Non-small Cell Lung Cancer (NSCLC)FINNNCT06487156
A Study to Evaluate First-line Ipilimumab + Nivolumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
An observational study of Non-small Cell Lung Cancer (NSCLC), run by Bristol-Myers Squibb at 1 site in Italy.
Trial summary
The purpose of this study is to collect and evaluate real-world data to describe the outcomes, patient characteristics, safety profile and treatment patterns of first-line nivolumab plus ipilimumab treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) in Italy 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
- How many people
- 404 participants
- Where
- 1 siteItaly
- Study dates
- 11 Oct 2023to 11 Oct 2030
- 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: Adult patients diagnosed with locally advanced or metastatic non-small cell lung cancer treated with nivolumab plus ipilimumab as first-line treatment
Who may be able to join
- Diagnosis of stage IV or recurrent NSCLC (histologically or cytologically confirmed stage), without known EGFR- or ALK-alterations
- Decision to initiate a first-line treatment with nivolumab plus ipilimumab for the treatment of NSCLC according to the Italy label has been made independently of the study
- Patient is at least 18 years of age at time of treatment decision
- Patient provided written informed consent to participate in the study
Who cannot join
- Current primary diagnosis of a cancer other than NSCLC that requires systemic or other treatment
- Patients with known EGFR- or ALK-alterations
- Previous treatment with nivolumab and/or ipilimumab
- Patient already included in an interventional clinical trial for their advanced or recurrent NSCLC (but: Patients who have completed their participation in an interventional trial, who are not receiving study drug any more, and who are only followed-up for OS, can be enrolled)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: FINN (First-line Ipilimumab + Nivolumab in NSCLC): An Italy, Nationwide, Prospective, Observational, Multicenter Study in Patients With First-line Nivolumab Plus Ipilimumab Therapy for Locally Advanced or Metastatic Non-Small Cell Lung Cancer
The purpose of this study is to collect and evaluate real-world data to describe the outcomes, patient characteristics, safety profile and treatment patterns of first-line nivolumab plus ipilimumab treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) in Italy
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Being tested
- Nivolumab + ipilimumab
- Keywords
- Non-small cell lung cancer (NSCLC)
- 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 + ipilimumabDrug
As per product label
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving first-line nivolumab plus ipilimumab | Not described Receives: Drug: Nivolumab + ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Measured: Up to 5 years
Secondary outcomes (15)
Progression-free survival (PFS)
Measured: Up to 5 years
Overall response rate (ORR)
Measured: Up to 5 years
Best overall response (BOR)
Measured: Up to 5 years
Best overall response rate (BORR)
Measured: Up to 5 years
Tumor response to treatment as classified by the treating physician and Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Measured: Up to 5 years
Duration of response (DOR)
Measured: Up to 5 years
Time to response (TTR)
Measured: Up to 5 years
European Quality of Life-5 Dimensions (EQ-5D) Score
Measured: Baseline and up to 5 years
Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) results
Measured: Baseline and up to 5 years
Treatment regimen
Measured: Up to 5 years
Stage IV or recurrent, not previously treated, squamous and non-squamous NSCLC as confirmed by histology and/or cytology test results
Measured: Baseline
Number of participants discontinuing treatment
Measured: Up to 5 years
Management of Adverse Events (AEs)
Measured: Up to 5 years
Participant socio-demographic characteristics
Measured: Baseline and up to 5 years
Participant clinical characteristics
Measured: Baseline and up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start11 Oct 2023
- Primary completion11 Oct 2030 (estimated)
- Study completion11 Oct 2030 (estimated)
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
- Prospective
- Enrolment
- 404 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
- NCT06487156
- Sponsor's protocol ID
- CA209-1409
- Acronym
- FINN
- Status last verified
- Jan 2026
- First submitted
- 6 Jun 2024
- Last updated
- 27 Jan 2026
- 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 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FINN (First-line Ipilimumab + Nivolumab in NSCLC): An Italy, Nationwide, Prospective, Observational, Multicenter Study in Patients With First-line Nivolumab Plus Ipilimumab Therapy for Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06487156
- Acronym / sponsor ID
- FINN / CA209-1409
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Keywords
- Non-small cell lung cancer (NSCLC)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 404 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- 11 Oct 2030 (estimated)
- Study completion
- 11 Oct 2030 (estimated)
- First posted
- 5 Jul 2024 (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 collect and evaluate real-world data to describe the outcomes, patient characteristics, safety profile and treatment patterns of first-line nivolumab plus ipilimumab treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) in Italy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants receiving first-line nivolumab plus ipilimumab | – | Drug: Nivolumab + ipilimumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with locally advanced or metastatic non-small cell lung cancer treated with nivolumab plus ipilimumab as first-line treatment
Key inclusion criteria (4 listed)
- Diagnosis of stage IV or recurrent NSCLC (histologically or cytologically confirmed stage), without known EGFR- or ALK-alterations
- Decision to initiate a first-line treatment with nivolumab plus ipilimumab for the treatment of NSCLC according to the Italy label has been made independently of the study
- Patient is at least 18 years of age at time of treatment decision
- Patient provided written informed consent to participate in the study
Key exclusion criteria (4 listed)
- Current primary diagnosis of a cancer other than NSCLC that requires systemic or other treatment
- Patients with known EGFR- or ALK-alterations
- Previous treatment with nivolumab and/or ipilimumab
- Patient already included in an interventional clinical trial for their advanced or recurrent NSCLC (but: Patients who have completed their participation in an interventional trial, who are not receiving study drug any more, and who are only followed-up for OS, can be enrolled)
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 + ipilimumabAs per product label | Drug | Participants receiving first-line nivolumab plus ipilimumab |
Primary outcome
Overall survival (OS)
Time frame: Up to 5 years
15 secondary outcomes
Progression-free survival (PFS)
Time frame: Up to 5 years
Overall response rate (ORR)
Time frame: Up to 5 years
Best overall response (BOR)
Time frame: Up to 5 years
Best overall response rate (BORR)
Time frame: Up to 5 years
Tumor response to treatment as classified by the treating physician and Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Time frame: Up to 5 years
Duration of response (DOR)
Time frame: Up to 5 years
Time to response (TTR)
Time frame: Up to 5 years
European Quality of Life-5 Dimensions (EQ-5D) Score
Time frame: Baseline and up to 5 years
Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) results
Time frame: Baseline and up to 5 years
Treatment regimen
Time frame: Up to 5 years
Stage IV or recurrent, not previously treated, squamous and non-squamous NSCLC as confirmed by histology and/or cytology test results
Time frame: Baseline
Number of participants discontinuing treatment
Time frame: Up to 5 years
Management of Adverse Events (AEs)
Time frame: Up to 5 years
Participant socio-demographic characteristics
Time frame: Baseline and up to 5 years
Participant clinical characteristics
Time frame: Baseline and up to 5 years
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 27 Jan 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 Italy.
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 4 inclusion and 4 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 27 Jan 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 Italy. 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?
Overall survival (OS) (time frame: Up to 5 years). 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 Jan 2026.