A Phase 3, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Tislelizumab (BGB-A317) (Anti-PD1 Antibody) Combined With Platinum-Pemetrexed Versus Platinum-Pemetrexed Alone as First-line Treatment for Patients With Stage IIIB or IV Non-Squamous Non-Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 334
- 试验地点
- 47
- 主要终点
- Progression Free Survival (PFS) Assessed by Independent Review Committee (IRC) Assessment
研究概览
简要总结
This study evaluated the efficacy and safety of tislelizumab in combination with platinum (cisplatin or carboplatin) and pemetrexed compared with platinum and pemetrexed alone as first-line treatment in participants with Stage IIIB or IV non-squamous non-small cell lung cancer (NSCLC).
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
- •Age 18-75 years old, male or female, signed informed consent form
- •Advanced NSCLC diagnosed by pathological or clinical physicians
- •Eastern Cooperative Oncology Group (ECOG) performance score ≤ 1
- •Participants must have ≥ 1 measurable lesion as defined per RECIST v1.1
- •Participants must have no prior systemic chemotherapy for advanced or metastatic NSCLC
- •Life expectancy ≥ 12 weeks
- •Participants must have adequate organ function
- •Male/female is willing to use a highly effective method of birth control
排除标准
- •Diagnosed with NSCLC but with epidermal growth factor receptor (EGFR)-sensitizing mutation or anaplastic lymphoma kinase (ALK) gene translocation
- •Received any approved systemic anticancer therapy within 28 days prior to the initiation of study treatment
- •Received prior treatment with EGFR inhibitors or ALK inhibitors
- •Received prior therapies targeting programmed cell death protein-1 (PD-1) or programmed cell death protein ligand-1 (PD-L1)
- •With history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases
- •Clinically significant pericardial effusion
- •Severe infections, active leptomeningeal disease or uncontrolled, untreated brain metastasis
- •Any major surgical procedure ≤ 28 days before randomization
- •Human immunodeficiency virus (HIV) infection
- •Participants with untreated hepatitis B or C virus (HBV/HCV)
- •Active autoimmune diseases or history of autoimmune diseases
- •History of allergic reactions to chemotherapy
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Tislelizumab + Platinum + Pemetrexed
Tislelizumab 200 milligrams (mg) administered intravenously (IV) once every 3 weeks plus cisplatin 75 mg/m^2 or carboplatin area under the plasma or serum concentration-time curve (AUC) 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m^2 once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)
干预措施: Tislelizumab (Drug)
Tislelizumab + Platinum + Pemetrexed
Tislelizumab 200 milligrams (mg) administered intravenously (IV) once every 3 weeks plus cisplatin 75 mg/m^2 or carboplatin area under the plasma or serum concentration-time curve (AUC) 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m^2 once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)
干预措施: Cisplatin (Drug)
Tislelizumab + Platinum + Pemetrexed
Tislelizumab 200 milligrams (mg) administered intravenously (IV) once every 3 weeks plus cisplatin 75 mg/m^2 or carboplatin area under the plasma or serum concentration-time curve (AUC) 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m^2 once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)
干预措施: Carboplatin (Drug)
Tislelizumab + Platinum + Pemetrexed
Tislelizumab 200 milligrams (mg) administered intravenously (IV) once every 3 weeks plus cisplatin 75 mg/m^2 or carboplatin area under the plasma or serum concentration-time curve (AUC) 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m^2 once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)
干预措施: Pemetrexed (Drug)
Platinum + Pemetrexed
Cisplatin 75 mg/m^2 or carboplatin AUC 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m^2 administered IV once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)
干预措施: Cisplatin (Drug)
Platinum + Pemetrexed
Cisplatin 75 mg/m^2 or carboplatin AUC 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m^2 administered IV once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)
干预措施: Carboplatin (Drug)
Platinum + Pemetrexed
Cisplatin 75 mg/m^2 or carboplatin AUC 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m^2 administered IV once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)
干预措施: Pemetrexed (Drug)
结局指标
主要结局
Progression Free Survival (PFS) Assessed by Independent Review Committee (IRC) Assessment
时间窗: Through primary analysis data cut-off date of 23JAN2020 (up to approximately 1 year and 6 months)
PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first, as assessed by the IRC per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
次要结局
- Objective Response Rate (ORR) by IRC Assessment(Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months))
- Duration of Response (DOR) by IRC Assessment(Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months))
- Overall Survival (OS)(Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months))
- PFS by Investigator Assessment(Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months))
- ORR by Investigator Assessment(Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months))
- DOR by Investigator Assessment(Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months))
- Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC13)(Baseline to Cycle 5 (each cycle is 21 days))
- 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(Baseline to Cycle 5 (each cycle is 21 days))
- Number of Participants With Adverse Events(Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months))
- PFS by IRC Based on Programmed Death Ligand 1 (PD-L1) Expression(Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months))