The Effectiveness Of Atezolizumab In Patients With Locally-Advanced Or Metastatic Non-Small Cell Lung Cancer After Prior Chemotherapy
1 other identifier
observational
358
1 country
94
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2018
Longer than P75 for all trials
94 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2018
CompletedStudy Start
First participant enrolled
May 30, 2018
CompletedFirst Posted
Study publicly available on registry
June 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2023
CompletedSeptember 1, 2023
August 1, 2023
5.2 years
May 7, 2018
August 31, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Time to loss of clinical benefit (TTLCB) from Atezolizumab treatment
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 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 Outcomes (8)
Disease control rate (DCR) of overall population
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 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 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
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
Best response achieved within 12 weeks as assessed in clinical routine, through the end of study (approximately 5 years)
- +3 more secondary outcomes
Other Outcomes (1)
Health-related quality of life (HRQoL)
Prior to first Atezolizumab infusion, during Atezolizumab treatment, and post Atezolizumab discontinuation, through the end of study (approximately 5 years)
Study Arms (2)
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
Interventions
Atezolizumab will be administered per the Summary of Product Characteristics (SmPC) from the European Medicines Agency (EMA).
Eligibility Criteria
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
You may qualify if:
- 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
- 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.
You may not qualify if:
- Patients not eligible for Atezolizumab treatment according to SmPC
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (94)
Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg
Aschaffenburg, 63739, Germany
Studienzentrum Aschaffenburg
Aschaffenburg, 63739, Germany
Zentralklinikum Augsburg
Augsburg, 86156, Germany
Dres. Helmut Tanzer Joachim Hornberger und Johannes Kern
Bad Reichenhall, 83435, Germany
Klinikum Mittelbaden; Medizinisches Versorgungszentrum - Hämatologie und Onkologie
Baden-Baden, 76530, Germany
Sozialstiftung Bamberg, Klinikum am Bruderwald, Gynäkologie
Bamberg, 96049, Germany
St. Hedwig Kliniken Berlin GmbH
Berlin, 10115, Germany
Onkologisches Versorgungszentrum Friedrichshain; Hämatologie, Onkologie und Palliativmedizin
Berlin, 10407, Germany
Praxis Dr. Med. Gunhild Kühn
Berlin, 10715, Germany
Onkologie am Segelfliegerdamm
Berlin, 12487, Germany
Klinikum Bielefeld Mitte Klinik für Hämatologie, Onkologie u. Palliativmedizin
Bielefeld, 33604, Germany
Onkologische Schwerpunktpraxis Bielefeld; Haemotologie & Internistische onkologie
Bielefeld, 33604, Germany
Augusta Kranken-Anstalt gGmbH
Bochum, 44791, Germany
Klinikum Koeln-Merheim; Lungenklinik
Cologne, 51109, Germany
Fachkrankenhaus Coswig GmbH Zentrum f.Pneumologie Beatmungsmedizin Thorax-u.Gefäßchirurgie
Coswig, 01640, Germany
Med. Versorgungszentrum Filiale Donauwörth Onkologisches Zentrum
Donauwörth, 86609, Germany
Medizinische Klinik Nord, Lungenkrebszentrum
Dortmund, 44145, Germany
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie
Dresden, 01307, Germany
Klinik St.Johannes-Hospital Medizinische Klinik I
Duisburg, 47166, Germany
Klinikum Barnim GmbH; Med. Klinik I, Gastroenterologie, Hämatologie, Onkologie
Eberswalde, 16225, Germany
Dres. Bruch, Buschmann, Linck
Euskirchen, 53879, Germany
Hämatologisch-Onkologische Fachpraxis Dr. med. Th. Ehlers & Dr. med. N. Karapanagiotidis
Frankenthal/Pfalz, 67227, Germany
Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I
Frankfurt, 60590, Germany
St. Elisabethen Krankenhaus
Frankfurt am Main, 60487, Germany
Klinikum Frankfurt Höchst GmbH; Klinik Innere Medizin 3 - Hämatologie, Onkologie, Palliativmedizin
Frankfurt am Main, 65929, Germany
Dres.Jochen Wilke und Harald Wagner
Fürth, 90766, Germany
Fachübergreifende Gemeinschaftspraxis Onkologie & Innere Medizin Dr. med. Haddadin & Panagiotou
Garbsen, 30827, Germany
Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH
Georgsmarienhütte, 49124, Germany
SRH Wald-Klinikum Gera; Zentrum fur klinische Studien (ZKS)
Gera, 07548, Germany
Agaplesion Pneumologische Klinik Waldhof Elgershausen; Pneumologie
Greifenstein, 35753, Germany
LungenClinic Großhansdorf GmbH
Großhansdorf, 22927, Germany
Diakoniekrankenhaus Halle; Klinik für Pneumologie
Halle, 06114, Germany
Praxis für Hämatologie und Onkologie in Hamburg
Hamburg, 20251, Germany
OncoResearch Lerchenfeld GmbH
Hamburg, 22081, Germany
Kath. Marienkrankenhaus gGmbH
Hamburg, 22087, Germany
Hämatologische-Onkologische Schwerpunktpraxis
Hamburg, 22457, Germany
Dres.Andreas Karcher und Stefan Fuxius
Heidelberg, 69115, Germany
Onkologische Praxis in Heidenheim
Heidenheim, 89522, Germany
Onkologische Schwerpunktpraxis Hof; Dres. Hanns-Detlev; Harich und Christian Kasper
Hof, 95028, Germany
Klinikum Idar-Oberstein; Klinik für Neurochirurgie
Idar-Oberstein, 55743, Germany
Klinikum Konstanz; MVZ Onkologie
Konstanz, 78464, Germany
MVZ Hämatologie und Onkologie Krefeld
Krefeld, 47805, Germany
Internistische Praxis Hämatologie und Onkologie
Kronach, 96317, Germany
Klinikum Landshut Medizinische Klinik I
Landshut, 84034, Germany
Gemeinschaftspraxis für Hämatologie und Onkologie, PD Dr. Bauer, Dr. Thiel
Lebach, 66822, Germany
Dres. Barbara Tschechne Stefanie Luft und Wolf-Oliver Jordan
Lehrte, 31275, Germany
Universität Leipzig; Medizinische Klinik und Poliklinik I, Abteilung Pneumologie
Leipzig, 04103, Germany
ÜBAG MVZ Mitte / MVZ Delitzsch GmbH, Standort Leipzig
Leipzig, 04103, Germany
Bonifatius Hospital Lingen gGmbH; Hämatologie und Onkologie
Lingen, 49808, Germany
Lungenklinik Lostau
Lostau, 39291, Germany
Klinikum Ludwigsburg; Studiensekretariat
Ludwigsburg, 71640, Germany
Onkologische Schwerpunktpraxis Lübeck
Lübeck, 23562, Germany
Klinikum Magdeburg gGmbH; Klinik für Hämatologie, Onkologie und Palliativmedizin
Magdeburg, 39130, Germany
Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach
Marburg, 35037, Germany
Philipps-Universität Marburg; Klinik für Innere Med.; Schwerpunkt Hämatologie/Onkologie/Immunologie
Marburg, 35043, Germany
Praxis für Innere Medizin und Pneumologie
Markkleeberg, 04416, Germany
Dres. Michael Maasberg Marion Schmitz und Maria Theresia Keller
Mayen, 56727, Germany
Joh. Wesling Klinikum Minden; Klinik fuer Hämatologie und Onkologie
Minden, 32429, Germany
Gem.Praxis im Ärztezentrum Dr.med.Jörg Wiegand Jochen Eggert
Moers, 47441, Germany
Kliniken Ostalb, Stauferklinikum Schwäbisch-Gmünd; Zentrum für Innere Medizin
Mutlangen, 73557, Germany
Klinikum der Universität München; Medizinische Innenstadt
München, 80336, Germany
Lungenklinik Münnerstadt, Thoraxzentrum Bezirk Unterfranken
Münnerstadt, 97702, Germany
Gemeinschaftspraxis für Hämatologie und Onkologie
Münster, 48153, Germany
Praxis Dr. Uhlig, Naunhof
Naunhof, 04683, Germany
Friedrich-Ebert-Krankenhaus Klinik f. Hämatologie/ Onkologie u. Nephrologie
Neumünster, 24534, Germany
Ruppiner Kliniken Medizinische Klinik A
Neuruppin, 16816, Germany
Praxis Dr. Losem
Neuss, 41462, Germany
Praxis für Hämatologie und Onkologie
Neuwied, 56564, Germany
Klinikum Nuernberg Nord; Medizinische Klinik 3, Pneumologie, Oncologie
Nuremberg, 90419, Germany
Pitri.Studien-GmbH (Ambulantes Therapiezentrum Hämatolgie/ Onkolgogie) Ärztehause 4 OG
Offenburg, 77654, Germany
Sana Kliniken Ostholtstein; Klinik Oldenburg; Innere Medizin; Onkologie
Oldenburg, 23758, Germany
Paracelsus-Klinik; Abteilung Haematologie und Onkologie
Osnabrück, 49076, Germany
Onkologische Studien GbR, Dres. Becker, Kreisel-Büstgens und Moorahrend
Porta Westfalica, 32457, Germany
Praxis für Hämatologie & Onkologie
Saarbrücken, 66113, Germany
Schwerpunktpraxis für Hämatologie und Onkologie Dr. Med. Thomas Edelmann
Schkeuditz, 04435, Germany
Zentrum Ambulante Onkologie
Schorndorf, 73614, Germany
Zentrum für ambulante Hämatologie und Onkologie; Onkologische Praxis
Siegburg, 53721, Germany
Onkologische Schwerpunktpraxis
Soest, 59494, Germany
MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -; Klinik Dr. Hancken
Stade, 21680, Germany
Medizinisches Versorgungszentrum Stolberg
Stolberg, 52222, Germany
Praxisnetzwerk Hämatologie und InternistischeIOnkologie
Troisdorf, 53840, Germany
Universitätsklinikum Tübingen; Innere Medizin VIII, Medizinische Onkologie und Pneumologie
Tübingen, 72076, Germany
Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.
Ulm, 89081, Germany
SHG-Kliniken Völklingen
Völklingen, 66333, Germany
Regio Klinikum Wedel; Pneumologie
Wedel, 22880, Germany
Praxis innere Medizin; Onkologie
Weimar, 99425, Germany
MedFISMO ltd.
Weinsberg, 74189, Germany
Gemeinschaftspraxis für Hämatologie und Onkologie Westerstede Aurich Rhauder
Westerstede, 26655, Germany
Dres.Klaus Josten und Ortwin Klein
Wiesbaden, 65191, Germany
Praxisgemeinschaft für Onkologie und Urologie, Wilhelmshaven
Wilhelmshaven, 26389, Germany
Klinikverbund St. Antonius und St. Josef GmbH Petrus-Krankenhaus; Medi. Klinik III
Wuppertal, 42283, Germany
MVZ West GmbH Wuerselen; Haematologie-Onkologie
Würselen, 52146, Germany
Klinikum Würzburg Mitte gGmbH; Standort Missioklinik
Würzburg, 97074, Germany
Praxis Dr.med. Mathias Schulze
Zittau, 02763, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2018
First Posted
June 18, 2018
Study Start
May 30, 2018
Primary Completion
August 20, 2023
Study Completion
August 20, 2023
Last Updated
September 1, 2023
Record last verified: 2023-08