Carcinoma, Non-Small-Cell LungNCT05250817
A Study of Preferences for the First-Line Treatment of Advanced/Metastatic Non-Small Cell Lung Cancer
An observational study of Carcinoma, Non-Small-Cell Lung, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this observational study is to determine participants' preferences for outcomes associated with first-line treatment of advanced/metastatic Non-Small Cell Lung Cancer (NSCLC) using a discrete-choice experiment (DCE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- How many people
- 501 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2021to 4 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: This observational study includes pretest interviews with 15 participants diagnosed with non-small cell lung cancer (NSCLC) and 15 participants selected from the general population following the study inclusion criteria. The final survey will be administered online to 150 participants with NSCLC and 500 participants from the general population.
Who may be able to join
- The following is the inclusion criteria for pretest interviews and final online survey.
- Participants:
- Must be 18 years of age or older
- Must be a US resident.
- Lung cancer participants with a physician diagnosis of NSCLC. Global Perspectives will be involved to suggest alternative strategies to a physician-confirmed diagnosis to ensure that actual cancer participants are recruited.
Who cannot join
- Not applicable
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
United States1 site
RTI Health Solutions
Research Triangle Park, North Carolina, 27709
About this study
Official title: Preferences for the First-Line Treatment of Advanced/Metastatic Non-Small Cell Lung Cancer
The purpose of this observational study is to determine participants' preferences for outcomes associated with first-line treatment of advanced/metastatic Non-Small Cell Lung Cancer (NSCLC) using a discrete-choice experiment (DCE).
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Preference, Advanced/Metastatic NSCLC, Discrete choice experiment (DCE)
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Participants with early stage and advanced/metastatic non-small cell lung cancer (NSCLC) | |
| Cohort 2 | Participants from the general population |
What is being measured
The primary outcome is the main question the study is designed to answer.
Set of relative preference weights for all attribute levels included in the Discrete Choice Experiment (DCE)
Measured: At Baseline
Respondents' baseline understanding of attribute descriptions
Measured: At Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start9 Dec 2021
- Primary completion4 Jan 2023
- Study completion4 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250817
- Sponsor's protocol ID
- CA209-69K
- Status last verified
- Jun 2023
- First submitted
- 11 Feb 2022
- Last updated
- 9 Jun 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preferences for the First-Line Treatment of Advanced/Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05250817
- Acronym / sponsor ID
- CA209-69K
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Preference, Advanced/Metastatic NSCLC, Discrete choice experiment (DCE)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 4 Jan 2023 (actual)
- Study completion
- 4 Jan 2023 (actual)
- First posted
- 22 Feb 2022 (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.
The purpose of this observational study is to determine participants' preferences for outcomes associated with first-line treatment of advanced/metastatic Non-Small Cell Lung Cancer (NSCLC) using a discrete-choice experiment (DCE).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Participants with early stage and advanced/metastatic non-small cell lung cancer (NSCLC) |
| Cohort 2 | – | –Participants from the general population |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This observational study includes pretest interviews with 15 participants diagnosed with non-small cell lung cancer (NSCLC) and 15 participants selected from the general population following the study inclusion criteria. The final survey will be administered online to 150 participants with NSCLC and 500 participants from the general population.
Key inclusion criteria (5 listed)
- The following is the inclusion criteria for pretest interviews and final online survey.
- Must be 18 years of age or older
- Must be a US resident.
- Lung cancer participants with a physician diagnosis of NSCLC. Global Perspectives will be involved to suggest alternative strategies to a physician-confirmed diagnosis to ensure that actual cancer participants are recruited.
Key exclusion criteria (2 listed)
- Not applicable
- Other protocol-defined inclusion/exclusion criteria apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Set of relative preference weights for all attribute levels included in the Discrete Choice Experiment (DCE)
Time frame: At Baseline
Respondents' baseline understanding of attribute descriptions
Time frame: At Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- BMS Clinical Trial InformationLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung, run by Bristol-Myers Squibb at 1 site 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 5 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: finished, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Set of relative preference weights for all attribute levels included in the Discrete Choice Experiment (DCE) (time frame: At Baseline). 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 9 Jun 2023.