ClinicalTrials.gg
CompletedNCT03782207IMrealUpdated Aug 13, 2026

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

An observational study in Urothelial Carcinoma, Non-Small Cell Lung Cancer and Small Cell Lung Cancer, sponsored by Hoffmann-La Roche. Completed at 257 sites in 30 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Hoffmann-La Roche · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,756
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Urothelial Carcinoma
  • Non-Small Cell Lung Cancer
  • Small Cell Lung Cancer
  • Hepatocellular Carcinoma
03

In context

Carcinoma, Transitional Cell

633 studies on the registry are indexed under Carcinoma, Transitional Cell; 181 are open to participants now.

This study's enrollment of 2,756 is above the median of 300 across 107 observational studies indexed under Carcinoma, Transitional Cell.

Browse Carcinoma, Transitional Cell studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 87 are open to participants now.

Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants diagnosed with locally advanced /mUC previously treated with platinum-containing chemotherapy, participants diagnosed with locally advanced/metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy, participants diagnosed with extensive-stage small cell lung cancer (ES-SCLC), participants diagnosed with metastatic NSCLC previously untreated,and participants diagnosed with locally unresectable locally advanced or metastatic hepatocellular carcinoma previously untreated with systemic therapy.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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/ 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 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 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

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/ 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,756 participants (actual)
Patient registry
No

Groups and cohorts

  • Cohort 1 (UC LOT2+later lines[LOT2+] & platinum eligible LOT1)

    Participants diagnosed with locally advanced or metastatic Urothelial Cancer previously treated with platinum-containing chemotherapy. Enrollment is closed.

    Drug: Atezolizumab

  • Cohort 2 (NSCLC LOT2 plus later lines [LOT2+])

    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.

    Drug: Atezolizumab

  • Cohort 3 (NSCLC LOT1 plus EGFR+/ALK+ LOT2+)

    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.

    Drug: Atezolizumab

  • Cohort 4 (ES-SCLC LOT1)

    Participants diagnosed with extensive stage (ES) small cell lung cancer (SCLC) not previously treated. Enrollment is closed.

    Drug: Atezolizumab

  • Cohort 5 (NSCLC LOT1)

    Participants diagnosed with metastatic Non-Small Cell Lung cancer with high PD-L1 expression, previously untreated.

    Drug: Atezolizumab

  • Cohort 6 (HCC LOT1)

    Participants diagnosed with unresectable locally advanced or metastatic hepatocellular carcinoma previously untreated with systemic therapy.

    Drug: Atezolizumab

Interventions

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

    Also known as: Tecentriq

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  1. 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

  2. Progression Free Survival (PFS)

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

    Time frame: Index date up to approximately 6 years

  3. 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

  4. Time to Response

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

    Time frame: Index date up to approximately 6 years

  5. 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

  6. 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

  7. 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

  8. 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)

  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

07

Study locations

257 sites
  • Hospital Universitario Austral
    Buenos Aires, 16290, Argentina
  • Lucen S.A.
    Buenos Aires, C1405CUB, Argentina
  • Consultorio Privado Korbenfeld
    CABA, C1426AGE, Argentina
  • Hospital Italiano de Buenos Aires
    Ciudad Autonoma Buenos Aires, C1199ABB, Argentina
  • Sanatorio Allende
    Córdoba, X5000JHQ, Argentina
  • Sanatorio de la Mujer
    Rosario, S2000ORE, Argentina
  • Fundacion Koriza
    Santa Rosa, 6300, Argentina
  • Klinikum Klagenfurt
    Klagenfurt, 9020, Austria
  • Landesklinikum Krems
    Krems, 3500, Austria
  • Salzkammergut-Klinikum Voecklabruck
    Vöcklabruck, 4840, Austria
  • Klinikum Wels-Grieskirchen
    Wels, 4600, Austria
  • AZ KLINA
    Brasschaat, 2930, Belgium
  • AZ St Maarten Campus Leopoldstr
    Mechelen, 2800, Belgium
  • CHU UCL Mont-Godinne
    Mont-godinne, 5530, Belgium
  • AZ Oostende
    Ostend, 8400, Belgium
  • AZ Delta (Campus Rumbeke)
    Roeselare, 8800, Belgium
  • Sint Trudo Ziekenhuis
    Sint-Truiden, 3800, Belgium
  • Beneficencia Portuguesa de Sao Paulo
    São Paulo, São Paulo 01323-900, Brazil
  • Complex Oncology Center Burgas
    Burgas, DUMMY_VALUE, Bulgaria
  • Multiprofile Hospital for Active Treatment Uni Hospital
    Panagyurishte, 4500, Bulgaria
  • Umhat Dr Georgi Stranski
    Pleven, 5800, Bulgaria
  • University Hospital Palmed
    Plovdiv, 4001, Bulgaria
  • Complex Oncological Center - Plovdiv, EOOD
    Plovdiv, 4004, Bulgaria
  • Complex Oncology Center - Plovdiv First Internal Chemotherapy Department
    Plovdiv, 4004, Bulgaria
  • DDODIU-Plovdiv, EOOD
    Plovdiv, 4004, Bulgaria
  • Complex Oncological Center-Ruse EOOD
    Rousse, 7000, Bulgaria
  • Tokuda Hospital
    Sofia, 1407, Bulgaria
  • UMHAT "Sv. Ivan Rilski", EAD
    Sofia, 1431, Bulgaria
  • MBAL Serdika EOOD
    Sofia, 1632, Bulgaria
  • MHAT SofiaMed
    Sofia, 1797, Bulgaria
  • Specialized Hospital for Active Cancer Treatment, Dr. Mark Antonov Markov - Varna Ltd
    Varna, 9010, Bulgaria
  • Centro de Estudios Clínicos SAGA
    Santiago, DUMMY_VALUE, Chile
  • Angiografia del Occidente
    Cali, 760045, Colombia
  • Fundacion Clinica Valle del Lili
    Cali, DUMMY_VALUE, Colombia
  • Hospital Pablo Tobon Uribe
    Medellín, 050034, Colombia
  • Clinica ASTORGA
    Medellín, 50010, Colombia
  • Clinical Hospital Centre Osijek
    Osijek, 31000, Croatia
  • Klinicki Bolnicki Centar Split
    Split, 21000, Croatia
  • Clinical Hospital Center Sestre Milosrdnice
    Zagreb, 10000, Croatia
  • Clinical Hospital Centre Zagreb
    Zagreb, 10000, Croatia
  • SUN Oncology center- Alexandria
    Alexandria, DUMMY_VALUE, Egypt
  • Yasser Abdel Kader Private Clinic
    Cairo, 11391, Egypt
  • Air Force Specialized Hospital
    Cairo, DUMMY_VALUE, Egypt
  • Barsoum Oncology Center
    Cairo, DUMMY_VALUE, Egypt
  • Cairo Oncology Center
    Cairo, DUMMY_VALUE, Egypt
  • International Medical Center
    Cairo, DUMMY_VALUE, Egypt
  • North Estonia Medical Centre Foundation
    Tallinn, 13419, Estonia
  • Tartu Uni Hospital
    Tartu, 51014, Estonia
  • Clinique Du Docteur Calabet
    Agen, 47000, France
  • Ch Du Pays D Aix
    Aix-en-Provence, 13616, France
  • Clinique de l'Europe
    Amiens, 80090, France
  • Centre Hospitalier Uni Ire
    Angers, 49933, France
  • Hopital Prive D Antony
    Antony, 92166, France
  • CHG Henri Dufaut médecine interne-onco-hematologie
    Avignon, 84902, France
  • CH de Beauvais
    Beauvais, 60000, France
  • Hopital Jean Minjoz
    Besançon, 25030, France
  • Ch De Beziers
    Béziers, 34525, France
  • Clinique Tivoli
    Bordeaux, 33030, France
  • Polyclinique Bordeaux Nord Aquitaine
    Bordeaux, 33077, France
  • Hopital Cote De Nacre
    Caen, 14033, France
  • Ch De Chambery
    Chambéry, 73011, France
  • Oncologie 37
    Chambray-lès-Tours, 37170, France
  • Hopital Gabriel Montpied
    Clermont-Ferrand, 63003, France
  • Ch De Compiegne
    Compiègne, 60321, France
  • Ch Laennec
    Creil, 60109, France
  • Centre Georges Francois Leclerc
    Dijon, 21079, France
  • Hopital Simone Veil Eaubonne
    Eaubonne, 95602, France
  • Chi Alpes Du Sud Site De Gap
    Gap, 05007, France
  • Hopital Nord Ouest
    Gleizé, 69400, France
  • Ch Saint Louis
    La Rochelle, 17019, France
  • Hopital La Source
    La Source, 45100, France
  • Hopital Louis Pasteur
    Le Coudray, 28630, France
  • Centre Hospitalier Du Mans
    Le Mans, 72037, France
  • Hôpital Privé La Louviere
    Lille, 59042, France
  • Hopital Dupuytren
    Limoges, 87042, France
  • Ch Bretagne Sud Site Scorff
    Lorient, 56100, France
  • Hopital Privé Jean Mermoz
    Lyon, 69008, France
  • Hopital Europeen
    Marseille, 13003, France
  • Clinique Clementville
    Montpellier, 34070, France
  • Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque
    Montpellier, 34298, France
  • Hopital Emile Muller
    Mulhouse, 68070, France
  • Hopital Caremeau
    Nîmes, 30029, France
  • Polyclinique Kenval
    Nîmes, 30900, France
  • Institut Curie
    Paris, 75005, France
  • Hopital Cochin
    Paris, 75014, France
  • Hopital Europeen Georges Pompidou
    Paris, 75908, France
  • Centre Hospitalier
    Pau, 64046, France
  • Centre Catalan D' Oncologie
    Perpignan, 66000, France
  • Ch Annecy - Genevois
    Pringy, 74374, France
  • Hopital De La Maison Blanche
    Reims, 51092, France
  • Clinique Mutualiste L Estuaire
    Saint-Nazaire, 44606, France
  • Hopital Nord
    Saint-Priest-en-Jarez, 42770, France
  • Ch De Saint Quentin
    Saint-Quentin, 02321, France
  • Hopital Robert Pax
    Sarreguemines, DUMMY_VALUE, France
  • Hopital Sainte Musse
    Toulon, 83056, France
  • Hopital Larrey
    Toulouse, 31059, France
  • Centre Hospitalier de Valence
    Valence, 26000, France
  • Service de pneumologie Clinique médico-chirurgicale Tessier
    Valenciennes, 59326, France
  • Ch Bretagne Atlantique
    Vannes, 56017, France
  • Hopital Robert Schuman
    Vantoux, 57070, France

Showing the first 100 of 257 sites across 30 countries. Choose a country and city above to see the rest.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03782207
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Dec 20, 2018
Start date
Feb 7, 2019
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026
Last update
Aug 13, 2026

Study contacts

Clinical Trials
study director · Hoffmann-La Roche

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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