Special Care Service for Lung Cancer

Not currently recruiting at 3 trial locations

Overseen By Research Nurse Navigator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Must be taking: Immune-checkpoint inhibitors

Disqualifiers: Other trials, Medical conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called ApricityRxTM to determine if it improves treatment outcomes for people with non-small cell lung cancer (NSCLC) receiving standard immunotherapy. The program, also known as the Apricity C.A.R.E. Program for Cancer Adverse events Rapid Evaluation, includes a digital tool and 24/7 support to quickly assess and address any new or worsening symptoms. Participants will either continue with regular care or use this new program to see if it reduces doctor or hospital visits. The trial seeks individuals diagnosed with NSCLC, currently on immunotherapy, who identify as part of an ethnic minority or underserved group. As an unphased trial, this study provides a unique opportunity to contribute to innovative care solutions for NSCLC patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the ApricityRx care service is safe for NSCLC patients?

Research shows that the Apricity C.A.R.E. Program helps cancer patients manage immunotherapy side effects. This program uses a digital tool to monitor symptoms and provides 24/7 support for quick intervention. Its safety is generally well-regarded due to its focus on timely assistance and reducing complication risks.

Although specific safety data for the Apricity C.A.R.E. Program is unavailable, the trial is in a "Not Applicable" phase, indicating it is likely non-invasive and primarily involves monitoring and support. Therefore, it is not expected to pose direct risks to patients but aims to improve treatment management by identifying potential issues early.

In summary, despite the lack of specific safety data, the program is designed to enhance patient care, likely ensuring its safety for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Apricity C.A.R.E. Program because it offers a new method for managing adverse events in lung cancer patients receiving immune checkpoint inhibitors (ICIs). Unlike traditional approaches that rely on routine monitoring, this program uses a digital solution combined with pulse oximeters and 24/7 support to quickly identify and respond to symptoms. This proactive approach could lead to faster intervention and improved patient outcomes by catching potential issues early and providing timely care.

What evidence suggests that the Apricity C.A.R.E. Program is effective for improving treatment outcomes in NSCLC patients?

Research shows that the Apricity C.A.R.E. Program, which participants in this trial may receive, could help lung cancer patients, especially those from minority groups, manage their treatment more effectively. Early results suggest that using technology to track symptoms can lead to better treatment outcomes. Similar digital health programs have helped patients stay more engaged in their care, leading to better adherence to treatment plans. Participants in these programs often experience fewer complications and require fewer additional doctor visits. Although more information is needed, these early signs are promising for improving lung cancer care. ^{1 2 3 4 5}

Who Is on the Research Team?

Brian Henick, MD

Principal Investigator

Assistant Professor of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 with confirmed non-small cell lung cancer (NSCLC) who are receiving immunotherapy and identify as part of an ethnic minority or underserved group. They must understand the study and agree to participate. Those in other clinical trials or with conditions that may hinder participation cannot join.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document

I have been diagnosed with non-small cell lung cancer.

I am being treated with drugs that boost my immune system to fight cancer.

Exclusion Criteria

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard of care immunotherapy and are monitored for immune-related adverse effects using the ApricityRx digital solution

2 years

Routine monitoring with digital solution and clinical visits as needed

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of treatment delays or discontinuation

6 months

Open-label extension (optional)

Participants may continue to use the ApricityRx digital solution for long-term monitoring

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Apricity C.A.R.E. Program for Cancer Adverse events Rapid Evaluation

Trial Overview The Apricity C.A.R.E. Program is being tested to see if it can improve treatment results for NSCLC patients from racial/ethnic minorities on immunotherapy, aiming to reduce their need for frequent healthcare visits.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 1 Intervention

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.

Group II: Control Arm Active Control 1 Intervention

Clinicians will monitor NSCLC patients on ICIs for irAEs as a standard of care using routine practices.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Published Research Related to This Trial

In a study of 1,371 patients with advanced-stage non-small-cell lung cancer, 58% received chemotherapy, with younger patients (under 55) more likely to be treated compared to older patients (47% for those 75 and older).

Despite having fewer pre-treatment medical events, older patients experienced more adverse events during chemotherapy, indicating a need to carefully consider the balance between treatment benefits and potential side effects in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events among the elderly receiving chemotherapy for advanced non-small-cell lung cancer. Chrischilles, EA., Pendergast, JF., Kahn, KL., et al.[2021]

Immune checkpoint inhibitors are now a standard treatment for non-small cell lung cancer (NSCLC), but they can cause immune-related adverse events (irAEs), which are unique inflammatory side effects that can complicate treatment.

Recognizing and managing these irAEs is crucial for healthcare providers, as they can lead to severe toxicities that may influence treatment decisions for patients with NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immune-Related Toxicity in Non-small cell Lung Cancer: Current State-of-The-Art and Emerging Clinical Challenges. O'Leary, CL., Pierce, N., Patel, SP., et al.[2023]

A systematic review of 119 studies on stage III non-small cell lung cancer (NSCLC) revealed that adverse events (AEs) were inconsistently reported, with 94.12% of studies documenting grade 3 AEs and 92.44% reporting grade 4 AEs, but only 53.78% and 63.03% for grade 1 and 2 AEs, respectively.

In studies involving surgical procedures, AEs were often underreported, with 10 out of 31 surgical treatment arms not mentioning any AEs, highlighting a significant gap in patient-relevant information that could impact treatment decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events reporting in stage III NSCLC trials investigating surgery and radiotherapy. Iseli, T., Berghmans, T., Glatzer, M., et al.[2022]

In a meta-analysis of 51 studies with 12,600 participants, the development of immune-related adverse events (irAEs) was linked to improved overall survival (OS) and objective response rate (ORR) in advanced non-small cell lung cancer (NSCLC).

Checkpoint inhibitor pneumonitis (CIP) did not significantly affect overall survival but was associated with a better treatment response, indicating that while CIP may not be detrimental to survival, it can enhance the effectiveness of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Immune-Related Adverse Events and Pneumonitis on Prognosis in Advanced Non-Small Cell Lung Cancer: A Comprehensive Systematic Review and Meta-analysis. Li, Y., Zhang, Y., Jia, X., et al.[2022]

In a review of 52 randomized controlled trials involving 23,322 patients with non-small cell lung cancer (NSCLC), the incidence of serious adverse events (AEs) was found to be similar between immune monotherapy and chemotherapy, with serious AEs occurring in about 33-48% of patients depending on the treatment type.

Certain immune-related adverse events (irAEs), such as colitis, pneumonitis, and rash, were more common in immunotherapy groups compared to chemotherapy, and interestingly, the occurrence of serious AEs like hepatitis and pneumonitis was positively correlated with better progression-free survival in patients receiving PD1 and PDL1 therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of immunotherapy in non-small cell lung cancer: A systematic review and network meta-analysis. Zhou, C., Li, M., Wang, Z., et al.[2022]

Citations

1. careacross.com careacross.com/clinical-trials/trial/NCT05812274

Apricity CARE to Improve ICI Outcomes of Ethnic/Racial ... Summary: The purpose of this trial is to study the effectiveness of the AprictyRxTM care service to improve treatment outcomes of ethnic/racial minority ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05812274

Apricity CARE to Improve ICI Outcomes of Ethnic/Racial ... 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. ...

3. clinicaltrials.med.nyu.edu clinicaltrials.med.nyu.edu/cancer/clinicaltrial/2521/phase-iv-study-apricity/

Perlmutter Cancer Center - Clinical Trials - NYU New life-saving treatments for NSCLC in clinical trial on A phase IV study of Apricity C.A.R.E. program for Cancer Adverse events Rapid Evaluation to ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41114973/

A Direct-to-Patient Digital Health Program for Lung Cancer ... Chest CT completion was higher in the mPATH-Lung group than in controls (24.5% [164/669] vs 17.0% [113/664]; odds ratio, 1.6; 95% CI, 1.2-2.1).

5. bmjopen.bmj.com bmjopen.bmj.com/content/12/6/e061740

APRICITY phase 3 study protocol APRICITY is a multicentre, prospective, double-blind, randomised controlled phase 3 study further evaluating the efficacy and safety of Cevira.