Clinical Trials in China / NCT07169708
Recruiting
Observational
A Retrospective Observational Study of Nivolumab in Combination With Chemotherapy as Neoadjuvant Therapy for Resectable NSCLC Patients: Real-World Experience in Taiwan (NEOREAL)
NCT07169708 · tracked via the Priya Life Science China tracker
Condition(s) studied
Non Small Cell Lung Cancer NSCLC
Study 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 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.
Eligibility
Inclusion Criteria:
1. Aged 18 years and older
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:
1. 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
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
Primary outcome measure(s)
- Pathological Complete Response (pCR) rate — At least 12 months retrospectively
Pathological complete response (pCR) is defined as the absence of viable tumor residue at the primary site. The pCR rate is defined as number of enrolled patients with absence of viable tumor residue in resected lung tissue, divided by the total number of enrolled patients who at least receive in the first dose of nivolumab. If non-pCR, the number of lymph node metastases will be documented if available. - Event-free survival (EFS) — At least 12 months retrospectively
Event-free survival (EFS) is defined as the time from the first dose of neoadjuvant treatment to the date when any of the following events is first confirmed: * Any disease progression precluding surgery * Progression for patients without surgery * Progression or recurrence after surgery * Death due to any cause If a patient does not experience any events and remains alive, the observation is expected to extend to the longest period allowed by the IRB. - Incidences of AE and SAE — At least 12 months retrospectively
An adverse event (AE) is defined as any untoward medical occurrence in a patient administered nivolumab and which does not necessarily have a causal relationship with this treatment. Serious adverse event (SAE) is any untoward medical occurrence at any dose that results in any of the following outcomes * Death * A life-threatening event, * Inpatient hospitalization or prolongation of existing hospitalization, * A persistent or significant disability/incapacity, * A congenital anomaly/birth defect, * Development of a serious undesired medical event requiring intervention to prevent permanent impairment or damage (devices).
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| Chang Gung Memorial Hospital Kaohsiung Branch | Kaohsiung City | Taiwan | Recruiting |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | Taiwan | Recruiting |
| Kaohsiung Veterns General Hospital | Kaohsiung City | Taiwan | Recruiting |
| China Medical University Hospital | Taichung | Taiwan | Recruiting |
| Taichung Veterans General Hospital | Taichung | Taiwan | Recruiting |
| Mackay Memorial Hospital Taipei Branch | Taipei | Taiwan | Recruiting |
| National Taiwan University Hospital | Taipei | Taiwan | Recruiting |
| Taipei Veteran General Hospital | Taipei | Taiwan | Recruiting |
| Chang Gung Memorial Hospital Linkou Branch | Taoyuan | Taiwan | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07169708 on ClinicalTrials.gov ↗ ← All trials in China