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
Recruiting · NCT06169956 · Observational (researchers observe without assigning treatment) · Lead sponsor: Bristol-Myers Squibb
View the official record on ClinicalTrials.gov →Interventions studied
Neoadjuvant nivolumab in combination with platinum-based chemotherapy
What this trial is 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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed.
- Klinikverbund Allgaeu - Kempten (Allgäu), Bavaria, Germany