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The purpose of the study is to collect real-life data during the early post-market authorization approval period in Germany.
The study aims at describing the outcomes, patient characteristics, safety profile, treatment patterns and patient-reported Quality of Life of first-line treatment with nivolumab plus ipilimumab in combination with two cycles of chemo therapy in participants with confirmed stage IV Non-Small Cell Lung Cancer (NSCLC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Participants with Metastatic Non-Small Cell Lung Cancer |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) according to subgroups of interest | Up to 5 years | |
| Progression-free survival (PFS) | Up to 5 years | |
| Duration of treatment |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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It is planned to include 825 patients at 100 sites in Germany in this observational study from marketing authorization by the European Medicines Agency (EMA) onwards.
The planned recruitment phase is approximately 24 months, the planned follow-up phase 60 months from the day of nivolumab plus ipilimumab plus two cycles of chemotherapy initiation (D0).
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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 | Leipzig | 04277 | Germany |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| Up to 5 years |
| Distribution of socio-demographic characteristics of participants | Age, Sex, Ethnicity, Height, Weight and BMI | At Baseline |
| Distribution of clinical characteristics of participants | Histology subtype, Tumor stage, Location or primary tumor and Location of metastases | At Baseline |
| Description of participant-reported outcomes (PROs) of participants using European Quality of Life-5 Dimensions (EQ-5D) questionnaires | Up to 5 years |
| Description of participant-reported outcomes (PROs) of participants using Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) | Up to 5 years |
| Management of AEs: Treatment of AEs | Up to 5 years |
| Management of AEs: Date of occurrence of AE | Up to 5 years |
| Management of AEs: Start of treatment | Up to 5 years |
| Treatment Patterns: Previous therapies | Up to 5 years |
| Treatment Patterns: Subsequent therapies | Up to 5 years |
| Treatment patterns: Concomitant medication | Up to 5 years |
| Treatment patterns : Management of treatment-related adverse events [AEs], previous and subsequent therapies | Up to 5 years |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009362 | Neoplasm Metastasis |
| 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 |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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