Looks at nivolumab with chemotherapy before surgery for lung cancer
Reviews nivolumab with chemotherapy before surgery in adults with lung cancer.
Key facts
- Who runs it
- Ono Pharmaceutical Co., Ltd.
- Where
- Kaohsiung City, Taichung, Taipei, and Taoyuan, TaiwanSee the 9 sites
- Trial code
- Registry title
- A Retrospective Observational Study of Nivolumab in Combination With Chemotherapy as Neoadjuvant Therapy for Resectable NSCLC Patients: Real-World Experience in Taiwan (NEOREAL)
- Status
- Recruiting
- People taking part
- 100 people, planned
- Started
- 20 Mar 2026
- Planned end
- 30 Jun 2026
- Type of study
- Observational
- Record updated
- 20 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with lung cancer (NSCLC) that has not spread and can be removed by surgery. They must have already had nivolumab with chemotherapy before surgery.
- Age
- 18 years and older
- Sex
- All sexes can join.
- Disease stage
- Non-small cell lung cancer, Stage II-III, not spread to distant parts of the body, and can be removed by surgery.
- Earlier treatment
- Must have had at least one cycle of nivolumab with chemotherapy before surgery since February 2023. Must not have had any earlier systemic therapy for NSCLC. Must have been followed for at least 12 months, with some exceptions.
- Biomarker or test result
- Cannot have a known EGFR mutation or ALK translocation.
Main reasons for not taking part
- Cancer that has spread to distant parts of the body before treatment
- N3 disease
- Known EGFR mutation or ALK translocation
- Any earlier systemic therapy for NSCLC
- Another cancer within 10 years before the first dose of nivolumab
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
- Patients with known EGFR mutations or ALK translocation
Where in Taiwan
- Chang Gung Memorial Hospital - Kaohsiung BranchKaohsiung City, TaiwanContact: Yu-Fen Study CoordinatorTaking people
- Kaohsiung Medical University Chung-Ho Memorial HospitalKaohsiung City, TaiwanContact: Wan-Ming Study CoordinatorTaking people
- Kaohsiung Veterns General HospitalKaohsiung City, TaiwanContact: Shuen-Dury YuTaking people
- China Medical University HospitalTaichung, TaiwanContact: Mei-Hui Study CoordinatorTaking people
- Taichung Veterans General HospitalTaichung, TaiwanContact: Shu-Jen Study CoordinatorTaking people
- Mackay Memorial Hospital-Taipei branchTaipei, TaiwanContact: Rainie Study CoordinatorTaking people
- National Taiwan University HospitalTaipei, TaiwanContact: Jo-Yu Study CoordinatorTaking people
- Taipei Veteran General HospitalTaipei, TaiwanContact: Ping-Ju Study CoordinatorTaking people
- Chang Gung Memorial Hospital, Linkou BranchTaoyuan, TaiwanContact: Wen Study CoordinatorTaking people
About the trial
What the trial wants to find out
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:
Read full original descriptionShow less
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.
The group in the trial
- Resectable NSCLC Patients
Receive Nivolumab in Combination with Chemotherapy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Retrospective Observational Study of Nivolumab in Combination With Chemotherapy as Neoadjuvant Therapy for Resectable NSCLC Patients: Real-World Experience in Taiwan
- Plain-language title
- Looks at nivolumab with chemotherapy before surgery for lung cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 20 May 2026