This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for 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) (NCT06094296), a randomized phase 2 study. The primary outcome is Objective Response Rate (ORR) for Part 2.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06094296 |
| Phase | Phase 2 |
| Condition | NSCLC |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 1 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Bristol-Myers Squibb |
| Results posted | Yes |
2. Clinical Question
Population
Adults with stage IV or recurrent non-small cell lung cancer (NSCLC) were the intended population for first-line treatment. The primary outcome was specified for Part 2 only. The registry record states that no participants were enrolled in Part 2 because the study was terminated; therefore, no primary endpoint data were collected. Further eligibility details are not reported in the registry record.
Intervention
The study planned to evaluate BMS-986315 with nivolumab and histology-based platinum doublet chemotherapy. Part 1 listed BMS-986315 dose level 1 and dose level 2 combinations. Part 2 also listed those dose levels with nivolumab and chemotherapy. The registry lists pemetrexed, cisplatin, carboplatin, and paclitaxel among the interventions. The arm descriptions do not give additional details about how the chemotherapy regimens were selected.
Comparator
The planned Part 2 comparator was nivolumab with histology-based platinum doublet chemotherapy. The primary outcome was intended to compare response under the BMS-986315 combinations with response under this comparator. Because Part 2 enrolled no participants, the registry record contains no observed comparison of these treatment groups.
Primary question
The primary question was whether adding BMS-986315 to nivolumab and chemotherapy changed the objective response rate (ORR) in Part 2. ORR was defined using confirmed complete or partial responses assessed by blinded independent central review under RECIST 1.1. The planned denominator was all randomized participants. With no Part 2 enrollment and no collected endpoint data, the registry record cannot answer this efficacy question.
3. Trial Design
This was a randomized, double-blind, phase 2 study with a parallel-group model and quadruple masking, according to the registry record. It planned to evaluate BMS-986315 plus nivolumab and platinum-based doublet chemotherapy against nivolumab and the same general chemotherapy approach as first-line treatment for stage IV or recurrent NSCLC. The registry lists pemetrexed, cisplatin, carboplatin, and paclitaxel as interventions. The specific chemotherapy choices and their allocation by histology are not described in the arm descriptions.
The record separates the study into Part 1 and Part 2. Part 1 listed BMS-986315 dose level 1 and dose level 2 with nivolumab and histology-based chemotherapy. Part 2 listed those dose-level combinations as well as nivolumab with histology-based chemotherapy alone. Part 2 was the only part specified for the primary ORR outcome. No participants were enrolled in Part 2 because of study termination, and no data were collected for that endpoint. The registry lists enrollment 1 overall and reports one Part 1 safety group.
The study start date is 2023-11-27, the primary completion date is 2024-08-08, and the status is terminated. The reason for termination is not reported in the registry record. Although randomization and masking are recorded as design features, details such as the randomization procedure, concealment, and how masking was maintained are not reported in the registry record. The planned study duration for the primary outcome was up to approximately 5 years, but that planned follow-up does not mean that participants were observed for that duration.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: In Part 1 one participant received study treatment. In Part 2 no participants were enrolled.
Overall Study
| Stage | Part 1: BMS-986315 + Nivolumab + Histology-based Chemotherapy | Part 2 Arm A: Nivolumab + Histology-based Chemotherapy | Part 2 Arm B: BMS-986315 + Nivolumab + Histology-based Chemotherapy | Part 2 Arm C: BMS-986315 + Nivolumab + Histology-based Chemotherapy |
|---|---|---|---|---|
| STARTED | 1 | 0 | 0 | 0 |
| COMPLETED | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 1 | 0 | 0 | 0 |
Reasons for not completing this period:
| Reason | Part 1: BMS-986315 + Nivolumab + Histology-based Chemotherapy | Part 2 Arm A: Nivolumab + Histology-based Chemotherapy | Part 2 Arm B: BMS-986315 + Nivolumab + Histology-based Chemotherapy | Part 2 Arm C: BMS-986315 + Nivolumab + Histology-based Chemotherapy |
|---|---|---|---|---|
| Progressive Disease | 1 | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: All Treated Participants for Part 1. Pre-specified to be reported for Part 1 only.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: In Part 2, no participants were enrolled, so no analysis was conducted
| Characteristic | Unit | Part 1: BMS-986315 + Nivolumab + Histology-based Chemotherapy | Part 2 Arm A: Nivolumab + Histology-based Chemotherapy | Part 2 Arm B: BMS-986315 + Nivolumab + Histology-based Chemotherapy | Part 2 Arm C: BMS-986315 + Nivolumab + Histology-based Chemotherapy | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 1 | 0 | 0 | 0 | 1 | |
| Age, Categorical: <=18 years | Participants | 0 | — | — | — | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 1 | — | — | — | 1 |
| Age, Categorical: >=65 years | Participants | 0 | — | — | — | 0 |
| Sex: Female, Male: Female | Participants | NA | — | — | — | NA |
| Sex: Female, Male: Male | Participants | NA | — | — | — | NA |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | NA | — | — | — | NA |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | NA | — | — | — | NA |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | NA | — | — | — | NA |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | NA | — | — | — | NA |
| Race (NIH/OMB): Asian | Participants | NA | — | — | — | NA |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | NA | — | — | — | NA |
| Race (NIH/OMB): Black or African American | Participants | NA | — | — | — | NA |
| Race (NIH/OMB): White | Participants | NA | — | — | — | NA |
| Race (NIH/OMB): More than one race | Participants | NA | — | — | — | NA |
| Race (NIH/OMB): Unknown or Not Reported | Participants | NA | — | — | — | NA |
6. Primary Endpoint
The registry lists the primary outcome as Objective Response Rate (ORR) for Part 2, measured over 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).
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was objective response rate (ORR) for Part 2. It was defined as the number of participants whose best overall response was a confirmed complete response or confirmed partial response, divided by all randomized participants. Response was to be assessed by blinded independent central review using RECIST 1.1. A complete response required disappearance of all target lesions and reduction of pathological lymph nodes to less than 10 mm in short axis. A partial response required at least a 30% decrease in the sum of target-lesion diameters relative to baseline.
ORR reduces tumor-response assessments to a proportion of participants meeting a specified response definition. It is useful for describing the frequency of confirmed responses under the assessment rules, but it does not by itself describe how long a response lasts, whether disease control persists, or how treatment groups compare on other outcomes. The registry also listed duration of response and progression-free survival as secondary outcomes for Part 2.
The planned assessment period ran from randomization until the first objectively documented progression or the start of subsequent therapy, whichever occurred first, with follow-up planned for up to approximately 5 years. The registry record says that no participants were enrolled in Part 2 and no data were collected for ORR. Thus, there is no observed Part 2 response proportion to interpret.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central statistical fact is that the primary endpoint belongs to Part 2, and Part 2 had no enrolled participants because the study was terminated. Consequently, the registry contains no observed Part 2 ORR, no estimate of the difference between the planned groups, and no uncertainty interval for that comparison. No efficacy conclusion about BMS-986315 with nivolumab and chemotherapy versus nivolumab with chemotherapy can be drawn from this endpoint record.
The registry lists enrollment 1 overall and reports a Part 1 safety group with 1 participant at risk. This does not constitute evidence for the planned randomized Part 2 comparison. The record contains no response data for that safety group, and its existence does not fill the missing primary outcome. The registry reports zero analyses. It therefore does not offer a sponsor analysis or an inferential result that could be used in place of the absent Part 2 comparison.
The planned ORR definition is specific: confirmed complete or partial response, assessed by blinded independent central review under RECIST 1.1, with all randomized participants as the denominator. These rules would define what is counted in an analysis if data had been collected. They do not produce an estimate when the relevant part enrolled no participants. In particular, the detailed response thresholds should not be mistaken for observed response findings.
The record also lists secondary outcomes, including progression-free survival, duration of response, and several adverse-event measures for Part 2. Their listing identifies intended measurements, not results. Since Part 2 did not enroll participants, no Part 2 data were collected for its primary endpoint; numerical results for those secondary outcomes are not reported in the registry record.
Termination is a status, not an explanation. The reason for termination is not reported in the registry record, so the record does not establish why enrollment stopped or whether the termination was related to safety, feasibility, a business decision, or another cause. Those explanations should not be inferred from the absence of efficacy data.
Overall, the posted information describes the intended comparison and reports limited Part 1 safety counts, but it does not estimate treatment efficacy. The appropriate statistical interpretation is that the planned Part 2 question remains unanswered in this registry record, rather than that the two regimens had equal or different response rates.
9. Statistical Methods Explained
The planned primary outcome was a proportion: the number of randomized participants meeting the confirmed-response definition divided by all randomized participants. In general, a proportion describes how often a binary event occurs within a defined group. For ORR, each participant would be classified according to whether the best overall response met the criteria for confirmed complete or partial response. The record gives those criteria and names blinded independent central review and RECIST 1.1 as the assessment framework.
In a comparative trial, the response proportion in each group can be estimated and contrasted. An estimate is a summary of the observed data, while a confidence interval describes the statistical uncertainty around an estimate under the assumptions of the method used. A wider interval generally indicates less precision; a narrow interval generally indicates greater precision. These are general statistical interpretations, not findings from this study. No Part 2 response proportions or confidence intervals are reported in the registry record because no participants were enrolled in Part 2 and no primary endpoint data were collected.
The definition of the endpoint matters because response classification depends on both the measurement rules and the assessment process. Complete response required disappearance of target lesions and a specified lymph-node size criterion. Partial response required a decrease in the sum of target-lesion diameters relative to baseline. Confirmation and independent central review are part of the registered definition. The registry record does not report operational details such as the timing or frequency of assessments, how missing or unevaluable scans would be handled, or how disagreements in review would be resolved.
Randomization is intended, in general, to support comparison by assigning participants to treatment groups through a chance-based process. It can reduce systematic differences between groups at baseline when implemented as planned, but it does not guarantee balance in every trial. The registry identifies the study as randomized, but the specific sequence-generation and allocation-concealment methods are not reported in the registry record. Because Part 2 enrolled no participants, the planned randomized contrast did not yield an efficacy comparison in this record.
Masking can reduce the influence of expectations on treatment delivery, outcome assessment, or reporting. The record labels the study quadruple-masked and double-blind in its official title. It does not specify which roles were masked or how masking was maintained. The primary endpoint was assigned to blinded independent central review, but no Part 2 assessments were collected. Masking describes a planned design feature; it cannot replace outcome data or establish that a treatment effect exists.
The record does not report the statistical analysis plan, including the planned model or test for comparing response rates, the handling of multiple dose levels, or the method for constructing confidence intervals. It also does not report a sample-size justification. Planning illustrations use a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation, with the effect to detect stated as a fraction of the observed effect. Such illustrations are planning calculations, not observed power and not proof that the trial was designed or conducted according to those assumptions. They should not be interpreted as evidence about efficacy.
Outcome populations are another important methods issue. The endpoint definition names all randomized participants as its denominator. The registry record does not report a detailed analysis-population specification, such as how participants who did not receive treatment or who lacked an evaluable assessment would be handled. Nor does it report rules for missing data, censoring, protocol deviations, or treatment changes. General statistical practice requires such rules to be specified because choices about inclusion and missing observations can affect estimates. No particular approach can be attributed to this study from the registry record.
Finally, the registry lists 21 outcome measures and zero analyses. Listing an endpoint records an intended measurement; it is not a statistical result. With no Part 2 enrollment, there is no Part 2 dataset from which to estimate ORR, progression-free survival, duration of response, or the listed Part 2 safety outcomes. The methods description therefore explains what the planned primary measure was designed to represent, but cannot establish how the planned comparative analysis would have performed on observed data.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists multiple outcomes and several planned BMS-986315 dose levels, but it does not report how multiplicity was to be handled. When several outcomes, dose levels, or statistical comparisons are examined, the chance of at least one apparently notable result can increase. Statistical plans sometimes address this through a prespecified hierarchy, adjustment procedure, or distinction between confirmatory and exploratory analyses. No such approach is reported in the registry record, so none should be assumed.
There are no reported Part 2 primary endpoint data to analyze. The record specifies all randomized participants as the denominator for ORR, but it does not describe how missing assessments, unevaluable responses, withdrawals, or deviations from treatment would be classified. It also does not report a missing-data method or sensitivity analyses. These omissions matter when interpreting a nonempty dataset, but they cannot be resolved by calculation in the absence of Part 2 enrollment and outcome data.
The analysis population definitions, handling of participants after subsequent therapy, and any rules for censoring time-to-event outcomes are not reported in the registry record. The primary endpoint's planned observation period mentions progression or start of subsequent therapy as its stopping condition, but the record does not provide a full analysis procedure. No assumptions about these matters can be inferred from the listed outcome names.
Because the registry reports zero analyses and no Part 2 enrollment, there are no Part 2 estimates whose multiplicity or missing-data handling can be evaluated. The absent statistical plan limits understanding of the intended inferential approach, while the absent endpoint observations mean there is no efficacy result to qualify.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Part 1: BMS-986315 + Nivolumab + Histology-based Chemotherapy | 0 | 1 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Part 1: BMS-986315 + Nivolumab + Histology-based Chemotherapy | 0 of 1 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Part 1: BMS-986315 + Nivolumab + Histology-based Chemotherapy | 1 of 1 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Part 1: BMS-986315 + Nivolumab + Histology-based Chemotherapy |
|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 1 of 1 |
| Fatigue | General disorders | 1 of 1 |
| Hyponatraemia | Metabolism and nutrition disorders | 1 of 1 |
| Depression | Psychiatric disorders | 1 of 1 |
| Insomnia | Psychiatric disorders | 1 of 1 |
| Rash | Skin and subcutaneous tissue disorders | 1 of 1 |
The registry reports one Part 1 safety group: BMS-986315 with nivolumab and histology-based chemotherapy. It lists 1 participant at risk for serious adverse events, 0 serious adverse events, 1 participant at risk for other adverse events, 1 participant with an other adverse event, and 0 deaths. These are the safety counts recorded for that group; they are not a comparison between randomized treatment arms.
The record does not list any serious adverse-event terms, so the types of serious events are not reported in the registry record. The listed other adverse event is not identified by term in the provided safety information. The counts alone do not describe severity, timing, duration, causality, or whether an event led to a treatment change. Those details are not reported in the registry record.
These data are limited to Part 1 and should not be used as safety results for Part 2. Part 2 had no enrolled participants, so its adverse-event outcomes were not collected. The small amount of recorded safety information does not permit a meaningful comparative safety estimate or establish the frequency of events in a broader population.
12. What the Result Does, and Does Not, Mean
The registry record documents a planned randomized comparison, but it does not contain an efficacy result for the primary question. Part 2 was designated for ORR, and no participants were enrolled in that part because the study was terminated. No response data were collected. The absence of an ORR estimate is not evidence that response rates were the same, and it is not evidence that one regimen was better than the other.
The record does report limited Part 1 safety counts. Those counts describe one registered safety group and do not provide a comparison between the planned Part 2 groups. They also do not establish the safety profile of either regimen in a broader patient population. The absence of serious adverse events in the recorded group should be read as a count in that group, not as proof that serious events cannot occur.
The endpoint definition and planned follow-up describe what the investigators intended to measure. They do not show that the outcome was assessed or that follow-up reached the planned duration. Likewise, listing progression-free survival, duration of response, and adverse-event measures does not mean those outcomes have reported results.
The study's terminated status is recorded, but the reason is not reported in the registry record. Without that context, termination should not be interpreted as evidence of a safety problem, lack of efficacy, or any other specific explanation. The statistical meaning is narrower: the planned Part 2 endpoint cannot be estimated from the reported record, and the intended treatment comparison remains unresolved.
13. Why This Trial Matters Statistically
This trial is statistically instructive because a clearly specified endpoint and a recognizable randomized design do not guarantee an interpretable treatment comparison. The registry describes how ORR was to be defined, who was to assess it, and the intended denominator. Yet no Part 2 participants were enrolled, so none of those design elements produced an observed efficacy estimate.
The distinction between an intended measurement and a result is essential when reading trial registries. An endpoint listing tells readers what investigators planned to measure; it does not show that observations were collected. Similarly, a planned follow-up horizon does not establish the duration of actual observation. In this record, the primary endpoint was planned for Part 2, while the reported safety data come from Part 1. Keeping those parts separate prevents the limited safety counts from being mistaken for evidence about the primary efficacy question.
The record also illustrates the value of reporting statistical methods and reasons for study status changes. The analysis plan and termination reason are not reported in the registry record. Their absence leaves readers unable to assess the planned inferential strategy or explain why the study ended. However, no methodological speculation can substitute for the missing endpoint data.
For biostatisticians and clinical researchers, the main lesson is to distinguish design, measurement, analysis, and results. Randomization and masking describe aspects of design; RECIST response rules define measurement; an analysis plan would specify how data are summarized and compared; observed responses would be needed to estimate efficacy. The registry documents parts of the first two layers but reports no Part 2 result for the primary question.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The principal limitation is that no participants were enrolled in Part 2, the part specified for the primary endpoint. No ORR data were collected, and the registry reports zero analyses. This prevents estimation of the planned treatment contrast and leaves the primary question unanswered in the record.
The registry lists enrollment 1 overall and reports a Part 1 safety group, but that limited information cannot stand in for Part 2 efficacy data. Safety counts are confined to the listed group, and no serious adverse-event terms are listed. Detailed event descriptions and comparative safety estimates are not reported in the registry record.
The study is marked terminated, but the reason for termination is not reported in the registry record. That missing context prevents an evidence-based explanation of why the study ended. The record also does not report the statistical analysis plan, sample-size justification, allocation procedure, detailed eligibility criteria, or planned handling of missing outcome data. These gaps limit assessment of the intended analysis and trial conduct.
Although the primary endpoint specifies response criteria and a planned assessment window, actual assessment schedules and follow-up duration are not reported. The planned maximum follow-up should not be treated as observed follow-up. The arm descriptions also do not provide additional regimen details. These limitations are specific to the information recorded and should not be filled in by assumptions about typical trial practice.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: 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) — NCT06094296.
- Registry record last updated 2025-04-16; status last verified 2025-03.
- Results first posted 2025-04-16.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT06094296 is a randomized, double-blind, phase 2, parallel-group study with quadruple masking, listed for first-line treatment of stage IV or recurrent NSCLC. It planned to compare BMS-986315 and nivolumab with chemotherapy against nivolumab with chemotherapy. The registry lists enrollment 1 overall, a start date of 2023-11-27, a primary completion date of 2024-08-08, and terminated status.
The primary endpoint was ORR for Part 2, defined using confirmed complete or partial responses assessed by blinded independent central review under RECIST 1.1. No participants were enrolled in Part 2 because the study was terminated, and no primary endpoint data were collected. The registry reports one Part 1 safety group, with 0 serious adverse events, 1 participant with an other adverse event, and 0 deaths. The reason for termination and the statistical analysis plan are not reported in the registry record.