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
Last Updated: 2024-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
400 participants
OBSERVATIONAL
2023-11-30
2030-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants receiving neoadjuvant nivolumab in combination with platinum-based chemotherapy
Neoadjuvant nivolumab in combination with platinum-based chemotherapy
Neoadjuvant treatment of resectable non-small cell lung cancer with nivolumab in combination with chemotherapy according to current summary of product characteristics
Interventions
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Neoadjuvant nivolumab in combination with platinum-based chemotherapy
Neoadjuvant treatment of resectable non-small cell lung cancer with nivolumab in combination with chemotherapy according to current summary of product characteristics
Eligibility Criteria
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Inclusion Criteria
* 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
* Other contraindications according to current Summary of product characteristics
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Klinikverbund Allgaeu
Kempten (Allgäu), Bavaria, Germany
Countries
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Central Contacts
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BMS Study Connect Contact Center www.BMSStudyConnect.com
Role: CONTACT
First line of the email MUST contain NCT # and Site #.
Role: CONTACT
Facility Contacts
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Christian Schumann, Site 0001
Role: primary
Related Links
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BMS Clinical Trial Information
FDA Safety Alerts and Recalls
Other Identifiers
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CA209-1210
Identifier Type: -
Identifier Source: org_study_id
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