Apricity CARE to Improve ICI Outcomes of Ethnic/Racial Minority NSCLC Patients

April 29, 2026 updated by: Brian Henick, MD, Columbia University

A Phase IV Study of Apricity C.A.R.E. Program for Cancer Adverse Events Rapid Evaluation to Improve Treatment Outcomes of Ethnic/Racial Minority Non-small Cell Lung Cancer (NSCLC) Patients Receiving Immunotherapy

The purpose of this trial is to study the effectiveness of the AprictyRxTM care service to improve treatment outcomes of ethnic/racial minority N.S.C.L.C. patients receiving standard of care immunotherapy, and reduce the frequency of healthcare system interactions.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Immune checkpoint inhibitors (I.C.I.) targeting the PD-1/PD-L1 axis have changed the treatment landscape of non-small cell lung cancer (N.S.C.L.C.). After demonstrating improved efficacy and tolerability compared to standard chemotherapy in several large clinical trials, these novel drugs are now F.D.A. approved in multiple treatment settings. With the increase in I.C.I. use, the incidence of immune-related adverse effects (irAEs) has also risen, occurring in up to 16% of ICI-treated patients. Prompt recognition and timely management are necessary to avert potential poor outcomes from direct toxicity and/or early treatment discontinuation. However, rapid adoption of I.C.I.s may limit healthcare providers' experience and comfort with managing important irAEs. Additionally, existing barriers to access care that disproportionately impact racial and ethnic minority patients may amplify the inability to manage patients on I.C.I.s effectively.

Using technologically-enabled health interventions in a culturally competent manner can improve access to health care resources and reduce health disparities. These platforms need to be optimized at the literacy level of underserved minority communities and can be adapted to meet the community's needs. Recently, technology-enabled services focused on patient-reported outcomes have garnered growing interest in oncology.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
      • New York, New York, United States, 10029
        • Montefiore Health Center
      • New York, New York, United States, 10029
        • NYU Medical Center
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center, Herbert Irving Comprehensive Cancer Center

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

Description

Inclusion Criteria:

  • Age≥ 18 years
  • Confirmed NSCLC diagnosis
  • Prescribed treatment with immune-checkpoint inhibitor, including in combination with chemotherapy
  • Ability to understand and the willingness to sign a written informed consent document
  • Self-identification as a member of an ethnic minority or underserved population.

Exclusion Criteria:

  • An individual with presence of any medical, psychological, or social condition that, in the opinion of the investigator would preclude participation in this study.
  • Patients enrolled in other interventional clinical trials at the time of screening will be excluded.

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm
Participants are provided with ApricityRx digital solution with pulse oximeters and 24/7 C.A.R.E. (Cancer Adverse event Rapid Evaluation) to monitor and capture ePRO, identify onset or progression of symptoms verified by nurse triage, trigger intervention by the study team.
Other: Apricity C.A.R.E. Program for Cancer Adverse events Rapid Evaluation

The Apricity CARE program for Cancer Adverse events Rapid Evaluation is a cloud-based 24/7 on-demand clinical coverage service, delivered exclusively via the ApricityRx digital care platform by certified and licensed healthcare professionals who are trained to monitor patient's symptoms and conduct standardized triage following guideline-based or protocol-specified pathways with 3 parts:

  • ApricityCare™ Mobile Application - to collect health data (PGHD) on biometrics and self-reported symptoms (PRO) of symptoms and potential side effects at home, in between doctors' visits, and offers educational content in video.
  • ApricityOncology™ Web-based Application - to provide authorized healthcare providers an organized, longitudinal and summarized view of a patient's pertinent cancer history and real world PGHD for purpose of symptom monitoring.
  • ApricityManage™ Dashboard - a dashboard intended for administrators, sponsors or funders to track program status.
Other Names:
  • Apricity CARE program
No Intervention: Control Arm
Clinicians will monitor NSCLC patients on ICIs for irAEs as a standard of care using routine practices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Likert-type scale score
Time Frame: 2 years
Two focus group discussions (FGDs), stratified on a Likert-type scale based on the frequency of utilization, to determine factors related to usage of ApricityCare app and utilization of the CARE monitoring service (Run-in phase). To assess factors related to suboptimal and optimal use of the ApricityCare app and the CARE monitoring service, collectively "the Apricity CARE program".
2 years
Percent of study patients who experienced treatment delay/discontinuation
Time Frame: 2 years
To determine the impact of the the Apricity CARE program on immunotherapy toxicity monitoring for N.S.C.L.C. patients receiving immunotherapy in a highly diverse New York City community. Immune Checkpoint Inhibitor (ICI) treatment delay or discontinuation is defined as a gap between doses of ICI beyond 60 days and/or the initiation of another cancer therapy without evidence of disease progression.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of study patients who experience a severe irAE (grade 3 or higher).
Time Frame: 2.5 years
To assess the percent of study patients who experience a severe irAE (grade 3 or higher) while on study. Information about individual treatment toxicities (i.e., type, frequency) will be obtained and recorded from the ApricityRxTM platform and patient's clinical note. Toxicity grade will be assigned using the NCI CTCAE v5.0 and tallied.
2.5 years
Time to irAE management
Time Frame: 2.5 years
To quantify time to irAE management with ICI. This will be defined as the time from the onset of irAE to time of active intervention (i.e., change in administration schedule, new prescription of supportive medication, telephone counseling about symptoms, unscheduled visits or referrals). Information will be obtained and recorded from the ApricityRxTM platform and patient's clinical note, and tallied. Unit measured in days.
2.5 years
Time to treatment discontinuation with ICI
Time Frame: 2.5 years
To quantify time to irAE management with ICI. This will be determined as starting date of ICI to date of the last dose of ICI for any reason specified by patient's EMR. Information will be obtained and recorded from the ApricityRxTM platform and patient's clinical note, and tallied. Unit measured in days.
2.5 years
Number of interactions with the care team and utilization
Time Frame: 2.5 years
This will be quantified as the number of clinical interactions between patients and providers from the patient's EMR and will include telephone encounters, unscheduled clinic visits, ED visits, hospital admissions - total will be tallied.
2.5 years
Number of interviews/surveys completed
Time Frame: 2.5 years
Patient and provider experience will be assessed with focus group discussions (FGDs), semi-structured interviews, and surveys
2.5 years

Collaborators and Investigators

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

Sponsor

Columbia University

Collaborators

Stand Up To Cancer

Investigators

  • Principal Investigator: Brian Henick, MD, Assistant Professor of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

May 31, 2023

Primary Completion (Actual)

July 30, 2025

Study Completion (Actual)

October 24, 2025

Study Registration Dates

First Submitted

March 30, 2023

First Submitted That Met QC Criteria

March 31, 2023

First Posted (Actual)

April 13, 2023

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAU2705

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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