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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
Part 1: Number of Participants with Adverse Events (AEs)
Timepoint [1] 0 0
Up to 100 days after discontinuation of study treatment
Primary outcome [2] 0 0
Part 1: Number of Participants with Treatment-related AEs (TRAEs)
Timepoint [2] 0 0
Up to 100 days after discontinuation of study treatment
Primary outcome [3] 0 0
Part 1: Number of Participants with Serious AEs (SAEs)
Timepoint [3] 0 0
Up to 100 days after discontinuation of study treatment
Primary outcome [4] 0 0
Part 1: Number of Participants with AEs Meeting Protocol-defined Dose Limiting Toxicity DLT Criteria
Timepoint [4] 0 0
Up to 100 days after discontinuation of study treatment
Primary outcome [5] 0 0
Part 1: Number of Participants with AEs Leading to Discontinuation
Timepoint [5] 0 0
Up to 100 days after discontinuation of study treatment
Primary outcome [6] 0 0
Part 1: Number of Participants with AEs Leading to Death
Timepoint [6] 0 0
Up to 100 days after discontinuation of study treatment
Primary outcome [7] 0 0
Part 2: Objective Response Rate (ORR)
Timepoint [7] 0 0
Up to 5 years
Secondary outcome [1] 0 0
Part 2: Progression Free Survival (PFS)
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [2] 0 0
Part 2: Number of Participants with AEs
Timepoint [2] 0 0
Up to 100 days after discontinuation of study treatment
Secondary outcome [3] 0 0
Part 2: Number of Participants with TRAEs
Timepoint [3] 0 0
Up to 100 days after discontinuation of study treatment
Secondary outcome [4] 0 0
Part 2: Number of Participants with SAEs
Timepoint [4] 0 0
Up to 100 days after discontinuation of study treatment
Secondary outcome [5] 0 0
Part 2: Number of Participants with AEs Meeting Protocol-defined Dose Limiting Toxicity DLT Criteria
Timepoint [5] 0 0
Up to 100 days after discontinuation of study treatment
Secondary outcome [6] 0 0
Part 2: Duration of Response (DOR)
Timepoint [6] 0 0
Up to 5 years
Secondary outcome [7] 0 0
Part 2: Time to Response (TTR)
Timepoint [7] 0 0
Up to 5 years
Secondary outcome [8] 0 0
Part 2: Disease Control Rate (DCR)
Timepoint [8] 0 0
Up to 5 years
Secondary outcome [9] 0 0
Part 2: Maximum Observed Serum Concentration (Cmax)
Timepoint [9] 0 0
Predose and postdose up to 2 years
Secondary outcome [10] 0 0
Part 2: Time of Cmax (Tmax)
Timepoint [10] 0 0
Predose and postdose up to 2 years
Secondary outcome [11] 0 0
Part 2: Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T])
Timepoint [11] 0 0
Predose and postdose up to 2 years
Secondary outcome [12] 0 0
Part 2: Number of Participants with Anti-drug Antibodies to BMS-986315
Timepoint [12] 0 0
Up to 5 years

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
Active, not recruiting
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
27/10/2027
Actual
Sample size
Target
196
Accrual to date
Final
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
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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)
When will data be available (start and end dates)?
See Plan Description
Available to whom?
See Plan Description
Available for what types of analyses?
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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06094296