NCT03285763已完成4 期
A Phase III/IV, Single Arm, Multicenter Study of Atezolizumab (Tecentriq) to Investigate Long-term Safety and Efficacy in Previously-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (TAIL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 619
- 试验地点
- 111
- 主要终点
- Percentage of Participants With Adverse Events
研究概览
简要总结
This is a Phase III/IV, single-arm, multicenter study of the long-term safety and efficacy of atezolizumab treatment in participants with Stage IIIb or Stage IV NSCLC who have progressed after standard systemic chemotherapy (including if given in combination with anti-programmed cell death protein 1 [anti-PD-1] therapy, after anti-PD-1 as monotherapy, or after tyrosine kinase inhibitor [TKI] therapy). The study will consist of a Screening Period, a Treatment Period, a Treatment Discontinuation Visit, and a Follow-Up Period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically or cytologically documented Stage IIIb or Stage IV NSCLC that has progressed following standard systemic chemotherapy (including if given in combination with anti-PD-1 therapy, after anti-PD-1 as monotherapy, or after TKI therapy). Participants with a previously detected sensitizing epidermal growth factor receptor (EGFR) mutation or echinoderm microtubule-associated protein-like 4-anaplastic lymphoma kinase (ALK) fusion oncogene must have received targeted therapy (TKI) followed by at least one line of standard systemic chemotherapy prior to receiving atezolizumab. Overall, participants should not have received more than two lines of standard systemic chemotherapy. Participants who have discontinued first-line or second-line therapy due to intolerance are also eligible
- •The last dose of prior systemic anticancer therapy or targeted therapy must have been administered more than or equal to (≥) 21 days prior to randomization.
- •The last dose of prior anti-PD-1 therapy must have been administered. Nivolumab must have been discontinued >= 14 days and pembrolizumab >= 21 days prior to study treatment initiation, providing that these treatments were not administered in a clinical trial setting.
- •Measurable disease, as defined by Response Evaluation Criteria for Solid Tumors, Version 1.1 (RECIST v1.1)
- •Participants with asymptomatic central nervous system (CNS) metastases (treated or untreated), as determined by computed tomography (CT) or magnetic resonance imaging evaluation during screening and prior radiographic evaluation, are eligible
- •Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- •Life expectancy ≥ 12 weeks
- •Adequate hematologic and end-organ function
- •For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of less than (<) 1 percent (%) per year during the treatment period and for at least 5 months after the last dose of atezolizumab
- •Participants must have recovered (i.e., improvement to Grade 1 or better) from all acute toxicities from previous therapy, excluding alopecia and toxicities related to prior anti-PD-1-therapy
排除标准
- •Symptomatic CNS metastases
- •Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥ 2 weeks prior to study treatment initiation
- •Leptomeningeal disease
- •Uncontrolled pericardial effusion or ascites requiring recurrent drainage procedures
- •Pregnant or lactating, or intending to become pregnant during the study
- •Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol, including significant liver disease (such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome)
- •Significant cardiovascular disease, such as New York Heart Association cardiac disease ≥ Class III, myocardial infarction within 3 months, unstable arrhythmias, or unstable angina
- •Significant renal disorder requiring dialysis or indication for renal transplant
- •Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to study treatment initiation
- •Major surgical procedure within 4 weeks prior to study treatment initiation or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis
- •Inability to understand the local language(s) for which the EORTC QLQ-LC13 and EQ-5D-5L questionnaires are available
- •History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- •Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
- •History of autoimmune disease are allowed if controlled and on stable treatment (i.e., same treatment, same dose) for the last 12 weeks
- •Prior allogeneic stem cell or solid organ transplantation
- •History of idiopathic pulmonary fibrosis, including pneumonitis, drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan
- •Active tuberculosis
- •Administration of a live, attenuated vaccine within 4 weeks prior to study treatment initiation
- •Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies other than anti-PD-1 therapy, including anti-programmed death-ligand 1 therapeutic antibodies
- •Treatment with systemic immunostimulatory agents (including, but not limited to, interferons or interleukin-2) within 4 weeks or five half-lives of the drug, whichever is longer, prior to initiation of study treatment
- •Specifically for participants without autoimmune disease: treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to study treatment initiation, or anticipated requirement for systemic immunosuppressive medications during the trial. For participants with CNS metastases, use of prednisone at a stable dose (or dose equivalent) of <= 20 mg/day is acceptable.
研究组 & 干预措施
Atezolizumab
Experimental
Participants with Stage IIIb or State IV NSCLC who have progressed after standard systemic chemotherapy will receive atezolizumab until Investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or participant's decision to withdraw from therapy, or death (whichever occurs first).
干预措施: Atezolizumab (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events
时间窗: Baseline up to 4 years
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unitended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a pharmaceutical product whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as a AEs.
次要结局
- Percentage of Participants Alive 2 Years After Initiation of Treatment(Baseline up to Year 2)
- Overall Survival (OS)(Baseline up to death (up to 4 years))
- Progression-Free Survival (PFS) as Evaluated By the Investigator in Accordance With Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (v.1.1)(Baseline up to disease progression or death whichever occurs first (up to 4 years))
- EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire - Mobility Item(Day 1 of first 2 cycles (21-day cycle), then every 6 weeks for 54 weeks; thereafter every 3 weeks or 6 weeks until disease progression or until treatment discontinuation (up to 4 years))
- EQ-5D-5L Questionnaire - Self-Care Item(Day 1 of first 2 cycles (21-day cycle), then every 6 weeks for 54 weeks; thereafter every 3 weeks or 6 weeks until disease progression or until treatment discontinuation (up to 4 years))
- EQ-5D-5L Questionnaire - Usual Activities Item(Day 1 of first 2 cycles (21-day cycle), then every 6 weeks for 54 weeks; thereafter every 3 weeks or 6 weeks until disease progression or until treatment discontinuation (up to 4 years))
- EQ-5D-5L Questionnaire - Pain/Discomfort Item(Day 1 of first 2 cycles (21-day cycle), then every 6 weeks for 54 weeks; thereafter every 3 weeks or 6 weeks until disease progression or until treatment discontinuation (up to 4 years))
- EQ-5D-5L Questionnaire - Anxiety/Depression Item(Day 1 of first 2 cycles (21-day cycle), then every 6 weeks for 54 weeks; thereafter every 3 weeks or 6 weeks until disease progression or until treatment discontinuation (up to 4 years))
- EQ-5D-5L Questionnaire - VAS Scores(Day 1 of first 2 cycles (21-day cycle), then every 6 weeks for 54 weeks; thereafter every 3 weeks or 6 weeks until disease progression or until treatment discontinuation (up to 4 years))
- European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Supplemental Lung Cancer Module (EORTC QLQ-LC13)(Day 1 of first 3 cycles (21-day cycle), then every 6 weeks for 48 weeks; thereafter every 9 weeks until disease progression or until treatment discontinuation (up to 4 years))
- Progression-Free Survival as Evaluated By the Investigator in Accordance With Modified RECIST(Baseline up to disease progression or death whichever occurs first (up to 4 years))
- Percentage of Participants Alive 3 Years After Initiation of Treatment(Baseline up to Year 3)
- Percentage of Participants With Objective Reponse as Assessed by the Investigator According to RECIST v1.1(Baseline up to disease progression or death whichever occurs first (up to 4 years))
- Percentage of Participants With Objective Reponse as Assessed by the Investigator According to Modified RECIST(Baseline up to disease progression or death whichever occurs first (up to 4 years))
- Duration of Response as Assessed by the Investigator According to RECIST v.1.1(From date of first objective response up to disease progression or death whichever occurs first (up to 4 years))
- Duration of Response as Assessed by the Investigator According to Modified RECIST(From date of first objective response up to disease progression or death whichever occurs first (up to 4 years))
研究者
研究点 (111)
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