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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab + Ipilimumab + Chemotherapy | Combination Product | As per product label |
|
| 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
• Participants will be excluded from analysis if any of the following criteria are met:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wielkopolska Center of Pulmonology and Thoracic Surgery of Eugenia and Janusz Zeyland | Poznan | Poland |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000074324 | Ipilimumab |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Baseline |
| Participant Neutrophil-to-Lymphocyte Ratio as Assessed by Standard peripheral Blood Count Analysis | Baseline |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D013812 | Therapeutics |