Non-small Cell Lung Cancer (NSCLC)NCT07215962
Long-Term Safety Outcomes and First-Line Treatment Patterns in Patients With Non-Small Cell Lung Cancer and Programmed Death-1 (Pd-L1) <1%
An observational study of Non-small Cell Lung Cancer (NSCLC), run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to assess the treatment-related adverse events and associated healthcare resource use in programmed death ligand 1 (PD-L1) negative individuals diagnosed with advanced/metastatic non-small cell lung cancer (NSCLC) who received first-line therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- Nivolumab + ipilimumab, Nivolumab + ipilimumab + platinum-based chemotherapy and Immuno-oncology-based therapy (excluding nivolumab-based regimens) with chemotherapy
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2024to 1 Jul 2025
- 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: The study population will comprise of programmed death ligand 1 (PD-L1) negative individuals diagnosed with advanced/metastatic non-small cell lung cancer (NSCLC) who received first-line therapy in routine clinical practice at the Florida Cancer Specialists and Research Institute
Who may be able to join
- Are ≥ 18 years of age at the index date
- Have a confirmed diagnosis of advanced/metastatic non-small cell lung cancer (NSCLC) (stage IIIB-IV) (squamous and non-squamous)
- Have PD-L1< 1% level as reported
- Received one of the following 1L treatments:
- Cohort 1: nivolumab + ipilimumab
- Cohort 2: nivolumab + ipilimumab + platinum-based chemotherapy
Show all 9Show fewer
- Cohort 3: Immuno-oncology (IO)-based therapy (excluding nivolumab-based regimens) with chemotherapy
- Cohort 4: Dual-IO with chemotherapy (eg. tremelimumab-actl + durvalumab + carboplatin + albumin-bound paclitaxel, tremelimumab-actl + durvalumab + [carboplatin or cisplatin] + gemcitabine, tremelimumab-actl + durvalumab + carboplatin + albumin-bound paclitaxel, tremelimumab-actl + durvalumab + [carboplatin or cisplatin] + pemetrexed)
- Have ≥ 6 months of documented post-index (follow-up) period after the index date - Participants who die within 6 months of follow-up will be included
Who cannot join
- Have positive or unknown EGFR or ALK mutation before the index date
- Have a gap of > 120 days between metastatic NSCLC diagnosis and index date
- Were included in a clinical trial for 1L therapy
- Enter a hospice within 6 months of the follow-up will be excluded
- Have other concurrent primary cancer diagnoses
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida Cancer Specialists & Research Institute
Fleming Island, Florida, 32003
About this study
Official title: Real-World Long-Term Safety Outcomes and First-Line Treatment Patterns in Patients With Non-Small Cell Lung Cancer and Pd-L1 <1% in the Florida Cancer Specialists & Research Institute Database
The purpose of this study is to assess the treatment-related adverse events and associated healthcare resource use in programmed death ligand 1 (PD-L1) negative individuals diagnosed with advanced/metastatic non-small cell lung cancer (NSCLC) who received first-line therapy
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Being tested
- Nivolumab + ipilimumab, Nivolumab + ipilimumab + platinum-based chemotherapy, Immuno-oncology-based therapy (excluding nivolumab-based regimens) with chemotherapy, Other dual-immuno-oncology therapy with chemotherapy
- 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.
Nivolumab + ipilimumabBiological
According to the product label
Nivolumab + ipilimumab + platinum-based chemotherapyBiological
According to the product label
Immuno-oncology-based therapy (excluding nivolumab-based regimens) with chemotherapyBiological
According to the product label
Other dual-immuno-oncology therapy with chemotherapyBiological
According to the product label
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Participants receiving nivolumab + ipilimumab treatment Receives: Biological: Nivolumab + ipilimumab | |
| Cohort 2 | Participants receiving nivolumab + ipilimumab + platinum-based chemotherapy Receives: Biological: Nivolumab + ipilimumab + platinum-based chemotherapy | |
| Cohort 3 | Participants receiving immuno-oncology therapy (excl nivolumab) with chemotherapy treatment Receives: Biological: Immuno-oncology-based therapy (excluding nivolumab-based regimens) with chemotherapy | |
| Cohort 4 | Participants receiving other dual-IO with chemotherapy Receives: Biological: Other dual-immuno-oncology therapy with chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-related adverse events
Measured: Baseline
Participant baseline clinical characteristics
Measured: Baseline
Time to onset of treatment-related adverse events
Measured: Up to 8 years
Number of treatment-related adverse events resolved
Measured: Up to 8 years
Number of participants receiving treatment for treatment-related adverse events by drug class
Measured: Up to 8 years
Number of participants that discontinued immune-oncology therapy due to treatment-related adverse events
Measured: Up to 8 years
Secondary outcomes (1)
Healthcare Resource Utilization (HCRU) associated with treatment-related adverse event
Measured: Up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2025
- Study start22 Nov 2024
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
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 Cancer (NSCLC)Studies 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
- 300 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
- NCT07215962
- Sponsor's protocol ID
- CA209-1542
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Long-Term Safety Outcomes and First-Line Treatment Patterns in Patients With Non-Small Cell Lung Cancer and Pd-L1 <1% in the Florida Cancer Specialists & Research Institute Database
- ClinicalTrials.gov ID
- NCT07215962
- Acronym / sponsor ID
- CA209-1542
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 14 Oct 2025 (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.
The purpose of this study is to assess the treatment-related adverse events and associated healthcare resource use in programmed death ligand 1 (PD-L1) negative individuals diagnosed with advanced/metastatic non-small cell lung cancer (NSCLC) who received first-line therapy
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Biological: Nivolumab + ipilimumabParticipants receiving nivolumab + ipilimumab treatment |
| Cohort 2 | – | Biological: Nivolumab + ipilimumab + platinum-based chemotherapyParticipants receiving nivolumab + ipilimumab + platinum-based chemotherapy |
| Cohort 3 | – | Biological: Immuno-oncology-based therapy (excluding nivolumab-based regimens) with chemotherapyParticipants receiving immuno-oncology therapy (excl nivolumab) with chemotherapy treatment |
| Cohort 4 | – | Biological: Other dual-immuno-oncology therapy with chemotherapyParticipants receiving other dual-IO with chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will comprise of programmed death ligand 1 (PD-L1) negative individuals diagnosed with advanced/metastatic non-small cell lung cancer (NSCLC) who received first-line therapy in routine clinical practice at the Florida Cancer Specialists and Research Institute
Key inclusion criteria (9 listed)
- Are ≥ 18 years of age at the index date
- Have a confirmed diagnosis of advanced/metastatic non-small cell lung cancer (NSCLC) (stage IIIB-IV) (squamous and non-squamous)
- Have PD-L1< 1% level as reported
- Received one of the following 1L treatments:
- Have ≥ 6 months of documented post-index (follow-up) period after the index date - Participants who die within 6 months of follow-up will be included
Key exclusion criteria (5 listed)
- Have positive or unknown EGFR or ALK mutation before the index date
- Have a gap of > 120 days between metastatic NSCLC diagnosis and index date
- Were included in a clinical trial for 1L therapy
- Enter a hospice within 6 months of the follow-up will be excluded
- Have other concurrent primary cancer diagnoses
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 |
|---|---|---|
| Nivolumab + ipilimumabAccording to the product label | Biological | Cohort 1 |
| Nivolumab + ipilimumab + platinum-based chemotherapyAccording to the product label | Biological | Cohort 2 |
| Immuno-oncology-based therapy (excluding nivolumab-based regimens) with chemotherapyAccording to the product label | Biological | Cohort 3 |
| Other dual-immuno-oncology therapy with chemotherapyAccording to the product label | Biological | Cohort 4 |
Primary outcome
Incidence of treatment-related adverse events
Time frame: Baseline
Participant baseline clinical characteristics
Time frame: Baseline
Time to onset of treatment-related adverse events
Time frame: Up to 8 years
Number of treatment-related adverse events resolved
Time frame: Up to 8 years
Number of participants receiving treatment for treatment-related adverse events by drug class
Time frame: Up to 8 years
Number of participants that discontinued immune-oncology therapy due to treatment-related adverse events
Time frame: Up to 8 years
1 secondary outcome
Healthcare Resource Utilization (HCRU) associated with treatment-related adverse event
Time frame: Up to 8 years
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 2 Nov 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 (NSCLC), run by Bristol-Myers Squibb at 1 site in United States.
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 9 inclusion and 5 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 2 Nov 2026. 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 United States. 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?
Incidence of treatment-related adverse events (time frame: Baseline). The study lists 6 primary outcomes in all. 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 2 Nov 2026.