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

NCT ID: NCT03559647

Last Updated: 2023-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

358 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-30

Study Completion Date

2023-08-20

Brief Summary

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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.

Detailed Description

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Conditions

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Non-Small Cell Lung Cancer (NSCLC)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

Participants who have demonstrated a lack of Clinical Benefit from Atezolizumab

No interventions assigned to this group

Cohort 2

Participants who demonstrated durability of Clinical Benefit and Tumor Response to Atezolizumab

Atezolizumab

Intervention Type DRUG

Atezolizumab will be administered per the Summary of Product Characteristics (SmPC) from the European Medicines Agency (EMA).

Interventions

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Atezolizumab

Atezolizumab will be administered per the Summary of Product Characteristics (SmPC) from the European Medicines Agency (EMA).

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg

Aschaffenburg, , Germany

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Studienzentrum Aschaffenburg

Aschaffenburg, , Germany

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Zentralklinikum Augsburg

Augsburg, , Germany

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Dres. Helmut Tanzer Joachim Hornberger und Johannes Kern

Bad Reichenhall, , Germany

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Klinikum Mittelbaden; Medizinisches Versorgungszentrum - Hämatologie und Onkologie

Baden-Baden, , Germany

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Sozialstiftung Bamberg, Klinikum am Bruderwald, Gynäkologie

Bamberg, , Germany

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St. Hedwig Kliniken Berlin GmbH

Berlin, , Germany

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Onkologisches Versorgungszentrum Friedrichshain; Hämatologie, Onkologie und Palliativmedizin

Berlin, , Germany

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Praxis Dr. Med. Gunhild Kühn

Berlin, , Germany

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Onkologie am Segelfliegerdamm

Berlin, , Germany

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Klinikum Bielefeld Mitte Klinik für Hämatologie, Onkologie u. Palliativmedizin

Bielefeld, , Germany

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Onkologische Schwerpunktpraxis Bielefeld; Haemotologie & Internistische onkologie

Bielefeld, , Germany

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Augusta Kranken-Anstalt gGmbH

Bochum, , Germany

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Klinikum Koeln-Merheim; Lungenklinik

Cologne, , Germany

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Fachkrankenhaus Coswig GmbH Zentrum f.Pneumologie Beatmungsmedizin Thorax-u.Gefäßchirurgie

Coswig, , Germany

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Med. Versorgungszentrum Filiale Donauwörth Onkologisches Zentrum

Donauwörth, , Germany

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Medizinische Klinik Nord, Lungenkrebszentrum

Dortmund, , Germany

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BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie

Dresden, , Germany

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Klinik St.Johannes-Hospital Medizinische Klinik I

Duisburg, , Germany

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Klinikum Barnim GmbH; Med. Klinik I, Gastroenterologie, Hämatologie, Onkologie

Eberswalde, , Germany

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Dres. Bruch, Buschmann, Linck

Euskirchen, , Germany

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Hämatologisch-Onkologische Fachpraxis Dr. med. Th. Ehlers & Dr. med. N. Karapanagiotidis

Frankenthal/Pfalz, , Germany

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Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I

Frankfurt, , Germany

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St. Elisabethen Krankenhaus

Frankfurt am Main, , Germany

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Klinikum Frankfurt Höchst GmbH; Klinik Innere Medizin 3 - Hämatologie, Onkologie, Palliativmedizin

Frankfurt am Main, , Germany

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Dres.Jochen Wilke und Harald Wagner

Fürth, , Germany

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Fachübergreifende Gemeinschaftspraxis Onkologie & Innere Medizin Dr. med. Haddadin & Panagiotou

Garbsen, , Germany

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Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH

Georgsmarienhütte, , Germany

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SRH Wald-Klinikum Gera; Zentrum fur klinische Studien (ZKS)

Gera, , Germany

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Agaplesion Pneumologische Klinik Waldhof Elgershausen; Pneumologie

Greifenstein, , Germany

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LungenClinic Großhansdorf GmbH

Großhansdorf, , Germany

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Diakoniekrankenhaus Halle; Klinik für Pneumologie

Halle, , Germany

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Praxis für Hämatologie und Onkologie in Hamburg

Hamburg, , Germany

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OncoResearch Lerchenfeld GmbH

Hamburg, , Germany

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Kath. Marienkrankenhaus gGmbH

Hamburg, , Germany

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Hämatologische-Onkologische Schwerpunktpraxis

Hamburg, , Germany

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Dres.Andreas Karcher und Stefan Fuxius

Heidelberg, , Germany

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Onkologische Praxis in Heidenheim

Heidenheim, , Germany

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Onkologische Schwerpunktpraxis Hof; Dres. Hanns-Detlev; Harich und Christian Kasper

Hof, , Germany

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Klinikum Idar-Oberstein; Klinik für Neurochirurgie

Idar-Oberstein, , Germany

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Klinikum Konstanz; MVZ Onkologie

Konstanz, , Germany

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MVZ Hämatologie und Onkologie Krefeld

Krefeld, , Germany

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Internistische Praxis Hämatologie und Onkologie

Kronach, , Germany

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Klinikum Landshut Medizinische Klinik I

Landshut, , Germany

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Gemeinschaftspraxis für Hämatologie und Onkologie, PD Dr. Bauer, Dr. Thiel

Lebach, , Germany

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Dres. Barbara Tschechne Stefanie Luft und Wolf-Oliver Jordan

Lehrte, , Germany

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Universität Leipzig; Medizinische Klinik und Poliklinik I, Abteilung Pneumologie

Leipzig, , Germany

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ÜBAG MVZ Mitte / MVZ Delitzsch GmbH, Standort Leipzig

Leipzig, , Germany

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Bonifatius Hospital Lingen gGmbH; Hämatologie und Onkologie

Lingen, , Germany

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Lungenklinik Lostau

Lostau, , Germany

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Klinikum Ludwigsburg; Studiensekretariat

Ludwigsburg, , Germany

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Onkologische Schwerpunktpraxis Lübeck

Lübeck, , Germany

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Klinikum Magdeburg gGmbH; Klinik für Hämatologie, Onkologie und Palliativmedizin

Magdeburg, , Germany

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Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach

Marburg, , Germany

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Philipps-Universität Marburg; Klinik für Innere Med.; Schwerpunkt Hämatologie/Onkologie/Immunologie

Marburg, , Germany

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Praxis für Innere Medizin und Pneumologie

Markkleeberg, , Germany

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Dres. Michael Maasberg Marion Schmitz und Maria Theresia Keller

Mayen, , Germany

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Joh. Wesling Klinikum Minden; Klinik fuer Hämatologie und Onkologie

Minden, , Germany

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Gem.Praxis im Ärztezentrum Dr.med.Jörg Wiegand Jochen Eggert

Moers, , Germany

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Kliniken Ostalb, Stauferklinikum Schwäbisch-Gmünd; Zentrum für Innere Medizin

Mutlangen, , Germany

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Klinikum der Universität München; Medizinische Innenstadt

München, , Germany

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Lungenklinik Münnerstadt, Thoraxzentrum Bezirk Unterfranken

Münnerstadt, , Germany

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Gemeinschaftspraxis für Hämatologie und Onkologie

Münster, , Germany

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Praxis Dr. Uhlig, Naunhof

Naunhof, , Germany

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Friedrich-Ebert-Krankenhaus Klinik f. Hämatologie/ Onkologie u. Nephrologie

Neumünster, , Germany

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Ruppiner Kliniken Medizinische Klinik A

Neuruppin, , Germany

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Praxis Dr. Losem

Neuss, , Germany

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Praxis für Hämatologie und Onkologie

Neuwied, , Germany

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Klinikum Nuernberg Nord; Medizinische Klinik 3, Pneumologie, Oncologie

Nuremberg, , Germany

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Pitri.Studien-GmbH (Ambulantes Therapiezentrum Hämatolgie/ Onkolgogie) Ärztehause 4 OG

Offenburg, , Germany

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Sana Kliniken Ostholtstein; Klinik Oldenburg; Innere Medizin; Onkologie

Oldenburg, , Germany

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Paracelsus-Klinik; Abteilung Haematologie und Onkologie

Osnabrück, , Germany

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Onkologische Studien GbR, Dres. Becker, Kreisel-Büstgens und Moorahrend

Porta Westfalica, , Germany

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Praxis für Hämatologie & Onkologie

Saarbrücken, , Germany

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Schwerpunktpraxis für Hämatologie und Onkologie Dr. Med. Thomas Edelmann

Schkeuditz, , Germany

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Zentrum Ambulante Onkologie

Schorndorf, , Germany

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Zentrum für ambulante Hämatologie und Onkologie; Onkologische Praxis

Siegburg, , Germany

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Onkologische Schwerpunktpraxis

Soest, , Germany

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MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -; Klinik Dr. Hancken

Stade, , Germany

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Medizinisches Versorgungszentrum Stolberg

Stolberg, , Germany

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Praxisnetzwerk Hämatologie und InternistischeIOnkologie

Troisdorf, , Germany

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Universitätsklinikum Tübingen; Innere Medizin VIII, Medizinische Onkologie und Pneumologie

Tübingen, , Germany

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Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.

Ulm, , Germany

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SHG-Kliniken Völklingen

Völklingen, , Germany

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Regio Klinikum Wedel; Pneumologie

Wedel, , Germany

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Praxis innere Medizin; Onkologie

Weimar, , Germany

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MedFISMO ltd.

Weinsberg, , Germany

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Gemeinschaftspraxis für Hämatologie und Onkologie Westerstede Aurich Rhauder

Westerstede, , Germany

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Dres.Klaus Josten und Ortwin Klein

Wiesbaden, , Germany

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Praxisgemeinschaft für Onkologie und Urologie, Wilhelmshaven

Wilhelmshaven, , Germany

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Klinikverbund St. Antonius und St. Josef GmbH Petrus-Krankenhaus; Medi. Klinik III

Wuppertal, , Germany

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MVZ West GmbH Wuerselen; Haematologie-Onkologie

Würselen, , Germany

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Klinikum Würzburg Mitte gGmbH; Standort Missioklinik

Würzburg, , Germany

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Praxis Dr.med. Mathias Schulze

Zittau, , Germany

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Countries

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Germany

Other Identifiers

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ML39885

Identifier Type: -

Identifier Source: org_study_id

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