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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

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)
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)
Secondary ID [1] 0 0
2022-503007-22
Secondary ID [2] 0 0
CA047-1009
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
NSCLC 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events (AEs) for Part 1
Timepoint [1] 0 0
From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)
Primary outcome [2] 0 0
Number of Participants With Treatment Related Adverse Events (TRAEs) for Part 1
Timepoint [2] 0 0
From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)
Primary outcome [3] 0 0
Number of Participants With Serious Adverse Events (SAEs) for Part 1
Timepoint [3] 0 0
From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)
Primary outcome [4] 0 0
Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria for Part 1
Timepoint [4] 0 0
From first dose (Cycle 1 Day 1) up to day 28
Primary outcome [5] 0 0
Number of Participants With Adverse Events (AEs) Leading to Discontinuation for Part 1
Timepoint [5] 0 0
From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)
Primary outcome [6] 0 0
Number of Participants Who Died in Part 1
Timepoint [6] 0 0
From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)
Primary outcome [7] 0 0
Objective Response Rate (ORR) for Part 2
Timepoint [7] 0 0
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)
Secondary outcome [1] 0 0
Progression Free Survival (PFS) for Part 2
Timepoint [1] 0 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)
Secondary outcome [2] 0 0
Number of Participants With Adverse Events (AEs) for Part 2
Timepoint [2] 0 0
Up to 100 days after discontinuation of study treatment
Secondary outcome [3] 0 0
Number of Participants With Treatment Related Adverse Events (TRAEs) for Part 2
Timepoint [3] 0 0
Up to 100 days after discontinuation of study treatment
Secondary outcome [4] 0 0
Number of Participants With Serious Adverse Events (SAEs) for Part 2
Timepoint [4] 0 0
Up to 100 days after discontinuation of study treatment
Secondary outcome [5] 0 0
Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria for Part 2
Timepoint [5] 0 0
Up to 100 days after discontinuation of study treatment
Secondary outcome [6] 0 0
Number of Participants With Adverse Events (AEs) Leading to Discontinuation for Part 2
Timepoint [6] 0 0
Up to 100 days after discontinuation of study treatment
Secondary outcome [7] 0 0
Number of Participants Who Died in Part 2
Timepoint [7] 0 0
Up to 100 days after discontinuation of study treatment
Secondary outcome [8] 0 0
Duration of Response (DoR) for Part 2
Timepoint [8] 0 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)
Secondary outcome [9] 0 0
Time to Objective Response (TTR) for Part 2
Timepoint [9] 0 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)
Secondary outcome [10] 0 0
Disease Control Rate (DCR) for Part 2
Timepoint [10] 0 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)
Secondary outcome [11] 0 0
Maximum Observed Serum Concentration (Cmax) for Part 2
Timepoint [11] 0 0
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)
Secondary outcome [12] 0 0
Time of Maximum Observed Concentration (Tmax) for Part 2
Timepoint [12] 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)
Secondary outcome [13] 0 0
Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for Part 2
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)
Secondary outcome [14] 0 0
Number of Participants With Anti-drug Antibodies (ADA) to BMS-986315 for Part 2
Timepoint [14] 0 0
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)

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/08/2024
Sample size
Target
Accrual to date
Final
1
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Local Institution - 0013 - St Leonards
Recruitment hospital [2] 0 0
Local Institution - 0021 - Tweed Heads
Recruitment hospital [3] 0 0
Local Institution - 0032 - Joondalup
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [3] 0 0
6027 - Joondalup
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Idaho
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BMS Study Connect Contact Center www.BMSStudyConnect.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT06094296