A Phase II Clinical Study of Ivonescimab Combination Therapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 3
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
The goal of this clinical trial is to learn if different combinations of a drug called Ivonescimab, along with chemotherapy and other investigational drugs, are safe and effective for the initial treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).
The main questions the study aims to answer are:
- What side effects do participants experience from these combination treatments?
- How well do the treatments work to shrink tumors?
Researchers will compare three groups to see which combination works best. All participants will receive Ivonescimab and chemotherapy (etoposide and carboplatin). The differences are:
- Group 1 will also receive an additional drug called AK117.
- Group 2 will also receive a different additional drug called Cadonilimab.
- Group 3 will receive Ivonescimab and chemotherapy only.
Participants will:
- Be assigned by chance to one of the three groups.
- Undergo an initial treatment phase (about 3 months), receiving chemotherapy plus the specific study drugs for their group.
- If the treatment is effective and side effects are manageable, continue with a maintenance phase using only the study drugs (without chemotherapy) for up to 2 years.
- Attend regular clinic visits for check-ups, blood tests, and imaging scans (like CT scans) to see how they are responding to the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).
- •No prior systemic therapy for ES-SCLC.
- •At least one measurable lesion as defined by RECIST v1.
- •Age 18 to 75 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Adequate organ function.
排除标准
- •Active or untreated central nervous system (CNS) metastases (Treated, stable brain metastases are allowed).
- •History of severe hypersensitivity to monoclonal antibodies.
- •Active autoimmune disease requiring systemic treatment within the past 2 years.
- •Significant cardiovascular disease.
- •Active hepatitis B or C, or HIV infection.
- •Interstitial lung disease or non-infectious pneumonitis.
- •Significant bleeding tendency or risk, including tumor invasion of major blood vessels.
- •Pregnancy or lactation.
- •Other active malignancies within 5 years prior to enrollment.
研究组 & 干预措施
Ivonescimab + Cadonilimab + Chemotherapy
干预措施: Etoposide (Drug)
Ivonescimab + Cadonilimab + Chemotherapy
干预措施: Carboplatin (AUC 5) (Drug)
Ivonescimab + Chemotherapy
干预措施: Ivonescimab (Drug)
Ivonescimab + Chemotherapy
干预措施: Etoposide (Drug)
Ivonescimab + AK117 + Chemotherapy
干预措施: Ivonescimab (Drug)
Ivonescimab + AK117 + Chemotherapy
干预措施: AK117 (Drug)
Ivonescimab + AK117 + Chemotherapy
干预措施: Etoposide (Drug)
Ivonescimab + AK117 + Chemotherapy
干预措施: Carboplatin (AUC 5) (Drug)
Ivonescimab + Cadonilimab + Chemotherapy
干预措施: Ivonescimab (Drug)
Ivonescimab + Cadonilimab + Chemotherapy
干预措施: Cadonilimab (Drug)
Ivonescimab + Chemotherapy
干预措施: Carboplatin (AUC 5) (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Up to approximately 2 years.
The proportion of participants achieving a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR), as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Incidence of Adverse Events (AEs)
时间窗: From first dose up to 90 days after last dose.
The number and percentage of participants experiencing any Adverse Event (AE). An AE is defined as any untoward medical occurrence in a participant administered a study drug, which may not have a causal relationship with the treatment. Severity will be graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
次要结局
- Disease Control Rate (DCR)(Up to approximately 2 years.)
- Duration of Response (DoR)(Up to approximately 2 years.)
- Time to Response (TTR)(Up to approximately 2 years.)
- Progression-Free Survival (PFS)(Up to approximately 2 years.)
- Overall Survival (OS)(Up to approximately 5 years.)
- Serum concentrations of Ivonescimab, Cadonilimab, and AK117(Up to approximately 2 years.)
- Incidence of Anti-drug Antibodies (ADA)(Up to approximately 2 years.)