Safety Study of Nivolumab to Treat Advanced or Metastatic Non-small Cell Lung Cancer

The number of participants who experienced at least 1 select AE of Grade 3-5, judged to be related to study drug per investigator with onset on or after first dose of study treatment and within 30 days of last dose of study treatment, divided by number of treated participants. AE grade is defined using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 criteria. The select AEs consist of pulmonary events, gastrointestinal events, hepatic events, renal events, skin events, endocrine events categories, thyroid disorders, diabetes, pituitary, adrenal disorder subcategories. Grade 3 is defined as severe or medically significant but not immediately life-threatening. Grade 4 is defined as life-threatening consequences and urgent intervention indicated. Grade 5 is defined as death related to AE.

Time frame: From the first dose of study treatment to up to 30 days of the last dose of study treatment (up to 24 months)

Population: All Treated Participants

Duration of Response (DOR) is defined as the time between the date of first confirmed response up to the date of the first documented tumor progression (per RECIST 1.1) as determined by complete response (CR) or partial response (PR), or death due to any cause, whichever occurs first. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. Participants who started any subsequent anti-cancer therapy (including palliative local therapy) without a prior reported progression will be censored at the last evaluable tumor assessment prior to or on the date of initiation of the subsequent anti-cancer therapy (including palliative local therapy). Complete response is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to \<10 mm. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions.

Time frame: From the date of first confirmed response up to the date of the first documented tumor progression (per RECIST 1.1), or death due to any cause, whichever occurs first (up to approximately 48 months).

Population: All Responder Participants (participants with confirmed CR or PR)

Objective Response Rate (ORR) defined as the percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) as assessed by investigator per RECIST 1.1. Complete response is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to \<10 mm. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions. Radiographic tumor assessments will be conducted at Week 8 (+/- 7 days) and every 8 weeks (+/- 7 days) until up to 2 years or until disease progression (or until discontinuation of study therapy in patients receiving nivolumab beyond progression), lost to follow-up, or withdrawal of study consent.

Time frame: From the date of first dose to the date of the initial objectively documented tumor progression or the date of subsequent therapy, whichever occurs first (up to approximately 25 months).

Population: All Treated Participants

Overall Survival (OS) is defined as the time between the first dosing date and the date of death due to any cause. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive.

Time frame: From first dosing date and the date of death due to any cause (up to approximately 4 years and 9 months)

Population: All Treated Participants

Progression free survival (PFS) is defined as the time between the date of randomization and the date of the first documented tumor progression accounting for subsequent therapy, based on BICR (blinded independent central review) assessments (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first. Participants will be censored at the last evaluable tumor assessment on or prior to the date of subsequent therapy. 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 (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Time frame: From first dose to the date of the first documented tumor progression (up to approximately 5 months)

Population: All Treated Participants

The number of participants who experienced at least 1 select AE of Grade 3-5, judged to be related to study drug per investigator with onset on or after first dose of study treatment and within 30 days of last dose of study treatment, divided by number of treated participants. AE grade is defined using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 criteria. The select AEs consist of pulmonary events, gastrointestinal events, hepatic events, renal events, skin events, endocrine events categories, thyroid disorders, diabetes, pituitary, adrenal disorder subcategories. Grade 3 is defined as severe or medically significant but not immediately life-threatening. Grade 4 is defined as life-threatening consequences and urgent intervention indicated. Grade 5 is defined as death related to AE. Note: This outcome measure represents an update to the primary endpoint to include additional data collection that occurred after the primary completion date.

Time frame: From the first dose of study treatment to up to 30 days of the last dose of study treatment (up to 25 months)

Population: All Treated Participants