A Non-Interventional, Multicenter, Multiple Cohort Study Investigating the Outcomes and Safety of Atezolizumab Under Real-World Conditions in Patients Treated in Routine Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,756
- 试验地点
- 263
- 主要终点
- OS at 2 Years
研究概览
简要总结
This is a non-interventional, multi-country, multi-centre, multiple cohort prospective study, with retrospective collection of prior medical/treatment history data from medical records, designed to assess the real-world outcomes and safety of atezolizumab for indications in the existing label in the real world setting of routine clinical practice.
详细描述
The study will be split into separate cohorts based on the approved indications for atezolizumab treatment, excluding cisplatin ineligible participants receiving atezolizumab as first line of therapy (LOT1) for locally advanced/metastatic urothelial cancer (locally advanced/metastatic UC). The study may be amended for inclusion of new cohorts as these are approved in the participating countries. Participants will be included into each cohort based on their indication for receiving atezolizumab.
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
- •Patient must have one of the following confirmed diagnoses for which atezolizumab is locally approved in the SmPC: (1) As monotherapy for the treatment of adult patients with locally advanced/metastatic UC after prior platinum-containing chemotherapy (Cohort 1 LOT2+mUC) or (2) As monotherapy for the treatment of adult patients with locally advanced/metastatic NSCLC after prior chemotherapy. Patients with EGFR activating mutations or ALK-positive tumour mutations should also have received targeted therapy before receiving atezolizumab (Cohort 2 LOT2+NSCLC) or (3) In combination with bevacizumab, paclitaxel and carboplatin for the first line treatment of adult patients with metastatic non-squamous NSCLC. Patients with EGFR activating mutations or ALK- positive tumour mutations should also have received targeted therapy (Cohort 3 LOT1 NSCLC) or (4) In combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) (Cohort 4 LOT1 ES-SCLC) or (5) As a monotherapy, for the treatment of metastatic NSCLC with high PD-L1 expression, previously untreated (Cohort 5 LOT1 NSCLC) or (6) In combination with bevacizumab for unresectable locally advanced or metastatic hepatocellular carcinoma previously untreated with systemic therapy (Cohort 6 LOT1 HCC) .
- •Patient is administered atezolizumab therapy for the first time.
- •Decision to administer atezolizumab must be made and documented prior to inclusion into the study and must follow local clinical practice.
排除标准
- •Patients not receiving treatment for a disease with atezolizumab according to standard of care and in line with the current summary of product characteristics (SPC) or local labelling. Cisplatin ineligible patients receiving atezolizumab LOT1 for the treatment of locally advanced/metastatic UC patients will be excluded
- •Concomitant anti-cancer therapy at the time of starting atezolizumab on the index date not part of locally approved combination therapy with atezolizumab.
- •Treatment with atezolizumab as part of a clinical trial or for compassionate use as part of a pre-approval or compassionate use program.
- •Patients not receiving atezolizumab, but a biosimilar or non-original biologic.
研究组 & 干预措施
Cohort 1 (UC LOT2+later lines[LOT2+] & platinum eligible LOT1)
Participants diagnosed with locally advanced or metastatic Urothelial Cancer previously treated with platinum-containing chemotherapy.
Enrollment is closed.
干预措施: Atezolizumab (Drug)
Cohort 5 (NSCLC LOT1)
Participants diagnosed with metastatic Non-Small Cell Lung cancer with high PD-L1 expression, previously untreated.
干预措施: Atezolizumab (Drug)
Cohort 3 (NSCLC LOT1 plus EGFR+/ALK+ LOT2+)
EMA: Participants diagnosed with locally advanced/metastatic non-squamous NSCLC not previously treated. Participants with EGFR-activating mutations or ALK-positive tumor mutations should have received at least one line of targeted therapy.
FDA: for the treatment of adult participants with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Participants with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving TECENTRIQ.
Enrollment is closed.
干预措施: Atezolizumab (Drug)
Cohort 2 (NSCLC LOT2 plus later lines [LOT2+])
Participants diagnosed with Locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) after prior chemotherapy. Participants with epidermal growth factor receptor (EGFR) activating mutations or anaplastic lymphoma kinase (ALK)-positive tumor mutations should also have received targeted therapy.
Enrollment closed.
干预措施: Atezolizumab (Drug)
Cohort 4 (ES-SCLC LOT1)
Participants diagnosed with extensive stage (ES) small cell lung cancer (SCLC) not previously treated.
Enrollment is closed.
干预措施: Atezolizumab (Drug)
Cohort 6 (HCC LOT1)
Participants diagnosed with unresectable locally advanced or metastatic hepatocellular carcinoma previously untreated with systemic therapy.
干预措施: Atezolizumab (Drug)
结局指标
主要结局
OS at 2 Years
时间窗: After index date up to 2 years
Percentage of participants alive 2 years after initiation of atezolizumab treatment.
Overall Survival (OS)
时间窗: Index date up to approximately 6 years
Time from index date until date of death from any cause. Index date is the date of administration of the first ever dose of atezolizumab for each patient.
次要结局
- Duration of Response (DoR)(Index date up to approximately 6 years)
- Time to Loss of Clinical Benefit (TTLCB)(Index date up to approximately 6 years)
- Progression Free Survival (PFS)(Index date up to approximately 6 years)
- Objective Response Rate (ORR)(After index date up to approximately 6 years)
- Time to Response(Index date up to approximately 6 years)
- EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Score(Index date or after ICF signature, & approx. at 6, 12, and 24 weeks of treatment; then at approx. 3 months, 6 months, 12 months, & every 12 months thereafter until end of study (study planned duration up to approximately 6 years))
- Total Number of Infusions of Atezolizuamb(Treatment period until discontinuation (up to approximately 6 years))
- Duration of Treatment With Atezolizumab(Index date until date of treatment discontinuation (up to approximately 6 years))
- Time to initiation of the first subsequent cancer-related therapy(Up to approximately 6 years)
- Number of Lines of Prior and Subsequent Cancer-Related Therapies(Up to approximately 6 years)
- Disease Control Rate (DCR)(From 12 weeks after index date up to approximately 6 years)
- Duration of DCR(After index date up to approximately 6 years)
- Number of Participants at Each Level of Karnofsky or ECOG Performance Status(At index date (Index date is the date of administration of the first ever dose of atezolizumab for each patient.)
- Number of Paricipants with Disease Stage TNM and IUCC(At index date (Index date is the date of administration of the first ever dose of atezolizumab for each patient.))
- Percentage of Participants with Adverse Events(Up to approximately 6 years)