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

NCT ID: NCT03911219

Last Updated: 2021-10-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 154 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-10
• Study Completion Date: 2021-07-01

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.

Detailed Description

Checkpoint inhibitors represent new, promising treatment opportunities in the palliative lung cancer setting. Among programmed cell death-1 (PD-1) and programmed cell death ligand-1 (PD-L1) inhibitors, atezolizumab (Tecentriq® ), a PD-L1 inhibitor, has been shown to ameliorate outcomes for NSCLC patients with metastatic disease: The open-label phase II multicenter studies POPLAR and BIRCH revealed an improved overall response rate and a benefit in overall survival (OS) under atezolizumab monotherapy. The open-label, randomized phase III OAK trial led to atezolizumab approval as monotherapy for patients with metastatic NSCLC whose disease progressed during or following platinumcontaining chemotherapy regardless of PD-L1 status.

Despite these developments, platinum-based chemotherapy regimens are still standard of care for lung cancer without druggable alterations. Lately combining conventional chemotherapeutics with immunotherapy showed promising results: A phase I study of first-line atezolizumab plus chemotherapy demonstrated efficacy regardless of PD-L1 status and an acceptable safety profile in multiple tumor types. Accordingly, ongoing phase III trials address potential benefits of platinum-based immunotherapy combinations in comparison to standard platinum-containing regimens in first-line NSCLC and SCLC. If additional bevacizumab might further enhance atezolizumab efficacy by inhibiting vascular Endothelial Growth Factor (VEGF)-related immunosuppression is currently investigated in the IMpower150 trial.

Patients under intensive care for advanced cancers develop symptoms due to cancer progression and, possibly, due to therapy-related sideeffects. These symptoms are often not detected promptly by the treating physician leading to functional impairment and deconditioning of the patient's status with potential implications for the general outcome. Improved symptom control in late-stage cancer under exhaustive therapy regimens was achieved through intensified symptom management. Systematic collection of symptom information by electronic patientreported outcomes (ePROs) in addition to clinical routine provides an attractive basis for intensified symptom management. However, despite new, intriguing results, the proof of a significant benefit (defined as primary outcome measure) under first-line treatment is still limited in oncology trials.

In the palliative setting of lung cancer, routine treatment monitoring includes imaging at certain intervals. However, as approaching imaging assessments clarify the patient's fate, they are often a source for anxiety and concern. Additionally, patients with emerging symptoms often wait until the next routinely scheduled consultation with their treating oncologist. As a consequence, tumor progression without therapeutic hindrance over several weeks may occur and naturally shorten the patient's survival time. Clinical monitoring via self-assessed symptom-based approaches endows several benefits. Remarkably, 75-95% of relapses in lung cancer patients come with symptoms and, thus, a direct PRO measurement might be useful in the detection of an early disease progression. Easily accessible web-based application tools such as CANKADO were developed to report PROs more frequently compared to routine assessment. These tools help to strengthen the connection between patient and treating physician and to reduce patients' anxiety. Of note, even during treatment with toxic chemotherapy, most patients are willing and able to self-report via the web. Physicians appreciate PROs and trust in patient-reported information. In line with this, several promising studies confirmed a benefit from proactive, web-based monitoring programs. If symptoms occurred or worsened, the respective physician was informed earlier what resulted n improved OS, quality of life (QoL) and also in economic advantages due to less unnecessary routine check-ups. So far, these studies were performed on heterogeneous patient populations during chemotherapy. 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.

Conditions

Stage IV Non-small Cell Lung Cancer; Extensive-stage Small Cell Lung Cancer; Advanced (Locally Advanced and Inoperable or Metastatic), PD-L1 IC-positive TNBC

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

eHealth system support for symptom management via CANKADO

Intervention Type: OTHER

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.

Control (Arm B)

Control arm without eHealth support: Patients recieve standard of care symptom management.

No interventions assigned to this group

Interventions

eHealth system support for symptom management via CANKADO

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. 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

2. Indication and decision for approved therapy with

1. 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

2. 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

3. 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

4. atezolizumab in combination with nab-paclitaxel in accordance to the current German SmPC of atezolizumab for treatment of advanced, PD-L1 IC-positive TNBC

3. Aged ≥ 18 years

4. ECOG 0-2

5. In possession of a web-connected, frequently used, electronic device (smartphone, tablet, PC)

6. 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

7. Fluent in written and spoken German

8. Written (signed and dated) informed consent

Exclusion Criteria

1. 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

2. History of severe (or known) hypersensitivity to chimeric or humanized antibodies or fusion proteins or any component of atezolizumab formulation

3. Pregnant or breast-feeding women

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roche Pharma AG

INDUSTRY

Sponsor Role: collaborator

iOMEDICO AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manfred Welslau, Dr.

Role: PRINCIPAL_INVESTIGATOR

MVZ am Klinikum Aschaffenburg

Locations

Onkologische Praxis im St. Marien-Krankenhaus

Ahaus, , Germany

Gesundheitszentrum St. Marien

Amberg, , Germany

Klinikum Arnsberg, Karolinen Hospital

Arnsberg, , Germany

MVZ am Klinikum Aschaffenburg

Aschaffenburg, , Germany

Klinikum Augsburg, II. Medizinische Klinik

Augsburg, , Germany

Gemeinschaftspraxis Dr. Heinrich, Prof. Dr. Bangerter

Augsburg, , Germany

Klinikum Bayreuth GmbH

Bayreuth, , Germany

Facharztpraxis am VPH Bensberg, Onkologie und Hämatologie

Bergisch Gladbach, , Germany

Onkologisches Versorgungszentrum Friedrichshain

Berlin, , Germany

Praxiskooperation Bonn-Euskirchen

Bonn, , Germany

Ev. Krankenhaus Göttingen-Weende gGmbH, Pneumologie, Beatmungsmedizin/Schlaflabor

Bovenden, , Germany

Hämato- Onkologische Praxis im Medicum

Bremen, , Germany

Klinikum Bremen-Ost, Pneumologie, Beatmungsmedizin

Bremen, , Germany

MVZ am Allgemeinen Krankenhaus

Celle, , Germany

MVZ des Städtischen Klinikums Dessau GmbH

Dessau, , Germany

Onkologiezentrum Donauwörth

Donauwörth, , Germany

Klinikum Dortmund, Pneumologie, Infektiologie, internistische Intensivmedizin

Dortmund, , Germany

Onkologische Gemeinschaftspraxis

Dresden, , Germany

Sana Kliniken Duisburg GmbH

Duisburg, , Germany

Klinikum Esslingen GmbH

Esslingen am Neckar, , Germany

Berufsausübungsgemeinschaft am Klinikum

Frankfurt (Oder), , Germany

Centrum für Hämatologie und Onkologie Bethanien

Frankfurt a.M., , Germany

Klinikum Frankfurt Höchst Innere Medizin 3

Frankfurt a.M., , Germany

Praxis Internistischer Onkologie und Hämatologie (PIOH)

Frechen, , Germany

Praxis für interdisziplinäre Onkologie & Hämatologie

Freiburg im Breisgau, , Germany

Onkologische Schwerpunktpraxis

Freital, , Germany

Gemeinschaftspraxis Panagiotou/Minaei (GbR)

Garbsen, , Germany

MVZ II der Niels Stensen Kliniken, Onkologie u. Hämatologie

Georgsmarienhütte, , Germany

SRH Wald-Klinikum Gera GmbH

Gera, , Germany

Universitätsklinikum Gießen, Medizinische Klinik V, Internistische Onkologie und Palliativmedizin

Giessen, , Germany

Überörtliche Berufsausübungsgemeinschaft

Goslar, , Germany

OSP Göttingen, Dres. Meyer / Ammon / Metz

Göttingen, , Germany

Krankenhaus Martha-Maria Halle-Döla

Halle, , Germany

Elbpneumologie im Struenseehaus

Hamburg, , Germany

Evangelisches Krankenhaus Hamm gGmbH

Hamm, , Germany

MediProjekt GbR

Hanover, , Germany

DIAKOVERE Henriettenstift

Hanover, , Germany

Westküstenkliniken Brunsbüttel und Heide, Medizinische Klinik I, Innere Medizin, Hämatologie, Onkologie

Heide, , Germany

Onkologische Schwerpunktpraxis Dr. med. Volker Petersen

Heidenheim, , Germany

Gemeinschaftskrankenhaus Herdecke

Herdecke, , Germany

Frauenarztpraxis Dr. Lorenz

Hildburghausen, , Germany

Praxisgemeinschaft Gynäkologische Onkologie & Spezielle Operative, Gynäkologie

Hildesheim, , Germany

St. Bernward Krankenhaus, Hämatologie & Internistische Onkologie

Hildesheim, , Germany

Onkologische Praxis

Hildesheim, , Germany

Universitätsklinikum des Saarlandes

Homburg (Saar), , Germany

Gynäko-Onkologische Praxis

Ilsede, , Germany

St. Vincentius-Kliniken gAG, Gynäkologie und Geburtshilfe

Karlsruhe, , Germany

Hämato-Onkologisches Zentrum Kassel

Kassel, , Germany

Internisten am Markt

Köthen, , Germany

Zentrum für ambulante gynäkologische Onkologie - ZAGO

Krefeld, , Germany

Onkologische Schwerpunktpraxis

Kronach, , Germany

ÜBAG - MVZ Dr. Vehling-Kaiser GmbH Landshut

Landshut, , 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, , Germany

Hämato-Onkologische Überörtliche Gemeinschaftspraxis

München, , Germany

Thoraxzentrum Bezirk Unterfranken

Münnerstadt, , 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, , Germany

Hämatologisch-Onkologische Gemeinschaftspraxis

Nordhorn, , Germany

medius KLINIK NÜRTINGEN

Nürtingen, , Germany

Onkologie Offenburg, Ambulantes Therapiezentrum für Hämatologie und Onkologie

Offenburg, , Germany

Onkologische Praxis Oldenburg

Oldenburg, , Germany

Pius-Hospital Oldenburg Universitätsklinik f. Innere Medizin Hämatologie und Onkologie

Oldenburg, , Germany

Praxis Dagmar Guth

Plauen, , Germany

Carl-von-Basedow-Klinikum, Medizinischen Klinik III, Pneumologie

Querfurt, , Germany

Praxis für Hämatologie und internistische Onkologie

Ratingen, , Germany

Praxis und Tagesklinik für Onkologie und Hämatologie

Recklinghausen, , Germany

Onkologische Praxis Remscheid

Remscheid, , Germany

Praxis und Tagesklinik für Onkologie und Hämatologie

Remscheid, , Germany

Elblandkliniken Stiftung & Co. KG, Elblandklinikum Riesa

Riesa, , Germany

Klinikum Südstadt Rostock, Innere Medizin III

Rostock, , Germany

Zentrum für Urologie und Onkologie

Rostock, , Germany

Praxis Dipl.-Med. René Schubert

Scheibenberg, , Germany

Diakonie-Klinikum Schwäbisch Hall, Frauenklinik

Schwäbisch Hall, , Germany

ZAHO Siegburg

Siegburg, , Germany

MVZ Kloster Paradiese GbR

Soest, , Germany

Hämatologie - Onkologie - Stolberg

Stolberg, , Germany

g.SUND Gynäkologie Kompetenzzentrum Stralsund

Stralsund, , Germany

Vinzenz von Paul Kliniken

Stuttgart, , Germany

Praxisnetzwerk Hämatologie / internistische Onkologie

Troisdorf, , Germany

SHG Kliniken Völklingen, Innere Medizin, Pneumologie, Thorakale Onkologie, Palliativmedizin

Völklingen, , Germany

MVZ Weiden GmbH

Weiden, , Germany

Gemeinschaftspraxis für Hämatologie und Onkologie

Westerstede, , Germany

Praxisgemeinschaft für Onkologie und Urologie

Wilhelmshaven, , Germany

GIM - Gemeinschaftspraxis Innere Medizin

Witten, , Germany

MVZ West GmbH Würselen Hämatologie-Onkologie

Würselen, , Germany

Praxis und Tagesklinik für Hämatologie/Onkologie

Zittau, , Germany

Countries

Germany

Other Identifiers

ML41161

Identifier Type: OTHER

Identifier Source: secondary_id

iOM-100392

Identifier Type: -

Identifier Source: org_study_id