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 (IMreal)

STATUS

Recruiting
End date

Dec 19, 2026
participants needed

3400
sponsor

Hoffmann-La Roche

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Updated on 18 October 2022

See if I qualify

paclitaxel

cancer

systemic therapy

carcinoma

lung cancer

etoposide

carboplatin

EGFR

bevacizumab

cancer chemotherapy

targeted therapy

atezolizumab

stage iv non-small cell lung cancer

lung carcinoma

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.

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.

Details

Condition	Urothelial Carcinoma, Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Hepatocellular Carcinoma
Treatment	Atezolizumab
Clinical Study Identifier	NCT03782207
Sponsor	Hoffmann-La Roche
Last Modified on	18 October 2022

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Eligibility		Yes	No	Not Sure
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

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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 (IMreal)