NCT03804554

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
503

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 3, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 12, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 15, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2021

Completed
Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

2.9 years

First QC Date

November 12, 2018

Last Update Submit

May 25, 2022

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Time to treatment failure (TTF)

    Approximately 27 months

Secondary Outcomes (8)

  • Best overall response (BOR)

    Approximately 27 months

  • Progression free survival rate (PFSR)

    Approximately 27 months

  • Overall survival rate (OSR)

    Approximately 27 months

  • Incidence of AE's

    Approximately 27 months

  • Incidence of SAE's

    Approximately 27 months

  • +3 more secondary outcomes

Study Arms (1)

Patients taking nivolumab

Other: Non-Interventional

Interventions

Non-InterventionalOTHER

Non-Interventional

Patients taking nivolumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Insufficient data available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Heidelburg, Victoria, 3084, Australia

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2018

First Posted

January 15, 2019

Study Start

October 3, 2018

Primary Completion

August 12, 2021

Study Completion

August 12, 2021

Last Updated

May 27, 2022

Record last verified: 2022-05

Locations

AU(1)