NCT06169956 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
| NCT ID | NCT06169956 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bristol-Myers Squibb |
| Condition | Resectable Non-small Cell Lung Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2023-11-30 |
| Primary Completion | 2030-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2023-11-30 with a primary completion date of 2030-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Bristol-Myers Squibb
STUDY DIRECTOR
Bristol-Myers Squibb
Frequently Asked Questions
Who can join the NCT06169956 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Resectable Non-small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06169956 currently recruiting?
Yes, NCT06169956 is actively recruiting participants. Contact the research team at Clinical.Trials@bms.com for enrollment information.
Where is the NCT06169956 trial being conducted?
This trial is being conducted at Kempten (Allgäu), Germany.
Who is sponsoring the NCT06169956 clinical trial?
NCT06169956 is sponsored by Bristol-Myers Squibb. The principal investigator is Bristol-Myers Squibb at Bristol-Myers Squibb. The trial plans to enroll 400 participants.
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