NCT03559647已完成不适用
The Effectiveness Of Atezolizumab Under Real-World Conditions In Patients With Locally-Advanced Or Metastatic Non-Small Cell Lung Cancer After Prior Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 358
- 试验地点
- 94
- 主要终点
- Duration of response (DOR) to Atezolizumab treatment
研究概览
简要总结
Hyperion Is A Prospective, Multicenter, Non-Interventional, Two-Cohort Study Collecting Primary Data In Patients With Locally Advanced Or Metastatic NSCLC Of Squamous Or Non-Squamous Histology After Prior Chemotherapy Being Treated With Atezolizumab In Routine Clinical Practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Diagnosis of locally advanced or metastatic NSCLC (histologically or cytologically confirmed stage IIIB/stage IV) and prior chemotherapy
- •Decision to be treated with Atezolizumab according to Summary of Product Characteristics (SmPC) by treating physician, independent of this non-interventional study
- •No contraindication to treatment with Atezolizumab
- •Retrospective Inclusion:
- •Participants may be included retrospectively. Retrospective inclusion and documentation is limited to up to 9 weeks after initial start of therapy with Atezolizumab (corresponding to a maximum of 3 treatment cycles with drug administrations at 3-week intervals), corresponding to a maximum of 9 weeks prior to date of informed consent. Quality of life for this population will be captured and assessed retrospectively with a modified questionnaire for the period immediately prior to treatment start until study inclusion. participants who started Atezolizumab therapy more than 9 weeks prior to ICF being obtained may not be included in the study.
- •Participants who give consent to be retrospectively enrolled but have already discontinued Atezolizumab for reasons such as loss of clinical benefit or toxicity may also take part in the study, given their first administration of Atezolizumab is within 9 weeks of consenting to take part, and they meet all other eligibility criteria.
排除标准
- •Patients not eligible for Atezolizumab treatment according to SmPC
研究组 & 干预措施
Cohort 2
Participants who demonstrated durability of Clinical Benefit and Tumor Response to Atezolizumab
干预措施: Atezolizumab (Drug)
结局指标
主要结局
Duration of response (DOR) to Atezolizumab treatment
时间窗: Time from first documentation of complete response (CR) or partial response (PR), whichever occurs first, until progressive disease (PD), as evaluated by the physician according to routine practice or death; through the end of study (~ 5 years)
Time to loss of clinical benefit (TTLCB) from Atezolizumab treatment
时间窗: Time from first dose to loss of clinical benefit as assessed by the treating physician, through the end of study (approximately 5 years).
次要结局
- Best overall response (BOR) of overall population(Best response achieved within 12 weeks as assessed in clinical routine, through the end of study (approximately 5 years))
- Progression-free survival (PFS) of overall population(Time from initiation of study treatment to the first occurrence of progressive disease (PD) or death from any cause, whichever occurs first, as evaluated by the physician according to clinical practice, through the end of study (approximately 5 years))
- Overall response rate (ORR) of overall population(Rate of CR and PR in patients as assessed in clinical routine, through end of study (approximately 5 years))
- Overall survival of cohort 2 ("Coh2 OS")(Time from initiation of Atezolizumab treatment to death from any cause (until the end of study, approximately 5 years).)
- Time to response (TTR) of overall population(Time from first dose to first response as assessed in clinical routine, through the end of study (approximately 5 years))
- Disease control rate (DCR) of overall population(Percentage of patients who achieved a CR, a PR, or stable disease (SD) as evaluated by the physician according to clinical practice at the time of the fifth Atezolizumab infusion; (until the end of study, approximately 5 years))
- Best overall response of patients in cohort 2 ("Coh2 BOR")(Baseline through the end of study (approximately 5 years))
- Percentage of participants with Adverse Events (AEs)(Baseline through the end of study (approximately 5 years))
研究者
研究点 (94)
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