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CompletedNCT03804554Updated May 27, 2022

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

An observational study in Non-Small Cell Lung Cancer, sponsored by Bristol-Myers Squibb. Completed at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-27.

Sponsored by Bristol-Myers Squibb · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
503
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Non-Small Cell Lung Cancer
03

In context

Carcinoma, Non-Small-Cell Lung

6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.

This study's enrollment of 503 is above the median of 164 across 974 observational studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,562 studies on the registry; 118 are open to participants now.

Of its 435 completed or terminated interventional studies of FDA-regulated products, 227 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Insufficient data available

Other protocol defined inclusion/exclusion criteria could apply

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
503 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients taking nivolumab

    Other: Non-Interventional

Interventions

  • OtherNon-Interventional

    Non-Interventional

06

What researchers measure

Primary outcomes

  1. Time to treatment failure (TTF)

    Time frame: Approximately 27 months

Secondary outcomes

  1. Best overall response (BOR)

    Time frame: Approximately 27 months

  2. Progression free survival rate (PFSR)

    Time frame: Approximately 27 months

  3. Overall survival rate (OSR)

    Time frame: Approximately 27 months

  4. Incidence of AE's

    Time frame: Approximately 27 months

  5. Incidence of SAE's

    Time frame: Approximately 27 months

  6. Reasons for ceasing treatment

    Any of the following: progressive disease, toxicity, patient wishes/preference, doctor decision, death

    Time frame: Approximately 27 months

  7. Incidence of patients with brain metastases

    Time frame: Approximately 27 months

  8. Incidence of re-treatment

    Time frame: Approximately 27 months

07

Study locations

1 site
  • Local Institution
    Heidelburg, Victoria 3084, Australia
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03804554
Responsible party
Sponsor
First posted
Jan 15, 2019
Start date
Oct 3, 2018
Primary completion
Aug 12, 2021
Completion
Aug 12, 2021
Last update
May 27, 2022

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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