Status:
ACTIVE_NOT_RECRUITING
A Study in Participants With First-Line Nivolumab Plus Ipilimumb Therapy Combined With Two Cycles of Chemotherapy for Metastatic Non-Small Cell Lung Cancer
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Brief Summary
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...
Eligibility Criteria
Inclusion
- Diagnosis of stage IV Non-Small Cell Lung Cancer (NSCLC) (histologically or cytologically confirmed stage), without known Epidermal Growth Factor Receptor (EGFR)- or Anaplastic Lymphoma Kinase (ALK)-alterations (according to label approved by EU)
- Decision to initiate a first-line treatment with nivolumab plus ipilimumab combined with two cycles of chemotherapy for the treatment of NSCLC according to the German label has been made independently of the study
Exclusion
- Current primary diagnosis of a cancer other than NSCLC that requires systemic or other treatment
- Participants with known EGFR- or ALK-alterations
- Other protocol-defined inclusion/exclusion criteria apply
Key Trial Info
Start Date :
December 22 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 22 2027
Estimated Enrollment :
825 Patients enrolled
Trial Details
Trial ID
NCT04794010
Start Date
December 22 2020
End Date
December 22 2027
Last Update
December 12 2024
Active Locations (1)
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1
Local Institution - 0001
Leipzig, Germany, 04277