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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
RECRUITINGSponsored by Bristol-Myers Squibb
Actively Recruiting
SponsorBristol-Myers Squibb
Started2023-11-30
Est. completion2030-09-30
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06169956
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
Age: 18 Years+Healthy volunteers accepted
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
Conditions3
CancerLung CancerResectable Non-Small-Cell Lung Cancer
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Actively Recruiting
SponsorBristol-Myers Squibb
Started2023-11-30
Est. completion2030-09-30
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06169956