NCT06169956 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
| NCT ID | NCT06169956 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bristol-Myers Squibb |
| Condition | Resectable Non-small Cell Lung Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2023-11-30 |
| Primary Completion | 2030-09-30 |
Trial Parameters
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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 participants with early-stage, resectable non-small cell lung cancer (NSCLC) in Germany
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
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