LBCTR2020033423招募中不适用
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 - IMReal
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 100（—）
- 性别
- All
入选标准
- •Patients must meet the following criteria for study entry:
- •1.Patient must have one of the following confirmed diagnoses for which atezolizumab is locally approved in the SmPC:
- •oAs monotherapy for the treatment of adult patients with locally advanced/metastatic UC after prior platinum-containing chemotherapy (Cohort 1 LOT2+ mUC).
- •oAs 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 (i.e. ALK /EGFR-TKIs) before receiving atezolizumab (Cohort 2 LOT2+ NSCLC).
- •oIn 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 (i.e. ALK /EGFR-TKIs). (Cohort 3 LOT1 NSCLC).
- •oIn 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)
- •2.Patient is prescribed atezolizumab therapy for the first time
- •3.Decision to prescribe atezolizumab must be made and documented prior to inclusion into the study and must follow local clinical practice.
- •4.Patient is aged = 18 years or older at the index date.
- •5.Patient has signed an informed consent form according to local regulations.
- •6.Data collection can only start after the signing of inform consent and not more than 28 days after initiation of atezolizumab. In countries where enrollment is only allowed after the treatment start, enrollment must be preceded by the administration of the first cycle of atezolizumab.
排除标准
- •Patients who meet any of the following criteria will be excluded from study entry:
- •1.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 *.
- •2.Concomitant anti-cancer therapy at the time of starting atezolizumab on the index date, not part of locally approved combination therapy with atezolizumab.
- •3.Treatment with atezolizumab as part of a clinical trial or for compassionate use as part of an access or compassionate use program.
- •4.Patients not receiving atezolizumab, but a biosimilar or non-original biologic.
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