Special Care Service for Lung Cancer

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

280 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

Is the Special Care Service for Lung Cancer safe for humans?

The safety data for treatments related to lung cancer, like immune checkpoint inhibitors, show that they can cause unique inflammatory side effects called immune-related adverse events (irAEs). These side effects can be serious, so recognizing and managing them is important in clinical practice. ^{1 2 3 4 5}

How does the Special Care Service for Lung Cancer treatment differ from other treatments for lung cancer?

The Special Care Service for Lung Cancer treatment may involve a unique approach that focuses on managing adverse events (side effects) associated with chemotherapy and immune checkpoint inhibitors, which are common treatments for non-small cell lung cancer. This could include specialized supportive care to help patients better tolerate these treatments and improve their quality of life. ^{1 2 4 6 7}

Research Team

Brian Henick, MD

Principal Investigator

Assistant Professor of Medicine

Eligibility Criteria

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 am 18 years old or older.

I have been diagnosed with non-small cell lung 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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Adverse events among the elderly receiving chemotherapy for advanced non-small-cell lung cancer. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Immune-Related Toxicity in Non-small cell Lung Cancer: Current State-of-The-Art and Emerging Clinical Challenges. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Adverse events reporting in stage III NSCLC trials investigating surgery and radiotherapy. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Adverse events of immunotherapy in non-small cell lung cancer: A systematic review and network meta-analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Impact of pretreatment factors on adverse events: a pooled analysis of North Central Cancer Treatment Group advanced stage non-small cell lung cancer trials. [2013]

6. United States 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. [2022]

7. India pubmed.ncbi.nlm.nih.gov

Adverse effects observed in lung cancer patients undergoing first-line chemotherapy and effectiveness of supportive care drugs in a resource-limited setting. [2022]