Cancer Patient Remote Monitoring for Timely Communication Study

NCT06623786 | Not Yet Recruiting

• 1 other identifier: The CONNECT Study
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

NSCLC Stage IV

Outcome Measures

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

  6 months

Study Arms (2)

Double immune checkpoint inhibitor

* 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

* 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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

You may qualify if:

• 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

You may not qualify if:

• Previous systemic treatment for metastatic or locally advanced disease

Sponsors & Collaborators

• Asklepios proresearch: lead
• Q1.6 B.V.: collaborator
• Medical University of Vienna: collaborator

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Nele Geßler

CONTACT

+49 40 1818853160; n.gessler@asklepios.com

Dagmar Pilz

CONTACT

+49 40 1818 853160; da.pilz@asklepios.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 2, 2024
• Study Start: October 1, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: October 2, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share