NCT07169708Recruiting
A Retrospective Observational Study of Nivolumab in Combination With Chemotherapy as Neoadjuvant Therapy for Resectable NSCLC Patients: Real-World Experience in Taiwan (NEOREAL)
A Retrospective Observational Study of Nivolumab in Combination With Chemotherapy as Neoadjuvant Therapy for Resectable NSCLC Patients: Real-World Experience in Taiwan
Source: ClinicalTrials.gov · Last updated 20 May 2026
Brief summary (registry, in English)
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 main question it aims to answer is: 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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 28 Aug 2025
- Start date
- 20 Mar 2026
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Diseases
- Lung cancer
- NCT number
- NCT07169708
What you commit to
- Study type: Observational
- Planned participants: 100
- From 20 Mar 2026 to the primary completion date, 30 Jun 2026
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 who have received any prior systemic therapy for NSCLC
Other illness
- Patients with N3 disease per AJCC 8th edition
- Patients with a history of previous cancers or other concurrent malignancies within 10 years before the first dose of nivolumab
Lab values
- Patients with known EGFR mutations or ALK translocation
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chang Gung Memorial Hospital - Kaohsiung Branch Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Recruiting |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Recruiting |
| Kaohsiung Veterns General Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Recruiting |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Recruiting |
| Taichung Veterans General Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Recruiting |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Mackay Memorial Hospital-Taipei branch Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Taipei Veteran General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Chang Gung Memorial Hospital, Linkou Branch Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.