A Study of BMS-986315 and Nivolumab in Combination With Chemotherapy in Participants With First-line Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)

Progression Free Survival (PFS) for Part 2

Progression free survival is defined as the time between the date of randomization and the first date of documented progression, per blinded independent central review (BICR) assessments using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), or death due to any cause, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the sum of the 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 5mm (Note: The appearance of 1or more new lesions is also considered progression). No participants were enrolled in Part 2 due to the study's termination; therefore, no data were collected for this endpoint.

Time frame: From randomization until the date of first objectively documented progression or death due to any cause, whichever occurred first (planned for up to approximately 5 years)

Number of Participants With Adverse Events (AEs) for Part 2

An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention. No participants were enrolled in Part 2 due to the study's termination; therefore, no data were collected for this endpoint.

Time frame: Up to 100 days after discontinuation of study treatment

Number of Participants With Treatment Related Adverse Events (TRAEs) for Part 2

An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention. No participants were enrolled in Part 2 due to the study's termination; therefore, no data were collected for this endpoint.

Time frame: Up to 100 days after discontinuation of study treatment

Number of Participants With Serious Adverse Events (SAEs) for Part 2

Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization. No participants were enrolled in Part 2 due to the study's termination; therefore, no data were collected for this endpoint.

Time frame: Up to 100 days after discontinuation of study treatment

Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria for Part 2

Dose-Limiting Toxicities (DLTs) are treatment effects serious enough to prevent dose increase. Severity grades: 1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening, 5=Death * Grade 2 uveitis or eye pain not improving or require systemic treatment * Grade 2 pneumonitis or interstitial lung disease \>14 days * Grade ≥ 3 uveitis, episcleritis, iritis, pneumonitis, bronchospasm or neurologic toxicity * Grade 3 colitis not responding \>48 hours * Hepatic abnormalities without liver metastases: serum transaminases (AST/ALT) \>5x \& ≤ 8xULN for \>2weeks, AST/ALT \>8xULN regardless of duration, total bilirubin \>3xULN, or concurrent AST/ALT \>3xULN \& total bilirubin \>2xULN * Hepatic abnormalities with liver metastases: AST/ALT \>8x \& ≤10xULN for \>2 weeks, AST/ALT \>10xULN regardless of duration, total bilirubin \> 3xULN, or concurrent AST/ALT \>8xULN \& total bilirubin \>2xULN * Grade 3 (hypersensitivity reaction not resolving to Grade 1 in 6 hours; fatigue \>7 days; nausea, vomiting, or diarrhea \>72 hours)

Time frame: Up to 100 days after discontinuation of study treatment

Number of Participants With Adverse Events (AEs) Leading to Discontinuation for Part 2

An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention. No participants were enrolled in Part 2 due to the study's termination; therefore, no data were collected for this endpoint.

Time frame: Up to 100 days after discontinuation of study treatment

Number of Participants Who Died in Part 2

Number of participants who died during the study No participants were enrolled in Part 2 due to the study's termination; therefore, no data were collected for this endpoint.

Time frame: Up to 100 days after discontinuation of study treatment

Duration of Response (DoR) for Part 2

Duration of response is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the 1st objectively documented tumor progression as determined by BICR (per RECIST 1.1), 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 \<10mm. 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 the 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 5mm (Note: The appearance of 1or more new lesions is also considered progression).

Time frame: From randomization until the date of first objectively documented progression or death due to any cause, whichever occurred first (planned for up to approximately 5 years)

Time to Objective Response (TTR) for Part 2

Time to response (TTR) assessed by BICR is defined as the time between the date of randomization and the first confirmed documented response (CR or PR) per RECIST 1.1 criteria. 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. No participants were enrolled in Part 2 due to the study's termination; therefore, no data were collected for this endpoint.

Time frame: From randomization until the date of first objectively documented progression or death due to any cause, whichever occurred first (planned for up to approximately 5 years)

Disease Control Rate (DCR) for Part 2

Disease control rate (DCR) is defined as the number of participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD), based on BICR assessments (using RECIST 1.1) divided by the number of all randomized participants. 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 to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. No participants were enrolled in Part 2 due to the study's termination; therefore, no data were collected for this endpoint.

Time frame: From randomization until the date of first objectively documented progression or death due to any cause, whichever occurred first (planned for up to approximately 5 years)

Maximum Observed Serum Concentration (Cmax) for Part 2

Cmax is the maximum observed serum concentration. No participants were enrolled in Part 2 due to the study's termination; therefore, no data were collected for this endpoint.

Time frame: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 (Each Cycle is of 21 Days)

Time of Maximum Observed Concentration (Tmax) for Part 2

Tmax is the time of maximum observed serum concentration. No participants were enrolled in Part 2 due to the study's termination; therefore, no data were collected for this endpoint.

Time frame: C1D1, C1D2, C1D4, C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C5D2, C5D4, C5D8, C5D15, Day 1 of every 4 cycles from cycle 6 (up to 2 years); at 30 and 100 days post last dose (Each Cycle is of 21 Days)

Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for Part 2

AUC (0-T) is the area under the serum concentration-time curve from time zero to time of last quantifiable concentration. No participants were enrolled in Part 2 due to the study's termination; therefore, no data were collected for this endpoint.

Time frame: C1D1, C1D2, C1D4, C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C5D2, C5D4, C5D8, C5D15, Day 1 of every 4 cycles from cycle 6 (up to 2 years); at 30 and 100 days post last dose (Each Cycle is of 21 Days)

Number of Participants With Anti-drug Antibodies (ADA) to BMS-986315 for Part 2

Number of Participants with Anti-drug Antibodies (ADA) to BMS-986315 No participants were enrolled in Part 2 due to the study's termination; therefore, no data were collected for this endpoint.

Time frame: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Day 1 of every 4 cycles from cycle 6 (up to 2 years); at 30 and 100 days post last dose (Each Cycle is of 21 Days)