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

Primary outcomes

1. Pathological Complete Response (pCR) rate

   Time frame: At least 12 months retrospectively

   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.

2. Event-free survival (EFS)

   Time frame: At least 12 months retrospectively

   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.

3. Incidences of AE and SAE

   Time frame: At least 12 months retrospectively

   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).