Evaluating nivolumab with chemotherapy for early-stage lung cancer 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
This study is testing whether combining nivolumab with chemotherapy can improve treatment outcomes for people in Germany with early-stage lung cancer that can be surgically removed.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Drugs / interventions | nivolumab, chemotherapy |
| Locations | 1 site (Kempten (Allgäu), Bavaria) |
| Trial ID | NCT06169956 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather and analyze real-world data on the effectiveness of neoadjuvant nivolumab combined with platinum-based chemotherapy in patients with early-stage, resectable non-small cell lung cancer (NSCLC) in Germany. Participants will be monitored for their treatment outcomes and patient-reported outcomes as they undergo this combination therapy. The study focuses on patients who have a specific level of PD-L1 expression in their tumors, which is crucial for determining eligibility for this treatment approach.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with non-metastatic non-small cell lung cancer and a PD-L1 expression level of 1% or more.
Not a fit: Patients with other primary cancers requiring treatment or contraindications as per the product characteristics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness of nivolumab combined with chemotherapy, potentially improving treatment outcomes for patients with early-stage lung cancer.
How similar studies have performed: Other studies have shown promising results with similar approaches using nivolumab in lung cancer treatment, indicating potential for success in this observational study.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Kempten (Allgäu), Bavaria
- Klinikverbund Allgaeu — Kempten (Allgäu), Bavaria, Germany (Recruiting)
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.