NSCLC Stage IV
Conditions
Brief summary
The study is designed as a prospective, single-arm observational, mixed-method study. Patients with stage IV NSCLC or inoperable mesothelioma will be included and will be treated with immunotherapy according to current guidelines and standard of care. Patients may receive either a PD1/L1 inhibitor monotherapy or, if indicated, together with a CTLA4 inhibitor. Immunotherapy may be administered alone or together with chemotherapy as per site standard/physician's choice. Patients will be given access to a mobile app. Patients will receive daily questions via the app to assess immune-related adverse events between clinic visits and their well-being.
Interventions
None listed
Sponsors
Q1.6 B.V.
Medical University of Vienna
Asklepios proresearch
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed Informed Consent Form * Age \> 18 years at the time of study entry * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 * Life expectancy \> 6 months * Patient is able and willing to use smart phone and a wearable device/technology/sensor
Exclusion criteria
* Previous systemic treatment for metastatic or locally advanced disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| adherence to use the remote monitoring app | 6 months | To measure the adherence to use the remote monitoring app, assessed as percentage of answered questions related to the total number of questions sent to the patients via Q1.6 app |
Contacts
Primary ContactNele Geßler
Backup ContactDagmar Pilz
Outcome results
None listed