A Phase 3, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of BGB-A317 (Anti-PD1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer Who Have Progressed on a Prior Platinum-Containing Regimen
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 805
- 试验地点
- 121
- 主要终点
- Overall Survival (OS) in All Participants (Co-primary Endpoint)
研究概览
简要总结
The purpose of this study is to show that tislelizumab will improve overall survival in participants with Stage IIIB or IV non-small cell lung cancer when compared to docetaxel in second or third-line treatment setting.
详细描述
This is a randomized, open-label, multicenter Phase 3 study in adult participants with histologically confirmed, locally advanced or metastatic (Stage IIIB or IV), NSCLC (squamous or non-squamous) who have disease progression during or after a platinum-containing regimen.
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
- •Age ≥ 18 years.
- •Signed Informed Consent Form.
- •Histologically confirmed locally advanced or metastatic (Stage IIIB or IV) NSCLC of either squamous or non-squamous histology types with disease progression during or following treatment with at least one platinum-containing regimen, but no more than 2 lines of systemic therapy.
- •Participants must be able to provide fresh or archival tumor tissues for central assessment of PD-L1 expression in tumor cells. Participants with non-squamous histology must provide evidence of not harboring sensitizing epidermal growth factor (EGFR) mutation tested by a histology-based method.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Adequate hematologic and end-organ function.
- •Expected life span > 12 weeks.
- •Willing to be compliance with birth control requirement during pre-specified study participating period
排除标准
- •Prior therapies of docetaxel or treatment targeting programmed cell death protein 1 (PD-1), PD-L1 or cytotoxic T-lymphocyte associated protein 4 (CTLA-4).
- •Harboring EGFR sensitizing mutation or anaplastic lymphoma kinase (ALK) gene translocation.
- •Unresolved side effects of Grade 2 and above from prior anti-cancer therapies, except for adverse events (AEs) not constituting a likely safety risk (e.g. alopecia, rash, pigmentation, specific lab abnormalities).
- •History of severe hypersensitivity reactions to other monoclonal antibodies (mAbs).
- •History of interstitial lung disease, non-infectious pneumonitis or participants with significantly impaired pulmonary function, or who require supplemental oxygen at baseline.
- •With uncontrollable pleural effusion, pericardial effusion, or clinically significant ascites requiring interventional treatment.
- •Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
- •Severe chronic or active infection requiring systemic treatment.
- •Known human immunodeficiency virus (HIV) infection, participants with untreated chronic hepatitis B, active vaccination treatment.
- •Insufficient cardiac functions and other underlying unfavorable cardiovascular conditions.
- •Prior allogeneic stem cell transplantation or organ transplantation.
- •Active autoimmune diseases or history of autoimmune diseases that may relapse.
- •With conditions requiring systemic treatment with either corticosteroids (>10 mg daily prednisone or equivalent) or other immunosuppressive medications.
- •With severe underlying medical conditions (including laboratory abnormalities) or alcohol or drug abuse that may affect the explanation of drug toxicity or AEs or result in impaired compliance with study conduct.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Tislelizumab
Participants received tislelizumab 200 mg intravenously (IV) once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
干预措施: Tislelizumab (Drug)
Docetaxel
Participants received docetaxel 75 mg/m² IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
干预措施: Docetaxel (Drug)
结局指标
主要结局
Overall Survival (OS) in All Participants (Co-primary Endpoint)
时间窗: From randomization to the data cutoff date of 10 August 2020; up to 32.4 months
OS was defined as the time from randomization to death from any cause. Median OS was calculated using the Kaplan-Meier method. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Data for participants who did not have postbaseline information were censored at the date of randomization.
Overall Survival (OS) in Programmed Cell Death Protein Ligand-1 (PD-L1)-Positive Participants (Co-primary Endpoint)
时间窗: From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months
OS was defined as the time from randomization to death from any cause. Median OS was calculated using the Kaplan-Meier method. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Data for participants who did not have postbaseline information were censored at the date of randomization.
次要结局
- Objective Response Rate (ORR) in All Participants(From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months)
- Objective Response Rate in PD-L1-Positive Participants(From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months)
- Progression-free Survival (PFS) in All Participants(From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months)
- Progression-free Survival in PD-L1 Positive Participants(From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months)
- Duration of Response (DOR) for All Responders(From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months)
- Duration of Response (DOR) in PD-L1-Positive Responders(From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months)
- Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 Items (QLQ-LC13) Coughing, Dyspnoea, and Chest Pain Scores(Baseline and Cycle 6 (each cycle was 3 weeks))
- Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL) Score(Baseline and Cycle 6 (each cycle was 3 weeks))
- Change From Baseline in European Quality of Life 5-Dimensions, 5-level (EQ-5D-5L) Visual Analogue Scale (VAS)(Baseline and Cycle 6 (each cycle was 3 weeks))
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(From first dose of study drug to 30 days after last dose, up to the study completion date cut-off date of 18 January 2024 (up to approximately 63 months))