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

Non-Small Cell Lung Cancer (NSCLC) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03559647
• Other study ID #: ML39885
• Status: Completed
• Start date: May 30, 2018
• Est. completion date: August 20, 2023

Study information

• Verified date: August 2023
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 358
• Est. completion date: August 20, 2023
• Est. primary completion date: August 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer (NSCLC)

Intervention

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

Locations

Country	Name	City	State
Germany	Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg	Aschaffenburg
Germany	Studienzentrum Aschaffenburg	Aschaffenburg
Germany	Zentralklinikum Augsburg	Augsburg
Germany	Dres. Helmut Tanzer Joachim Hornberger und Johannes Kern	Bad Reichenhall
Germany	Klinikum Mittelbaden; Medizinisches Versorgungszentrum - Hämatologie und Onkologie	Baden-Baden
Germany	Sozialstiftung Bamberg, Klinikum am Bruderwald, Gynäkologie	Bamberg
Germany	Onkologie am Segelfliegerdamm	Berlin
Germany	Onkologisches Versorgungszentrum Friedrichshain; Hämatologie, Onkologie und Palliativmedizin	Berlin
Germany	Praxis Dr. Med. Gunhild Kühn	Berlin
Germany	St. Hedwig Kliniken Berlin GmbH	Berlin
Germany	Klinikum Bielefeld Mitte Klinik für Hämatologie, Onkologie u. Palliativmedizin	Bielefeld
Germany	Onkologische Schwerpunktpraxis Bielefeld; Haemotologie & Internistische onkologie	Bielefeld
Germany	Augusta Kranken-Anstalt gGmbH	Bochum
Germany	Fachkrankenhaus Coswig GmbH Zentrum f.Pneumologie Beatmungsmedizin Thorax-u.Gefäßchirurgie	Coswig
Germany	Med. Versorgungszentrum Filiale Donauwörth Onkologisches Zentrum	Donauwörth
Germany	Medizinische Klinik Nord, Lungenkrebszentrum	Dortmund
Germany	BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie	Dresden
Germany	Klinik St.Johannes-Hospital Medizinische Klinik I	Duisburg
Germany	Klinikum Barnim GmbH; Med. Klinik I, Gastroenterologie, Hämatologie, Onkologie	Eberswalde
Germany	Dres. Bruch, Buschmann, Linck	Euskirchen
Germany	Hämatologisch-Onkologische Fachpraxis Dr. med. Th. Ehlers & Dr. med. N. Karapanagiotidis	Frankenthal/Pfalz
Germany	Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I	Frankfurt
Germany	Klinikum Frankfurt Höchst GmbH; Klinik Innere Medizin 3 - Hämatologie, Onkologie, Palliativmedizin	Frankfurt am Main
Germany	St. Elisabethen Krankenhaus	Frankfurt am Main
Germany	Dres.Jochen Wilke und Harald Wagner	Fürth
Germany	Fachübergreifende Gemeinschaftspraxis Onkologie & Innere Medizin Dr. med. Haddadin & Panagiotou	Garbsen
Germany	Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH	Georgsmarienhütte
Germany	SRH Wald-Klinikum Gera; Zentrum fur klinische Studien (ZKS)	Gera
Germany	Agaplesion Pneumologische Klinik Waldhof Elgershausen; Pneumologie	Greifenstein
Germany	LungenClinic Großhansdorf GmbH	Großhansdorf
Germany	Diakoniekrankenhaus Halle; Klinik für Pneumologie	Halle
Germany	Hämatologische-Onkologische Schwerpunktpraxis	Hamburg
Germany	Kath. Marienkrankenhaus gGmbH	Hamburg
Germany	OncoResearch Lerchenfeld GmbH	Hamburg
Germany	Praxis für Hämatologie und Onkologie in Hamburg	Hamburg
Germany	Dres.Andreas Karcher und Stefan Fuxius	Heidelberg
Germany	Onkologische Praxis in Heidenheim	Heidenheim
Germany	Onkologische Schwerpunktpraxis Hof; Dres. Hanns-Detlev; Harich und Christian Kasper	Hof
Germany	Klinikum Idar-Oberstein; Klinik für Neurochirurgie	Idar-Oberstein
Germany	Klinikum Koeln-Merheim; Lungenklinik	Köln
Germany	Klinikum Konstanz; MVZ Onkologie	Konstanz
Germany	MVZ Hämatologie und Onkologie Krefeld	Krefeld
Germany	Internistische Praxis Hämatologie und Onkologie	Kronach
Germany	Klinikum Landshut Medizinische Klinik I	Landshut
Germany	Gemeinschaftspraxis für Hämatologie und Onkologie, PD Dr. Bauer, Dr. Thiel	Lebach
Germany	Dres. Barbara Tschechne Stefanie Luft und Wolf-Oliver Jordan	Lehrte
Germany	ÜBAG MVZ Mitte / MVZ Delitzsch GmbH, Standort Leipzig	Leipzig
Germany	Universität Leipzig; Medizinische Klinik und Poliklinik I, Abteilung Pneumologie	Leipzig
Germany	Bonifatius Hospital Lingen gGmbH; Hämatologie und Onkologie	Lingen
Germany	Lungenklinik Lostau	Lostau
Germany	Onkologische Schwerpunktpraxis Lübeck	Lübeck
Germany	Klinikum Ludwigsburg; Studiensekretariat	Ludwigsburg
Germany	Klinikum Magdeburg gGmbH; Klinik für Hämatologie, Onkologie und Palliativmedizin	Magdeburg
Germany	Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach	Marburg
Germany	Philipps-Universität Marburg; Klinik für Innere Med.; Schwerpunkt Hämatologie/Onkologie/Immunologie	Marburg
Germany	Praxis für Innere Medizin und Pneumologie	Markkleeberg
Germany	Dres. Michael Maasberg Marion Schmitz und Maria Theresia Keller	Mayen
Germany	Joh. Wesling Klinikum Minden; Klinik fuer Hämatologie und Onkologie	Minden
Germany	Gem.Praxis im Ärztezentrum Dr.med.Jörg Wiegand Jochen Eggert	Moers
Germany	Klinikum der Universität München; Medizinische Innenstadt	München
Germany	Lungenklinik Münnerstadt, Thoraxzentrum Bezirk Unterfranken	Münnerstadt
Germany	Gemeinschaftspraxis für Hämatologie und Onkologie	Münster
Germany	Kliniken Ostalb, Stauferklinikum Schwäbisch-Gmünd; Zentrum für Innere Medizin	Mutlangen
Germany	Praxis Dr. Uhlig, Naunhof	Naunhof
Germany	Friedrich-Ebert-Krankenhaus Klinik f. Hämatologie/ Onkologie u. Nephrologie	Neumunster
Germany	Ruppiner Kliniken Medizinische Klinik A	Neuruppin
Germany	Praxis Dr. Losem	Neuss
Germany	Praxis für Hämatologie und Onkologie	Neuwied
Germany	Klinikum Nuernberg Nord; Medizinische Klinik 3, Pneumologie, Oncologie	Nürnberg
Germany	Pitri.Studien-GmbH (Ambulantes Therapiezentrum Hämatolgie/ Onkolgogie) Ärztehause 4 OG	Offenburg
Germany	Sana Kliniken Ostholtstein; Klinik Oldenburg; Innere Medizin; Onkologie	Oldenburg
Germany	Paracelsus-Klinik; Abteilung Haematologie und Onkologie	Osnabrueck
Germany	Onkologische Studien GbR, Dres. Becker, Kreisel-Büstgens und Moorahrend	Porta Westfalica
Germany	Praxis für Hämatologie & Onkologie	Saarbruecken
Germany	Schwerpunktpraxis für Hämatologie und Onkologie Dr. Med. Thomas Edelmann	Schkeuditz
Germany	Zentrum Ambulante Onkologie	Schorndorf
Germany	Zentrum für ambulante Hämatologie und Onkologie; Onkologische Praxis	Siegburg
Germany	Onkologische Schwerpunktpraxis	Soest
Germany	MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -; Klinik Dr. Hancken	Stade
Germany	Medizinisches Versorgungszentrum Stolberg	Stolberg
Germany	Praxisnetzwerk Hämatologie und InternistischeIOnkologie	Troisdorf
Germany	Universitätsklinikum Tübingen; Innere Medizin VIII, Medizinische Onkologie und Pneumologie	Tübingen
Germany	Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.	Ulm
Germany	SHG-Kliniken Völklingen	Völklingen
Germany	Regio Klinikum Wedel; Pneumologie	Wedel
Germany	Praxis innere Medizin; Onkologie	Weimar
Germany	MedFISMO ltd.	Weinsberg
Germany	Gemeinschaftspraxis für Hämatologie und Onkologie Westerstede Aurich Rhauder	Westerstede
Germany	Dres.Klaus Josten und Ortwin Klein	Wiesbaden
Germany	Praxisgemeinschaft für Onkologie und Urologie, Wilhelmshaven	Wilhelmshaven
Germany	Klinikverbund St. Antonius und St. Josef GmbH Petrus-Krankenhaus; Medi. Klinik III	Wuppertal
Germany	MVZ West GmbH Wuerselen; Haematologie-Onkologie	Würselen
Germany	Klinikum Würzburg Mitte gGmbH; Standort Missioklinik	Würzburg
Germany	Praxis Dr.med. Mathias Schulze	Zittau

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Primary	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).
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Best overall response of patients in cohort 2 ("Coh2 BOR")		Baseline through the end of study (approximately 5 years)
Secondary	Overall survival of cohort 2 ("Coh2 OS")		Time from initiation of Atezolizumab treatment to death from any cause (until the end of study, approximately 5 years).
Secondary	Percentage of participants with Adverse Events (AEs)		Baseline through the end of study (approximately 5 years)