NCT06169956Recruiting
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
Source: ClinicalTrials.gov · Last updated 18 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 17 Nov 2023
- Start date
- 30 Nov 2023
- Primary completion date
- 30 Sept 2030
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Lung cancer
- NCT number
- NCT06169956
What you commit to
- Study type: Observational
- Planned participants: 400
- From 30 Nov 2023 to the primary completion date, 30 Sept 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Current primary diagnosis of cancer other than non-small cell lung cancer that requires systemic or other treatment
Other
- Other contraindications according to current Summary of product characteristics
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Klinikverbund Allgaeu Coordinator of this site? Confirm its status | Kempten (Allgäu) | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.