Trial results for a Phase 2 study (NCT06094296) evaluating nivolumab and BMS-986315 in combination with chemotherapy for non-small cell lung cancer (NSCLC) were posted on ClinicalTrials.gov on 2025-04-16. The study was terminated after enrolling only one participant, with safety data reported for this single individual.
Background
The study aimed to evaluate the efficacy and safety of BMS-986315 plus nivolumab in combination with platinum-based doublet chemotherapy (PDCT) compared to nivolumab in combination with PDCT. This was intended for the first-line treatment of Stage IV or recurrent non-small cell lung cancer (NSCLC).
Trial design
The study (NCT06094296) was a Phase 2 trial designed to investigate combination therapies for first-line Stage IV or recurrent non-small cell lung cancer (NSCLC). It intended to compare BMS-986315 plus nivolumab with platinum-based doublet chemotherapy (including pemetrexed, cisplatin, or carboplatin) against nivolumab with platinum-based doublet chemotherapy. The trial was terminated with an enrollment of only one participant.
Key results
Results posted detail safety outcomes for the one participant enrolled in Part 1 (BMS-986315 + Nivolumab + Histology-based Chemotherapy) of the study:
- The number of participants with Adverse Events (AEs) was 1.
- The number of participants with Treatment Related Adverse Events (TRAEs) was 1.
- The number of participants with Serious Adverse Events (SAEs) was 0.
- The number of participants with Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria was 0.
- The number of participants with Adverse Events (AEs) Leading to Discontinuation was 0.
- The number of participants who died was 0.
What this means
Due to the early termination of the study and the enrollment of only one participant, no conclusions regarding the efficacy or overall safety profile of the investigational combinations in a broader patient population can be drawn from these posted results. The safety data reflects the experience of a single individual.
Source
The information for this article was sourced from ClinicalTrials.gov, a public database of clinical studies. The trial results for study NCT06094296, titled "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)," were posted on 2025-04-16 on clinicaltrials.gov.