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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOno Pharmaceutical Co., Ltd.

About this trial

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

Qualifiers

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 expired within 12 months of follow-up

Disqualifiers

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 with N3 disease per AJCC 8th edition

Patients with known EGFR mutations or ALK translocation

Patients who have received any prior systemic therapy for NSCLC

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

100 Participants
are grouped into 1 trial group

Sponsors and collaborators

Ono Pharmaceutical Co., Ltd.

Lead sponsor

Bristol-Myers Squibb

Collaborator