A Study of Preferences for the First-Line Treatment of Ad... | NCT05250817

Studies
A Study of Preferences for the First-Line Treatment of Advanced/Metastatic Non-Small Cell Lung Cancer

NCT05250817

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Jun 9, 2023Actual

Enrollment

501Actual

Phase

Not provided

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 9, 2021Actual

Primary Completion Date

Jan 4, 2023Actual

Completion Date

Jan 4, 2023Actual

First Submitted Date

Feb 11, 2022

First Submission Date that Met QC Criteria

Feb 11, 2022

First Posted Date

Feb 22, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2023

Last Update Posted Date

Jun 9, 2023Actual

Description Module

Brief 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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

501Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1		Participants with early stage and advanced/metastatic non-small cell lung cancer (NSCLC)
Cohort 2		Participants from the general population

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Set of relative preference weights for all attribute levels included in the Discrete Choice Experiment (DCE)		At Baseline
Respondents' baseline understanding of attribute descriptions		At Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Not applicable

Other protocol-defined inclusion/exclusion criteria apply

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
RTI Health Solutions		Research Triangle Park	North Carolina	27709	United States

References Module

Citations

Not provided

Label	URL
BMS Clinical Trial Information	View source
Investigator Inquiry Form	View source
FDA Safety Alerts and Recalls

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms