NCT07802821尚未招募3 期
A Phase III, Randomized, Controlled, Open-label Clinical Study to Compare the Efficacy and Safety of QLC5508 in Combination With QL2107 Versus Tislelizumab Plus Platinum-based Chemotherapy as First-line Treatment in Participants With Extensive-stage Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 556
- 主要终点
- Overall survival (OS)
研究概览
简要总结
This trial is a Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of QLC5508 in combination with QL2107 versus Tislelizumab plus platinum and etoposide as first-line treatment in participants with extensive-stage small cell lung cancer.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Participants with histologically or cytologically confirmed Extensive-Stage Small Cell Lung Cancer (ES-SCLC) per the Veterans Administration Lung Cancer Study Group (VALG) staging system.
- •No prior systemic treatment for ES-SCLC.
- •At least one extracranial measurable lesion according to RECIST v1.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, without deterioration within 2 weeks prior to the first dose of study treatment.
- •Life expectancy ≥12 weeks.
- •Has adequate organ function.
- •Male and female participants of reproductive/childbearing potential must agree to avoid pregnancy.
- •Voluntarily sign the written informed consent form and comply with the protocol requirements.
排除标准
- •Has received or undergoing any of the following treatment:
- •Previous or current treatment with B7-H3 targeted therapy. Previous or current treatment with topoisomerase I inhibitors.
- •Participants with transformed Non-Small Cell Lung Cancer (NSCLC), epidermal growth factor receptor (EGFR) mutation-positive NSCLC that has transformed to SCLC, or mixed SCLC-NSCLC histology.
- •Presence with active brain metastases, leptomeningeal metastasis, brainstem metastasis or spinal cord compression.
- •Radiotherapy with a limited field of radiation within 2 weeks prior to the study treatment; more than 30% of the bone marrow irradiation or large-scale radiotherapy within 4 weeks prior to study treatment.
- •Major surgery within 4 weeks prior to the study treatment.
- •Unresolved AEs ≥ Grade 2 (CTCAE v6.0) from prior therapy.
- •Previous or concurrent primary malignancies.
- •History of severe heart disease or cerebrovascular disease.
- •History of Severe or uncontrolled hypertension or diabetes mellitus.
- •Severe infection within 4 weeks prior to study treatment; or uncontrolled active infection at screening.
- •Known or suspected interstitial lung disease/non-infectious pneumonitis; or other moderate to severe pulmonary diseases that significantly impair respiratory function and may interfere with the detection or management of drug-related pulmonary toxicity.
- •Known history of pre-existing or newly diagnosed autoimmune disease.
- •History of severe neuropathy or mental disorders.
- •History of severe hypersensitivity reaction, severe infusion reaction or idiosyncrasy to drugs chemically related to study drugs or any components of the study drugs.
- •Unlikely to comply with study procedures and requirements in the opinion of the investigator.
- •Any disease or condition that, in the opinion of the investigator, would compromise participant safety or interfere with study assessments.
研究组 & 干预措施
QLC5508 in combination with QL2107
Experimental
干预措施: QLC5508 (Drug)
Tislelizumab in Combination with Platinum-based Chemotherapy
Active Comparator
干预措施: Carboplatin (Drug)
Tislelizumab in Combination with Platinum-based Chemotherapy
Active Comparator
干预措施: Etoposide (Drug)
Tislelizumab in Combination with Platinum-based Chemotherapy
Active Comparator
干预措施: Tislelizumab (Drug)
Tislelizumab in Combination with Platinum-based Chemotherapy
Active Comparator
干预措施: Cisplatin (Drug)
QLC5508 in combination with QL2107
Experimental
干预措施: QL2107 (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: Up to approximately 36 months
OS is defined as the duration from the date of randomization to the date of death due to any cause.
次要结局
- 12-month OS rate(Up to approximately 36 months)
- 24-month OS rate(Up to approximately 36 months)
- Treatment Emergent Adverse Event (TEAE)(Up to approximately 36 months)
- Progression-free survival (PFS)(Up to approximately 36 months)
- Objective response rate (ORR)(Up to approximately 36 months)
- Duration of response (DOR)(Up to approximately 36 months)
- Disease control rate (DCR)(Up to approximately 36 months)
- 6-month PFS rate(Up to approximately 36 months)
- 12-month PFS rate(Up to approximately 36 months)
研究者
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