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The purpose of this study is to assess the treatment-related adverse events and associated healthcare resource use in programmed death ligand 1 (PD-L1) negative individuals diagnosed with advanced/metastatic non-small cell lung cancer (NSCLC) who received first-line therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Participants receiving nivolumab + ipilimumab treatment |
| |
| Cohort 2 | Participants receiving nivolumab + ipilimumab + platinum-based chemotherapy |
| |
| Cohort 3 | Participants receiving immuno-oncology therapy (excl nivolumab) with chemotherapy treatment |
| |
| Cohort 4 | Participants receiving other dual-IO with chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab + ipilimumab | Biological | According to the product label |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-related adverse events | Baseline | |
| Participant baseline clinical characteristics | Baseline | |
| Time to onset of treatment-related adverse events | Up to 8 years | |
| Number of treatment-related adverse events resolved | Up to 8 years | |
| Number of participants receiving treatment for treatment-related adverse events by drug class | Up to 8 years | |
| Number of participants that discontinued immune-oncology therapy due to treatment-related adverse events | Up to 8 years |
| Measure | Description | Time Frame |
|---|---|---|
| Healthcare Resource Utilization (HCRU) associated with treatment-related adverse event | Up to 8 years |
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Inclusion Criteria:Inclusion Criteria:
Are ≥ 18 years of age at the index date
Have a confirmed diagnosis of advanced/metastatic non-small cell lung cancer (NSCLC) (stage IIIB-IV) (squamous and non-squamous)
Have PD-L1< 1% level as reported
Received one of the following 1L treatments:
Have ≥ 6 months of documented post-index (follow-up) period after the index date - Participants who die within 6 months of follow-up will be included
Exclusion Criteria:
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The study population will comprise of programmed death ligand 1 (PD-L1) negative individuals diagnosed with advanced/metastatic non-small cell lung cancer (NSCLC) who received first-line therapy in routine clinical practice at the Florida Cancer Specialists and Research Institute
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| Name | Affiliation | Role |
|---|---|---|
| Bristol Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Cancer Specialists & Research Institute | Fleming Island | Florida | 32003 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
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| Nivolumab + ipilimumab + platinum-based chemotherapy |
| Biological |
According to the product label |
|
| Immuno-oncology-based therapy (excluding nivolumab-based regimens) with chemotherapy | Biological | According to the product label |
|
| Other dual-immuno-oncology therapy with chemotherapy | Biological | According to the product label |
|
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000074324 | Ipilimumab |
| D017671 | Platinum Compounds |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D007287 | Inorganic Chemicals |
| D013812 | Therapeutics |
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