Cancer Patient Remote Monitoring for Timely Communication Study (CONNECT)

Asklepios proresearch

Status: Not yet enrolling

Conditions: NSCLC Stage IV

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06623786

The CONNECT Study

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

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

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