NSCLC Stage IVCONNECTNCT06623786
Cancer Patient Remote Monitoring for Timely Communication Study
An observational study of NSCLC Stage IV, run by Asklepios proresearch.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC Stage IV
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Previous systemic treatment for metastatic or locally advanced disease
Trial locations and contacts
No sites are listed yet.
About this study
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
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study startOct 2024 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Stage IVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asklepios proresearch
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Q1.6 B.V., Medical University of Vienna
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623786
- Sponsor's protocol ID
- The CONNECT Study
- Acronym
- CONNECT
- Status last verified
- Aug 2024
- First submitted
- 30 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Patient Remote Monitoring for Timely Communication Study
- ClinicalTrials.gov ID
- NCT06623786
- Acronym / sponsor ID
- CONNECT / The CONNECT Study
- Conditions
- NSCLC Stage IV
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Asklepios proresearchIndustry (pharma, biotech, devices)
- Collaborators
- Q1.6 B.V., Medical University of Vienna
- Study start
- Oct 2024 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Previous systemic treatment for metastatic or locally advanced disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC Stage IV, run by Asklepios proresearch.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nele Geßler (+49 40 1818853160, n.gessler@asklepios.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adherence to use the remote monitoring app (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.