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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

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chang Gung Memorial Hospital - Kaohsiung Branch
Coordinator of this site? Confirm its status
Kaohsiung CityTaiwanRecruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Coordinator of this site? Confirm its status
Kaohsiung CityTaiwanRecruiting
Kaohsiung Veterns General Hospital
Coordinator of this site? Confirm its status
Kaohsiung CityTaiwanRecruiting
China Medical University Hospital
Coordinator of this site? Confirm its status
TaichungTaiwanRecruiting
Taichung Veterans General Hospital
Coordinator of this site? Confirm its status
TaichungTaiwanRecruiting
National Taiwan University Hospital
Coordinator of this site? Confirm its status
TaipeiTaiwanRecruiting
Mackay Memorial Hospital-Taipei branch
Coordinator of this site? Confirm its status
TaipeiTaiwanRecruiting
Taipei Veteran General Hospital
Coordinator of this site? Confirm its status
TaipeiTaiwanRecruiting
Chang Gung Memorial Hospital, Linkou Branch
Coordinator of this site? Confirm its status
TaoyuanTaiwanRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.