NCT06094296

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)

Terminated Phase 2 Results posted Last updated 16 April 2025

What this trial tests

Phase 2 trial testing BMS-986315 in NSCLC in 1 participant. Terminated before completion.

Timeline

27 November 2023

Primary endpoint
8 August 2024

8 August 2024

Quick facts

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	1
Start date	27 November 2023
Primary completion	8 August 2024
Estimated completion	8 August 2024
Sites	8 locations across United States, Australia

Drugs / interventions tested

• BMS-986315
• Nivolumab
• Pemetrexed — full drug profile →
• Cisplatin (cisplatin) — full drug profile →
• Carboplatin
• Paclitaxel — full drug profile →

Conditions studied

• NSCLC — all drugs for NSCLC →

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

18 and older, any sex, with NSCLC. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Adverse Events (AEs) for Part 1 Primary · 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.

Group	Value	95% CI
Part 1: BMS-986315 + Nivolumab + Histology-based Chemotherapy	1

Number of Participants With Treatment Related Adverse Events (TRAEs) for Part 1 Primary · 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.

Group	Value	95% CI
Part 1: BMS-986315 + Nivolumab + Histology-based Chemotherapy	1

Number of Participants With Serious Adverse Events (SAEs) for Part 1 Primary · 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.

Group	Value	95% CI
Part 1: BMS-986315 + Nivolumab + Histology-based Chemotherapy	0

Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria for Part 1 Primary · 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 b

Group	Value	95% CI
Part 1: BMS-986315 + Nivolumab + Histology-based Chemotherapy	0

Number of Participants With Adverse Events (AEs) Leading to Discontinuation for Part 1 Primary · 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.

Group	Value	95% CI
Part 1: BMS-986315 + Nivolumab + Histology-based Chemotherapy	0

Number of Participants Who Died in Part 1 Primary · 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

Group	Value	95% CI
Part 1: BMS-986315 + Nivolumab + Histology-based Chemotherapy	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 7 months). SAEs and Other AEs were assessed from first dose through 100 days following last dose of study treatment (up to approximately 7 months).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1: BMS-986315 + Nivolumab + Histology-based Chemotherapy

Serious: 0/1 (0%)

Deaths: 0/1

Other adverse events (6 terms — click to expand)

Reaction	System	Part 1: BMS-986315 + Nivol…
Anaemia	Blood and lymphatic system disorders	—
Fatigue	General disorders	—
Hyponatraemia	Metabolism and nutrition disorders	—
Depression	Psychiatric disorders	—
Insomnia	Psychiatric disorders	—
Rash	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT06094296 adverse events section.

Sponsor's own description

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).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Unlocking the therapeutic potential of the NKG2A-HLA-E immune checkpoint pathway in T cells and NK cells for cancer immunotherapy.
   Li Y, Li Z, Tang Y, Zhuang X, et al · · 2024 · cited 26× · PMID 39486805 · DOI 10.1136/jitc-2024-009934
2. Targeting Immune Checkpoint Inhibitors for Non-Small-Cell Lung Cancer: Beyond PD-1/PD-L1 Monoclonal Antibodies.
   Roussot N, Kaderbhai C, Ghiringhelli F. · · 2025 · cited 8× · PMID 40075753 · DOI 10.3390/cancers17050906
3. Strategies to disrupt NKG2A:HLA-E interactions for improved anti-cancer immunity.
   Fisher JG, Graham LV, Blunt MD. · · 2024 · cited 4× · PMID 39018202 · DOI 10.18632/oncotarget.28610
4. CD40L and IL-4 suppress NK cell-mediated antibody-dependent cellular cytotoxicity through the HLA-E:NKG2A axis.
   Graham LV, Horehajova L, Haselager MV, Fisher JG, et al · · 2025 · cited 1× · PMID 40977848 · DOI 10.1093/immadv/ltaf029