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

NCT07526961 | Completed FDA Drug

• 1 other identifier: CA209-1570
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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. The study will also describe treatment patterns and clinical outcomes, associated with immunotherapy.

Conditions

Non-Small Cell Lung Cancer

Keywords

Non-Small Cell Lung Cancer; NSCLC; nivolumab; ipilimumab; chemotherapy; Poland

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (4)

• 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

Study Arms (1)

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

Interventions

Nivolumab + Ipilimumab + Chemotherapy COMBINATION_PRODUCT

As per product label

Overall Study Population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Wielkopolska Center of Pulmonology and Thoracic Surgery of Eugenia and Janusz Zeyland

Poznan, Poland

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Nivolumab; Ipilimumab; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 14, 2026
• Study Start: December 1, 2025
• Primary Completion: January 20, 2026
• Study Completion: January 20, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)