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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06094296
Registration number
NCT06094296
Ethics application status
Date submitted
17/10/2023
Date registered
23/10/2023
Date last updated
16/04/2025
Titles & IDs
Public title
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)
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Scientific title
A Randomized, Double-blind, Phase 2 Study of BMS-986315 and Nivolumab in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy as First-line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)
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Secondary ID [1]
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2022-503007-22
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Secondary ID [2]
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CA047-1009
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
NSCLC
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Condition category
Condition code
Cancer
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0
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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0
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0
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BMS-986315
Treatment: Drugs - Nivolumab
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Cisplatin
Treatment: Drugs - Carboplatin
Treatment: Drugs - Paclitaxel
Experimental: Part 1: BMS-986315 Dose Level (DL) 1 + Nivolumab + Histology-based PDCT -
Experimental: Part 1: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT -
Active comparator: Part 2: Nivolumab + Histology-based PDCT -
Experimental: Part 2: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT -
Experimental: Part 2: BMS-986315 DL 1 + Nivolumab + Histology-based PDCT -
Treatment: Drugs: BMS-986315
Specified dose on specified days
Treatment: Drugs: Nivolumab
Specified dose on specified days
Treatment: Drugs: Pemetrexed
Specified dose on specified days
Treatment: Drugs: Cisplatin
Specified dose on specified days
Treatment: Drugs: Carboplatin
Specified dose on specified days
Treatment: Drugs: Paclitaxel
Specified dose on specified days
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Adverse Events (AEs) for Part 1
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Assessment method [1]
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0
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.
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Timepoint [1]
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0
From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)
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Primary outcome [2]
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Number of Participants With Treatment Related Adverse Events (TRAEs) for Part 1
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Assessment method [2]
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0
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.
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Timepoint [2]
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0
From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)
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Primary outcome [3]
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Number of Participants With Serious Adverse Events (SAEs) for Part 1
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Assessment method [3]
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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.
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Timepoint [3]
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From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)
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Primary outcome [4]
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Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria for Part 1
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Assessment method [4]
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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)
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Timepoint [4]
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0
From first dose (Cycle 1 Day 1) up to day 28
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Primary outcome [5]
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Number of Participants With Adverse Events (AEs) Leading to Discontinuation for Part 1
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Assessment method [5]
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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.
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Timepoint [5]
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0
From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)
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Primary outcome [6]
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Number of Participants Who Died in Part 1
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Assessment method [6]
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Number of participants who died during the study
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Timepoint [6]
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From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)
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Primary outcome [7]
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Objective Response Rate (ORR) for Part 2
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Assessment method [7]
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Objective response rate (ORR) is defined as the number of participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on blinded independent central review (BICR) assessments using Response Evaluation Criteria in Solid Tumors (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. No participants were enrolled in Part 2 due to the study termination; therefore, no data were collected for this endpoint.
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Timepoint [7]
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From randomization until the date of first objectively documented progression or start of subsequent therapy whichever occurred first (planned for up to approximately 5 years)
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Secondary outcome [1]
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Progression Free Survival (PFS) for Part 2
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Assessment method [1]
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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.
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Timepoint [1]
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0
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)
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Secondary outcome [2]
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0
Number of Participants With Adverse Events (AEs) for Part 2
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Assessment method [2]
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0
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.
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Timepoint [2]
0
0
Up to 100 days after discontinuation of study treatment
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Secondary outcome [3]
0
0
Number of Participants With Treatment Related Adverse Events (TRAEs) for Part 2
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Assessment method [3]
0
0
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.
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Timepoint [3]
0
0
Up to 100 days after discontinuation of study treatment
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Secondary outcome [4]
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0
Number of Participants With Serious Adverse Events (SAEs) for Part 2
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Assessment method [4]
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0
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.
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Timepoint [4]
0
0
Up to 100 days after discontinuation of study treatment
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Secondary outcome [5]
0
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Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria for Part 2
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Assessment method [5]
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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)
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Timepoint [5]
0
0
Up to 100 days after discontinuation of study treatment
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Secondary outcome [6]
0
0
Number of Participants With Adverse Events (AEs) Leading to Discontinuation for Part 2
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Assessment method [6]
0
0
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.
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Timepoint [6]
0
0
Up to 100 days after discontinuation of study treatment
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Secondary outcome [7]
0
0
Number of Participants Who Died in Part 2
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Assessment method [7]
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0
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.
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Timepoint [7]
0
0
Up to 100 days after discontinuation of study treatment
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Secondary outcome [8]
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0
Duration of Response (DoR) for Part 2
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Assessment method [8]
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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).
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Timepoint [8]
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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)
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Secondary outcome [9]
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Time to Objective Response (TTR) for Part 2
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Assessment method [9]
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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.
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Timepoint [9]
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0
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)
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Secondary outcome [10]
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Disease Control Rate (DCR) for Part 2
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Assessment method [10]
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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.
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Timepoint [10]
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0
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)
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Secondary outcome [11]
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Maximum Observed Serum Concentration (Cmax) for Part 2
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Assessment method [11]
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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.
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Timepoint [11]
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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)
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Secondary outcome [12]
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Time of Maximum Observed Concentration (Tmax) for Part 2
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Assessment method [12]
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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.
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Timepoint [12]
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0
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)
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Secondary outcome [13]
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Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for Part 2
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Assessment method [13]
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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.
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Timepoint [13]
0
0
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)
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Secondary outcome [14]
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Number of Participants With Anti-drug Antibodies (ADA) to BMS-986315 for Part 2
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Assessment method [14]
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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.
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Timepoint [14]
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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)
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Eligibility
Key inclusion criteria
* Participants must have NSCLC with Stage IV or recurrent disease following multimodal therapy for locally advanced disease.
* Study treatment must be first-line therapy for Stage IV or recurrent disease.
* Participants in all parts of the study must have:
* measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1. (RECIST v1.1)
* an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* a life expectancy of at least 3 months at the time of first dose
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Untreated symptomatic central nervous system metastases
* Participants with epidermal growth factor receptor (EGFR)/ALK receptor tyrosine kinase (ALK)/ROS proto-oncogene 1 (ROS1)/neurotrophic tyrosine receptor kinase (NTRK)/MET proto-oncogene (MET)/B-Raf proto-oncogene (BRAF)/RET proto-oncogene (RET) mutations amenable to targeted therapies
* Participants with any known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results
Note: Other protocol-defined inclusion/exclusion criteria apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/11/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
8/08/2024
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Sample size
Target
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Accrual to date
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Final
1
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Recruitment in Australia
Recruitment state(s)
NSW,WA
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Recruitment hospital [1]
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0
Local Institution - 0013 - St Leonards
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Recruitment hospital [2]
0
0
Local Institution - 0021 - Tweed Heads
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Recruitment hospital [3]
0
0
Local Institution - 0032 - Joondalup
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Recruitment postcode(s) [1]
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0
2065 - St Leonards
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Recruitment postcode(s) [2]
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0
2485 - Tweed Heads
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Recruitment postcode(s) [3]
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6027 - Joondalup
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Florida
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Idaho
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Country [4]
0
0
United States of America
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State/province [4]
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0
Texas
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the efficacy and safety of BMS-986315 plus nivolumab in combination with platinum-based doublet chemotherapy (PDCT) versus nivolumab in combination with PDCT in the first-line treatment of Stage IV or recurrent non-small cell lung cancer (NSCLC).
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Trial website
https://clinicaltrials.gov/study/NCT06094296
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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0
Bristol-Myers Squibb
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Address
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0
Bristol-Myers Squibb
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
BMS Study Connect Contact Center www.BMSStudyConnect.com
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Address
0
0
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Country
0
0
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Phone
0
0
855-907-3286
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Fax
0
0
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Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
See Plan Description
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Available to whom?
See Plan Description
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/96/NCT06094296/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/96/NCT06094296/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT06094296
Download to PDF