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

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 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

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

June 2021