A Randomized Phase 3 Study of Tislelizumab in Combination With Sitravatinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer That Progressed on or After Platinum-Based Chemotherapy and Anti-PD-(L)1 Antibody
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 377
- 试验地点
- 61
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The purpose of this study was to evaluate the efficacy and safety of tislelizumab in combination with sitravatinib compared to docetaxel in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) who experienced disease progression following platinum-based chemotherapy and anti-programmed cell death protein-1 (PD-1)/programmed cell death ligand-1 (PD-L1) antibody treatment, with the anti-PD-(L)1 antibody administered either in combination with or sequentially before or after the platinum-based chemotherapy.
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
- •Metastatic or unresectable locally advanced histologically or cytologically confirmed Non-Small Cell Lung Cancer (NCSLC), not amenable to treatment with curative intent
- •Able to provide archival/fresh tumor tissues for biomarker analysis to assess PD-L1 expression and other biomarkers.
- •No known Epidermal Growth Factor Receptor (EGFR) or B-Raf proto-oncogene (BRAF) sensitizing mutation, or anaplastic lymphoma kinase (ALK) rearrangement or ROS proto oncogene 1 (ROS1) rearrangement
- •Radiographic progression per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 on or after anti-PD-(L)1 containing therapy for locally advanced and unresectable or metastatic NSCLC.
- •No prior anticancer therapy having the same mechanism of action as sitravatinib (eg, tyrosine kinase inhibitor with a similar target profile or vascular endothelial growth factor (VEGF)- or VEGFR inhibitor)
- •At least 1 measurable lesion as defined based on RECIST v1.1 by investigator
排除标准
- •Has received docetaxel as monotherapy or in combination with other therapies.
- •Squamous NSCLC with central cavitation, or NSCLC with hemoptysis (> 50 mL/day)
- •Participants with tumor shown by imaging to be located around important vascular structures or if the investigator determines that the tumor is likely to invade important blood vessels and may cause fatal bleeding.
- •Active leptomeningeal disease for metastatic NSCLC, or uncontrolled or untreated brain metastasis.
- •Active autoimmune diseases or history of autoimmune diseases that may relapse.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Tislelizumab + Sitravatinib
Participants received 200 mg of intravenous tislelizumab every 3 weeks, combined with 100 mg of oral sitravatinib daily until disease progression, intolerable toxicity, death, or withdrawal of consent, whichever occurred earlier.
干预措施: Tislelizumab (Drug)
Tislelizumab + Sitravatinib
Participants received 200 mg of intravenous tislelizumab every 3 weeks, combined with 100 mg of oral sitravatinib daily until disease progression, intolerable toxicity, death, or withdrawal of consent, whichever occurred earlier.
干预措施: Sitravatinib (Drug)
Docetaxel
Participants received 75 mg/m² of intravenous docetaxel once every 3 weeks until disease progression, intolerable toxicity, death, or withdrawal of consent, whichever occurred earlier.
干预措施: Docetaxel (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months).
Defined as the time from randomization until the date of death due to any cause. Kaplan-Meier methodology was used to estimate the median OS.
Progression Free Survival (PFS) as Assessed by the Independent Review Committee (IRC)
时间窗: Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months).
Defined as the time from randomization until first documentation of disease progression as assessed by the IRC based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death from any cause, whichever occured first. Kaplan-Meier methodology was used to estimate the median PFS.
次要结局
- Progression Free Survival (PFS) as Assessed by the Investigator(Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months).)
- Overall Response Rate (ORR)(Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months).)
- Duration of Response (DOR)(Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months).)
- Disease Control Rate (DCR)(Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months).)
- Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (GHS) and Physical Functioning Scores(Baseline and Cycle 5 Day 1 (Week 12) and Cycle 7 Day 1 (Week 18))
- Change From Baseline in EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) Coughing, Dyspnoea, and Chest Pain Scales(Baseline and Cycle 5 Day 1 (Week 12) and Cycle 7 Day 1 (Week 18))
- Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D-5L) Visual Analogue Scale (VAS)(Baseline and Cycle 5 Day 1 (Week 12) and Cycle 7 Day 1 (Week 18))
- Number of Participants With Adverse Events(From the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2).)