The Effectiveness Of Atezolizumab In Patients With Locally-Advanced Or Metastatic Non-Small Cell Lung Cancer After Prior Chemotherapy

August 31, 2023 updated by: Hoffmann-La Roche

The Effectiveness Of Atezolizumab Under Real-World Conditions In Patients With Locally-Advanced Or Metastatic Non-Small Cell Lung Cancer After Prior Chemotherapy

Hyperion Is A Prospective, Multicenter, Non-Interventional, Two-Cohort Study Collecting Primary Data In Patients With Locally Advanced Or Metastatic NSCLC Of Squamous Or Non-Squamous Histology After Prior Chemotherapy Being Treated With Atezolizumab In Routine Clinical Practice.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

358

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aschaffenburg, Germany, 63739
        • Studienzentrum Aschaffenburg
      • Aschaffenburg, Germany, 63739
        • Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg
      • Augsburg, Germany, 86156
        • Zentralklinikum Augsburg
      • Bad Reichenhall, Germany, 83435
        • Dres. Helmut Tanzer Joachim Hornberger und Johannes Kern
      • Baden-Baden, Germany, 76530
        • Klinikum Mittelbaden; Medizinisches Versorgungszentrum - Hämatologie und Onkologie
      • Bamberg, Germany, 96049
        • Sozialstiftung Bamberg, Klinikum am Bruderwald, Gynäkologie
      • Berlin, Germany, 10115
        • St. Hedwig Kliniken Berlin GmbH
      • Berlin, Germany, 10407
        • Onkologisches Versorgungszentrum Friedrichshain; Hämatologie, Onkologie und Palliativmedizin
      • Berlin, Germany, 10715
        • Praxis Dr. Med. Gunhild Kühn
      • Berlin, Germany, 12487
        • Onkologie am Segelfliegerdamm
      • Bielefeld, Germany, 33604
        • Onkologische Schwerpunktpraxis Bielefeld; Haemotologie & Internistische onkologie
      • Bielefeld, Germany, 33604
        • Klinikum Bielefeld Mitte Klinik für Hämatologie, Onkologie u. Palliativmedizin
      • Bochum, Germany, 44791
        • Augusta Kranken-Anstalt gGmbH
      • Coswig, Germany, 01640
        • Fachkrankenhaus Coswig GmbH Zentrum f.Pneumologie Beatmungsmedizin Thorax-u.Gefäßchirurgie
      • Donauwörth, Germany, 86609
        • Med. Versorgungszentrum Filiale Donauwörth Onkologisches Zentrum
      • Dortmund, Germany, 44145
        • Medizinische Klinik Nord, Lungenkrebszentrum
      • Dresden, Germany, 01307
        • BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie
      • Duisburg, Germany, 47166
        • Klinik St.Johannes-Hospital Medizinische Klinik I
      • Eberswalde, Germany, 16225
        • Klinikum Barnim GmbH; Med. Klinik I, Gastroenterologie, Hämatologie, Onkologie
      • Euskirchen, Germany, 53879
        • Dres. Bruch, Buschmann, Linck
      • Frankenthal/Pfalz, Germany, 67227
        • Hämatologisch-Onkologische Fachpraxis Dr. med. Th. Ehlers & Dr. med. N. Karapanagiotidis
      • Frankfurt, Germany, 60590
        • Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I
      • Frankfurt am Main, Germany, 60487
        • St. Elisabethen Krankenhaus
      • Frankfurt am Main, Germany, 65929
        • Klinikum Frankfurt Höchst GmbH; Klinik Innere Medizin 3 - Hämatologie, Onkologie, Palliativmedizin
      • Fürth, Germany, 90766
        • Dres.Jochen Wilke und Harald Wagner
      • Garbsen, Germany, 30827
        • Fachübergreifende Gemeinschaftspraxis Onkologie & Innere Medizin Dr. med. Haddadin & Panagiotou
      • Georgsmarienhütte, Germany, 49124
        • Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH
      • Gera, Germany, 07548
        • SRH Wald-Klinikum Gera; Zentrum fur klinische Studien (ZKS)
      • Greifenstein, Germany, 35753
        • Agaplesion Pneumologische Klinik Waldhof Elgershausen; Pneumologie
      • Großhansdorf, Germany, 22927
        • LungenClinic Grosshansdorf GmbH
      • Halle, Germany, 06114
        • Diakoniekrankenhaus Halle; Klinik für Pneumologie
      • Hamburg, Germany, 22081
        • OncoResearch Lerchenfeld GmbH
      • Hamburg, Germany, 20251
        • Praxis für Hämatologie und Onkologie in Hamburg
      • Hamburg, Germany, 22087
        • Kath. Marienkrankenhaus gGmbH
      • Hamburg, Germany, 22457
        • Hämatologische-Onkologische Schwerpunktpraxis
      • Heidelberg, Germany, 69115
        • Dres.Andreas Karcher und Stefan Fuxius
      • Heidenheim, Germany, 89522
        • Onkologische Praxis in Heidenheim
      • Hof, Germany, 95028
        • Onkologische Schwerpunktpraxis Hof; Dres. Hanns-Detlev; Harich und Christian Kasper
      • Idar-Oberstein, Germany, 55743
        • Klinikum Idar-Oberstein; Klinik für Neurochirurgie
      • Konstanz, Germany, 78464
        • Klinikum Konstanz; MVZ Onkologie
      • Krefeld, Germany, 47805
        • MVZ Hämatologie und Onkologie Krefeld
      • Kronach, Germany, 96317
        • Internistische Praxis Hämatologie und Onkologie
      • Köln, Germany, 51109
        • Klinikum Koeln-Merheim; Lungenklinik
      • Landshut, Germany, 84034
        • Klinikum Landshut Medizinische Klinik I
      • Lebach, Germany, 66822
        • Gemeinschaftspraxis für Hämatologie und Onkologie, PD Dr. Bauer, Dr. Thiel
      • Lehrte, Germany, 31275
        • Dres. Barbara Tschechne Stefanie Luft und Wolf-Oliver Jordan
      • Leipzig, Germany, 04103
        • Universität Leipzig; Medizinische Klinik und Poliklinik I, Abteilung Pneumologie
      • Leipzig, Germany, 04103
        • ÜBAG MVZ Mitte / MVZ Delitzsch GmbH, Standort Leipzig
      • Lingen, Germany, 49808
        • Bonifatius Hospital Lingen gGmbH; Hämatologie und Onkologie
      • Lostau, Germany, 39291
        • Lungenklinik Lostau
      • Ludwigsburg, Germany, 71640
        • Klinikum Ludwigsburg; Studiensekretariat
      • Lübeck, Germany, 23562
        • Onkologische Schwerpunktpraxis Lübeck
      • Magdeburg, Germany, 39130
        • Klinikum Magdeburg gGmbH; Klinik für Hämatologie, Onkologie und Palliativmedizin
      • Marburg, Germany, 35037
        • Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach
      • Marburg, Germany, 35043
        • Philipps-Universität Marburg; Klinik für Innere Med.; Schwerpunkt Hämatologie/Onkologie/Immunologie
      • Markkleeberg, Germany, 04416
        • Praxis für Innere Medizin und Pneumologie
      • Mayen, Germany, 56727
        • Dres. Michael Maasberg Marion Schmitz und Maria Theresia Keller
      • Minden, Germany, 32429
        • Joh. Wesling Klinikum Minden; Klinik fuer Hämatologie und Onkologie
      • Moers, Germany, 47441
        • Gem.Praxis im Ärztezentrum Dr.med.Jörg Wiegand Jochen Eggert
      • Mutlangen, Germany, 73557
        • Kliniken Ostalb, Stauferklinikum Schwäbisch-Gmünd; Zentrum für Innere Medizin
      • München, Germany, 80336
        • Klinikum der Universität München; Medizinische Innenstadt
      • Münnerstadt, Germany, 97702
        • Lungenklinik Münnerstadt, Thoraxzentrum Bezirk Unterfranken
      • Münster, Germany, 48153
        • Gemeinschaftspraxis für Hämatologie und Onkologie
      • Naunhof, Germany, 04683
        • Praxis Dr. Uhlig, Naunhof
      • Neumunster, Germany, 24534
        • Friedrich-Ebert-Krankenhaus Klinik f. Hämatologie/ Onkologie u. Nephrologie
      • Neuruppin, Germany, 16816
        • Ruppiner Kliniken Medizinische Klinik A
      • Neuss, Germany, 41462
        • Praxis Dr. Losem
      • Neuwied, Germany, 56564
        • Praxis fur Hamatologie und Onkologie
      • Nürnberg, Germany, 90419
        • Klinikum Nuernberg Nord; Medizinische Klinik 3, Pneumologie, Oncologie
      • Offenburg, Germany, 77654
        • Pitri.Studien-GmbH (Ambulantes Therapiezentrum Hämatolgie/ Onkolgogie) Ärztehause 4 OG
      • Oldenburg, Germany, 23758
        • Sana Kliniken Ostholtstein; Klinik Oldenburg; Innere Medizin; Onkologie
      • Osnabrueck, Germany, 49076
        • Paracelsus-Klinik; Abteilung Haematologie und Onkologie
      • Porta Westfalica, Germany, 32457
        • Onkologische Studien GbR, Dres. Becker, Kreisel-Büstgens und Moorahrend
      • Saarbruecken, Germany, 66113
        • Praxis für Hämatologie & Onkologie
      • Schkeuditz, Germany, 04435
        • Schwerpunktpraxis für Hämatologie und Onkologie Dr. Med. Thomas Edelmann
      • Schorndorf, Germany, 73614
        • Zentrum Ambulante Onkologie
      • Siegburg, Germany, 53721
        • Zentrum für ambulante Hämatologie und Onkologie; Onkologische Praxis
      • Soest, Germany, 59494
        • Onkologische Schwerpunktpraxis
      • Stade, Germany, 21680
        • MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -; Klinik Dr. Hancken
      • Stolberg, Germany, 52222
        • Medizinisches Versorgungszentrum Stolberg
      • Troisdorf, Germany, 53840
        • Praxisnetzwerk Hämatologie und InternistischeIOnkologie
      • Tübingen, Germany, 72076
        • Universitätsklinikum Tübingen; Innere Medizin VIII, Medizinische Onkologie und Pneumologie
      • Ulm, Germany, 89081
        • Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.
      • Völklingen, Germany, 66333
        • SHG-Kliniken Völklingen
      • Wedel, Germany, 22880
        • Regio Klinikum Wedel; Pneumologie
      • Weimar, Germany, 99425
        • Praxis innere Medizin; Onkologie
      • Weinsberg, Germany, 74189
        • MedFISMO ltd.
      • Westerstede, Germany, 26655
        • Gemeinschaftspraxis für Hämatologie und Onkologie Westerstede Aurich Rhauder
      • Wiesbaden, Germany, 65191
        • Dres.Klaus Josten und Ortwin Klein
      • Wilhelmshaven, Germany, 26389
        • Praxisgemeinschaft für Onkologie und Urologie, Wilhelmshaven
      • Wuppertal, Germany, 42283
        • Klinikverbund St. Antonius und St. Josef GmbH Petrus-Krankenhaus; Medi. Klinik III
      • Würselen, Germany, 52146
        • MVZ West GmbH Wuerselen; Haematologie-Onkologie
      • Würzburg, Germany, 97074
        • Klinikum Würzburg Mitte gGmbH; Standort Missioklinik
      • Zittau, Germany, 02763
        • Praxis Dr.med. Mathias Schulze

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Eligible are participants with locally advanced or metastatic NSCLC after prior chemotherapy, who have been chosen by their treating physicians to receive atezolizumab according to the current Summary of Product Characteristics (SmPC) of TECENTRIQ

Description

Inclusion Criteria:

  • Diagnosis of locally advanced or metastatic NSCLC (histologically or cytologically confirmed stage IIIB/stage IV) and prior chemotherapy
  • Decision to be treated with Atezolizumab according to Summary of Product Characteristics (SmPC) by treating physician, independent of this non-interventional study
  • No contraindication to treatment with Atezolizumab

Retrospective Inclusion:

  • Participants may be included retrospectively. Retrospective inclusion and documentation is limited to up to 9 weeks after initial start of therapy with Atezolizumab (corresponding to a maximum of 3 treatment cycles with drug administrations at 3-week intervals), corresponding to a maximum of 9 weeks prior to date of informed consent. Quality of life for this population will be captured and assessed retrospectively with a modified questionnaire for the period immediately prior to treatment start until study inclusion. participants who started Atezolizumab therapy more than 9 weeks prior to ICF being obtained may not be included in the study.
  • Participants who give consent to be retrospectively enrolled but have already discontinued Atezolizumab for reasons such as loss of clinical benefit or toxicity may also take part in the study, given their first administration of Atezolizumab is within 9 weeks of consenting to take part, and they meet all other eligibility criteria.

Exclusion Criteria:

Patients not eligible for Atezolizumab treatment according to SmPC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1
Participants who have demonstrated a lack of Clinical Benefit from Atezolizumab
Cohort 2
Participants who demonstrated durability of Clinical Benefit and Tumor Response to Atezolizumab
Drug: Atezolizumab
Atezolizumab will be administered per the Summary of Product Characteristics (SmPC) from the European Medicines Agency (EMA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to loss of clinical benefit (TTLCB) from Atezolizumab treatment
Time Frame: Time from first dose to loss of clinical benefit as assessed by the treating physician, through the end of study (approximately 5 years).
Time from first dose to loss of clinical benefit as assessed by the treating physician, through the end of study (approximately 5 years).
Duration of response (DOR) to Atezolizumab treatment
Time Frame: Time from first documentation of complete response (CR) or partial response (PR), whichever occurs first, until progressive disease (PD), as evaluated by the physician according to routine practice or death; through the end of study (~ 5 years)
Time from first documentation of complete response (CR) or partial response (PR), whichever occurs first, until progressive disease (PD), as evaluated by the physician according to routine practice or death; through the end of study (~ 5 years)

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease control rate (DCR) of overall population
Time Frame: Percentage of patients who achieved a CR, a PR, or stable disease (SD) as evaluated by the physician according to clinical practice at the time of the fifth Atezolizumab infusion; (until the end of study, approximately 5 years)
Percentage of patients who achieved a CR, a PR, or stable disease (SD) as evaluated by the physician according to clinical practice at the time of the fifth Atezolizumab infusion; (until the end of study, approximately 5 years)
Progression-free survival (PFS) of overall population
Time Frame: Time from initiation of study treatment to the first occurrence of progressive disease (PD) or death from any cause, whichever occurs first, as evaluated by the physician according to clinical practice, through the end of study (approximately 5 years)
Time from initiation of study treatment to the first occurrence of progressive disease (PD) or death from any cause, whichever occurs first, as evaluated by the physician according to clinical practice, through the end of study (approximately 5 years)
Time to response (TTR) of overall population
Time Frame: Time from first dose to first response as assessed in clinical routine, through the end of study (approximately 5 years)
Time from first dose to first response as assessed in clinical routine, through the end of study (approximately 5 years)
Overall response rate (ORR) of overall population
Time Frame: Rate of CR and PR in patients as assessed in clinical routine, through end of study (approximately 5 years)
Rate of CR and PR in patients as assessed in clinical routine, through end of study (approximately 5 years)
Best overall response (BOR) of overall population
Time Frame: Best response achieved within 12 weeks as assessed in clinical routine, through the end of study (approximately 5 years)
Best response achieved within 12 weeks as assessed in clinical routine, through the end of study (approximately 5 years)
Best overall response of patients in cohort 2 ("Coh2 BOR")
Time Frame: Baseline through the end of study (approximately 5 years)
Baseline through the end of study (approximately 5 years)
Overall survival of cohort 2 ("Coh2 OS")
Time Frame: Time from initiation of Atezolizumab treatment to death from any cause (until the end of study, approximately 5 years).
Time from initiation of Atezolizumab treatment to death from any cause (until the end of study, approximately 5 years).
Percentage of participants with Adverse Events (AEs)
Time Frame: Baseline through the end of study (approximately 5 years)
Baseline through the end of study (approximately 5 years)

Other Outcome Measures

Outcome Measure
Time Frame
Health-related quality of life (HRQoL)
Time Frame: Prior to first Atezolizumab infusion, during Atezolizumab treatment, and post Atezolizumab discontinuation, through the end of study (approximately 5 years)
Prior to first Atezolizumab infusion, during Atezolizumab treatment, and post Atezolizumab discontinuation, through the end of study (approximately 5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2018

Primary Completion (Actual)

August 20, 2023

Study Completion (Actual)

August 20, 2023

Study Registration Dates

First Submitted

May 7, 2018

First Submitted That Met QC Criteria

June 6, 2018

First Posted (Actual)

June 18, 2018

Study Record Updates

Last Update Posted (Actual)

September 1, 2023

Last Update Submitted That Met QC Criteria

August 31, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML39885

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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