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

Active, not recruiting

• Conditions: Urothelial Carcinoma; Non-Small Cell Lung Cancer; Small Cell Lung Cancer; Hepatocellular Carcinoma
• Interventions: Drug: Atezolizumab

• Registration Number: NCT03782207
• Lead Sponsor: Hoffmann-La Roche

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 Timeline

• Study First Submitted: 2018-11-28
• Study First Submitted QC: 2018-12-18
• Study First Posted: 2018-12-20
• Study Start: 2019-02-07
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-23
• Last Update Posted: 2025-06-24
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2756

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 5 (NSCLC LOT1)	Atezolizumab	Participants diagnosed with metastatic Non-Small Cell Lung cancer with high PD-L1 expression, previously untreated.
Cohort 4 (ES-SCLC LOT1)	Atezolizumab	Participants diagnosed with extensive stage (ES) small cell lung cancer (SCLC) not previously treated. Enrollment is closed.
Cohort 1 (UC LOT2+later lines[LOT2+] & platinum eligible LOT1)	Atezolizumab	Participants diagnosed with locally advanced or metastatic Urothelial Cancer previously treated with platinum-containing chemotherapy. Enrollment is closed.
Cohort 2 (NSCLC LOT2 plus later lines [LOT2+])	Atezolizumab	Participants diagnosed with Locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) after prior chemotherapy. Participants with epidermal growth factor receptor (EGFR) activating mutations or anaplastic lymphoma kinase (ALK)-positive tumor mutations should also have received targeted therapy. Enrollment closed.
Cohort 3 (NSCLC LOT1 plus EGFR+/ALK+ LOT2+)	Atezolizumab	EMA: Participants diagnosed with locally advanced/metastatic non-squamous NSCLC not previously treated. Participants with EGFR-activating mutations or ALK-positive tumor mutations should have received at least one line of targeted therapy. FDA: for the treatment of adult participants with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Participants with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving TECENTRIQ. Enrollment is closed.
Cohort 6 (HCC LOT1)	Atezolizumab	Participants diagnosed with unresectable locally advanced or metastatic hepatocellular carcinoma previously untreated with systemic therapy.

Primary Outcome Measures

Name	Time	Method
OS at 2 Years	After index date up to 2 years	Percentage of participants alive 2 years after initiation of atezolizumab treatment.
Overall Survival (OS)	Index date up to approximately 6 years	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.

Secondary Outcome Measures

Name	Time	Method
Duration of Response (DoR)	Index date up to approximately 6 years	Time from first documentation of CR or PR (whichever occurs first) after index until death or PD.
Time to Loss of Clinical Benefit (TTLCB)	Index date up to approximately 6 years	Time from the index date to loss of clinical benefit as assessed by the treating physician.
Progression Free Survival (PFS)	Index date up to approximately 6 years	Time from index date to death or disease progression (PD).
Objective Response Rate (ORR)	After index date up to approximately 6 years	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 to Response	Index date up to approximately 6 years	Time from index date to first objective tumor response, CR or PR.
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Score	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)	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).
Total Number of Infusions of Atezolizuamb	Treatment period until discontinuation (up to approximately 6 years)
Duration of Treatment With Atezolizumab	Index date until date of treatment discontinuation (up to approximately 6 years)
Time to initiation of the first subsequent cancer-related therapy	Up to approximately 6 years
Number of Lines of Prior and Subsequent Cancer-Related Therapies	Up to approximately 6 years
Disease Control Rate (DCR)	From 12 weeks after index date up to approximately 6 years	Percentage of participants who have achieved CR, PR and stable disease at least 12 weeks after the index date.
Duration of DCR	After index date up to approximately 6 years	Time from first documentation of CR, PR or stable disease (whichever occurs first) after index until death or PD.
Number of Participants at Each Level of Karnofsky or ECOG Performance Status	At index date (Index date is the date of administration of the first ever dose of atezolizumab for each patient.
Number of Paricipants with Disease Stage TNM and IUCC	At index date (Index date is the date of administration of the first ever dose of atezolizumab for each patient.)
Percentage of Participants with Adverse Events	Up to approximately 6 years

Trial Locations

Locations (256)

Hospital Universitario Austral; 🇦🇷 Buenos Aires, Argentina

Consultorio Privado Korbenfeld; 🇦🇷 Caba, Argentina

Hospital Italiano de Buenos Aires; 🇦🇷 Ciudad Autonoma Buenos Aires, Argentina

Lucen S.A.; 🇦🇷 Ciudad Autónoma de Buenos Aires, Argentina

Sanatorio Allende; 🇦🇷 Cordoba, Argentina

Sanatorio de la Mujer; 🇦🇷 Rosario, Argentina

Fundacion Koriza; 🇦🇷 Santa Rosa, Argentina

Klinikum Klagenfurt; 🇦🇹 Klagenfurt, Austria

Landesklinikum Krems; 🇦🇹 Krems, Austria

Salzkammergut-Klinikum Voecklabruck; 🇦🇹 Vöcklabruck, Austria

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