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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
25/06/2024
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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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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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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Part 1: Number of Participants with Adverse Events (AEs)
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Assessment method [1]
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Timepoint [1]
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Up to 100 days after discontinuation of study treatment
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Primary outcome [2]
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Part 1: Number of Participants with Treatment-related AEs (TRAEs)
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Assessment method [2]
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0
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Timepoint [2]
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Up to 100 days after discontinuation of study treatment
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Primary outcome [3]
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Part 1: Number of Participants with Serious AEs (SAEs)
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Assessment method [3]
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Timepoint [3]
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Up to 100 days after discontinuation of study treatment
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Primary outcome [4]
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Part 1: Number of Participants with AEs Meeting Protocol-defined Dose Limiting Toxicity DLT Criteria
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Assessment method [4]
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Timepoint [4]
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Up to 100 days after discontinuation of study treatment
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Primary outcome [5]
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Part 1: Number of Participants with AEs Leading to Discontinuation
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Assessment method [5]
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Timepoint [5]
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Up to 100 days after discontinuation of study treatment
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Primary outcome [6]
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Part 1: Number of Participants with AEs Leading to Death
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Assessment method [6]
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Timepoint [6]
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Up to 100 days after discontinuation of study treatment
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Primary outcome [7]
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Part 2: Objective Response Rate (ORR)
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Assessment method [7]
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Timepoint [7]
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Up to 5 years
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Secondary outcome [1]
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Part 2: Progression Free Survival (PFS)
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Assessment method [1]
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Timepoint [1]
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Up to 5 years
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Secondary outcome [2]
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Part 2: Number of Participants with AEs
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Assessment method [2]
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0
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Timepoint [2]
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Up to 100 days after discontinuation of study treatment
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Secondary outcome [3]
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Part 2: Number of Participants with TRAEs
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Assessment method [3]
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0
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Timepoint [3]
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Up to 100 days after discontinuation of study treatment
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Secondary outcome [4]
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Part 2: Number of Participants with SAEs
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Assessment method [4]
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Timepoint [4]
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Up to 100 days after discontinuation of study treatment
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Secondary outcome [5]
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Part 2: Number of Participants with AEs Meeting Protocol-defined Dose Limiting Toxicity DLT Criteria
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Assessment method [5]
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0
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Timepoint [5]
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Up to 100 days after discontinuation of study treatment
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Secondary outcome [6]
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Part 2: Duration of Response (DOR)
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Assessment method [6]
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0
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Timepoint [6]
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Up to 5 years
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Secondary outcome [7]
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Part 2: Time to Response (TTR)
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Assessment method [7]
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Timepoint [7]
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Up to 5 years
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Secondary outcome [8]
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Part 2: Disease Control Rate (DCR)
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Assessment method [8]
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Timepoint [8]
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Up to 5 years
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Secondary outcome [9]
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Part 2: Maximum Observed Serum Concentration (Cmax)
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Assessment method [9]
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Timepoint [9]
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Predose and postdose up to 2 years
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Secondary outcome [10]
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Part 2: Time of Cmax (Tmax)
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Assessment method [10]
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Timepoint [10]
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Predose and postdose up to 2 years
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Secondary outcome [11]
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Part 2: Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T])
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Assessment method [11]
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Timepoint [11]
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Predose and postdose up to 2 years
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Secondary outcome [12]
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Part 2: Number of Participants with Anti-drug Antibodies to BMS-986315
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Assessment method [12]
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Timepoint [12]
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Up to 5 years
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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
Active, not recruiting
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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
27/10/2027
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Actual
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Sample size
Target
196
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,WA
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Recruitment hospital [1]
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Local Institution - 0013 - St Leonards
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Recruitment hospital [2]
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Local Institution - 0021 - Tweed Heads
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Recruitment hospital [3]
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Local Institution - 0032 - Joondalup
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Recruitment postcode(s) [1]
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2065 - St Leonards
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Recruitment postcode(s) [2]
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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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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Florida
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Country [3]
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United States of America
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State/province [3]
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Idaho
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Country [4]
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United States of America
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State/province [4]
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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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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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BMS Study Connect Contact Center www.BMSStudyConnect.com
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Address
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Country
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Phone
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855-907-3286
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/study/NCT06094296
Download to PDF