Clinical trial NCT03559647: The Effectiveness Of Atezolizumab In Patients With Locally-Advanced Or Metastatic Non-Small Cell Lung Cancer After Prior Chemotherapy
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Small Cell Lung Cancer (NSCLC)
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2018-06-18
Enrollment: 358
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to loss of clinical benefit (TTLCB) from Atezolizumab treatment
timeFrame: Time from first dose to loss of clinical benefit as assessed by the treating physician, through the end of study (approximately 5 years).
measure: Duration of response (DOR) to Atezolizumab treatment
timeFrame: 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:
measure: Disease control rate (DCR) of overall population
timeFrame: 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)
measure: Progression-free survival (PFS) of overall population
timeFrame: 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)
measure: Time to response (TTR) of overall population
timeFrame: Time from first dose to first response as assessed in clinical routine, through the end of study (approximately 5 years)
measure: Overall response rate (ORR) of overall population
timeFrame: Rate of CR and PR in patients as assessed in clinical routine, through end of study (approximately 5 years)
measure: Best overall response (BOR) of overall population
timeFrame: Best response achieved within 12 weeks as assessed in clinical routine, through the end of study (approximately 5 years)
measure: Best overall response of patients in cohort 2 ("Coh2 BOR")
timeFrame: Baseline through the end of study (approximately 5 years)
measure: Overall survival of cohort 2 ("Coh2 OS")
timeFrame: Time from initiation of Atezolizumab treatment to death from any cause (until the end of study, approximately 5 years).
measure: Percentage of participants with Adverse Events (AEs)
timeFrame: Baseline through the end of study (approximately 5 years)
Other outcomes:
measure: Health-related quality of life (HRQoL)
timeFrame: Prior to first Atezolizumab infusion, during Atezolizumab treatment, and post Atezolizumab discontinuation, through the end of study (approximately 5 years)
Locations:
city: Aschaffenburg
country: Germany
facility: Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg
city: Aschaffenburg
country: Germany
facility: Studienzentrum Aschaffenburg
city: Augsburg
country: Germany
facility: Zentralklinikum Augsburg
city: Bad Reichenhall
country: Germany
facility: Dres. Helmut Tanzer Joachim Hornberger und Johannes Kern
city: Baden-Baden
country: Germany
facility: Klinikum Mittelbaden; Medizinisches Versorgungszentrum - Hämatologie und Onkologie
city: Bamberg
country: Germany
facility: Sozialstiftung Bamberg, Klinikum am Bruderwald, Gynäkologie
city: Berlin
country: Germany
facility: St. Hedwig Kliniken Berlin GmbH
city: Berlin
country: Germany
facility: Onkologisches Versorgungszentrum Friedrichshain; Hämatologie, Onkologie und Palliativmedizin
city: Berlin
country: Germany
facility: Praxis Dr. Med. Gunhild Kühn
city: Berlin
country: Germany
facility: Onkologie am Segelfliegerdamm
city: Bielefeld
country: Germany
facility: Klinikum Bielefeld Mitte Klinik für Hämatologie, Onkologie u. Palliativmedizin
city: Bielefeld
country: Germany
facility: Onkologische Schwerpunktpraxis Bielefeld; Haemotologie & Internistische onkologie
city: Bochum
country: Germany
facility: Augusta Kranken-Anstalt gGmbH
city: Coswig
country: Germany
facility: Fachkrankenhaus Coswig GmbH Zentrum f.Pneumologie Beatmungsmedizin Thorax-u.Gefäßchirurgie
city: Donauwörth
country: Germany
facility: Med. Versorgungszentrum Filiale Donauwörth Onkologisches Zentrum
city: Dortmund
country: Germany
facility: Medizinische Klinik Nord, Lungenkrebszentrum
city: Dresden
country: Germany
facility: BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie
city: Duisburg
country: Germany
facility: Klinik St.Johannes-Hospital Medizinische Klinik I
city: Eberswalde
country: Germany
facility: Klinikum Barnim GmbH; Med. Klinik I, Gastroenterologie, Hämatologie, Onkologie
city: Euskirchen
country: Germany
facility: Dres. Bruch, Buschmann, Linck
city: Frankenthal/Pfalz
country: Germany
facility: Hämatologisch-Onkologische Fachpraxis Dr. med. Th. Ehlers & Dr. med. N. Karapanagiotidis
city: Frankfurt am Main
country: Germany
facility: St. Elisabethen Krankenhaus
city: Frankfurt am Main
country: Germany
facility: Klinikum Frankfurt Höchst GmbH; Klinik Innere Medizin 3 - Hämatologie, Onkologie, Palliativmedizin
city: Frankfurt
country: Germany
facility: Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I
city: Fürth
country: Germany
facility: Dres.Jochen Wilke und Harald Wagner
city: Garbsen
country: Germany
facility: Fachübergreifende Gemeinschaftspraxis Onkologie & Innere Medizin Dr. med. Haddadin & Panagiotou
city: Georgsmarienhütte
country: Germany
facility: Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera; Zentrum fur klinische Studien (ZKS)
city: Greifenstein
country: Germany
facility: Agaplesion Pneumologische Klinik Waldhof Elgershausen; Pneumologie
city: Großhansdorf
country: Germany
facility: LungenClinic Großhansdorf GmbH
city: Halle
country: Germany
facility: Diakoniekrankenhaus Halle; Klinik für Pneumologie
city: Hamburg
country: Germany
facility: Praxis für Hämatologie und Onkologie in Hamburg
city: Hamburg
country: Germany
facility: OncoResearch Lerchenfeld GmbH
city: Hamburg
country: Germany
facility: Kath. Marienkrankenhaus gGmbH
city: Hamburg
country: Germany
facility: Hämatologische-Onkologische Schwerpunktpraxis
city: Heidelberg
country: Germany
facility: Dres.Andreas Karcher und Stefan Fuxius
city: Heidenheim
country: Germany
facility: Onkologische Praxis in Heidenheim
city: Hof
country: Germany
facility: Onkologische Schwerpunktpraxis Hof; Dres. Hanns-Detlev; Harich und Christian Kasper
city: Idar-Oberstein
country: Germany
facility: Klinikum Idar-Oberstein; Klinik für Neurochirurgie
city: Konstanz
country: Germany
facility: Klinikum Konstanz; MVZ Onkologie
city: Krefeld
country: Germany
facility: MVZ Hämatologie und Onkologie Krefeld
city: Kronach
country: Germany
facility: Internistische Praxis Hämatologie und Onkologie
city: Köln
country: Germany
facility: Klinikum Koeln-Merheim; Lungenklinik
city: Landshut
country: Germany
facility: Klinikum Landshut Medizinische Klinik I
city: Lebach
country: Germany
facility: Gemeinschaftspraxis für Hämatologie und Onkologie, PD Dr. Bauer, Dr. Thiel
city: Lehrte
country: Germany
facility: Dres. Barbara Tschechne Stefanie Luft und Wolf-Oliver Jordan
city: Leipzig
country: Germany
facility: Universität Leipzig; Medizinische Klinik und Poliklinik I, Abteilung Pneumologie
city: Leipzig
country: Germany
facility: ÜBAG MVZ Mitte / MVZ Delitzsch GmbH, Standort Leipzig
city: Lingen
country: Germany
facility: Bonifatius Hospital Lingen gGmbH; Hämatologie und Onkologie
city: Lostau
country: Germany
facility: Lungenklinik Lostau
city: Ludwigsburg
country: Germany
facility: Klinikum Ludwigsburg; Studiensekretariat
city: Lübeck
country: Germany
facility: Onkologische Schwerpunktpraxis Lübeck
city: Magdeburg
country: Germany
facility: Klinikum Magdeburg gGmbH; Klinik für Hämatologie, Onkologie und Palliativmedizin
city: Marburg
country: Germany
facility: Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach
city: Marburg
country: Germany
facility: Philipps-Universität Marburg; Klinik für Innere Med.; Schwerpunkt Hämatologie/Onkologie/Immunologie
city: Markkleeberg
country: Germany
facility: Praxis für Innere Medizin und Pneumologie
city: Mayen
country: Germany
facility: Dres. Michael Maasberg Marion Schmitz und Maria Theresia Keller
city: Minden
country: Germany
facility: Joh. Wesling Klinikum Minden; Klinik fuer Hämatologie und Onkologie
city: Moers
country: Germany
facility: Gem.Praxis im Ärztezentrum Dr.med.Jörg Wiegand Jochen Eggert
city: Mutlangen
country: Germany
facility: Kliniken Ostalb, Stauferklinikum Schwäbisch-Gmünd; Zentrum für Innere Medizin
city: München
country: Germany
facility: Klinikum der Universität München; Medizinische Innenstadt
city: Münnerstadt
country: Germany
facility: Lungenklinik Münnerstadt, Thoraxzentrum Bezirk Unterfranken
city: Münster
country: Germany
facility: Gemeinschaftspraxis für Hämatologie und Onkologie
city: Naunhof
country: Germany
facility: Praxis Dr. Uhlig, Naunhof
city: Neumunster
country: Germany
facility: Friedrich-Ebert-Krankenhaus Klinik f. Hämatologie/ Onkologie u. Nephrologie
city: Neuruppin
country: Germany
facility: Ruppiner Kliniken Medizinische Klinik A
city: Neuss
country: Germany
facility: Praxis Dr. Losem
city: Neuwied
country: Germany
facility: Praxis für Hämatologie und Onkologie
city: Nürnberg
country: Germany
facility: Klinikum Nuernberg Nord; Medizinische Klinik 3, Pneumologie, Oncologie
city: Offenburg
country: Germany
facility: Pitri.Studien-GmbH (Ambulantes Therapiezentrum Hämatolgie/ Onkolgogie) Ärztehause 4 OG
city: Oldenburg
country: Germany
facility: Sana Kliniken Ostholtstein; Klinik Oldenburg; Innere Medizin; Onkologie
city: Osnabrueck
country: Germany
facility: Paracelsus-Klinik; Abteilung Haematologie und Onkologie
city: Porta Westfalica
country: Germany
facility: Onkologische Studien GbR, Dres. Becker, Kreisel-Büstgens und Moorahrend
city: Saarbruecken
country: Germany
facility: Praxis für Hämatologie & Onkologie
city: Schkeuditz
country: Germany
facility: Schwerpunktpraxis für Hämatologie und Onkologie Dr. Med. Thomas Edelmann
city: Schorndorf
country: Germany
facility: Zentrum Ambulante Onkologie
city: Siegburg
country: Germany
facility: Zentrum für ambulante Hämatologie und Onkologie; Onkologische Praxis
city: Soest
country: Germany
facility: Onkologische Schwerpunktpraxis
city: Stade
country: Germany
facility: MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -; Klinik Dr. Hancken
city: Stolberg
country: Germany
facility: Medizinisches Versorgungszentrum Stolberg
city: Troisdorf
country: Germany
facility: Praxisnetzwerk Hämatologie und InternistischeIOnkologie
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen; Innere Medizin VIII, Medizinische Onkologie und Pneumologie
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.
city: Völklingen
country: Germany
facility: SHG-Kliniken Völklingen
city: Wedel
country: Germany
facility: Regio Klinikum Wedel; Pneumologie
city: Weimar
country: Germany
facility: Praxis innere Medizin; Onkologie
city: Weinsberg
country: Germany
facility: MedFISMO ltd.
city: Westerstede
country: Germany
facility: Gemeinschaftspraxis für Hämatologie und Onkologie Westerstede Aurich Rhauder
city: Wiesbaden
country: Germany
facility: Dres.Klaus Josten und Ortwin Klein
city: Wilhelmshaven
country: Germany
facility: Praxisgemeinschaft für Onkologie und Urologie, Wilhelmshaven
city: Wuppertal
country: Germany
facility: Klinikverbund St. Antonius und St. Josef GmbH Petrus-Krankenhaus; Medi. Klinik III
city: Würselen
country: Germany
facility: MVZ West GmbH Wuerselen; Haematologie-Onkologie
city: Würzburg
country: Germany
facility: Klinikum Würzburg Mitte gGmbH; Standort Missioklinik
city: Zittau
country: Germany
facility: Praxis Dr.med. Mathias Schulze
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: