Cancer Patient Remote Monitoring for Timely Communication Study
ConditionNSCLC Stage IV
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAsklepios proresearch
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Previous systemic treatment for metastatic or locally advanced disease
Trial population
Cohort 1: Double immune checkpoint inhibition * Histologically or cytologically confirmed stage IV NSCLC without EGFR sensitizing mutations or ALK translocations OR * Histologically or cytologically confirmed advanced, malignant pleural mesothelioma * Eligible for double immune checkpoint inhibition with an anti PD1/L1 inhibitor and a CTLA-4 inhibitor with or without chemotherapy according to current guidelines and SmPCs Cohort 2: Immunotherapy with PD1/L1 inhibitor: * Histologically or cytologically confirmed stage IV NSCLC without EGFR sensitizing mutations or ALK translocations * Eligible for treatment with an anti-PD-1/L1 inhibitor with or without chemotherapy according to current guidelines and SmPCs
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 2 trial groupsGroup A: Double immune checkpoint inhibitor
Group B: Immunotherapy with PD1/L1 inhibitor
Trial outcomes
Primary outcomes
1
adherence to use the remote monitoring app
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
Time frame
6 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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