NSCLCPhase 2NCT06094296
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)
A Phase 2 study testing BMS-986315, Nivolumab and Pemetrexed in people with NSCLC, run by Bristol-Myers Squibb at 8 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- BMS-986315, Nivolumab and Pemetrexed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 27 Nov 2023to 8 Aug 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States5 sites
Local Institution - 0058
Boise, Idaho, 83706
Local Institution - 0044
Clermont, Florida, 34711
Local Institution - 0038
Glendale, California, 37219
Local Institution - 0049
Houston, Texas, 77090
Local Institution - 0040
Orange City, Florida, 32763
Australia3 sites
Local Institution - 0032
Joondalup, Western Australia, 6027
Local Institution - 0013
St Leonards, New South Wales, 2065
Local Institution - 0021
Tweed Heads, New South Wales, 2485
About this study
Official 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)
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).
- Conditions
- NSCLC
- Being tested
- BMS-986315, Nivolumab, Pemetrexed, Cisplatin, Carboplatin
- Keywords
- Pharmacokinetics, BMS-986315, Nivolumab, Platinum doublet chemotherapy, NSCLC, Lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986315Drug
Also called Anti-NKG2A
Specified dose on specified days
NivolumabDrug
Also called Opdivo, BMS-936558
Specified dose on specified days
PemetrexedDrug
Specified dose on specified days
CisplatinDrug
Specified dose on specified days
CarboplatinDrug
Specified dose on specified days
PaclitaxelDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1: BMS-986315 Dose Level (DL) 1 + Nivolumab + Histology-based PDCT | Experimental | Not described Receives: Drug: BMS-986315; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel |
| Part 1: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT | Experimental | Not described Receives: Drug: BMS-986315; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel |
| Part 2: Nivolumab + Histology-based PDCT | Active comparator | Not described Receives: Drug: Nivolumab; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel |
| Part 2: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT | Experimental | Not described Receives: Drug: BMS-986315; Drug: Nivolumab; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel |
| Part 2: BMS-986315 DL 1 + Nivolumab + Histology-based PDCT | Experimental | Not described Receives: Drug: BMS-986315; Drug: Nivolumab; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs) for Part 1
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.
Measured: From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)
Number of Participants With Treatment Related Adverse Events (TRAEs) for Part 1
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.
Measured: From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)
Number of Participants With Serious Adverse Events (SAEs) for Part 1
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.
Measured: From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)
Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria for Part 1
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)
Measured: From first dose (Cycle 1 Day 1) up to day 28
Number of Participants With Adverse Events (AEs) Leading to Discontinuation for Part 1
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.
Measured: From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)
Number of Participants Who Died in Part 1
Number of participants who died during the study
Measured: From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)
Objective Response Rate (ORR) for Part 2
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.
Measured: 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 outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start27 Nov 2023
- Primary completion8 Aug 2024
- Study completion8 Aug 2024
Why it stopped: Business objectives have changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094296
- Sponsor's protocol ID
- CA047-1009
- Other IDs
- 2022-503007-22, U1111-1282-5699
- Status last verified
- Mar 2025
- First submitted
- 17 Oct 2023
- Last updated
- 16 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT06094296
- Acronym / sponsor ID
- CA047-1009
- Conditions
- NSCLC
- Keywords
- Pharmacokinetics, BMS-986315, Nivolumab, Platinum doublet chemotherapy, NSCLC, Lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business objectives have changed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 8 Aug 2024 (actual)
- Study completion
- 8 Aug 2024 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Posted 16 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1: BMS-986315 Dose Level (DL) 1 + Nivolumab + Histology-based PDCT | Experimental | Drug: BMS-986315, Drug: Pemetrexed, Drug: Cisplatin, Drug: Carboplatin, Drug: Paclitaxel |
| Part 1: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT | Experimental | Drug: BMS-986315, Drug: Pemetrexed, Drug: Cisplatin, Drug: Carboplatin, Drug: Paclitaxel |
| Part 2: Nivolumab + Histology-based PDCT | Active comparator | Drug: Nivolumab, Drug: Pemetrexed, Drug: Cisplatin, Drug: Carboplatin, Drug: Paclitaxel |
| Part 2: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT | Experimental | Drug: BMS-986315, Drug: Nivolumab, Drug: Pemetrexed, Drug: Cisplatin, Drug: Carboplatin, Drug: Paclitaxel |
| Part 2: BMS-986315 DL 1 + Nivolumab + Histology-based PDCT | Experimental | Drug: BMS-986315, Drug: Nivolumab, Drug: Pemetrexed, Drug: Cisplatin, Drug: Carboplatin, Drug: Paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-986315Also: Anti-NKG2ASpecified dose on specified days | Drug | Part 1: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT, Part 1: BMS-986315 Dose Level (DL) 1 + Nivolumab + Histology-based PDCT, Part 2: BMS-986315 DL 1 + Nivolumab + Histology-based PDCT, Part 2: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT |
| NivolumabAlso: Opdivo, BMS-936558Specified dose on specified days | Drug | Part 2: BMS-986315 DL 1 + Nivolumab + Histology-based PDCT, Part 2: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT, Part 2: Nivolumab + Histology-based PDCT |
| PemetrexedSpecified dose on specified days | Drug | Part 1: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT, Part 1: BMS-986315 Dose Level (DL) 1 + Nivolumab + Histology-based PDCT, Part 2: BMS-986315 DL 1 + Nivolumab + Histology-based PDCT, Part 2: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT, Part 2: Nivolumab + Histology-based PDCT |
| CisplatinSpecified dose on specified days | Drug | Part 1: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT, Part 1: BMS-986315 Dose Level (DL) 1 + Nivolumab + Histology-based PDCT, Part 2: BMS-986315 DL 1 + Nivolumab + Histology-based PDCT, Part 2: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT, Part 2: Nivolumab + Histology-based PDCT |
| CarboplatinSpecified dose on specified days | Drug | Part 1: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT, Part 1: BMS-986315 Dose Level (DL) 1 + Nivolumab + Histology-based PDCT, Part 2: BMS-986315 DL 1 + Nivolumab + Histology-based PDCT, Part 2: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT, Part 2: Nivolumab + Histology-based PDCT |
| PaclitaxelSpecified dose on specified days | Drug | Part 1: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT, Part 1: BMS-986315 Dose Level (DL) 1 + Nivolumab + Histology-based PDCT, Part 2: BMS-986315 DL 1 + Nivolumab + Histology-based PDCT, Part 2: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT, Part 2: Nivolumab + Histology-based PDCT |
Primary outcome
Number of Participants With Adverse Events (AEs) for Part 1
Time frame: From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)
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.
Number of Participants With Treatment Related Adverse Events (TRAEs) for Part 1
Time frame: From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)
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.
Number of Participants With Serious Adverse Events (SAEs) for Part 1
Time frame: From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)
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.
Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria for Part 1
Time frame: From first dose (Cycle 1 Day 1) up to day 28
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)
Number of Participants With Adverse Events (AEs) Leading to Discontinuation for Part 1
Time frame: From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)
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.
Number of Participants Who Died in Part 1
Time frame: From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)
Number of participants who died during the study
Objective Response Rate (ORR) for Part 2
Time frame: 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)
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.
14 secondary outcomes
Progression Free Survival (PFS) for Part 2
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
Time frame: Up to 100 days after discontinuation of study treatment
Number of Participants With Treatment Related Adverse Events (TRAEs) for Part 2
Time frame: Up to 100 days after discontinuation of study treatment
Number of Participants With Serious Adverse Events (SAEs) for Part 2
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
Time frame: Up to 100 days after discontinuation of study treatment
Number of Participants With Adverse Events (AEs) Leading to Discontinuation for Part 2
Time frame: Up to 100 days after discontinuation of study treatment
Number of Participants Who Died in Part 2
Time frame: Up to 100 days after discontinuation of study treatment
Duration of Response (DoR) for Part 2
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 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
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
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
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
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
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMS-986315, Nivolumab and Pemetrexed in people with NSCLC, run by Bristol-Myers Squibb at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs) for Part 1 (time frame: From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.