A Phase 3, Multicenter, Randomized Open-Label Study to Compare the Efficacy and Safety of Tislelizumab (BGB A317, Anti-PD1 Antibody) Combined With Paclitaxel Plus Carboplatin or Nab Paclitaxel Plus Carboplatin Versus Paclitaxel Plus Carboplatin Alone as First-Line Treatment for Untreated Advanced 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
- 360
- 试验地点
- 51
- 主要终点
- Progression Free Survival (PFS) by Independent Review Committee (IRC) Assessment as of Data Cut-off Date of 06DEC2019
研究概览
简要总结
An open-label, randomized, multicenter Phase 3 study designed to compare the efficacy and safety of tislelizumab combined with chemotherapy versus chemotherapy only as first-line treatment in advanced 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, and signed informed consent form (ICF)
- •Advanced NSCLC diagnosed by pathological or clinical physicians
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1
- •Participants must have ≥ 1 measurable lesion as defined per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- •Must be treatment-naive for locally advanced or metastatic squamous 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 receptors (EGFR)-sensitizing mutation or anaplastic lymphoma kinase (ALK) gene translocation
- •Received any approved systemic anticancer therapy
- •Received prior treatment with EGFR inhibitors or ALK inhibitors
- •Received prior therapies targeting programmed death 1 (PD-1) or programmed death ligand 1 (PD-L1)
- •With history of interstitial lung disease
- •Clinically significant pericardial effusion
- •Severe infections, active leptomeningeal disease or uncontrolled, untreated brain metastasis
- •Any major surgical procedure before randomization
- •Human immunodeficiency virus infection
- •Untreated hepatitis B virus (HBV)/hepatitis C virus (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 + Paclitaxel + Carboplatin
Tislelizumab 200 milligrams (mg) plus paclitaxel 175 mg/m^2 and carboplatin area under the plasma or serum concentration-time curve (AUC) 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)
干预措施: Tislelizumab (Drug)
Tislelizumab + Paclitaxel + Carboplatin
Tislelizumab 200 milligrams (mg) plus paclitaxel 175 mg/m^2 and carboplatin area under the plasma or serum concentration-time curve (AUC) 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)
干预措施: Paclitaxel (Drug)
Tislelizumab + Paclitaxel + Carboplatin
Tislelizumab 200 milligrams (mg) plus paclitaxel 175 mg/m^2 and carboplatin area under the plasma or serum concentration-time curve (AUC) 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)
干预措施: Carboplatin (Drug)
Tislelizumab + Nab-paclitaxel + Carboplatin
Tislelizumab 200 mg on Day 1 plus Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; Nab-paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)
干预措施: Tislelizumab (Drug)
Tislelizumab + Nab-paclitaxel + Carboplatin
Tislelizumab 200 mg on Day 1 plus Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; Nab-paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)
干预措施: Nab-paclitaxel (Drug)
Tislelizumab + Nab-paclitaxel + Carboplatin
Tislelizumab 200 mg on Day 1 plus Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; Nab-paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)
干预措施: Carboplatin (Drug)
Paclitaxel + Carboplatin
Paclitaxel 175 mg/m^2 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks for 4 to 6 cycles (each cycle is 21 days)
干预措施: Paclitaxel (Drug)
Paclitaxel + Carboplatin
Paclitaxel 175 mg/m^2 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks for 4 to 6 cycles (each cycle is 21 days)
干预措施: Carboplatin (Drug)
结局指标
主要结局
Progression Free Survival (PFS) by Independent Review Committee (IRC) Assessment as of Data Cut-off Date of 06DEC2019
时间窗: Through primary analysis data cut-off date of 06DEC2019 (up to approximately 1 year and 4 months)
PFS is defined as the time from randomization until first documentation of disease progression as assessed by the IRC per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurs first
PFS by IRC Assessment as of Data Cut-off Date of 30SEP2020
时间窗: Through primary analysis data cut-off date of 30SEP2020 (up to approximately 2 years and 2 months)
PFS is defined as the time from randomization until first documentation of disease progression as assessed by the IRC per RECIST v1.1 or death from any cause, whichever occurs first
次要结局
- Overall Survival (OS)(Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months))
- Objective Response Rate (ORR) by IRC Assessment(Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months))
- ORR by Investigator Assessment(Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months))
- Duration of Response (DOR) by IRC Assessment(Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months))
- DOR by Investigator Assessment(Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months))
- PFS by Investigator Assessment(Through study completion data cut-off date of 28APR2023 (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 28APR2023 (up to approximately 4 years and 9 months))
- 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)
- 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(From first dose to 30 days after the last dose (up to approximately 4 years and 9 months))