Impact of eHealth Monitoring on Overall Survival in Patients With Metastatic NSCLC / Extensive-stage SCLC / Advanced TNBC Under First-line Treatment With Atezolizumab Plus Chemotherapy
CHAPLIN
Multicenter Study to Evaluate the Impact of eHealth Monitoring on Overall Survival in Patients With Metastatic Non-squamous NSCLC or Extensive-stage SCLC or Advanced TNBC Under First-line Treatment With Atezolizumab in Combination With Chemotherapy
2 other identifiers
observational
154
1 country
92
Brief Summary
The current study is aimed to test the benefit of a web-based application tool in NSCLC, SCLC and TNBC patients during the recently approved first-line treatment strategy with atezolizumab in combination with chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2019
92 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
April 1, 2019
CompletedFirst Posted
Study publicly available on registry
April 11, 2019
CompletedStudy Start
First participant enrolled
July 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedOctober 5, 2021
October 1, 2021
2 years
April 1, 2019
October 4, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
Time from randomization to death from any cause. Patients not experiencing an event (i.e., patients alive at their individual end of study) will be censored with the last date the patient was known to be alive.
72 months
Secondary Outcomes (24)
Best response
72 months
Overall response rate (ORR)
72 months
Disease control rate (DCR)
72 months
Progression Free Survival (PFS)
72 months
Change from baseline in the global health scale score
72 months
- +19 more secondary outcomes
Study Arms (2)
CANKADO (Arm A)
CANKADO application as eHealth support system: Patients use CANKADO for regular symptom self-reporting in addition to standard of care symptom management.
Control (Arm B)
Control arm without eHealth support: Patients recieve standard of care symptom management.
Interventions
Regular use of eHealth support system CANKADO by the patient: symptom self-reporting triggering alerts to the patient; in addition to standard of care symptom management.
Eligibility Criteria
Eligible are patients with histologically or cytologically confirmed stage IV NSCLC or extensive-stage SCLC who have already been scheduled to receive first-line treatment with atezolizumab in combination with platinum-based chemotherapy induction followed by atezolizumab-containing maintenance therapy according to the German SmPC (Fachinformation) OR patients with advanced (locally advanced and inoperable or metastatic), PD-L1 IC-positive TNBC who have been scheduled for first-line treatment with atezolizumab in combination with nab-paclitaxel according to the German SmPC (Fachinformation).
You may qualify if:
- Histologically or cytologically confirmed stage IV non-squamous NSCLC or histologically or cytologically confirmed extensive-stage SCLC or histologically or cytologically confirmed advanced (locally advanced and inoperable or metastatic), PD-L1 IC-positive TNBC, respectively
- Indication and decision for approved therapy with
- atezolizumab and bevacizumab in combination with carboplatin and paclitaxel induction followed by atezolizumab/bevacizumab maintenance therapy in accordance with the current German SmPC of atezolizumab for first-line treatment of stage IV non-squamous NSCLC
- atezolizumab in combination with carboplatin and nab-paclitaxel induction followed by atezolizumab maintenance therapy in accordance to the current German SmPC of atezolizumab for first-line treatment of stage IV non-squamous NSCLC
- atezolizumab in combination with carboplatin and etoposide induction followed by atezolizumab maintenance therapy in accordance to the current German SmPC of atezolizumab for first-line treatment of extensive-stage SCLC
- atezolizumab in combination with nab-paclitaxel in accordance to the current German SmPC of atezolizumab for treatment of advanced, PD-L1 IC-positive TNBC
- Aged ≥ 18 years
- ECOG 0-2
- In possession of a web-connected, frequently used, electronic device (smartphone, tablet, PC)
- Willingness and ability to participate at the paper-based or digital questionnaire project and to participate at an initial training and to regularly use the web-based application tool CANKADO
- Fluent in written and spoken German
- Written (signed and dated) informed consent
You may not qualify if:
- Prior treatment for stage IV non-squamous NSCLC (prior TKI therapy is allowed for EGFR mutant or ALK-positive NSCLC) or prior systemic treatment for extensive-stage SCLC or prior systemic chemotherapy for advanced TNBC
- History of severe (or known) hypersensitivity to chimeric or humanized antibodies or fusion proteins or any component of atezolizumab formulation
- Pregnant or breast-feeding women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- iOMEDICO AGlead
- Roche Pharma AGcollaborator
Study Sites (92)
Onkologische Praxis im St. Marien-Krankenhaus
Ahaus, Germany
Gesundheitszentrum St. Marien
Amberg, Germany
Klinikum Arnsberg, Karolinen Hospital
Arnsberg, 59759, Germany
MVZ am Klinikum Aschaffenburg
Aschaffenburg, Germany
Klinikum Augsburg, II. Medizinische Klinik
Augsburg, 86156, Germany
Gemeinschaftspraxis Dr. Heinrich, Prof. Dr. Bangerter
Augsburg, Germany
Klinikum Bayreuth GmbH
Bayreuth, 95445, Germany
Facharztpraxis am VPH Bensberg, Onkologie und Hämatologie
Bergisch Gladbach, 51429, Germany
Onkologisches Versorgungszentrum Friedrichshain
Berlin, 10407, Germany
Praxiskooperation Bonn-Euskirchen
Bonn, Germany
Ev. Krankenhaus Göttingen-Weende gGmbH, Pneumologie, Beatmungsmedizin/Schlaflabor
Bovenden, 37120, Germany
Hämato- Onkologische Praxis im Medicum
Bremen, 28209, Germany
Klinikum Bremen-Ost, Pneumologie, Beatmungsmedizin
Bremen, 28325, Germany
MVZ am Allgemeinen Krankenhaus
Celle, 29223, Germany
MVZ des Städtischen Klinikums Dessau GmbH
Dessau, 06847, Germany
Onkologiezentrum Donauwörth
Donauwörth, Germany
Klinikum Dortmund, Pneumologie, Infektiologie, internistische Intensivmedizin
Dortmund, 44145, Germany
Onkologische Gemeinschaftspraxis
Dresden, Germany
Sana Kliniken Duisburg GmbH
Duisburg, 47055, Germany
Klinikum Esslingen GmbH
Esslingen am Neckar, Germany
Berufsausübungsgemeinschaft am Klinikum
Frankfurt (Oder), 15236, Germany
Centrum für Hämatologie und Onkologie Bethanien
Frankfurt a.M., 60389, Germany
Klinikum Frankfurt Höchst Innere Medizin 3
Frankfurt a.M., 65929, Germany
Praxis Internistischer Onkologie und Hämatologie (PIOH)
Frechen, 50226, Germany
Praxis für interdisziplinäre Onkologie & Hämatologie
Freiburg im Breisgau, Germany
Onkologische Schwerpunktpraxis
Freital, 01705, Germany
Gemeinschaftspraxis Panagiotou/Minaei (GbR)
Garbsen, 30823, Germany
MVZ II der Niels Stensen Kliniken, Onkologie u. Hämatologie
Georgsmarienhütte, 49124, Germany
SRH Wald-Klinikum Gera GmbH
Gera, 07548, Germany
Universitätsklinikum Gießen, Medizinische Klinik V, Internistische Onkologie und Palliativmedizin
Giessen, 35392, Germany
Überörtliche Berufsausübungsgemeinschaft
Goslar, Germany
OSP Göttingen, Dres. Meyer / Ammon / Metz
Göttingen, 37073, Germany
Krankenhaus Martha-Maria Halle-Döla
Halle, Germany
Elbpneumologie im Struenseehaus
Hamburg, 22767, Germany
Evangelisches Krankenhaus Hamm gGmbH
Hamm, 59063, Germany
MediProjekt GbR
Hanover, 30171, Germany
DIAKOVERE Henriettenstift
Hanover, 30559, Germany
Westküstenkliniken Brunsbüttel und Heide, Medizinische Klinik I, Innere Medizin, Hämatologie, Onkologie
Heide, 25746, Germany
Onkologische Schwerpunktpraxis Dr. med. Volker Petersen
Heidenheim, 89522, Germany
Gemeinschaftskrankenhaus Herdecke
Herdecke, 58313, Germany
Frauenarztpraxis Dr. Lorenz
Hildburghausen, 98646, Germany
Praxisgemeinschaft Gynäkologische Onkologie & Spezielle Operative, Gynäkologie
Hildesheim, 31134, Germany
St. Bernward Krankenhaus, Hämatologie & Internistische Onkologie
Hildesheim, 31134, Germany
Onkologische Praxis
Hildesheim, Germany
Universitätsklinikum des Saarlandes
Homburg (Saar), 66421, Germany
Gynäko-Onkologische Praxis
Ilsede, 31241, Germany
St. Vincentius-Kliniken gAG, Gynäkologie und Geburtshilfe
Karlsruhe, 76135, Germany
Hämato-Onkologisches Zentrum Kassel
Kassel, Germany
Internisten am Markt
Köthen, 06366, Germany
Zentrum für ambulante gynäkologische Onkologie - ZAGO
Krefeld, 47805, Germany
Onkologische Schwerpunktpraxis
Kronach, 96317, Germany
ÜBAG - MVZ Dr. Vehling-Kaiser GmbH Landshut
Landshut, 84036, Germany
POIS - Leipzig GbR Geßner u. Geßner
Leipzig, Germany
Onkologische Schwerpunktpraxis
Loerrach, Germany
Klinik Löwenstein
Löwenstein, Germany
Universitätsklinikum Gießen und Marburg
Marburg, Germany
Onkologische Gemeinschaftspraxis
Mayen, Germany
Gemeinschaftspraxis für Hämatologie und internistische Onkologie
Mülheim, 45468, Germany
Hämato-Onkologische Überörtliche Gemeinschaftspraxis
München, Germany
Thoraxzentrum Bezirk Unterfranken
Münnerstadt, 97702, Germany
Praxis Dr. med. Jens Uhlig
Naunhof, Germany
MVZ für Onkologie und Hämatologie im Rhein-Kreis Neuss
Neuss, Germany
MVZ Onko Medical GmbH Neustadt, Innere Med./Hämatologie-Onkologie
Neustadt am Rübenberge, 31535, Germany
Hämatologisch-Onkologische Gemeinschaftspraxis
Nordhorn, 48527, Germany
medius KLINIK NÜRTINGEN
Nürtingen, 72622, Germany
Onkologie Offenburg, Ambulantes Therapiezentrum für Hämatologie und Onkologie
Offenburg, 77654, Germany
Onkologische Praxis Oldenburg
Oldenburg, 26121, Germany
Pius-Hospital Oldenburg Universitätsklinik f. Innere Medizin Hämatologie und Onkologie
Oldenburg, 26121, Germany
Praxis Dagmar Guth
Plauen, 08525, Germany
Carl-von-Basedow-Klinikum, Medizinischen Klinik III, Pneumologie
Querfurt, 06268, Germany
Praxis für Hämatologie und internistische Onkologie
Ratingen, Germany
Praxis und Tagesklinik für Onkologie und Hämatologie
Recklinghausen, 45659, Germany
Onkologische Praxis Remscheid
Remscheid, Germany
Praxis und Tagesklinik für Onkologie und Hämatologie
Remscheid, Germany
Elblandkliniken Stiftung & Co. KG, Elblandklinikum Riesa
Riesa, 01589, Germany
Klinikum Südstadt Rostock, Innere Medizin III
Rostock, 18059, Germany
Zentrum für Urologie und Onkologie
Rostock, 18107, Germany
Praxis Dipl.-Med. René Schubert
Scheibenberg, 09481, Germany
Diakonie-Klinikum Schwäbisch Hall, Frauenklinik
Schwäbisch Hall, 74523, Germany
ZAHO Siegburg
Siegburg, Germany
MVZ Kloster Paradiese GbR
Soest, 59494, Germany
Hämatologie - Onkologie - Stolberg
Stolberg, 52222, Germany
g.SUND Gynäkologie Kompetenzzentrum Stralsund
Stralsund, 18435, Germany
Vinzenz von Paul Kliniken
Stuttgart, Germany
Praxisnetzwerk Hämatologie / internistische Onkologie
Troisdorf, Germany
SHG Kliniken Völklingen, Innere Medizin, Pneumologie, Thorakale Onkologie, Palliativmedizin
Völklingen, 66333, Germany
MVZ Weiden GmbH
Weiden, 92637, Germany
Gemeinschaftspraxis für Hämatologie und Onkologie
Westerstede, Germany
Praxisgemeinschaft für Onkologie und Urologie
Wilhelmshaven, 26389, Germany
GIM - Gemeinschaftspraxis Innere Medizin
Witten, Germany
MVZ West GmbH Würselen Hämatologie-Onkologie
Würselen, Germany
Praxis und Tagesklinik für Hämatologie/Onkologie
Zittau, 02763, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Manfred Welslau, Dr.
MVZ am Klinikum Aschaffenburg
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2019
First Posted
April 11, 2019
Study Start
July 10, 2019
Primary Completion
July 1, 2021
Study Completion
July 1, 2021
Last Updated
October 5, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share