Metastatic Non-small Cell Lung CancerNCT07024862
Long-term Outcomes Among Patients With Programmed Death-ligand 1 <1% Metastatic Non-small Cell Lung Cancer Treated With First-line Nivolumab + Ipilimumab + 2 Cycles of Chemotherapy
An observational study of Metastatic Non-small Cell Lung Cancer, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The study will assess the long-term real-world outcomes among adults diagnosed with programmed death-ligand 1 (PD-L1) <1% metastatic non-small cell lung cancer (mNSCLC) treated with first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy (NIC) in the US Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Non-small Cell Lung Cancer
- What is being tested?
- nivolumab + ipilimumab
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2024to 30 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 include adults diagnosed with programmed death-ligand 1 (PD-L1) <1% metastatic non-small cell lung cancer (NSCLC) and treated with 1L combination nivolumab, ipilimumab, and 2 cycles of platinum-doublet chemotherapy (NIC) in the US community oncology setting
Who may be able to join
- At least 18 years old at confirmed diagnosis with metastatic non-small cell lung cancer (NSCLC) (stage IV), squamous or non-squamous histology
- Initiated first-line (1L) combination nivolumab, ipilimumab, and 2 cycles of platinum-doublet chemotherapy (NIC) regimen between 01 January 2018 and 2 years prior to study launch
- Tumor programmed death-ligand 1 (PD-L1) negative expression (i.e., PD-L1 <1%)
- No EGFR, ALK, or ROS1 genetic mutation (i.e., wild type)
- Minimum of 6 months of follow-up after initiation of 1L NIC*
Who cannot join
- Any prior systemic therapy for metastatic non-small cell lung cancer (NSCLC)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-Term Real-World Outcomes Among Patients With Programmed Death-Ligand 1 (PD-L1) <1% Metastatic Non-Small Cell Lung Cancer (mNSCLC) Treated With First-Line (1l) Nivolumab + Ipilimumab + 2 Cycles Of Chemotherapy (NIC)
The study will assess the long-term real-world outcomes among adults diagnosed with programmed death-ligand 1 (PD-L1) <1% metastatic non-small cell lung cancer (mNSCLC) treated with first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy (NIC) in the US
- Conditions
- Metastatic Non-small Cell Lung Cancer
- Being tested
- nivolumab + ipilimumab
- Keywords
- Metastatic non-small cell lung cancer
- 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
First-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy (NIC)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Adults diagnosed with programmed death-ligand 1 (PD-L1) <1% metastatic non-small cell lung cancer (mNSCLC) treated with first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy (NIC) in the US Receives: Biological: nivolumab + ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant baseline socio-demographics
Measured: Baseline
Participant baseline clinical characteristics
Measured: Baseline
Participant treatment history
Measured: Baseline
Treatment start and stop dates
Measured: Up to 6-months
Reasons for 1L treatment selection
Measured: Day 1
Initial 1L NIC treatment dose received
NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy
Measured: Day 1
Type of chemotherapy received as part of NIC treatment
NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy
Measured: Day 1
Participant NIC treatment chemotherapy schedule
NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy
Measured: Day 1
Number of NIC treatment interruptions
NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy
Measured: Up to 6-months
Date(s) of NIC treatment interruptions
NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy
Measured: Up to 6-months
Reasons for NIC treatment interruptions
NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy
Measured: Up to 6-months
Length of NIC treatment delay/interruption
NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy
Measured: Up to 6-months
Reasons for NIC treatment discontinuation
NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy
Measured: Up to 6-months
Type of 2L treatment received
Measured: Up to 6-months
Reasons for not initiating 2L treatment
Measured: Up to 6-months
Start and stop dates of 2L treatment initiation
Measured: Up to 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start24 Oct 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol Myers Squibb Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024862
- Sponsor's protocol ID
- CA209-1496
- Status last verified
- Jun 2025
- First submitted
- 9 Jun 2025
- Last updated
- 17 Jun 2025
- Results posted
- 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 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Real-World Outcomes Among Patients With Programmed Death-Ligand 1 (PD-L1) <1% Metastatic Non-Small Cell Lung Cancer (mNSCLC) Treated With First-Line (1l) Nivolumab + Ipilimumab + 2 Cycles Of Chemotherapy (NIC)
- ClinicalTrials.gov ID
- NCT07024862
- Acronym / sponsor ID
- CA209-1496
- Conditions
- Metastatic Non-small Cell Lung Cancer
- Keywords
- Metastatic non-small cell lung cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 17 Jun 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 study will assess the long-term real-world outcomes among adults diagnosed with programmed death-ligand 1 (PD-L1) <1% metastatic non-small cell lung cancer (mNSCLC) treated with first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy (NIC) in the US
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Biological: nivolumab + ipilimumabAdults diagnosed with programmed death-ligand 1 (PD-L1) <1% metastatic non-small cell lung cancer (mNSCLC) treated with first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy (NIC) in the US |
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 include adults diagnosed with programmed death-ligand 1 (PD-L1) <1% metastatic non-small cell lung cancer (NSCLC) and treated with 1L combination nivolumab, ipilimumab, and 2 cycles of platinum-doublet chemotherapy (NIC) in the US community oncology setting
Key inclusion criteria (5 listed)
- At least 18 years old at confirmed diagnosis with metastatic non-small cell lung cancer (NSCLC) (stage IV), squamous or non-squamous histology
- Initiated first-line (1L) combination nivolumab, ipilimumab, and 2 cycles of platinum-doublet chemotherapy (NIC) regimen between 01 January 2018 and 2 years prior to study launch
- Tumor programmed death-ligand 1 (PD-L1) negative expression (i.e., PD-L1 <1%)
- No EGFR, ALK, or ROS1 genetic mutation (i.e., wild type)
- Minimum of 6 months of follow-up after initiation of 1L NIC*
Key exclusion criteria (1 listed)
- Any prior systemic therapy for metastatic non-small cell lung cancer (NSCLC)
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 + ipilimumabFirst-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy (NIC) | Biological | Cohort 1 |
Primary outcome
Participant baseline socio-demographics
Time frame: Baseline
Participant baseline clinical characteristics
Time frame: Baseline
Participant treatment history
Time frame: Baseline
Treatment start and stop dates
Time frame: Up to 6-months
Reasons for 1L treatment selection
Time frame: Day 1
Initial 1L NIC treatment dose received
Time frame: Day 1
NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy
Type of chemotherapy received as part of NIC treatment
Time frame: Day 1
NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy
Participant NIC treatment chemotherapy schedule
Time frame: Day 1
NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy
Number of NIC treatment interruptions
Time frame: Up to 6-months
NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy
Date(s) of NIC treatment interruptions
Time frame: Up to 6-months
NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy
Reasons for NIC treatment interruptions
Time frame: Up to 6-months
NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy
Length of NIC treatment delay/interruption
Time frame: Up to 6-months
NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy
Reasons for NIC treatment discontinuation
Time frame: Up to 6-months
NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy
Type of 2L treatment received
Time frame: Up to 6-months
Reasons for not initiating 2L treatment
Time frame: Up to 6-months
Start and stop dates of 2L treatment initiation
Time frame: Up to 6-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- 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 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 Metastatic Non-small Cell Lung Cancer, 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 5 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Participant baseline socio-demographics (time frame: Baseline). The study lists 16 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 17 Jun 2025.