A Retrospective Observational Study of Nivolumab in Combination With Chemotherapy as Neoadjuvant Therapy for Resectable NSCLC Patients: Real-World Experience in Taiwan (NEOREAL)
Recruiting · NCT07169708 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
9 locations listed.
- Chang Gung Memorial Hospital Kaohsiung Branch - Kaohsiung City, Taiwan
- Kaohsiung Medical University Chung-Ho Memorial Hospital - Kaohsiung City, Taiwan
- Kaohsiung Veterns General Hospital - Kaohsiung City, Taiwan
- China Medical University Hospital - Taichung, Taiwan
- Taichung Veterans General Hospital - Taichung, Taiwan
- Mackay Memorial Hospital Taipei Branch - Taipei, Taiwan
- National Taiwan University Hospital - Taipei, Taiwan
- Taipei Veteran General Hospital - Taipei, Taiwan
- Chang Gung Memorial Hospital Linkou Branch - Taoyuan, Taiwan