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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

NCT03911219

CompletedN/A

Sponsor: iOMEDICO AG

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

Interventions: eHealth system support for symptom management via CANKADO

Countries: Germany

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

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

Locations (92)

Ahaus, Germany
Amberg, Germany
Arnsberg, Germany
Aschaffenburg, Germany
Augsburg, Germany
Augsburg, Germany
Bayreuth, Germany
Bergisch Gladbach, Germany
Berlin, Germany
Bonn, Germany
Bovenden, Germany
Bremen, Germany
Bremen, Germany
Celle, Germany
Dessau, Germany
Donauwörth, Germany
Dortmund, Germany
Dresden, Germany
Duisburg, Germany
Esslingen am Neckar, Germany
Frankfurt (Oder), Germany
Frankfurt a.M., Germany
Frankfurt a.M., Germany
Frechen, Germany
Freiburg im Breisgau, Germany
Freital, Germany
Garbsen, Germany
Georgsmarienhütte, Germany
Gera, Germany
Giessen, Germany
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