Real-World Outcomes of First-Line Nivolumab + Ipilimumab With Chemotherapy in Non-Small Cell Lung Cancer in Poland

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.

Study Overview

• Status: Completed
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Combination product: Nivolumab + Ipilimumab + Chemotherapy

• Study Type: Observational
• Enrollment (Actual): 240

Contacts and Locations

Study Locations

• Poland
  • Poznan, Poland
    • Wielkopolska Center of Pulmonology and Thoracic Surgery of Eugenia and Janusz Zeyland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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
• 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

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Combination product: Nivolumab + Ipilimumab + Chemotherapy; As per product label

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Second-line systemic anticancer treatment prescribed after progression/discontinuation of first-line therapy		Up to 26 months
Third-line systemic anticancer treatment prescribed after progression/discontinuation of second-line therapy		Up to 26 months
Overall Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.		Up to 26 months
Disease Control Rate (DCR) Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.		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.	Up to 26 months
Duration of Response (DOR) Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.		Up to 26 months
Overall Survival (OS)	Time from initiation of first-line treatment to death from any cause.	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.	Up to 26 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Participant tumor burden assessed by the number of metastatic sites	Baseline
Number of Participants with Central Nervous System Metastases	Baseline
Number of Participants with Liver Metastases	Baseline
Participant Neutrophil-to-Lymphocyte Ratio as Assessed by Standard peripheral Blood Count Analysis	Baseline

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Actual): January 20, 2026
• Study Completion (Actual): January 20, 2026

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Non-Small Cell Lung Cancer; NSCLC; nivolumab; ipilimumab; chemotherapy; Poland
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Amino Acids, Peptides, and Proteins; Proteins; Therapeutics; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Nivolumab; Ipilimumab; Drug Therapy
• Other Study ID Numbers: CA209-1570

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No