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AzTrials

Stage IV Non-small Cell Lung CancerCHAPLINNCT03911219

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

An observational study of Stage IV Non-small Cell Lung Cancer and Extensive-stage Small Cell Lung Cancer, run by iOMEDICO AG at 92 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
eHealth system support for symptom management via CANKADO
How many people
154 participants
Where
92 sitesGermany
Study dates
10 Jul 2019to 1 Jul 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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).

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

92 sites in 1 country.

92 sites in 1 country

Germany92 sites

  • Onkologische Praxis im St. Marien-Krankenhaus

    Ahaus

  • Gesundheitszentrum St. Marien

    Amberg

  • Klinikum Arnsberg, Karolinen Hospital

    Arnsberg, 59759

  • MVZ am Klinikum Aschaffenburg

    Aschaffenburg

  • Klinikum Augsburg, II. Medizinische Klinik

    Augsburg, 86156

  • Gemeinschaftspraxis Dr. Heinrich, Prof. Dr. Bangerter

    Augsburg

  • Klinikum Bayreuth GmbH

    Bayreuth, 95445

  • Facharztpraxis am VPH Bensberg, Onkologie und Hämatologie

    Bergisch Gladbach, 51429

  • Onkologisches Versorgungszentrum Friedrichshain

    Berlin, 10407

  • Praxiskooperation Bonn-Euskirchen

    Bonn

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

    Bovenden, 37120

  • Hämato- Onkologische Praxis im Medicum

    Bremen, 28209

  • Klinikum Bremen-Ost, Pneumologie, Beatmungsmedizin

    Bremen, 28325

  • MVZ am Allgemeinen Krankenhaus

    Celle, 29223

  • MVZ des Städtischen Klinikums Dessau GmbH

    Dessau, 06847

  • Onkologiezentrum Donauwörth

    Donauwörth

  • Klinikum Dortmund, Pneumologie, Infektiologie, internistische Intensivmedizin

    Dortmund, 44145

  • Onkologische Gemeinschaftspraxis

    Dresden

  • Sana Kliniken Duisburg GmbH

    Duisburg, 47055

  • Klinikum Esslingen GmbH

    Esslingen am Neckar

  • Berufsausübungsgemeinschaft am Klinikum

    Frankfurt (Oder), 15236

  • Centrum für Hämatologie und Onkologie Bethanien

    Frankfurt a.M., 60389

  • Klinikum Frankfurt Höchst Innere Medizin 3

    Frankfurt a.M., 65929

  • Praxis Internistischer Onkologie und Hämatologie (PIOH)

    Frechen, 50226

  • Praxis für interdisziplinäre Onkologie & Hämatologie

    Freiburg im Breisgau

  • Onkologische Schwerpunktpraxis

    Freital, 01705

  • Gemeinschaftspraxis Panagiotou/Minaei (GbR)

    Garbsen, 30823

  • MVZ II der Niels Stensen Kliniken, Onkologie u. Hämatologie

    Georgsmarienhütte, 49124

  • SRH Wald-Klinikum Gera GmbH

    Gera, 07548

  • Universitätsklinikum Gießen, Medizinische Klinik V, Internistische Onkologie und Palliativmedizin

    Giessen, 35392

  • Überörtliche Berufsausübungsgemeinschaft

    Goslar

  • OSP Göttingen, Dres. Meyer / Ammon / Metz

    Göttingen, 37073

  • Krankenhaus Martha-Maria Halle-Döla

    Halle

  • Elbpneumologie im Struenseehaus

    Hamburg, 22767

  • Evangelisches Krankenhaus Hamm gGmbH

    Hamm, 59063

  • MediProjekt GbR

    Hanover, 30171

  • DIAKOVERE Henriettenstift

    Hanover, 30559

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

    Heide, 25746

  • Onkologische Schwerpunktpraxis Dr. med. Volker Petersen

    Heidenheim, 89522

  • Gemeinschaftskrankenhaus Herdecke

    Herdecke, 58313

  • Frauenarztpraxis Dr. Lorenz

    Hildburghausen, 98646

  • Praxisgemeinschaft Gynäkologische Onkologie & Spezielle Operative, Gynäkologie

    Hildesheim, 31134

  • St. Bernward Krankenhaus, Hämatologie & Internistische Onkologie

    Hildesheim, 31134

  • Onkologische Praxis

    Hildesheim

  • Universitätsklinikum des Saarlandes

    Homburg (Saar), 66421

  • Gynäko-Onkologische Praxis

    Ilsede, 31241

  • St. Vincentius-Kliniken gAG, Gynäkologie und Geburtshilfe

    Karlsruhe, 76135

  • Hämato-Onkologisches Zentrum Kassel

    Kassel

  • Internisten am Markt

    Köthen, 06366

  • Zentrum für ambulante gynäkologische Onkologie - ZAGO

    Krefeld, 47805

  • Onkologische Schwerpunktpraxis

    Kronach, 96317

  • ÜBAG - MVZ Dr. Vehling-Kaiser GmbH Landshut

    Landshut, 84036

  • POIS - Leipzig GbR Geßner u. Geßner

    Leipzig

  • Onkologische Schwerpunktpraxis

    Loerrach

  • Klinik Löwenstein

    Löwenstein

  • Universitätsklinikum Gießen und Marburg

    Marburg

  • Onkologische Gemeinschaftspraxis

    Mayen

  • Gemeinschaftspraxis für Hämatologie und internistische Onkologie

    Mülheim, 45468

  • Hämato-Onkologische Überörtliche Gemeinschaftspraxis

    München

  • Thoraxzentrum Bezirk Unterfranken

    Münnerstadt, 97702

  • Praxis Dr. med. Jens Uhlig

    Naunhof

  • MVZ für Onkologie und Hämatologie im Rhein-Kreis Neuss

    Neuss

  • MVZ Onko Medical GmbH Neustadt, Innere Med./Hämatologie-Onkologie

    Neustadt am Rübenberge, 31535

  • Hämatologisch-Onkologische Gemeinschaftspraxis

    Nordhorn, 48527

  • medius KLINIK NÜRTINGEN

    Nürtingen, 72622

  • Onkologie Offenburg, Ambulantes Therapiezentrum für Hämatologie und Onkologie

    Offenburg, 77654

  • Onkologische Praxis Oldenburg

    Oldenburg, 26121

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

    Oldenburg, 26121

  • Praxis Dagmar Guth

    Plauen, 08525

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

    Querfurt, 06268

  • Praxis für Hämatologie und internistische Onkologie

    Ratingen

  • Praxis und Tagesklinik für Onkologie und Hämatologie

    Recklinghausen, 45659

  • Onkologische Praxis Remscheid

    Remscheid

  • Praxis und Tagesklinik für Onkologie und Hämatologie

    Remscheid

  • Elblandkliniken Stiftung & Co. KG, Elblandklinikum Riesa

    Riesa, 01589

  • Klinikum Südstadt Rostock, Innere Medizin III

    Rostock, 18059

  • Zentrum für Urologie und Onkologie

    Rostock, 18107

  • Praxis Dipl.-Med. René Schubert

    Scheibenberg, 09481

  • Diakonie-Klinikum Schwäbisch Hall, Frauenklinik

    Schwäbisch Hall, 74523

  • ZAHO Siegburg

    Siegburg

  • MVZ Kloster Paradiese GbR

    Soest, 59494

  • Hämatologie - Onkologie - Stolberg

    Stolberg, 52222

  • g.SUND Gynäkologie Kompetenzzentrum Stralsund

    Stralsund, 18435

  • Vinzenz von Paul Kliniken

    Stuttgart

  • Praxisnetzwerk Hämatologie / internistische Onkologie

    Troisdorf

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

    Völklingen, 66333

  • MVZ Weiden GmbH

    Weiden, 92637

  • Gemeinschaftspraxis für Hämatologie und Onkologie

    Westerstede

  • Praxisgemeinschaft für Onkologie und Urologie

    Wilhelmshaven, 26389

  • GIM - Gemeinschaftspraxis Innere Medizin

    Witten

  • MVZ West GmbH Würselen Hämatologie-Onkologie

    Würselen

  • Praxis und Tagesklinik für Hämatologie/Onkologie

    Zittau, 02763

Other trials in Germany

About this study

Official title: 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

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.

Read the 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.

Being tested
eHealth system support for symptom management via CANKADO
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • eHealth system support for symptom management via CANKADOOther

    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.

Study groups in NCT03911219
Study groupRoleWhat they receive
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.
Receives: Other: eHealth system support for symptom management via CANKADO
Control (Arm B)Control arm without eHealth support: Patients recieve standard of care symptom management.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 72 months

Secondary outcomes (24)

  1. Best response

    The best documented response (in terms of complete response [CR], partial response [PR], stable disease [SD], or progressive disease [PD]) per patient, as assessed by the treating physician.

    Measured: 72 months

  2. Overall response rate (ORR)

    The proportion of patients showing a best overall response of CR or PR (as assessed by the treating physician).

    Measured: 72 months

  3. Disease control rate (DCR)

    The proportion of patients showing a best overall response of CR, PR, or SD (as assessed by the treating physician).

    Measured: 72 months

  4. Progression Free Survival (PFS)

    The time from randomization to tumor progression or death from any cause, whatever occurs first. Patients being event-free (i.e., alive and progression-free) by the time of analysis or starting a new antineoplastic therapy before progression, will be censored at the date of the last adequate tumor assessment.

    Measured: 72 months

  5. Change from baseline in the global health scale score

    To compare patient-reported outcomes (PROs) on quality of life (QoL) of the two study arms: Change from baseline in the global health scale score

    Measured: 72 months

  6. Change from baseline in the functional/symptom scores

    To compare patient-reported outcomes (PROs) on quality of life (QoL) of the two study arms: Change from baseline in the functional/symptom scores

    Measured: 72 months

  7. Time to deterioration in global health scale score

    To compare patient-reported outcomes (PROs) on quality of life (QoL) of the two study arms: Time to deterioration (TTD) by ≥ 10 points in the global health scale score

    Measured: 72 months

  8. Time to deterioration in functional/symptom scores

    To compare patient-reported outcomes (PROs) on quality of life (QoL) of the two study arms: Time to deterioration (TTD) by ≥ 10 points in the functional/symptom scores

    Measured: 72 months

  9. Alerts

    Frequency and total number of eHealth Support system (EHSS) alerts.

    Measured: 72 months

  10. Sensitivity of alerts

    Ratio of alert-initiated visits that result in detection of tumor progression and/or action-requiring symptom management (as evaluated by the oncologist) and all visits which result in detection of tumor progression and/or action-requiring symptom management.

    Measured: 72 months

  11. Specifity of alerts

    Ratio of non-alert-initiated visits with neither detected tumor progression nor action-requiring symptom management (as evaluated by the oncologist) and all visits with neither detected tumor progression nor action-requiring symptom management.

    Measured: 72 months

  12. Positive predictive value of alerts

    Ratio of alert-initiated visits that resulted in detection of tumor progression and/or action-requiring symptom management and all alert-initiated visits.

    Measured: 72 months

  13. Negative predictive value of alerts

    Ratio of non-alert-initiated visits with no result (i.e., neither detected tumor progression nor action-requiring symptom management) and all non-alert-initiated visits.

    Measured: 72 months

  14. Progression-detection rate

    The proportion of individuals who test positive for a first tumor progression during atezolizumab therapy in a specific type of tumor assessment (i.e., alert-triggered vs. non-alert-triggered), compared to the total number of first detected progressions during atezolizumab therapy (i.e., progressions detected in all tumor assessments during scheduled as well as unscheduled visits).

    Measured: 72 months

  15. Patient compliance

    Intensity of use of application tool (defined as number of utilizations per week over the total observation time).

    Measured: 72 months

  16. Safety and tolerability

    Frequency and severity of (serious) adverse events ((S)AEs) coded by the Medical Dictionary for Regulatory Activities (MedDRA), summarized by Preferred Term and System Organ Class and graded according to CTCAE v5.0.

    Frequency and severity of (serious) adverse drug reactions ((S)ADRs) with causal relationship to bevacizumab and/or atezolizumab coded by the MedDRA, summarized by Preferred Term and System Organ Class and graded according to CTCAE v5.0.

    Measured: 72 months

  17. Treatment duration of first-line atezolizumab

    Treatment duration of first-line atezolizumab (including maintenance therapy)

    Measured: 72 months

  18. Relative dose intensity of first-line atezolizumab

    Relative dose intensity of first-line atezolizumab (including maintenance therapy)

    Measured: 72 months

  19. Treatment duration of each combined first-line antineoplastic therapy substance

    Treatment duration of each combined first-line antineoplastic therapy substance

    Measured: 72 months

  20. Relative dose intensity of each combined first-line antineoplastic therapy substance

    Relative dose intensity of each combined first-line antineoplastic therapy substance

    Measured: 72 months

  21. Treatment duration of combined first-line bevacizumab

    Treatment duration of combined first-line bevacizumab (including maintenance therapy)

    Measured: 72 months

  22. Treatment modifications of first-line atezolizumab and all combined antineoplastic substances

    Therapy details and subsequent therapy lines based on Treatment modifications of first-line atezolizumab and all combined antineoplastic substances

    Measured: 72 months

  23. Subsequent antineoplastic therapy lines

    Therapy details and subsequent antineoplastic therapy lines

    Measured: 72 months

  24. Subscale scores and single item responses

    To compare patient-reported outcomes (PROs) on quality of life (QoL) of the two study arms Subscale scores and single item responses in Patient Reported Outcomes on QoL in both arms

    Measured: 72 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2019
  2. Study start10 Jul 2019
  3. Primary completion1 Jul 2021
  4. Study completion1 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03911219
Sponsor's protocol ID
iOM-100392
Other IDs
ML41161
Acronym
CHAPLIN
Status last verified
Oct 2021
First submitted
1 Apr 2019
Last updated
5 Oct 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Stage IV Non-small Cell Lung Cancer and Extensive-stage Small Cell Lung Cancer, run by iOMEDICO AG at 92 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: 72 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03911219.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.

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