Status:
NOT_YET_RECRUITING
A Retrospective Observational Study of Nivolumab in Combination With Chemotherapy as Neoadjuvant Therapy for Resectable NSCLC Patients: Real-World Experience in Taiwan (NEOREAL)
Lead Sponsor:
Ono Pharmaceutical Co. Ltd
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Non Small Cell Lung Cancer NSCLC
Eligibility:
All Genders
18+ years
Brief Summary
The goal of this observational study is to learn about the effectiveness of Nivolumab in combination with chemotherapy as Neoadjuvant therapy for patients with non-small cell lung cancer (NSCLC). The ...
Detailed Description
Rationale : In Taiwan, lung cancer is the most common cancer and has the highest mortality rate among the top 10 cancers, accounting for 19.4% of all cancer-related deaths in 2022. Additionally, 94.3...
Eligibility Criteria
Inclusion
- Aged 18 years and older
- Patients who are diagnosed with pathologically confirmed, non-metastatic, resectable NSCLC
- Patients who have received at least one cycle of neoadjuvant nivolumab combined with chemotherapy since the approval of the regimen in February 2023, and who have at least one imaging assessment of EFS and surgical status recorded. For patients who underwent surgery, at least one pathological report is required.
- Patients who have been followed up for at least 12 months (from first dose of neoadjuvant therapy to last medical record date at study site), exceptional case as follows:
- Patients who expired within 12 months of follow-up
- Patients who experience disease progression or recurrence but continue to follow-up
- Participants with histologically confirmed Stage II-III NSCLC (per the 8th International Association for the Study of Lung Cancer) who are considered resectable.
Exclusion
- Patients with distant metastasis (M1 disease according to the eighth edition of the American Joint Committee on Cancer \[AJCC\] cancer staging manual) prior to neoadjuvant therapy
- Patients with N3 disease per AJCC 8th edition
- Patients with known EGFR mutations or ALK translocation
- Patients who have received any prior systemic therapy for NSCLC
- Patients with a history of previous cancers or other concurrent malignancies within 10 years before the first dose of nivolumab
Key Trial Info
Start Date :
January 31 2026
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07169708
Start Date
January 31 2026
End Date
December 31 2026
Last Update
September 12 2025
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