RecruitingNCT06169956

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

Neoadjuvant Nivolumab (OPDIVO®) in Combination With Platinum-Based Chemotherapy for Non-Metastatic NSCLC: A German, Nationwide, Prospective, Observational, Multicenter Study in Patients Scheduled to Receive 3 Cycles Nivolumab in Combination With Platinum-Based Chemotherapy for Non-Metastatic (Stage and PD-L1 Expression According to Label) Non-Small Cell Lung Cancer

Sponsor

Bristol-Myers Squibb

Enrollment

400 participants

Start Date

Nov 30, 2023

Study Type

OBSERVATIONAL

Conditions

Resectable Non-small Cell Lung Cancer

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

Min Age: 18 Years

Inclusion Criteria6

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 Criteria2

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

Interventions

DRUGNeoadjuvant nivolumab in combination with platinum-based chemotherapy

Neoadjuvant treatment of resectable non-small cell lung cancer with nivolumab in combination with chemotherapy according to current summary of product characteristics

Locations(1)

Klinikverbund Allgaeu

Kempten (Allgäu), Bavaria, Germany

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