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NCT Number: NCT07339254

Experiences w/ & Attitudes Towards Immune Chckpt Inhibitors in NSCLC Patients 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.

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Key information

Conditions

Lung Non-Small Cell Carcinoma Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Los Angeles General Medical Center, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Other names: Non-Interventional Observational Study, Noninterventional (Observational) Study

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Reason for Discontinuation of ICI therapy.

    Time frame: Through study completion, up to 1 year.

    Collected from the medical record.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • Bristol-Myers Squibb
  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 14, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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