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 Study of PULSAR-ICI +/- IMSA101 in Patients With Oligometastatic NSCLC and RCC (NCT05846646), a randomized phase 2 study. The primary outcome is Anti-tumor Effects.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05846646 |
| Phase | Phase 2 |
| Condition | Oligometastatic Disease |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 6 |
| Arms in the primary outcome | n/a |
| Lead sponsor | ImmuneSensor Therapeutics Inc. |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned patients with oligometastatic non-small cell lung cancer (NSCLC) or renal cell carcinoma (RCC). The registry record identifies oligometastatic disease as the condition but does not report detailed eligibility criteria, patient characteristics, or how the two cancer types were represented among participants.
Intervention
The experimental treatment combined personalized ultra-fractionated stereotactic adaptive radiotherapy (PULSAR) and immune checkpoint inhibitor (ICI) therapy with the STING agonist IMSA101. The adverse-event record labels experimental groups by IMSA101 dose: 800 mcg and 1200 mcg. The registry record does not report further details about treatment delivery or how dose groups were assigned.
Comparator
The control treatment was PULSAR combined with ICI therapy, without IMSA101. The official title names pembrolizumab or nivolumab as the ICI options. The registry record does not report which ICI individual participants received or provide adverse-event counts for participants at risk in the control arm.
Primary question
The primary outcome was the progression-free rate at 18 months. The clinical question was whether outcomes differed between PULSAR-ICI with IMSA101 and PULSAR-ICI alone, alongside evaluation of safety. The registry record states that the study terminated before participants' assessment at the 18-month time point, so the primary outcome was not collected. It therefore supplies no estimate of the between-arm difference for that outcome.
3. Trial Design
This was a phase 2, randomized, open-label, parallel-group study. Its stated purpose was to compare the safety and efficacy of PULSAR-ICI with IMSA101 against PULSAR-ICI alone in patients with NSCLC or RCC and oligometastatic disease. The registry lists an enrollment of 6. The experimental treatment is represented in the adverse-event record by groups labelled 800 mcg and 1200 mcg; the control arm is listed separately.
The registry records the study start as 2023-06-28 and the primary completion date as 2024-09-16. Its status is terminated. The primary outcome timeframe was 18 months, but the record says data were not collected because the study terminated before participants' assessment at that time point. The reason for termination is not reported in the registry record.
Randomization is intended to support a fair comparison by allocating participants to treatment groups using chance, reducing systematic differences in expectation. Open-label means treatment assignment was not masked. Knowledge of assignment can affect experiences or assessments, depending on the outcome, but the registry record does not describe procedures to address that possibility.
The record lists secondary outcomes concerning treatment-related adverse events, anti-tumor effects, and quality of life. It reports 6 outcome measures and 0 analyses. Detailed randomization procedures, allocation concealment, treatment schedules, analysis populations, and statistical analysis methods are not reported in the registry record.
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.
Overall Study
| Stage | Experimental Arm (800 mcg) | Experimental Arm (1200 mcg) | Control Arm |
|---|---|---|---|
| STARTED | 3 | 3 | 0 |
| COMPLETED | 0 | 0 | 0 |
| NOT COMPLETED | 3 | 3 | 0 |
Reasons for not completing this period:
| Reason | Experimental Arm (800 mcg) | Experimental Arm (1200 mcg) | Control Arm |
|---|---|---|---|
| Physician Decision | 1 | 0 | 0 |
| Lack of Efficacy | 1 | 1 | 0 |
| Early Study Termination | 1 | 2 | 0 |
Analysis population for the primary outcome, as defined in the registry: Data were not collected due to study termination prior to participants' assessment at the 18-month time point
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: All patients enrolled to Safety Run In portion of trial where all everyone assigned to Experimental Arm.
| Characteristic | Unit | Experimental Arm (800 mcg) | Experimental Arm (1200 mcg) | Control Arm | Total |
|---|---|---|---|---|---|
| Participants analysed | 3 | 3 | 0 | 6 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 1 | 0 | 1 |
| Age, Categorical: >=65 years | Participants | 3 | 2 | 0 | 5 |
| Sex: Female, Male: Female | Participants | 2 | 1 | 0 | 3 |
| Sex: Female, Male: Male | Participants | 1 | 2 | 0 | 3 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 1 | 0 | 0 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 2 | 3 | 0 | 5 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 0 | 0 | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 2 | 3 | 0 | 5 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Anti-tumor Effects, measured over 18 months.
| 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 the progression-free rate at 18 months. A progression-free rate describes the proportion of a group that has not experienced disease progression by a specified time, according to the trial's outcome definition. It is a time-specific summary of disease control and can help characterize how outcomes evolve over follow-up. The registry record does not give the operational definition of progression, the assessment schedule, or how deaths and other incomplete follow-up would be handled.
General statistical context: a fixed-time rate can be useful because it focuses interpretation on a clinically meaningful follow-up point. It is different from a time-to-event summary, which uses information about when progression occurs across follow-up. The suitability and precision of either measure depend on the amount and quality of follow-up and on the analysis plan.
For this trial, the record says the study terminated before participants' assessment at the 18-month time point, and data for the primary outcome were not collected. Consequently, there is no reported 18-month progression-free rate, estimate of a treatment contrast, or uncertainty interval for the primary endpoint. The record's stated timeframe does not itself establish that any participant reached that assessment.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive fact is that the primary endpoint was not collected. The registry record identifies progression-free rate at 18 months as the primary outcome, but states that the study terminated before participants' assessment at that time point. There is therefore no posted primary efficacy estimate to compare between PULSAR-ICI with IMSA101 and PULSAR-ICI alone. No conclusion about the relative anti-tumor effects can be drawn from this endpoint in the registry record.
The record lists enrollment of 6, but that figure does not replace an outcome estimate. Without primary outcome observations, an estimate of the treatment contrast, its confidence interval, and a test of the contrast are not available. The record reports 0 analyses. Statistical significance, precision, and the direction or size of any primary-outcome difference are not reported in the registry record.
Safety information is listed for the two experimental dose-labelled groups. The control arm has zero participants at risk in the posted adverse-event figures, so those entries do not provide an observed safety comparison with control. The reported serious adverse-event terms each have a listed frequency of 33.3%, but the registry excerpt does not specify their denominator or give enough context to interpret these as comparative rates. These figures should not be treated as evidence of a treatment effect or as a complete account of safety.
The study was randomized, which is a design strength for comparisons when outcomes are collected and analyzed as planned. However, randomization cannot supply missing outcome data. The open-label design is also relevant when considering outcomes that involve judgment or participant reporting; the record does not describe masking of assessors or other safeguards.
Overall, the posted information describes the trial question, design, and limited safety entries, but does not answer the primary efficacy question. The registry record does not report why the trial was terminated, the follow-up actually achieved, or whether any other efficacy assessments were available for analysis.
9. Statistical Methods Explained
Randomized allocation uses chance to assign participants to treatment groups. In general, this can reduce systematic differences between groups and support an interpretable comparison. It does not guarantee that groups will be similar in every characteristic, particularly in a small study. The registry identifies this study as randomized, but the specific randomization method and allocation-concealment procedures are not reported in the registry record.
What does open-label mean?
Open-label means participants and study personnel are not masked to treatment assignment. General statistical context: awareness of treatment can influence care, reporting, or assessments, especially for outcomes requiring judgment or relying on participant reports. An objective outcome definition and masked assessment can help limit some sources of bias, but the registry record does not report whether outcome assessors were masked or what safeguards were used.
What does a progression-free rate measure?
A progression-free rate at a fixed follow-up point is a summary of the share of participants who have not had the defined event by that point. In general, interpretation requires a clear event definition, follow-up information, and a stated approach to participants whose status is unknown. This record specifies progression-free rate at 18 months but says the data were not collected because termination occurred before participant assessment at that time. It does not report the event definition or how incomplete follow-up was intended to be handled.
What can a confidence interval tell readers?
General statistical context: a confidence interval expresses uncertainty around an estimate under the assumptions of the analysis. A narrow interval indicates greater precision than a wide interval, while an interval that includes values corresponding to no difference may be compatible with a range of possibilities. No confidence interval for the primary outcome is reported in the registry record because that outcome was not collected. No inferential estimate for a primary treatment contrast is reported either.
Why does over-dispersion matter?
General statistical context: over-dispersion occurs when variation in data exceeds what a statistical model assumes. For count outcomes, ignoring it can make uncertainty appear smaller than it is and can distort inference. Whether over-dispersion is relevant depends on the outcome and model. The registry record reports 0 analyses and does not report a statistical model, so it is not possible to determine whether this issue arose or how it would have been addressed.
What do the planning assumptions mean?
The record describes a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. For time-to-event illustrations, the stated quantity is total events; for other illustrations, it is participants per arm. These are planning conventions, not trial results or observed power. The registry record does not report numerical illustration results. Since the primary outcome was not reduced to one comparison, no single comparison is available for such a recalculation.
More generally, a sample-size illustration depends on assumptions about the target effect, variability, allocation, significance level, and desired power. Changing those assumptions can change the planning requirement. Such an illustration cannot establish that a trial had adequate information or that an effect was present. The record does not report the trial's own sample-size justification or statistical analysis plan, so the planning assumptions should not be read as a description of the original design rationale.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 6 outcome measures, including treatment-related adverse events, anti-tumor effects, and quality of life. It also reports 0 analyses. The record does not describe a multiplicity strategy for interpreting several outcomes, time points, or comparisons. Without such a plan, the relationship among outcome tests and any adjustment to account for multiple testing are not reported in the registry record. The primary outcome is named, but its data were not collected.
The registry's analysis note says the primary outcome has several categories or time points and was not reduced to one comparison. This means the record does not support a single recalculated primary comparison from the posted information. No primary estimate, confidence interval, or p-value is reported. Statistical details such as model choice, covariate adjustment, handling of censoring, and analysis population are not reported in the registry record.
Missing outcome data are central to interpretation because termination occurred before assessment at the 18-month time point. The record does not report the number of participants with primary endpoint observations, follow-up duration by participant, reasons for missing assessments, or a missing-data method. It is therefore not possible to assess whether missingness could have introduced bias or to reproduce an analysis of the stated primary endpoint.
The record does not report whether the intended analysis was based on all randomized participants, participants who received treatment, or another population. It also does not report how participants who discontinued treatment or had incomplete follow-up would be included. These omissions limit reproducibility and make the planned estimand—the precise treatment effect the study intended to estimate—not fully clear.
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 |
|---|---|---|---|
| Experimental Arm (800 mcg) | 2 | 3 | 66.7% |
| Experimental Arm (1200 mcg) | 1 | 3 | 33.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Experimental Arm (800 mcg) | 0 of 3 |
| Experimental Arm (1200 mcg) | 0 of 3 |
| Control Arm | 0 of 0 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Experimental Arm (800 mcg) | 3 of 3 |
| Experimental Arm (1200 mcg) | 3 of 3 |
| Control Arm | 0 of 0 |
Most frequent serious adverse event terms
| Event term | Organ system | Experimental Arm (800 mcg) | Experimental Arm (1200 mcg) | Control Arm |
|---|---|---|---|---|
| Possible Sepsis | Infections and infestations | 1 of 3 | 0 of 3 | 0 of 0 |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | 1 of 3 | 0 of 3 | 0 of 0 |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 0 of 3 | 1 of 3 | 0 of 0 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Experimental Arm (800 mcg) | Experimental Arm (1200 mcg) | Control Arm |
|---|---|---|---|---|
| Chills | General disorders | 3 of 3 | 2 of 3 | 0 of 0 |
| Fatigue | General disorders | 2 of 3 | 3 of 3 | 0 of 0 |
| Diarrhoea | Gastrointestinal disorders | 1 of 3 | 2 of 3 | 0 of 0 |
| Weight decreased | Investigations | 2 of 3 | 1 of 3 | 0 of 0 |
| Cough | Respiratory, thoracic and mediastinal disorders | 1 of 3 | 2 of 3 | 0 of 0 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 2 of 3 | 1 of 3 | 0 of 0 |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 2 of 3 | 1 of 3 | 0 of 0 |
| Anaemia | Blood and lymphatic system disorders | 2 of 3 | 0 of 3 | 0 of 0 |
| Nausea | Gastrointestinal disorders | 1 of 3 | 1 of 3 | 0 of 0 |
| Non-cardiac chest pain | General disorders | 0 of 3 | 2 of 3 | 0 of 0 |
Serious events with the highest arm-level rate: possible sepsis (33.3%), pneumonia (33.3%), pneumothorax (33.3%).
The adverse-event record lists serious events for the experimental group labelled 800 mcg as 2 affected among 3 at risk, and other adverse events as 3 affected among 3 at risk. For the experimental group labelled 1200 mcg, it lists 1 affected among 3 at risk for serious events and 3 affected among 3 at risk for other events. Deaths are listed as 0 in both experimental groups.
The control arm is recorded with 0 participants at risk for these adverse-event summaries and 0 deaths. Those zero entries do not provide evidence that the control arm had no events; with no participants at risk listed, they cannot serve as a meaningful observed comparison. The registry record does not explain why the control arm has no participants at risk in these figures.
The listed serious-event terms are Possible Sepsis, Pneumonia, and Pneumothorax, each with a frequency of 33.3%. The registry excerpt does not state the denominator for these percentages or link each term to a specific treatment group. They should therefore be read as reported descriptive frequencies, not as comparative risks. The record does not provide event timing, severity grades beyond the serious-event classification, attribution details, or a complete narrative of adverse events.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized phase 2 study was intended to compare PULSAR-ICI with IMSA101 against PULSAR-ICI alone in oligometastatic NSCLC or RCC. It also identifies progression-free rate at 18 months as the primary endpoint and records the study as terminated. These details define the research question and its intended comparison.
They do not establish whether adding IMSA101 changed progression-free outcomes. The primary endpoint data were not collected before assessment at the stated time point, and the record reports 0 analyses. No primary efficacy estimate, uncertainty interval, or statistical test is reported. The available registry information therefore cannot show the size, direction, or precision of a treatment difference.
The adverse-event entries describe reported counts in the two experimental dose-labelled groups, but do not support a comparative safety conclusion because the control arm has no participants at risk recorded. The listed serious-event terms also lack denominator and group context in the record. The figures should not be interpreted as a complete safety profile.
General statistical context: an inconclusive or unavailable estimate is not the same as evidence of no effect. When an endpoint was not collected, the data do not resolve whether groups differed on that outcome. Likewise, a small enrollment figure alone cannot quantify treatment benefit or harm. The record does not report the reason for termination or the extent of follow-up, so those circumstances cannot be used to explain the missing endpoint.
The most defensible conclusion is limited: the registry describes the design and intended endpoint, but it does not report results that answer the primary efficacy question. Any broader claim about efficacy or comparative safety would go beyond the posted information.
13. Why This Trial Matters Statistically
This trial illustrates an important distinction between a well-defined research question and an answerable one. Randomization and a named primary endpoint establish a framework for comparison, but interpretation still depends on collecting outcome data and reporting the analysis. In this record, the central 18-month progression-free assessment was not collected before termination. The intended primary comparison is therefore unavailable.
That distinction matters for researchers reading registry results. A study can have a stated endpoint and a recorded completion date without having observations for that endpoint. Readers need to check whether the outcome was actually assessed, whether an analysis is reported, and whether the comparison includes the relevant groups. Here, the registry reports 0 analyses and does not provide a primary efficacy estimate.
The safety entries also show why denominators and group context matter. The experimental groups have participants listed at risk, while the control arm has none in the adverse-event summary. Without comparable exposure information and clear definitions, descriptive event frequencies cannot establish a difference between treatments.
For trial design and reporting, this record underscores the value of making termination reasons, follow-up achieved, analysis populations, missing-data handling, and outcome definitions explicit. Such information can help readers distinguish a null result from an unavailable result. The record does not report those details, so the primary clinical question remains unanswered by the posted data.
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 primary limitation is that the stated progression-free rate at 18 months was not collected. The registry attributes this to study termination before assessment at that time point. As a result, there is no reported primary outcome estimate or comparison between treatment arms.
The registry status is terminated, but the reason for termination is not reported in the registry record. Nor does the record describe the follow-up achieved, whether other tumor assessments were collected, or whether any efficacy analyses were performed outside the listed record. It reports 0 analyses.
Safety interpretation is limited by the absence of participants at risk in the control-arm adverse-event figures. The serious-event term frequencies are listed without a stated denominator or treatment-group attribution. Details about event timing, grading, exposure, and attribution are not reported in the registry record.
Additional design and analysis details are also absent, including eligibility criteria, participant characteristics, randomization procedures, analysis populations, endpoint definitions, handling of missing data, and the statistical analysis plan. The record names an open-label design but does not describe outcome-assessment masking or procedures to reduce assessment bias.
The record lists two experimental dose labels, but does not report how participants were assigned across those groups or provide a basis for interpreting dose-specific efficacy. With the primary outcome unavailable and limited comparative safety information, the posted record cannot support conclusions about efficacy or comparative safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study of PULSAR-ICI +/- IMSA101 in Patients With Oligometastatic NSCLC and RCC — NCT05846646.
- Registry record last updated 2025-10-20; status last verified 2025-09.
- Results first posted 2025-10-20.
- 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
NCT05846646 was a randomized, open-label, parallel-group phase 2 study of PULSAR-ICI with or without IMSA101 in patients with oligometastatic NSCLC or RCC. The registry lists enrollment of 6 and records the study as terminated. The primary outcome was progression-free rate at 18 months, but the record states that it was not collected because termination occurred before assessment at that time point. The record reports 0 analyses. Adverse-event figures are listed for two experimental dose-labelled groups, but the control arm has 0 participants at risk in those summaries. The posted information therefore does not provide a primary efficacy comparison or a comparative safety assessment.