Status:
ACTIVE_NOT_RECRUITING
A Study Investigating the Outcomes and Safety of Atezolizumab Under Real-World Conditions in Patients Treated in Routine Clinical Practice
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Urothelial Carcinoma
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Brief Summary
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 as...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 7 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2026
Estimated Enrollment :
2756 Patients enrolled
Trial Details
Trial ID
NCT03782207
Start Date
February 7 2019
End Date
July 31 2026
Last Update
January 8 2026
Active Locations (258)
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1
Hospital Universitario Austral
Buenos Aires, Argentina, 16290
2
Lucen S.A.
Buenos Aires, Argentina, C1405CUB
3
Consultorio Privado Korbenfeld
CABA, Argentina, C1426AGE
4
Hospital Italiano de Buenos Aires
Ciudad Autonoma Buenos Aires, Argentina, C1199ABB