Brief Title
A Study Investigating the Outcomes and Safety of Atezolizumab Under Real-World Conditions in Patients Treated in Routine Clinical Practice
Official Title
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
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 assess the real-world outcomes and safety of atezolizumab for indications in the
existing label in the real world setting of routine clinical practice.
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 (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.
Study Type
Observational
Primary Outcome
Overall Survival (OS)
Secondary Outcome
Time to Loss of Clinical Benefit (TTLCB)
Condition
Urothelial Carcinoma
Intervention
Atezolizumab
Study Arms / Comparison Groups
Cohort 1 (UC LOT2+later lines[LOT2+] & platinum eligible LOT1)
Description: Participants diagnosed with locally advanced or metastatic Urothelial Cancer previously treated with platinum-containing chemotherapy. Enrollment is closed.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
3400
Start Date
February 7, 2019
Completion Date
December 19, 2026
Primary Completion Date
December 19, 2026
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Clinical Trials, 888-662-6728 (U.S. and Canada), [email protected]
Location Countries
Argentina
Location Countries
Argentina
Administrative Informations
NCT ID
NCT03782207
Organization ID
MO40653
Responsible Party
Sponsor
Study Sponsor
Hoffmann-La Roche
Study Sponsor
Clinical Trials, Study Director, Hoffmann-La Roche
Verification Date
September 2022