Clinical trial · Observational
Cancer Patient Remote Monitoring for Timely Communication Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC Stage IV | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Double immune checkpoint inhibitor
- description
- * 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 SmPC
- label
- Immunotherapy with PD1/L1 inhibitor
- description
- * 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
Primary outcomes (1)
- measure
- adherence to use the remote monitoring app
- timeFrame
- 6 months
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available