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NCT Number: NCT03782207

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Urothelial Carcinoma Adenocarcinoma Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Hepatocellular Carcinoma, Non-Small-Cell Lung Carcinoma, Transitional Cell Digestive System Diseases Digestive System Neoplasms Hepatocellular Carcinoma Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-small Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Cancer Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Austral, Buenos Aires, Argentina

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Atezolizumab

Drug

Atezolizumab will be administered at the discretion of the treating physician per local guidelines and independently of participation in this study.

Other names: Tecentriq

Primary outcomes

  1. Overall Survival (OS)

    Time frame: 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.

  2. OS at 2 Years

    Time frame: After index date up to 2 years

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

Secondary outcomes

  1. Time to Loss of Clinical Benefit (TTLCB)

    Time frame: Index date up to approximately 6 years

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

  2. Progression Free Survival (PFS)

    Time frame: Index date up to approximately 6 years

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

  3. Objective Response Rate (ORR)

    Time frame: 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.

  4. Time to Response

    Time frame: Index date up to approximately 6 years

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

  5. Duration of Response (DoR)

    Time frame: Index date up to approximately 6 years

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

  6. Disease Control Rate (DCR)

    Time frame: 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.

  7. Duration of DCR

    Time frame: 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.

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

    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)

    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).

  9. 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.)

  10. 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.

  11. Total Number of Infusions of Atezolizuamb

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

  12. Duration of Treatment With Atezolizumab

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

  13. Time to initiation of the first subsequent cancer-related therapy

    Time frame: Up to approximately 6 years

  14. Percentage of Participants with Adverse Events

    Time frame: Up to approximately 6 years

  15. Number of Lines of Prior and Subsequent Cancer-Related Therapies

    Time frame: Up to approximately 6 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Acronym: IMreal

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Dec 20, 2018
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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