A Study of Participants in Australia Who Have Non-small C... | NCT03804554

Studies
A Study of Participants in Australia Who Have Non-small Cell Lung Cancer Being Treated With Nivolumab

NCT03804554

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

May 27, 2022Actual

Enrollment

503Actual

Phase

Not provided

Conditions

Non-Small Cell Lung Cancer

Interventions

Non-Interventional

Countries

Australia

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

May 2022

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

Oct 3, 2018Actual

Primary Completion Date

Aug 12, 2021Actual

Completion Date

Aug 12, 2021Actual

First Submitted Date

Nov 12, 2018

First Submission Date that Met QC Criteria

Jan 14, 2019

First Posted Date

Jan 15, 2019Actual

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

May 25, 2022

Last Update Posted Date

May 27, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is to capture and describe the patient and disease characteristics and the outcomes of adult patients with previously-treated advanced NSCLC who have been treated with Nivolumab

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

503Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients taking nivolumab			Other: Non-Interventional

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-Interventional	Other	Non-Interventional	Patients taking nivolumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to treatment failure (TTF)		Approximately 27 months

Secondary Outcomes

Measure	Description	Time Frame
Best overall response (BOR)		Approximately 27 months
Progression free survival rate (PFSR)		Approximately 27 months
Overall survival rate (OSR)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Adult male or female (≥18 years of age) patients with NSCLC
Treated with nivolumab on the Australian PAP
Initiated Nivolumab between May 2015 and August 2017
Attending clinician agreeable to provide patient data
Local institutional ethics requirements satisfied

Exclusion Criteria:

Insufficient data available

Other protocol defined inclusion/exclusion criteria could 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

Previously-treated advanced NSCLC patients commencing treatment with nivolumab between May 2015 and August 2017 under the Australian Patient Access Program

Sampling Method

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
Local Institution		Heidelburg	Victoria	3084	Australia

References Module

Citations

Not provided

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

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