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

Hoffmann-La Roche2,756 enrolled

Overview

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.

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

Enrollment

2,756

Conditions

Urothelial Carcinoma Non-Small Cell Lung Cancer Small Cell Lung Cancer Hepatocellular Carcinoma

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Hospital Universitario Austral

Buenos Aires, Argentina

Lucen S.A.

Buenos Aires, Argentina

Consultorio Privado Korbenfeld

CABA, Argentina

Hospital Italiano de Buenos Aires

Ciudad Autonoma Buenos Aires, Argentina

Sanatorio Allende

Córdoba, Argentina

Sanatorio de la Mujer

Outcomes

Primary Outcomes

Overall Survival (OS)

Time from index date until date of death from any cause. Index date is the date of administration of the first ever dose of atezolizumab for each patient.

Time frame: Index date up to approximately 6 years

OS at 2 Years

Percentage of participants alive 2 years after initiation of atezolizumab treatment.

Time frame: After index date up to 2 years

Secondary Outcomes

Time to Loss of Clinical Benefit (TTLCB)

Time from the index date to loss of clinical benefit as assessed by the treating physician.

Time frame: Index date up to approximately 6 years

Progression Free Survival (PFS)

Time from index date to death or disease progression (PD).

Time frame: Index date up to approximately 6 years

Objective Response Rate (ORR)

Percentage of participants who have a best overall response (BOR) of Complete Response (CR) or Partial Response (PR). BOR for each participant is the best response achieved after the index date prior to initiation of any subsequent treatment.

Time frame: After index date up to approximately 6 years

Time to Response

Time from index date to first objective tumor response, CR or PR.

Time frame: Index date up to approximately 6 years

Duration of Response (DoR)

Time from first documentation of CR or PR (whichever occurs first) after index until death or PD.

Time frame: Index date up to approximately 6 years

Disease Control Rate (DCR)

Percentage of participants who have achieved CR, PR and stable disease at least 12 weeks after the index date.

Time frame: From 12 weeks after index date up to approximately 6 years

Duration of DCR

Time from first documentation of CR, PR or stable disease (whichever occurs first) after index until death or PD.

Time frame: After index date up to approximately 6 years

EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Score

EQ-5D-5L during and after atezolizumab treatment will be used to assess HRQoL. Scale is from 1-5 (no problems, slight problems, moderate problems, severe problems and extreme problems).

Time frame: Index date or after ICF signature, & approx. at 6, 12, and 24 weeks of treatment; then at approx. 3 months, 6 months, 12 months, & every 12 months thereafter until end of study (study planned duration up to approximately 6 years)

Number of Paricipants with Disease Stage TNM and IUCC

Time frame: At index date (Index date is the date of administration of the first ever dose of atezolizumab for each patient.)

Number of Participants at Each Level of Karnofsky or ECOG Performance Status

Time frame: At index date (Index date is the date of administration of the first ever dose of atezolizumab for each patient.

Total Number of Infusions of Atezolizuamb

Time frame: Treatment period until discontinuation (up to approximately 6 years)

Duration of Treatment With Atezolizumab

Time frame: Index date until date of treatment discontinuation (up to approximately 6 years)

Time to initiation of the first subsequent cancer-related therapy

Time frame: Up to approximately 6 years

Percentage of Participants with Adverse Events

Time frame: Up to approximately 6 years

Number of Lines of Prior and Subsequent Cancer-Related Therapies

Time frame: Up to approximately 6 years