A Retrospective Observational Study of Nivolumab in Combination With Chemotherapy as Neoadjuvant Therapy for Resectable NSCLC Patients: Real-World Experience in Taiwan (NEOREAL)
NCT ID: NCT07169708
Last Updated: 2025-09-12
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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NOT_YET_RECRUITING
100 participants
OBSERVATIONAL
2026-01-31
2026-12-31
Brief Summary
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Does patient with NSCLC in treatment of Nivolumab combined with chemotherapy demonstrate better pCR and PFS ? Is it safe for patient with NSCLC in treatment of Nivolumab combined with chemotherapy ?
The data for those participants already receiving nivolumab in combination with chemotherapy as part of their regular medical care for NSCLC will be collected within the designated collection period.
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Detailed Description
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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% of lung cancer cases were diagnosed as NSCLC (n = 16,420). Based on clinical staging (per AJCC 8th edition), 2.26% of NSCLC cases were classified as stage 0, 35.75% as stage I, 3.79% as stage II, 8.80% as stage III, 41.01% as stage IV, and 8.39% had an unknown stage.25 The US Food and Drug Administration (FDA) approved nivolumab in combination with platinum-doublet chemotherapy for the neoadjuvant treatment of patients with resectable NSCLC in March 2022 and Taiwan subsequently approved this indication in February 2023. However, the real-world effectiveness of this treatment and the NSCLC patient profile, particularly in the Taiwanese population, remains unclear, as does the patient profile for adjuvant therapy following neoadjuvant chemo-immunotherapy (chemo-IO). Therefore, this study aims to address these gaps and consolidate nivolumab's role in resectable NSCLC by bridging the data gap with real-world evidence.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Resectable NSCLC Patients
Receive Nivolumab in Combination with Chemotherapy
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Patients who are diagnosed with pathologically confirmed, non-metastatic, resectable NSCLC
3. 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.
4. 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
5. Participants with histologically confirmed Stage II-III NSCLC (per the 8th International Association for the Study of Lung Cancer) who are considered resectable.
Exclusion Criteria
2. Patients with N3 disease per AJCC 8th edition
3. Patients with known EGFR mutations or ALK translocation
4. Patients who have received any prior systemic therapy for NSCLC
5. Patients with a history of previous cancers or other concurrent malignancies within 10 years before the first dose of nivolumab
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Ono Pharmaceutical Co. Ltd
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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R1132-NIV-24
Identifier Type: -
Identifier Source: org_study_id
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