A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 for Injection Combined With Tislelizumab Versus Platinum-containing Chemotherapy Combined With Tislelizumab as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 562
- 试验地点
- 3
- 主要终点
- Overall survival (OS)
研究概览
简要总结
This trial is a registrational Phase III, randomized, open-label, multicenter study to compare the efficacy and safety of BL-B01D1 in combination with tislelizumab versus platinum-based chemotherapy in combination with tislelizumab in first-line patients 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
- •Voluntarily sign the informed consent form and comply with the protocol requirements;
- •Age ≥ 18 years;
- •Expected survival time ≥ 3 months;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- •Patients with histopathologically and/or cytologically confirmed extensive-stage small cell lung cancer;
- •Agree to provide archived tumor tissue specimens from the primary or metastatic lesions within 3 years, or fresh tissue samples;
- •Must have at least one measurable lesion as defined by RECIST v1.1;
- •Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
- •No severe cardiac dysfunction, with left ventricular ejection fraction ≥ 50%;
- •Organ function levels must meet the requirements;
- •Urinary protein ≤ 2+ or < 1000 mg/24h;
- •For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, and the serum pregnancy test must be negative; patients must not be breastfeeding. All enrolled patients (regardless of male or female) must use adequate barrier contraception throughout the entire treatment period and for 6 months after the end of treatment.
排除标准
- •Pathology indicates small cell carcinoma containing non-small cell carcinoma components;
- •Patients who have previously received systemic treatment;
- •Previous treatment with ADC drugs where the small molecule toxin is a topoisomerase I inhibitor;
- •Use of immunomodulatory drugs within 14 days prior to the first dose of the study drug;
- •History of severe heart disease or cerebrovascular disease;
- •Receiving long-term systemic corticosteroid therapy at a dose >10 mg/day of prednisone or equivalent prior to the first dose;
- •Active autoimmune diseases and inflammatory diseases;
- •Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening;
- •Prolonged QT interval, complete left bundle branch block, etc.;
- •Diagnosis of active malignancy within 3 years prior to study randomization;
- •Hypertension inadequately controlled with two antihypertensive medications;
- •Poorly controlled diabetes mellitus;
- •History of interstitial lung disease (ILD)/pneumonitis requiring steroid therapy, etc.;
- •Concurrent pulmonary disease resulting in clinically severe impairment of respiratory function;
- •Patients with active central nervous system (CNS) metastases;
- •Severe infection within 4 weeks prior to study randomization;
- •Presence of large serous cavity effusions, or serous cavity effusions with symptoms, etc.;
- •Imaging findings indicating tumor invasion or encasement of major blood vessels in the abdomen, chest, neck, or pharynx;
- •Severe, non-healing wound, ulcer, or bone fracture within 4 weeks prior to signing informed consent;
- •Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent;
- •Patients with inflammatory bowel disease, history of extensive bowel resection, history of immune-related enteritis, intestinal obstruction, or chronic diarrhea;
- •History of allergy to recombinant humanized antibodies or any excipient component of BL-B01D1;
- •History of autologous or allogeneic stem cell transplantation;
- •Positive for human immunodeficiency virus antibody, active hepatitis B virus infection, or hepatitis C virus infection;
- •History of severe neurological or psychiatric disorders;
- •Receipt of other unapproved clinical study drugs or treatments within 4 weeks prior to study randomization;
- •Subjects planning to receive or having received live vaccines within 28 days prior to study randomization;
- •Other conditions deemed by the investigator to make the subject unsuitable for participation in this clinical trial due to complications or other circumstances.
研究组 & 干预措施
BL-B01D1+Tislelizumab
Participants receive BL-B01D1+Tislelizumab in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
干预措施: BL-B01D1 (Drug)
BL-B01D1+Tislelizumab
Participants receive BL-B01D1+Tislelizumab in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
干预措施: Tislelizumab (Drug)
Carboplatin+Etoposide +Tislelizumab
Participants receive Carboplatin+Etoposide +Tislelizumab in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
干预措施: Etoposide (Drug)
Carboplatin+Etoposide +Tislelizumab
Participants receive Carboplatin+Etoposide +Tislelizumab in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
干预措施: Tislelizumab (Drug)
Carboplatin+Etoposide +Tislelizumab
Participants receive Carboplatin+Etoposide +Tislelizumab in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
干预措施: Carboplatin (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: Up to approximately 24 months
Overall survival (OS) is defined as the time between the subject's randomization date and subject's death.
次要结局
- Objective Response Rate (ORR)(Up to approximately 24 months)
- Progression-free survival (PFS)(Up to approximately 24 months)
- Disease Control Rate (DCR)(Up to approximately 24 months)
- Duration of Response (DOR)(Up to approximately 24 months)
- Treatment Emergent Adverse Event (TEAE)(Up to approximately 24 months)
- Anti-drug antibody (ADA)(Up to approximately 24 months)