Cancer Patient Remote Monitoring for Timely Communication Study (CONNECT)

September 30, 2024 updated by: Asklepios proresearch
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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adherence to use the remote monitoring app
Time Frame: 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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asklepios proresearch

Collaborators

Medical University of Vienna
Q1.6 B.V.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

September 30, 2024

First Submitted That Met QC Criteria

September 30, 2024

First Posted (Actual)

October 2, 2024

Study Record Updates

Last Update Posted (Actual)

October 2, 2024

Last Update Submitted That Met QC Criteria

September 30, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • The CONNECT Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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