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A Study Investigating the Outcomes and Safety of Atezolizumab Under Real-World Conditions in Patients Treated in Routine Clinical Practice

NCT03782207

CompletedN/A

Sponsor: Hoffmann-La Roche

Conditions: Urothelial Carcinoma, Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Hepatocellular Carcinoma

Interventions: Atezolizumab

Countries: Argentina, Austria, Belgium, Brazil, Bulgaria, Chile, Colombia, Croatia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Locations (257)

Buenos Aires, Argentina
Buenos Aires, Argentina
CABA, Argentina
Ciudad Autonoma Buenos Aires, Argentina
Córdoba, Argentina
Rosario, Argentina
Santa Rosa, Argentina
Klagenfurt, Austria
Krems, Austria
Vöcklabruck, Austria
Wels, Austria
Brasschaat, Belgium
Mechelen, Belgium
Mont-godinne, Belgium
Ostend, Belgium
Roeselare, Belgium
Sint-Truiden, Belgium
São Paulo, São Paulo, Brazil
Burgas, Bulgaria
Panagyurishte, Bulgaria
Pleven, Bulgaria
Plovdiv, Bulgaria
Plovdiv, Bulgaria
Plovdiv, Bulgaria
Plovdiv, Bulgaria
Rousse, Bulgaria
Sofia, Bulgaria
Sofia, Bulgaria
Sofia, Bulgaria
Sofia, Bulgaria
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