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 (NENI)

Bristol-Myers Squibb (BMS)

Status: Enrolling

Conditions: Resectable Non-small Cell Lung Cancer

Treatments: Drug: Neoadjuvant nivolumab in combination with platinum-based chemotherapy

Study type: Observational

Funder types: Industry

Identifiers

NCT06169956

CA209-1210

Details and patient eligibility

About

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

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

400 participants in 1 patient group

Participants receiving neoadjuvant nivolumab in combination with platinum-based chemotherapy

Treatment:

Drug: Neoadjuvant nivolumab in combination with platinum-based chemotherapy