Experiences w/ & Attitudes Towards Immune Chckpt Inhibitors in NSCLC Patients Single Center Survey Based Study

March 13, 2026 updated by: University of Southern California

Experiences With and Attitudes Towards Immune Checkpoint Inhibitors in Patients With Non-Small Cell Lung Cancer (NSCLC) - A Single Center, Survey-Based Study

This study evaluates patient satisfaction with receiving intravenous (IV) and/or subcutaneous (SC) immunotherapy and to assess patient preference for IV immunotherapy administration versus SC immunotherapy administration either at the hospital or at home.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To assess patient satisfaction with receiving IV immune checkpoint inhibitors, reflecting whether the patient thought that the experience was safe, convenient, comfortable and proceeded smoothly.

II. To assess patient preference for IV versus home SC ICI administration.

OUTLINE: This is an observational study.

Patients complete surveys on study.

Study Type

Observational

Enrollment (Estimated)

40

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
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • USC / Norris Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Robert Hsu
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Los Angeles General Medical Center
        • Contact:
        • Principal Investigator:
          • Robert Hsu

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

Sampling Method

Non-Probability Sample

Study Population

Patients with non-small cell lung cancer, currently receiving Atezolizumab, Cemiplimab, Durvalumab, Nivolumab, or Pembrolizumab.

Description

Inclusion Criteria:

  • * Age ≥ 18 years.
  • * Patients must have histopathologically/cytologically confirmed non-small cell lung cancer, currently receiving Atezolizumab, Cemiplimab, Durvalumab, Nivolumab, Pembrolizumab (i.e. the patient has already received at least one cycle of therapy)
  • * Previous chemotherapy/radiotherapy/targeted/immunotherapy is allowed at any prior timepoint.
  • * Ability to understand and the willingness to sign a written informed consent or presence of a surrogate decision maker who can give consent.

Exclusion Criteria:

  • * Patients is unable to consent for themselves
  • * Patient has not yet completed the 1st cycle of ICI-based therapy

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational
Patients complete surveys on study.
Other: Non-Interventional Study
Non-interventional study
Other Names:
  • Non-Interventional Observational Study
  • Noninterventional (Observational) Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Strength of patient perception of Intravenous (IV) Immune Checkpoint Inhibitor (ICI) therapy
Time Frame: At Baseline through study completion, up to 1 year.
Outcome data will be collected using a questionnaire per study protocol. A Likert scale rating system of Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree will be used. Summaries of data will be descriptive and standard statistical methods (median) will be used to present the results. Pearson's chi-square test, the Mantel-Haenszel test (or corresponding exact tests, if resulting expected numbers are small) will be used; the resulting p-value will be used as an indication of strength of an observed association.
At Baseline through study completion, up to 1 year.
Patient interest in home SC ICI administration vs. IV ICI administration at the infusion center
Time Frame: At Baseline through study completion, up to 1 year.
Outcome data will be collected using a questionnaire per study protocol. Results will be summarized with point estimates and confidence intervals; p-values, when calculated, will be used to indicate the strength of an observed association (not just the magnitude).
At Baseline through study completion, up to 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Strength of patient perception of Subcutaneous (SC) Immune Checkpoint Inhibitor (ICI) therapy.
Time Frame: At Baseline through study completion, up to 1 year.
Outcome data will be collected using a questionnaire per study protocol. A Likert scale rating system of Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree will be used. Summaries of data will be descriptive and standard statistical methods (median) will be used to present the results. Pearson's chi-square test, the Mantel-Haenszel test (or corresponding exact tests, if resulting expected numbers are small) will be used; the resulting p-value will be used as an indication of strength of an observed association.
At Baseline through study completion, up to 1 year.
Strength of patient interest in home IV ICI administration vs. SC ICI administration at the infusion center.
Time Frame: At Baseline through study completion, up to 1 year.
Outcome data will be collected using a questionnaire per study protocol. A Likert scale rating system of Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree will be used. Summaries of data will be descriptive and standard statistical methods (median) will be used to present the results. Pearson's chi-square test, the Mantel-Haenszel test (or corresponding exact tests, if resulting expected numbers are small) will be used; the resulting p-value will be used as an indication of strength of an observed association.
At Baseline through study completion, up to 1 year.
Transportation and social barriers to obtaining Intravenous (IV) Immune Checkpoint Inhibitor (ICI) therapy.
Time Frame: At Baseline through study completion, up to 1 year.
Outcome data will be collected using a questionnaire consisting of 7 questions. The proportion of participants who select each possible category will be reported. The proportions should add up to 1.0. Results will be summarized in 2-way contingency tables to display any associations between these transportation responses. The Mantel-Haenszel test will be used to estimate the strength of the associations in each contingency table.
At Baseline through study completion, up to 1 year.
Quality of life while on Immune Checkpoint Inhibitor (ICI) therapy
Time Frame: At Baseline through study completion, up to 1 year.
Patient-Reported Outcomes Measurement Information System (PROMIS-29 v2.1) will be used. This is a standardized, self-report questionnaire with 29 items measuring core health areas like physical function, pain (interference & intensity), anxiety, depression, fatigue, sleep, and social participation, providing T-scores (mean 50, SD 10) for consistent comparison, used to capture patient-reported quality of life.
At Baseline through study completion, up to 1 year.
Duration of ICI therapy
Time Frame: Through study completion, up to 1 year.
Collected from the medical record and will be calculated using the start and end dates.
Through study completion, up to 1 year.
Reason for Discontinuation of ICI therapy.
Time Frame: Through study completion, up to 1 year.
Collected from the medical record.
Through study completion, up to 1 year.

Collaborators and Investigators

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

Sponsor

University of Southern California

Collaborators

Bristol-Myers Squibb
National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Robert Hsu, University of Southern California

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)

March 12, 2026

Primary Completion (Estimated)

March 12, 2027

Study Completion (Estimated)

March 12, 2028

Study Registration Dates

First Submitted

December 23, 2025

First Submitted That Met QC Criteria

January 12, 2026

First Posted (Actual)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2N-25-8 (Other Identifier: USC / Norris Comprehensive Cancer Center)
  • P30CA014089 (U.S. NIH Grant/Contract)
  • NCI-2025-09218 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • HS-25-00563

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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