Nivolumab with chemotherapy as neoadjuvant therapy for resectable NSCLC in Taiwan

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a retrospective observational study using data from patients who received neoadjuvant nivolumab combined with chemotherapy for resectable NSCLC in Taiwan. It aims to describe effectiveness and safety in real clinical practice, including outcomes like pathologic complete response and progression-free survival. Eligible participants are adults with non-metastatic, stage II-III NSCLC who had at least one cycle of neoadjuvant therapy since February 2023 and have sufficient imaging and surgical/pathology data, with at least 12 months of follow-up when possible. Data will be collected from medical records at participating Taiwanese institutions. The study is sponsored by Ono Pharmaceutical with collaboration from Bristol-Myers Squibb to consolidate real-world evidence for this neoadjuvant regimen.

Why it matters

Who can join: the full rules

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

Where it's running

• 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

Study contacts

• Study coordinator: Penny Medical Affairs Specialist, Clinical Pharmacology
• Email: penny.tsai@ono-pharma.com
• Phone: 886-2-8786-9750

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.