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.
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
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
The cohort patients will be selected from the assigned medical centers.
Cohort
Retrospective
Not listed
Pathological Complete Response (pCR) rate
Pathological complete response (pCR) is defined as the absence of viable tumor residue at the primary site. The pCR rate is defined as number of enrolled patients with absence of viable tumor residue in resected lung tissue, divided by the total number of enrolled patients who at least receive in the first dose of nivolumab. If non-pCR, the number of lymph node metastases will be documented if available.
Event-free survival (EFS)
Event-free survival (EFS) is defined as the time from the first dose of neoadjuvant treatment to the date when any of the following events is first confirmed: * Any disease progression precluding surgery * Progression for patients without surgery * Progression or recurrence after surgery * Death due to any cause If a patient does not experience any events and remains alive, the observation is expected to extend to the longest period allowed by the IRB.
Incidences of AE and SAE
An adverse event (AE) is defined as any untoward medical occurrence in a patient administered nivolumab and which does not necessarily have a causal relationship with this treatment. Serious adverse event (SAE) is any untoward medical occurrence at any dose that results in any of the following outcomes * Death * A life-threatening event, * Inpatient hospitalization or prolongation of existing hospitalization, * A persistent or significant disability/incapacity, * A congenital anomaly/birth defect, * Development of a serious undesired medical event requiring intervention to prevent permanent impairment or damage (devices).
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Ono Pharmaceutical Co., Ltd.
Lead sponsor
Bristol-Myers Squibb
Collaborator
