Cancer Patient Remote Monitoring for Timely Communication Study

NCT ID: NCT06623786

Last Updated: 2024-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-31

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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NSCLC Stage IV

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Q1.6 B.V.

UNKNOWN

Sponsor Role collaborator

Medical University of Vienna

OTHER

Sponsor Role collaborator

Asklepios proresearch

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Nele Geßler

Role: CONTACT

+49 40 1818853160

Dagmar Pilz

Role: CONTACT

+49 40 1818 853160

Other Identifiers

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The CONNECT Study

Identifier Type: -

Identifier Source: org_study_id

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