Non-Small Cell Lung CancerNCT03804554
A Study of Participants in Australia Who Have Non-small Cell Lung Cancer Being Treated With Nivolumab
An observational study of Non-Small Cell Lung Cancer, run by Bristol-Myers Squibb at 1 site in Australia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Non-Interventional
- How many people
- 503 participants
- Where
- 1 siteAustralia
- Study dates
- 3 Oct 2018to 12 Aug 2021
- 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: Previously-treated advanced NSCLC patients commencing treatment with nivolumab between May 2015 and August 2017 under the Australian Patient Access Program
Who may be able to join
- 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
Who cannot join
- Insufficient data available
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nivolumab in the Treatment of Patients With Non-small Cell Lung Cancer: The Australian Experience
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
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Non-Interventional
- 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.
Non-InterventionalOther
Non-Interventional
| Study group | Role | What they receive |
|---|---|---|
| Patients taking nivolumab | Not described Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to treatment failure (TTF)
Measured: Approximately 27 months
Secondary outcomes (8)
Best overall response (BOR)
Measured: Approximately 27 months
Progression free survival rate (PFSR)
Measured: Approximately 27 months
Overall survival rate (OSR)
Measured: Approximately 27 months
Incidence of AE's
Measured: Approximately 27 months
Incidence of SAE's
Measured: Approximately 27 months
Reasons for ceasing treatment
Any of the following: progressive disease, toxicity, patient wishes/preference, doctor decision, death
Measured: Approximately 27 months
Incidence of patients with brain metastases
Measured: Approximately 27 months
Incidence of re-treatment
Measured: Approximately 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start3 Oct 2018
- Primary completion12 Aug 2021
- Study completion12 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies 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
- Retrospective
- Enrolment
- 503 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
- NCT03804554
- Sponsor's protocol ID
- CA209-8MH
- Status last verified
- May 2022
- First submitted
- 12 Nov 2018
- Last updated
- 27 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nivolumab in the Treatment of Patients With Non-small Cell Lung Cancer: The Australian Experience
- ClinicalTrials.gov ID
- NCT03804554
- Acronym / sponsor ID
- CA209-8MH
- Conditions
- Non-Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 503 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2018 (actual)
- Primary completion
- 12 Aug 2021 (actual)
- Study completion
- 12 Aug 2021 (actual)
- First posted
- 15 Jan 2019 (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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients taking nivolumab | – | Other: Non-Interventional |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Previously-treated advanced NSCLC patients commencing treatment with nivolumab between May 2015 and August 2017 under the Australian Patient Access Program
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Insufficient data available
- Other protocol defined inclusion/exclusion criteria could apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-InterventionalNon-Interventional | Other | Patients taking nivolumab |
Primary outcome
Time to treatment failure (TTF)
Time frame: Approximately 27 months
8 secondary outcomes
Best overall response (BOR)
Time frame: Approximately 27 months
Progression free survival rate (PFSR)
Time frame: Approximately 27 months
Overall survival rate (OSR)
Time frame: Approximately 27 months
Incidence of AE's
Time frame: Approximately 27 months
Incidence of SAE's
Time frame: Approximately 27 months
Reasons for ceasing treatment
Time frame: Approximately 27 months
Incidence of patients with brain metastases
Time frame: Approximately 27 months
Incidence of re-treatment
Time frame: Approximately 27 months
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 27 May 2022.
- BMS Clinical Trial InformationLink 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 Non-Small Cell Lung Cancer, run by Bristol-Myers Squibb at 1 site in Australia.
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 27 May 2022. 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 Australia. 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?
Time to treatment failure (TTF) (time frame: Approximately 27 months). 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 27 May 2022.