
- •Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) per VALG staging.
- •No prior systemic therapy for ES-SCLC.
- •At least one measurable lesion as defined by RECIST 1.1 criteria.
- •Age 18-75 years.
- •ECOG performance status of 0-
- •Life expectancy of ≥3 months.
- •Adequate hematologic and organ function:
- •Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L.
- •Platelet count ≥ 100 × 10^9/L.
- •Hemoglobin ≥ 80 g/L.
- •Creatinine clearance ≥ 50 mL/min.
- •Total bilirubin ≤ 1.5 × upper limit of normal (ULN).
- •AST and ALT ≤ 2.5 × ULN.
- •Albumin ≥ 28 g/L.
- •INR and APTT ≤ 1.5 × ULN.
- •Left ventricular ejection fraction (LVEF) ≥ 50%.
- •For females of childbearing potential: negative serum pregnancy test within 3 days prior to dosing and agreement to use highly effective contraception.
- •For males: agreement to use barrier contraception.
- •Willing and able to provide written informed consent and comply with study procedures.
排除标准
- •Symptomatic brain metastases. (Asymptomatic, treated, and stable brain metastases for ≥1 month without steroids are allowed).
- •Prior thoracic radiotherapy for SCLC.
- •Prior treatment with anti-angiogenic agents (e.g., anlotinib, bevacizumab) or anti-PD-1/PD-L1 therapies.
- •Factors affecting oral medication intake (e.g., inability to swallow, major gastrointestinal resection).
- •Uncontrolled effusions requiring repeated drainage (pleural, pericardial, or ascites).
- •Imaging evidence of tumor invasion of major blood vessels or high risk of fatal hemorrhage as judged by the investigator.
- •History of significant bleeding tendency or coagulopathy, including clinically significant hemoptysis (>1 tablespoon daily within 3 months) or significant bleeding within 4 weeks prior to enrollment.
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment.
- •Arterial/venous thrombotic events within 6 months prior to enrollment (e.g., cerebrovascular accident, deep vein thrombosis, pulmonary embolism).
- •Active autoimmune disease requiring systemic treatment within 2 years prior to first dose.
- •Any other condition that, in the investigator's judgment, increases risk or renders the patient unsuitable for the study.
研究组 & 干预措施
Experimental Group
Participants receive a multi-phase experimental regimen. Induction (4 cycles, q3w): Bemotuzumab (1200 mg IV, Day 1) combined with investigator's choice of platinum-etoposide chemotherapy (Carboplatin AUC=5 or Cisplatin 75-80 mg/m² on Day 1, plus Etoposide 100 mg/m² IV on Days 1-3) and oral Anlotinib (12 mg once daily on Days 1-14, then 7 days off).
Consolidation (2 cycles, q3w): Bemotuzumab (same dose) + Anlotinib (same schedule) with concurrent hypofractionated thoracic radiotherapy (5 Gy per fraction for 5 fractions).
Maintenance: Bemotuzumab (q3w) + Anlotinib (same schedule) until disease progression, unacceptable toxicity, or other withdrawal criteria. Anlotinib dose may be reduced (12mg → 10mg → 8mg) for managing toxicity.
干预措施: Bemotuzumab + Anlotinib + Chemotherapy + Radiotherapy (Combination Product)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: From enrollment until disease progression or death from any cause, assessed up to approximately 24 months.
PFS is defined as the time from enrollment to the first documented disease progression according to RECIST 1.1 criteria or death from any cause, whichever occurs first. Tumor assessments are performed every 6 weeks (every 2 treatment cycles).
次要结局
- Objective Response Rate (ORR)(From enrollment until the first documented CR or PR, assessed up to approximately 24 months.)
- Overall Survival (OS)(From enrollment until death from any cause, assessed up to approximately 24 months.)
- Incidence of Grade ≥3 Immune-Related Adverse Events (irAEs)(From first dose of study drug until 28 days after the last dose, assessed up to approximately 24 months.)