Non-Small Cell Lung CancerNCT07526961
Real-World Outcomes of First-Line Nivolumab + Ipilimumab With Chemotherapy in Non-Small Cell Lung Cancer in Poland
An observational study of Non-Small Cell Lung Cancer, run by Bristol-Myers Squibb at 1 site in Poland.
Trial summary
This study will review medical records from hospitals in Poland to describe the demographics and baseline clinical characteristics of adults with advanced non-small cell lung cancer who received first-line nivolumab plus ipilimumab with chemotherapy in routine care between 01 January 2023 and 31 December 2023. 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?
- Nivolumab + Ipilimumab + Chemotherapy
- How many people
- 240 participants
- Where
- 1 sitePoland
- Study dates
- 1 Dec 2025to 20 Jan 2026
- 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: Adults with inoperable locally advanced or metastatic non-small cell lung cancer with programmed death-ligand 1 tumor proportion score <50% treated with first-line nivolumab plus ipilimumab plus chemotherapy in participating hospitals in Poland under the Polish Drug Program.
Who may be able to join
- Adults aged 18 years or older
- Prescribed first-line nivolumab plus ipilimumab plus chemotherapy for non-small cell lung cancer between 01 January 2023 and 31 December 2023 in the Polish Drug Program
- Diagnosis of inoperable locally advanced or metastatic non-small cell lung cancer with programmed death-ligand 1 tumor proportion score <50%
- Eastern Cooperative Oncology Group performance status 0 to 1
- At least one measurable lesion or a countable number of non-measurable lesions
- Absence of activating mutations in the epidermal growth factor receptor (EGFR) gene or rearrangements in the anaplastic lymphoma kinase (ALK) gene and ROS1 gene
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- Absence of comorbid conditions that were not adequately controlled with pharmacological therapy and that, in the opinion of the treating physician, could compromise the safe administration of the study treatment
- Absence of active autoimmune disease, except type 1 diabetes, hypothyroidism, psoriasis, or vitiligo
- Hematopoietic function allowing treatment according to the current Summary of Product Characteristics (SmPC)
- Absence of contraindications to nivolumab or ipilimumab according to the SmPC
- Treatment history and response available for chart abstraction from treatment initiation through death or study end in living patients
- Participants with central nervous system metastases may be included if they had no neurological symptoms, had at least stable disease after local treatment, and did not require chronic immunosuppressive doses of glucocorticoids
Who cannot join
- Participants will be excluded from analysis if any of the following criteria are met:
- Confirmed disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, unless treatment was continued following local ablative therapy in cases of oligoprogression (including central nervous system lesions).
- Clinically significant deterioration without radiological evidence of disease progression.
- Unacceptable or life-threatening toxicity, including any toxicity requiring treatment discontinuation as per the product's SmPC.
- Clinically relevant hypersensitivity to the study drug or its components.
- Decline in performance status to Eastern Cooperative Oncology Group (ECOG) grade 3 or 4.
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- Treatment interruption due to adverse events exceeding 12 weeks.
- Significant deterioration in quality of life, as documented in medical records.
- Withdrawal of consent for continued treatment or participation.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Wielkopolska Center of Pulmonology and Thoracic Surgery of Eugenia and Janusz Zeyland
Poznan
About this study
Official title: Retrospective Hospitals' Database Analysis to Evaluate Efficacy and Safety of Double Immunochemotherapy in First-Line Non-Small Cell Lung Cancer in Real Clinical Practice in Poland
This study will review medical records from hospitals in Poland to describe the demographics and baseline clinical characteristics of adults with advanced non-small cell lung cancer who received first-line nivolumab plus ipilimumab with chemotherapy in routine care between 01 January 2023 and 31 December 2023. The study will also describe treatment patterns and clinical outcomes, associated with immunotherapy.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Nivolumab + Ipilimumab + Chemotherapy
- Keywords
- Non-Small Cell Lung Cancer; NSCLC; nivolumab; ipilimumab; chemotherapy; Poland
- 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 + Ipilimumab + ChemotherapyCombination product
As per product label
| Study group | Role | What they receive |
|---|---|---|
| Overall Study Population | Adults with inoperable locally advanced or metastatic non-small cell lung cancer with programmed death-ligand 1 (PD-L1) tumor proportion score <50% who were prescribed first-line nivolumab plus ipilimumab plus chemotherapy in the Polish Drug Program between 01 January 2023 and 31 December 2023 at participating hospitals in Poland. Receives: Combination Product: Nivolumab + Ipilimumab + Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Second-line systemic anticancer treatment prescribed after progression/discontinuation of first-line therapy
Measured: Up to 26 months
Third-line systemic anticancer treatment prescribed after progression/discontinuation of second-line therapy
Measured: Up to 26 months
Overall Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: Up to 26 months
Disease Control Rate (DCR) Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: Up to 26 months
Progression-Free Survival (PFS)
Time from first-line treatment to documented disease progression or death from any cause, whichever occurs first.
Measured: Up to 26 months
Duration of Response (DOR) Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: Up to 26 months
Overall Survival (OS)
Time from initiation of first-line treatment to death from any cause.
Measured: Up to 26 months
Duration of Treatment
Duration of first-line treatment, defined as the time from the first dose to the last dose recorded in the medical record.
Measured: Up to 26 months
Secondary outcomes (4)
Participant tumor burden assessed by the number of metastatic sites
Measured: Baseline
Number of Participants with Central Nervous System Metastases
Measured: Baseline
Number of Participants with Liver Metastases
Measured: Baseline
Participant Neutrophil-to-Lymphocyte Ratio as Assessed by Standard peripheral Blood Count Analysis
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 Dec 2025
- Primary completion20 Jan 2026
- Study completion20 Jan 2026
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
- 240 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
- NCT07526961
- Sponsor's protocol ID
- CA209-1570
- Status last verified
- Mar 2026
- First submitted
- 8 Apr 2026
- Last updated
- 14 Apr 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 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Hospitals' Database Analysis to Evaluate Efficacy and Safety of Double Immunochemotherapy in First-Line Non-Small Cell Lung Cancer in Real Clinical Practice in Poland
- ClinicalTrials.gov ID
- NCT07526961
- Acronym / sponsor ID
- CA209-1570
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer; NSCLC; nivolumab; ipilimumab; chemotherapy; Poland
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 20 Jan 2026 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 14 Apr 2026 (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 will review medical records from hospitals in Poland to describe the demographics and baseline clinical characteristics of adults with advanced non-small cell lung cancer who received first-line nivolumab plus ipilimumab with chemotherapy in routine care between 01 January 2023 and 31 December 2023. The study will also describe treatment patterns and clinical outcomes, associated with immunotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overall Study Population | – | Combination Product: Nivolumab + Ipilimumab + ChemotherapyAdults with inoperable locally advanced or metastatic non-small cell lung cancer with programmed death-ligand 1 (PD-L1) tumor proportion score <50% who were prescribed first-line nivolumab plus ipilimumab plus chemotherapy in the Polish Drug Program between 01 January 2023 and 31 December 2023 at participating hospitals in Poland. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with inoperable locally advanced or metastatic non-small cell lung cancer with programmed death-ligand 1 tumor proportion score <50% treated with first-line nivolumab plus ipilimumab plus chemotherapy in participating hospitals in Poland under the Polish Drug Program.
Key inclusion criteria (12 listed)
- Adults aged 18 years or older
- Prescribed first-line nivolumab plus ipilimumab plus chemotherapy for non-small cell lung cancer between 01 January 2023 and 31 December 2023 in the Polish Drug Program
- Diagnosis of inoperable locally advanced or metastatic non-small cell lung cancer with programmed death-ligand 1 tumor proportion score <50%
- Eastern Cooperative Oncology Group performance status 0 to 1
- At least one measurable lesion or a countable number of non-measurable lesions
Key exclusion criteria (9 listed)
- Participants will be excluded from analysis if any of the following criteria are met:
- Confirmed disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, unless treatment was continued following local ablative therapy in cases of oligoprogression (including central nervous system lesions).
- Clinically significant deterioration without radiological evidence of disease progression.
- Unacceptable or life-threatening toxicity, including any toxicity requiring treatment discontinuation as per the product's SmPC.
- Clinically relevant hypersensitivity to the study drug or its components.
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 + Ipilimumab + ChemotherapyAs per product label | Combination product | Overall Study Population |
Primary outcome
Second-line systemic anticancer treatment prescribed after progression/discontinuation of first-line therapy
Time frame: Up to 26 months
Third-line systemic anticancer treatment prescribed after progression/discontinuation of second-line therapy
Time frame: Up to 26 months
Overall Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: Up to 26 months
Disease Control Rate (DCR) Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: Up to 26 months
Progression-Free Survival (PFS)
Time frame: Up to 26 months
Time from first-line treatment to documented disease progression or death from any cause, whichever occurs first.
Duration of Response (DOR) Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: Up to 26 months
Overall Survival (OS)
Time frame: Up to 26 months
Time from initiation of first-line treatment to death from any cause.
Duration of Treatment
Time frame: Up to 26 months
Duration of first-line treatment, defined as the time from the first dose to the last dose recorded in the medical record.
4 secondary outcomes
Participant tumor burden assessed by the number of metastatic sites
Time frame: Baseline
Number of Participants with Central Nervous System Metastases
Time frame: Baseline
Number of Participants with Liver Metastases
Time frame: Baseline
Participant Neutrophil-to-Lymphocyte Ratio as Assessed by Standard peripheral Blood Count Analysis
Time frame: Baseline
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 14 Apr 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, run by Bristol-Myers Squibb at 1 site in Poland.
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 12 inclusion and 9 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 14 Apr 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 Poland. 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?
Second-line systemic anticancer treatment prescribed after progression/discontinuation of first-line therapy (time frame: Up to 26 months). The study lists 8 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 14 Apr 2026.