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A Retrospective Observational Study of Nivolumab in Combination With Chemotherapy as Neoadjuvant Therapy for Resectable NSCLC Patients: Real-World Experience in Taiwan

Status: Recruiting
Location: See all (9) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Taiwan
Chang Gung Memorial Hospital Kaohsiung Branch
RECRUITING
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
Kaohsiung Veterns General Hospital
RECRUITING
Kaohsiung City
China Medical University Hospital
RECRUITING
Taichung
Taichung Veterans General Hospital
RECRUITING
Taichung
Mackay Memorial Hospital Taipei Branch
RECRUITING
Taipei
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veteran General Hospital
RECRUITING
Taipei
Chang Gung Memorial Hospital Linkou Branch
RECRUITING
Taoyuan
Contact Information
Primary
Penny Medical Affairs Specialist, Clinical Pharmacology
penny.tsai@ono-pharma.com
886-2-8786-9750
Time Frame
Start Date: 2026-03-20
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 100
Treatments
Resectable NSCLC Patients
Receive Nivolumab in Combination with Chemotherapy
Sponsors
Collaborators: Bristol-Myers Squibb
Leads: Ono Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov