A Phase 2, Multicenter, Randomized, 3-Arm, Open-Label Study to Investigate the Preliminary Efficacy and Safety of the Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) Plus Tislelizumab Plus Concurrent Chemoradiotherapy in Patients With Untreated Limited-Stage Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 52
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
This phase 2 trial examining the combination of ociperlimab plus tislelizumab plus cCRT is expected to provide valuable data to advance treatment options in the serious unmet medical need population of LS-SCLC patients. Immunotherapy combined with chemoradiotherapy may have a synergetic anti -cancer activities. The combination of anti-TIGIT antibody and anti-PD-1/L1 antibody may augment the immune effect with tolerable safety profile. The novel therapeutic strategy with dule immune therapy in combination with CRT is expected to provide valuable data to advance treatment options in the population of LS-SCLC patients.
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
- •Patient has pathologically (histologically or cytologically) proven diagnosis of small cell lung cancer
- •Has limited-stage disease (stage Tx, T1-T4, N0-3, M0; AJCC staging, 8th edition), and can be safely treated with definitive radiation doses.
- •Patient has not received any prior treatment for LS-SCLC.
- •Patient has measurable disease as assessed according to RECIST v1.1 that is appropriate for selection as a target lesion for repeat measurement, as determined by local site investigator/radiology review
- •ECOG Performance Status ≤ 2 assessed within 7 days before the first administration of study intervention, and must have a life expectancy of ≥ 12 weeks.
排除标准
- •Mixed small cell lung cancer histology. Note: mixed SCLC with the component of neuroendocrine carcinoma origin is considered eligible
- •Have received surgical resection for LS-SCLC
- •Any patient for whom the tumor is considered resectable by surgery or stereotactic body radiation therapy/stereotactic ablative radiotherapy should be considered ineligible
- •Is expected to require any other form of antineoplastic therapy while on study.
- •Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-TIGIT, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways
- •Note: Other protocol-defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
Arm A: Ociperlimab + Tislelizumab
Ociperlimab plus tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles (each cycle is 28 days), followed by ociperlimab plus tislelizumab
干预措施: Ociperlimab (Drug)
Arm A: Ociperlimab + Tislelizumab
Ociperlimab plus tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles (each cycle is 28 days), followed by ociperlimab plus tislelizumab
干预措施: Tislelizumab (Drug)
Arm A: Ociperlimab + Tislelizumab
Ociperlimab plus tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles (each cycle is 28 days), followed by ociperlimab plus tislelizumab
干预措施: Concurrent Chemoradiotherapy (Drug)
Arm B: Tislelizumab
Tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone
干预措施: Tislelizumab (Drug)
Arm B: Tislelizumab
Tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone
干预措施: Concurrent Chemoradiotherapy (Drug)
Arm C: Concurrent Chemoradiotherapy (cCRT)
cCRT only for 4 cycles at the investigator's discretion
干预措施: Concurrent Chemoradiotherapy (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Up to approximately 2 years
Defined as the time from the date of randomization to the date of the first documented disease progression as determined by the investigator per RECIST v1.1 or death from any cause (whichever occurs first)
次要结局
- Complete Response Rate (CR)(Up to approximately 2 years)
- Overall Response Rate (ORR)(Up to approximately 2 years)
- Overall Response Rate (ORR) in the Programmed Death-Ligand 1 (PD-L1) Analysis Set(Up to approximately 2 years)
- Overall Response Rate (ORR) in the T Cell Immunoreceptor With Immunoglobulin and ITIM Domain (TIGIT) Analysis Set(Up to approximately 2 years)
- Duration of Response (DOR)(Up to approximately 2 years)
- Overall Survival (OS) in the ITT Analysis Set(Up to approximately 2 years)
- Overall Survival (OS) in the PD-L1 Analysis Set(Up to approximately 2 years)
- Overall Survival (OS) in the TIGIT Analysis Set(Up to approximately 2 years)
- Distant Metastasis-free Survival (DMFS)(Up to approximately 2 years)
- PFS in the PD-L1 Analysis Set(Up to approximately 2 years)
- PFS in the TIGIT Analysis Set(Up to approximately 2 years)
- Number of Participants Experiencing Adverse Events (AEs)(From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years)