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The purpose of this study is to describe the real-world patient and disease characteristics of metastatic non-small cell lung cancer (NSCLC) participants initiated on first-line (1L) treatment with nivolumab, ipilimumab, and platinum-based chemotherapy (NIVO/IPI/PBC), in the overall study population and the subpopulations per histological subtype of NSCLC and PD-L1 expression level.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with metastatic NSCLC initiated on 1L treatment with NIVO/IPI/PBC |
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| Measure | Description | Time Frame |
|---|---|---|
| Baseline participant and disease characteristics of interest in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level | Baseline | |
| Number of NIVO/IPI/PBC doses administered in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level | Up to 157 weeks | |
| Time interval between infusions in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level | Up to 157 weeks | |
| Rate of dose modifications in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level | Up to 157 weeks | |
| Rate of permanent treatment discontinuation in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level | Up to 157 weeks | |
| Frequencies of reasons for dose modifications/discontinuations in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level | Up to 157 weeks | |
| Cumulative dose of NIVO and IPI administered in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level | Up to 157 weeks | |
| Relative dose intensity (RDI) in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level |
| Measure | Description | Time Frame |
|---|---|---|
| Proportions of participants who have not progressed or died from any cause at 12, 24, and 36 months after NIVO/IPI/PBC initiation in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level | 12, 24, and 36 months | |
| Proportions of participants with an investigator-assessed best overall response (BOR) of either a confirmed complete response (CR) or partial response (PR) after NIVO/IPI/PBC initiation in the overall population and the NSCLC and PD-L1 subpopulations |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with metastatic non-small cell lung cancer initiated on first-line treatment with nivolumab, ipilimumab, and platinum-based chemotherapy
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Athens | 15561 | Greece |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls |
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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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RDI (%) will be calculated as follows:
For NIVO: [Cumulative dose (mg)/((Last Nivolumab dose date - Nivolumab Start dose date + 21) x 360/21)] x 100] For IPI: [Cumulative dose (mg)/((Last Ipilimumab dose date - Ipilimumab Start dose date + 21) x 360/21)] x 100]
| Up to 157 weeks |
| Proportion of participants receiving ≥90% RDI of NIVO and IPI in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level | Up to 157 weeks |
| Time from NIVO/IPI/PBC initiation until discontinuation due to any reason in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level | Up to 157 weeks |
| Proportions of participants surviving at the landmark timepoints of 12, 24, and 36 months after NIVO/IPI/PBC initiation in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level | 12, 24, and 36 months |
| 12, 24, and 36 months |
| Proportions of participants with an investigator-assessed BOR of a confirmed CR, PR, or stable disease (Disease Control Rate (DCR)) after NIVO/IPI/PBC initiation in the overall study population and the NSCLC and PD-L1 subpopulations | 12, 24, and 36 months |
| Time from start of NIVO/IPI/PBC treatment to the first documented investigator-assessed response (CR or PR), among participants who achieved at least PR in the overall study population and the NSCLC and PD-L1 subpopulations | Up to 157 weeks |
| Time from first documented response to progression or death due to any cause in the absence of progression (Kaplan Meier DoR), among participants who achieved at least PR in the overall study population and the NSCLC and PD-L1 subpopulations | Up to 157 weeks |
| Types of next treatment planned to be administered for NSCLC after NIVO/IPI/PBC discontinuation in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level | Up to 157 weeks |
| Frequencies of next treatment planned to be administered for NSCLC after NIVO/IPI/PBC discontinuation in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level | Up to 157 weeks |
| Exposure-adjusted incidence rate (EAIR) of the following types of treatment-related AEs in the overall study population |
| Up to 157 weeks |
| Severity (grade) of the following types of treatment-related AEs in the overall study population |
| Up to 157 weeks |
| Seriousness of the following types of treatment-related AEs in the overall study population |
| Up to 157 weeks |
| Outcome of the following types of treatment-related AEs in the overall study population |
| Up to 157 weeks |
| Action taken with study treatment of the following types of treatment-related AEs in the overall study population |
| Up to 157 weeks |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |