A Randomized, Multicenter, Open-Label Cross-Over Study to Evaluate Participant and Healthcare Professional Reported Preference for Subcutaneous Atezolizumab Compared With Intravenous Atezolizumab Formulation in Participants With Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 179
- 试验地点
- 36
- 主要终点
- Percentage of Participants Who Preferred Atezolizumab SC to Atezolizumab IV Assessed Using Patient Preference Questionnaire (PPQ)
研究概览
简要总结
This is a Phase II, randomized, multi-center, multinational, open-label, cross-over study in adult participants with PD-L1-positive NSCLC. Two populations will be included: participants with resected Stage II, IIIA, and selected IIIB (T3-N2) NSCLC who have completed adjuvant platinum-based chemotherapy without evidence of disease relapse/recurrence, and chemotherapy-naïve participants with Stage IV NSCLC. The study will evaluate participant- and healthcare professionals (HCP)-reported preference for atezolizumab subcutaneous (SC) compared with atezolizumab intravenous (IV).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment A
Participants will receive atezolizumab SC followed by atezolizumab IV.
干预措施: Atezolizumab (Drug)
Treatment B
Participants will receive atezolizumab IV followed by atezolizumab SC.
干预措施: Atezolizumab (Drug)
结局指标
主要结局
Percentage of Participants Who Preferred Atezolizumab SC to Atezolizumab IV Assessed Using Patient Preference Questionnaire (PPQ)
时间窗: Cycle 6 Day 1 (cycle length=21 days)
Participants preference was assessed based on the Question 1 of PPQ. Question 1 (All things considered, which route of administration did you prefer?) asks participants to report their preference for the route of administration (IV, SC, or no preference). A point estimate with associated 95% CI for the percentage of participants who preferred atezolizumab SC was calculated. Participants experiencing any of the following events: treatment withdrawal prior to eligibility for PPQ, or death without answering Question 1 of PPQ, or treatment not started; were excluded from the analysis set. Participants who answered Question 1 of the PPQ without having at least 2 consecutive administrations of treatment with each administration modality (SC and IV) were excluded from the analysis. Percentages have been rounded off. As planned, participant preference was summarized and presented by overall (all participants) and by randomized treatment sequence using FAS.
次要结局
- Number of Participants by Their Level of Satisfaction With Atezolizumab SC and Atezolizumab IV Assessed Using Therapy Administration Satisfaction Questionnaire - Subcutaneous (TASQ-SC) and Intravenous (TASQ-IV)(Cycles 3 Day 1 and Cycle 6 Day 1 (cycle length=21 days))
- Percentage of Participants Who Select Atezolizumab SC for Treatment Continuation Period(Cycle 6 Day 1 (Cycle length=21 days))
- Duration of Treatment Preparation According to Healthcare Professionals (HCPs) Response to Perception of Time, Assessed Using Question 1 of Healthcare Professional Questionnaires (HCPQs) - Drug Preparation Area(Day 1 of Cycles 1 to 6 (cycle length= 21 days))
- Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area(Cycle 6 Day 1 (cycle length=21 days))
- Percentage of HCPs by Their Response to Perception of Time/Resource Use for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 and 4 of HCPQ - Drug Preparation Area(Cycle 6 Day 1 (cycle length= 21 days))
- Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs - Treatment Room(Day 1 of Cycles 1 to 6 (cycle length=21 days))
- Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room(Cycle 6 Day 1 (cycle length=21 days))
- Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 to 7 of HCPQ - Treatment Room(Cycle 6 Day 1 (cycle length=21 days))
- Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 8 of HCPQ - Treatment Room(Cycle 6 Day 1 (cycle length= 21 days))
- Change From Baseline Over Time in Physical Functioning Scale Score as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30)(Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years))
- Change From Baseline Over Time in Role Functioning Scale Score as Assessed by EORTC-QLQ-C30(Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years))
- Change From Baseline Over Time in Emotional Functioning Scale Score as Assessed by EORTC-QLQ-C30(Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years))
- Change From Baseline Over Time in Cognitive Functioning Scale Score as Assessed by EORTC-QLQ-C30(Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years))
- Change From Baseline Over Time in Social Functioning Scale Score as Assessed by EORTC-QLQ-C30(Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years))
- Change From Baseline Over Time in Fatigue Scale Score as Assessed by EORTC-QLQ-C30(Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years))
- Change From Baseline Over Time in Nausea and Vomiting Scale Score as Assessed by EORTC-QLQ-C30(Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years))
- Change From Baseline Over Time in Pain Scale Score as Assessed by EORTC-QLQ-C30(Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years))
- Change From Baseline Over Time in Dyspnoea Scale Score as Assessed by EORTC-QLQ-C30(Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years))
- Change From Baseline Over Time in Insomnia Scale Score as Assessed by EORTC-QLQ-C30(Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years))
- Change From Baseline Over Time in Appetite Loss Scale Score as Assessed by EORTC-QLQ-C30(Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years))
- Change From Baseline Over Time in Constipation Scale Score as Assessed by EORTC-QLQ-C30(Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years))
- Change From Baseline Over Time in Diarrhoea Scale Score as Assessed by EORTC-QLQ-C30(Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years))
- Change From Baseline Over Time in Financial Difficulties Scale Score as Assessed by EORTC-QLQ-C30(Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years))
- Change From Baseline Over Time in Health-related Quality of Life (HRQoL) Score as Assessed by GHS/QoL Scale of the EORTC-QLQ-C30(Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years))
- Percentage of Participants With Ongoing Clinical Benefit(Up to Cycle 16 (cycle length= 21 days))
- Percentage of Participants With Adverse Events (AEs)(Up to 90 days after the final dose of study drug (Up to 2.4 years))
- Percentage of Participants With AEs During Treatment Cross-over Period(From Cycle 1 Day 1 up to Cycle 3 Day 21; From Cycle 4 Day 1 up to Cycle 6 Day 21 (cycle length=21 days))