Actively Recruiting
Observational Study of Neoadjuvant Nivolumab with Platinum-Based Chemotherapy for Early-Stage Non-Metastatic Non-Small Cell Lung Cancer in Germany
Led by Bristol-Myers Squibb · Updated on 2024-04-18
400
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the real-world use of neoadjuvant nivolumab combined with platinum-based chemotherapy in adults with early-stage, resectable non-metastatic non-small cell lung cancer NSCLC. This observational study aims to assess how effective this combination treatment is in routine clinical practice across Germany, led by Bristol-Myers Squibb. Participants receive three cycles of neoadjuvant nivolumab along with platinum-based chemotherapy before surgery, following current approved guidelines. The study observes these treatments as given independently of the study, without altering usual care. During the study, researchers collect detailed information including tumor response, surgical outcomes, patient health status, adverse events, and quality of life measures. Follow-up lasts up to five years to monitor event-free survival and other long-term outcomes. Participants complete questionnaires and undergo regular medical assessments and imaging as part of this comprehensive data collection.
CONDITIONS
Brief Title
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
Research Team
B
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