Lung Non-Small Cell CarcinomaNCT07339254
Experiences w/ & Attitudes Towards Immune Chckpt Inhibitors in NSCLC Patients Single Center Survey Based Study
An observational study of Lung Non-Small Cell Carcinoma, run by University of Southern California at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Non-Small Cell Carcinoma
- What is being tested?
- Non-Interventional Study
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Mar 2026to 12 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with non-small cell lung cancer, currently receiving Atezolizumab, Cemiplimab, Durvalumab, Nivolumab, or Pembrolizumab.
Who may be able to join
- * 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.
Who cannot join
- * Patients is unable to consent for themselves
- * Patient has not yet completed the 1st cycle of ICI-based therapy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Los Angeles General Medical Center
Los Angeles, California, 90033
Sandy Tran, 323-865-3000, sandy.tran@med.usc.edu
Robert Hsu
- Recruiting
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Sandy Tran, 323-865-3000, sandy.tran@med.usc.edu
Robert Hsu
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Lung Non-Small Cell Carcinoma
- Being tested
- Non-Interventional Study
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Also called Non-Interventional Observational Study, Noninterventional (Observational) Study
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational | Patients complete surveys on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strength of patient perception of Intravenous (IV) Immune Checkpoint Inhibitor (ICI) therapy
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.
Measured: At Baseline through study completion, up to 1 year.
Patient interest in home SC ICI administration vs. IV ICI administration at the infusion center
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).
Measured: At Baseline through study completion, up to 1 year.
Secondary outcomes (6)
Strength of patient perception of Subcutaneous (SC) Immune Checkpoint Inhibitor (ICI) therapy.
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.
Measured: 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.
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.
Measured: At Baseline through study completion, up to 1 year.
Transportation and social barriers to obtaining Intravenous (IV) Immune Checkpoint Inhibitor (ICI) therapy.
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.
Measured: At Baseline through study completion, up to 1 year.
Quality of life while on Immune Checkpoint Inhibitor (ICI) therapy
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.
Measured: At Baseline through study completion, up to 1 year.
Duration of ICI therapy
Collected from the medical record and will be calculated using the start and end dates.
Measured: Through study completion, up to 1 year.
Reason for Discontinuation of ICI therapy.
Collected from the medical record.
Measured: Through study completion, up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start12 Mar 2026
- Primary completion12 Mar 2027 (estimated)
- Study completion12 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Non-Small Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Robert Hsu, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07339254
- Sponsor's protocol ID
- 2N-25-8
- Other IDs
- NCI-2025-09218, HS-25-00563, 2N-25-8, P30CA014089
- Status last verified
- Mar 2026
- First submitted
- 23 Dec 2025
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experiences With and Attitudes Towards Immune Checkpoint Inhibitors in Patients With Non-Small Cell Lung Cancer (NSCLC) - A Single Center, Survey-Based Study
- ClinicalTrials.gov ID
- NCT07339254
- Acronym / sponsor ID
- 2N-25-8
- Conditions
- Lung Non-Small Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Bristol-Myers Squibb
- Study start
- 12 Mar 2026 (actual)
- Primary completion
- 12 Mar 2027 (estimated)
- Study completion
- 12 Mar 2028 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyPatients complete surveys on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-small cell lung cancer, currently receiving Atezolizumab, Cemiplimab, Durvalumab, Nivolumab, or Pembrolizumab.
Key inclusion criteria (4 listed)
- * 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.
Key exclusion criteria (2 listed)
- * Patients is unable to consent for themselves
- * Patient has not yet completed the 1st cycle of ICI-based therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyAlso: Non-Interventional Observational Study, Noninterventional (Observational) StudyNon-interventional study | Other | Observational |
Primary outcome
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.
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).
6 secondary outcomes
Strength of patient perception of Subcutaneous (SC) Immune Checkpoint Inhibitor (ICI) therapy.
Time frame: 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.
Transportation and social barriers to obtaining Intravenous (IV) Immune Checkpoint Inhibitor (ICI) therapy.
Time frame: 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.
Duration of ICI therapy
Time frame: Through study completion, up to 1 year.
Reason for Discontinuation of ICI therapy.
Time frame: Through study completion, up to 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
USC / Norris Comprehensive Cancer Center
Los Angeles, United States
Robert Hsu principal investigator
University of Southern California
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Non-Small Cell Carcinoma, run by University of Southern California at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strength of patient perception of Intravenous (IV) Immune Checkpoint Inhibitor (ICI) therapy (time frame: At Baseline through study completion, up to 1 year.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.