Status:
RECRUITING
An Observational Study to Evaluate Neoadjuvant Nivolumab (OPDIVO®) in Combination With Platinum-Based Chemotherapy in Non-Metastatic Non-Small Cell Lung Cancer Participants in Germany
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Resectable Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this observational study is to collect and evaluate real-world data to assess the effectiveness of neoadjuvant nivolumab when given in combination with platinum-based chemotherapy in pa...
Eligibility Criteria
Inclusion
- Aged 18 years or older
- Diagnosis of non-metastatic non-small cell lung cancer with tumor Programmed death-ligand 1 (PD-L1) expression level of 1% or more (tumor proportion score (TPS); according to label approved in the European Union)
- Decision to initiate a neoadjuvant treatment with nivolumab plus platinum-based chemotherapy for treatment of non-small cell lung cancer according to current Summary of product characteristics and independent of the study
- Willing to complete patient-reported outcome questionnaires and sufficient understanding of the German language
- Signed written informed consent
- Other criteria according to current Summary of product characteristics
Exclusion
- Current primary diagnosis of cancer other than non-small cell lung cancer that requires systemic or other treatment
- Other contraindications according to current Summary of product characteristics
Key Trial Info
Start Date :
November 30 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2030
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06169956
Start Date
November 30 2023
End Date
September 30 2030
Last Update
April 18 2024
Active Locations (1)
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1
Klinikverbund Allgaeu
Kempten (Allgäu), Bavaria, Germany, 87439