A Study of Nivolumab and Ipilimumab in Untreated Participants With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery

Progression-Free Survival then (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first based on Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the 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.

Time frame: From randomization untill disease progression or death, whichever occurs first (up to approximately 53 months)

Population: Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study. Participant in Arm A and C were only considered in the analysis.

Progression-Free Survival (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first based on Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the 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.

Time frame: From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)

Population: Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study.

The NSCLC-SAQ is a questionnaire used in clinical trials to understand how non-small cell lung cancer (NSCLC) affects your daily life and well-being. It has 7 questions that ask about your symptoms over the past 7 days, including cough, pain, shortness of breath, fatigue, and appetite loss. The total scores from the questionnaire range from 0 to 20. A higher score means you have more severe symptoms and are feeling worse, which is a bad outcome. A lower score means you have fewer symptoms and are feeling better, which is a good outcome.

Time frame: Baseline (Day 1) and Week 48

Population: All randomized participants. Only participants with data available at the specified timepoint are included in the analysis.

Duration of objective response (DoR) is defined as the time between the date of first confirmed response (CR or PR) to the date of the first documented tumor progression (per RECIST 1.1) per BICR assessment, or death due to any cause, whichever occurs first. 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. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the 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.

Time frame: From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)

Population: Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study. Participants with CR or PR were included in the analysis.

Duration of objective response (DoR) is defined as the time between the date of first confirmed response (CR or PR) to the date of the first documented tumor progression (per RECIST 1.1) per investigator assessment, or death due to any cause, whichever occurs first. 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. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the 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.

Time frame: From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)

Population: Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study. Participants with CR or PR were included in the analysis.

An Adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of medicinal product, whether or not considered related to the investigational medicinal product. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, 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), requires inpatient hospitalization or causes prolongation of existing hospitalization.

Time frame: From first dose (Day 1) till 30 days after the last dose (up to approximately 19 months)

Population: All treated participants

Objective Response Rate (ORR) is defined as the percentage of participants whose best overall response (BOR) is either CR or PR by blinded independent central review (BICR) per response evaluation criteria in solid tumors (RECIST) v1.1. 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. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the 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.

Time frame: From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)

Population: Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study.

ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR by investigator assessment per response evaluation criteria in solid tumors (RECIST) v1.1. 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. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the 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.

Time frame: From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)

Population: Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study.

Overall Survival (OS) for all randomized participants is the time between randomization and the date of death from any cause based on Kaplan-Meier estimates. For participants who are alive, their survival time was censored at the last date that they were known to be alive. OS was censored for participants at the date of randomization if they had no follow-up.

Time frame: From randomization untill death (up to approximately 61 months)

Population: All enrolled participants who are randomized to any treatment arm in the study.

Progression-Free Survival then (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on Investigator assessments (per RECIST v1.1), or death due to any cause, whichever occurs first Calculated using Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the 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.

Time frame: From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)

Population: Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study.

Time to Death or Distant Metastases (TDDM) is defined as the time from the date of randomization until the first date of distant metastasis or death in the absence of distant metastasis based on Kaplan-Meier estimates. Distant metastasis is defined as any new lesion that is outside of the thorax (except for heart) according to RECIST 1.1, as assessed by the Investigator.

Time frame: From randomization until metastases or death, whichever occurs first (up to approximately 61 months)

Population: Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study.

Time to response (TTR) is defined as the time, in months, from randomization to the first objective documentation of PR or better assessed per BICR. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the 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. 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.

Time frame: From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)

Population: Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study. Participants with CR or PR were included in the analysis.

Time to response (TTR) is defined as the time, in months, from randomization to the first objective documentation of PR or better assessed per investigator assessment. 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. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the 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.

Time frame: From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)

Population: Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study. Participants with CR or PR were included in the analysis.