NCT07169708 A Retrospective Observational Study of Nivolumab in Combination With Chemotherapy as Neoadjuvant Therapy for Resectable NSCLC Patients: Real-World Experience in Taiwan (NEOREAL)
| NCT ID | NCT07169708 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ono Pharmaceutical Co., Ltd. |
| Condition | Non Small Cell Lung Cancer NSCLC |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-03-20 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2026-03-20 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Penny Medical Affairs Specialist, Clinical Pharmacology
✉ penny.tsai@ono-pharma.com📞 886-2-8786-9750
Frequently Asked Questions
Who can join the NCT07169708 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non Small Cell Lung Cancer NSCLC. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07169708 currently recruiting?
Yes, NCT07169708 is actively recruiting participants. Contact the research team at penny.tsai@ono-pharma.com for enrollment information.
Where is the NCT07169708 trial being conducted?
This trial is being conducted at Kaohsiung City, Taiwan, Kaohsiung City, Taiwan, Kaohsiung City, Taiwan, Taichung, Taiwan and 5 additional locations.
Who is sponsoring the NCT07169708 clinical trial?
NCT07169708 is sponsored by Ono Pharmaceutical Co., Ltd.. The trial plans to enroll 100 participants.
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