A Dose Frequency Optimization,Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer Who Received Up to 12 Months of Nivolumab at 3 mg/kg or 240 mg Every 2 Weeks

Progression Free Survival Rate (PFSR) by Response Criteria at 12 Months

The proportion of participants remaining progression free and surviving at 12 months. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage from the baseline study to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Time frame: At 12 Months

Overall Survival (OS) Rate at 12 Months

The proportion of participants alive at 12 months. OS is defined as time from the date of randomization to the date of death. Participants who did not die by the end of the study will be censored at the last known date alive.

Time frame: At 12 Months

Overall Survival (OS) Rate up to 60 Months

The proportion of participants alive up to 60 months. OS is defined as time from the date of randomization to the date of death. Participants who did not die by the end of the study will be censored at the last known date alive.

Time frame: From randomization to the date of death, Up to 60 Months

Overall Survival Rate by Histology at 12 Months

The proportion of participants alive at 12 months. OS is defined as time from the date of randomization to the date of death. Participants who did not die by the end of the study will be censored at the last known date alive. OS rate by histology did not have data collected after 12 months randomization.

Time frame: at 12 Months

Overall Survival Rate by Response Criteria at 12 Months

The proportion of participants alive at 12 months. OS is defined as time from the date of randomization to the date of death. Participants who did not die by the end of the study will be censored at the last known date alive. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage from the baseline study to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. OS rate by response did not have data collected after 12 months randomization.

Time frame: 12 Months

Percentage of Participants With an Adverse Events (AEs)

Percentage of participants with an Adverse Event due to any cause 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 drug and that does not necessarily have a causal relationship with this treatment.

Time frame: Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)

Percentage of Participants With an Serious Adverse Events (SAEs)

Percentage of participants with an Serious Adverse Event due to any cause. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: 1. results in death 2. is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe) 3. requires inpatient hospitalization or causes prolongation of existing hospitalization 4. results in persistent or significant disability/incapacity 5. is a congenital anomaly/birth defect 6. is an important medical event (defined as a medical event(s) that may not be immediately life-threatening or result in death or hospitalization but, based upon appropriate medical and scientific judgment, may jeopardize the participant or may require intervention \[eg, medical, surgical\] to prevent one of the other serious outcomes listed in the definition above.)

Time frame: Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)

Percentage of Participants With an Adverse Events Leading to Discontinuation (AEsDC)

Percentage of Participants with an Adverse Event leading to discontinuation (AEsDC) due to any cause. 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 drug and that does not necessarily have a causal relationship with this treatment.

Time frame: Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)

Percentage of Participants With an Immune Mediated Adverse Events (IMAEs)

Percentage of Participants with an Immune Mediated Adverse Events treated with Immune-Modulating Medication

Time frame: Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)

Percentage of Participants With an Select Adverse Events

Percentage of Participants with an Select Adverse Event due to any cause Select adverse events include adverse events in the following systems: Gastrointestinal, Hepatic, Pulmonary, Renal, Skin, Hypersensitivity/Infusion reaction and Endocrine.

Time frame: Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)

Percentage of Participants With an Event of Special Interest (ESI)

Other ESI included the following categories: demyelination, encephalitis, Guillain-Barré syndrome (GBS), myasthenic syndrome, pancreatitis, uveitis, myositis, myocarditis, rhabdomyolysis, and Graft Versus Host Disease (GVHD).

Time frame: Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)

Percentage of Participants Who Experienced Death

Percentage of Participants who experienced Death due to any cause

Time frame: Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)

Number of Participants With Laboratory Test Abnormalities

Number of participants with any laboratory test result that is clinically significant or meets the definition of an SAE (Grade 3+4 combined)

Time frame: Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)