A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer

The length of time from randomization to any of the following events: progression of disease or worsening of disease precluding surgery, if surgery is attempted but gross resection is abandoned due to unresectable tumor or worsening of disease, progression or recurrence of disease after surgery, progression or recurrence of disease without surgery, or death due to any cause. Progression/recurrence will be assessed by BICR per RECIST 1.1. Participants who do not undergo surgery for reason other than progression will be considered to have an event at RECIST 1.1 progression or death

OS is defined as the time between the date of randomization and the date of death due to any cause. OS will be censored on the last date a subject was known to be alive.

Pathologic complete response (pCR) rate is defined as the percentage of randomized participants with absence of residual viable tumor in lung and lymph nodes as evaluated by blinded independent pathology review (BIPR).

Major pathological response (MPR) rate is defined as the percentage of randomized participants with ≤10% residual viable tumor in lung and lymph nodes as evaluated by blinded independent pathology review (BIPR).

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

Select AEs include endocrinopathies, diarrhea/colitis, hepatitis, pneumonitis, interstitial nephritis, and rash. Multiple event terms that may describe each of these were grouped into endocrine, GI, hepatic, pulmonary, renal, and skin select AE categories, respectively. Hypersensitivity/infusion reactions were analyzed along with the select AE categories.