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 Trial With Chemotherapy, Immunotherapy, and Radiotherapy for Patients With Newly Diagnosed Stage IV Small Cell Lung Cancer (NCT04951115), a na phase 2 study. The primary outcome is Number of Toxicities Grade 3 or Above Related to Therapy.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04951115 |
| Phase | Phase 2 |
| Condition | Small-cell Lung Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 6 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Weill Medical College of Cornell University |
| Results posted | Yes |
2. Clinical Question
Population
The intended population was people with untreated, newly diagnosed stage IV small cell lung cancer. The registry reports enrollment of 6 participants. It does not report additional eligibility details or describe the characteristics of the participants who enrolled.
Intervention
The planned treatment combined stereotactic body radiotherapy with platinum-etoposide chemotherapy and durvalumab. The brief summary describes radiation therapy for five days, followed by etoposide with carboplatin or cisplatin plus durvalumab for 4 cycles. It says participants might continue durvalumab after those cycles until disease progression. The record does not establish that every participant received every planned treatment or how treatment was delivered in practice.
Comparator
There was no concurrent comparison group. The study is listed as a single-group trial with no masking, and allocation is recorded as not applicable. Its results therefore cannot provide a randomized, like-for-like contrast against chemotherapy and immunotherapy alone, radiotherapy alone, or another treatment approach.
Primary question
The primary endpoint asks for the number of toxicities graded 3 or above that were judged definitely or probably related to study treatment, over a timeframe of up to 29 months. This is a treatment-related safety question, not a direct comparison of tumor response or survival between treatment groups. The registry record does not give a posted value for this primary endpoint, so the number of qualifying toxicities cannot be described from the available outcome information.
3. Trial Design
This was a phase II, single-group study sponsored by Weill Medical College of Cornell University. The registry lists small-cell lung cancer as the condition and describes a treatment strategy for people with untreated stage IV disease. The study had no masking, and allocation was recorded as not applicable. With no separate control group, its design is not a randomized comparison.
The planned regimen paired stereotactic body radiotherapy with platinum-etoposide chemotherapy and durvalumab. The brief summary describes five days of radiation therapy followed by etoposide with carboplatin or cisplatin and durvalumab for 4 cycles. Participants might continue durvalumab after the 4 cycles until disease progression. These details describe the planned approach in the registry summary; the record does not state how many participants completed each component or give individual treatment histories.
Enrollment was 6. The study started on 2021-07-12, had a primary completion date of 2024-01-17, and is listed as terminated. The reason for termination is not reported in the registry record. A target enrollment, recruitment history, and explanation of whether the study ended as planned are also not reported in the registry record.
The listed secondary outcomes include objective response rate using RECIST 1.1, overall survival from first study treatment to death from any cause, and patterns of progression in radiated and non-radiated lesions, including new lesions. The registry lists 8 outcome measures overall but does not describe posted analyses for them. No statistical analysis results are listed. The record therefore supplies the design and outcome definitions, but not a complete set of results with which to assess the planned treatment strategy.
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 | Radiation + Chemo-Immunotherapy |
|---|---|
| STARTED | 6 |
| COMPLETED | 5 |
| NOT COMPLETED | 1 |
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.
| Characteristic | Unit | Radiation + Chemo-Immunotherapy |
|---|---|---|
| Participants analysed | 6 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 2 |
| Age, Categorical: >=65 years | Participants | 4 |
| Sex: Female, Male: Female | Participants | 1 |
| Sex: Female, Male: Male | Participants | 5 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 6 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 |
| Race (NIH/OMB): White | Participants | 3 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 |
| Region of Enrollment: United States | participants | 6 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Toxicities Grade 3 or Above Related to Therapy, measured over Up to 29 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | serious adverse events |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the number of toxicities graded 3 or above that were judged definitely or probably related to the treatments given during study treatment. The registry gives a timeframe of up to 29 months. This endpoint is intended to describe serious treatment-related toxicity during the study, rather than tumor response or survival.
Counting treatment-related toxicities can help characterize the safety burden observed during a regimen. The grade threshold focuses attention on events considered more severe under the grading system used by the study, while the attribution requirement narrows the endpoint to events investigators judged definitely or probably related to treatment. Those judgments are not the same as proof that treatment caused an event.
The registry does not state the grading system used, whether the endpoint counts events or participants with at least one qualifying event, or how repeated events in the same participant are handled. The definition names a count of toxicities, but the primary outcome value itself is not reported in the registry record. The serious adverse-event figures listed elsewhere in the record should not automatically be treated as the primary endpoint: seriousness and severity grade are distinct classifications, and the record does not establish that those counts correspond to the endpoint’s specific grade and attribution criteria.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The main interpretive constraint is the size and structure of the study. Enrollment was 6, and the design was single-group. The registry can describe what was observed among enrolled participants, but without a concurrent comparator it cannot isolate the contribution of radiotherapy from the chemotherapy-immunotherapy regimen or distinguish treatment effects from other influences. Results from this design are descriptive rather than a randomized estimate of comparative effects.
The primary endpoint is defined as a number of toxicities graded 3 or above and judged definitely or probably related to treatment, with a timeframe of up to 29 months. No value for that endpoint is reported in the registry record. Consequently, its observed frequency, distribution, and precision cannot be evaluated from the posted primary outcome information. The safety counts listed in the adverse-event record provide separate information, but they do not resolve that missing primary result.
The adverse-event record lists serious adverse events affecting 5 participants among 6 at risk, other adverse events affecting 6 among 6 at risk, and 1 death. These are counts for the study group, not comparative estimates. The record does not say that the death was caused by treatment, and the counts alone do not establish causation. Serious adverse events are not interchangeable with events meeting a grade threshold; the primary endpoint also requires a specified relationship to study treatment.
The listed serious-event terms include pleural effusion and atrial fibrillation, each recorded as 33.3%, and anemia, anuric renal failure, colonic perforation, and dyspepsia, each recorded as 16.7%. These percentages are reproduced as registry entries. The record does not provide enough context to determine from those percentages alone whether they refer to participants, events, or another reporting basis, so they should not be converted into counts or interpreted as comparative risks.
The listed secondary outcomes concern response, survival, and patterns of disease progression. Their definitions indicate what the trial intended to assess, but the registry record does not include results for those outcomes. It is therefore not possible to describe response, survival, or progression findings from the posted information. Nor does the record provide confidence intervals or other uncertainty estimates for the reported adverse-event counts.
Overall, the available information is a limited descriptive safety record for a small cohort, accompanied by a defined but unreported primary endpoint and listed secondary outcomes without posted analyses. It supports careful description of what the registry records, not claims about comparative benefit or a definitive safety profile.
9. Statistical Methods Explained
The statistical interpretation depends first on matching each number to the outcome definition it represents. The primary outcome is a count of toxicities graded 3 or above and considered definitely or probably related to treatment. The adverse-event entries use separate categories for serious events and other events, along with a count of deaths. Without a stated mapping between these categories and the primary endpoint, they should be read as distinct summaries.
What does a single-group design estimate?
General explanation: A single-group study describes outcomes among participants who receive the study regimen. It has no concurrent control group to show what would have happened under another strategy during the same period. For that reason, observed events can be counted and described, but a treatment contrast cannot be estimated from this design alone. In this trial, the registry records a single group and no masking; it does not describe a randomized allocation procedure.
General explanation: Even when an outcome is common or clinically important, an uncontrolled count does not show how much of the outcome was caused by treatment. The observed record can include effects of underlying disease, other care, participant characteristics, and chance. Attribution judgments can inform a safety summary, but they do not replace a comparison group or establish causation.
How should counts and percentages be read?
The adverse-event record reports participants at risk and participants affected for serious and other events. It also lists selected serious-event terms with percentages. These measures answer different descriptive questions: the affected-participant counts indicate how many people in the group were recorded as having events in the specified category, while the term percentages are presented as the registry records them. The record does not state the denominator or counting convention for those term percentages. They should therefore be quoted as reported, without inferring event counts or treating them as directly comparable rates.
General explanation: A count is often easier to interpret when its denominator and event definition are clear. A percentage may express the same underlying information in a different form, but its interpretation depends on who or what was counted. Small cohorts also make estimates sensitive to each participant’s outcome. Here, the enrollment and risk counts are explicitly recorded, but the available information does not include uncertainty intervals around the adverse-event summaries.
What would an uncertainty interval add?
General explanation: A confidence interval describes the range of estimates compatible with the observed data under a statistical model and its assumptions. It communicates precision; it does not guarantee that the true value lies in the interval, and it does not correct for bias or a weak study design. The registry record does not report confidence intervals for the safety counts or the primary endpoint. With no primary outcome value posted, there is also no estimate around which to assess its precision.
Why does the missing comparator matter?
General explanation: In a controlled comparison, investigators can estimate the difference between outcomes under assigned strategies, subject to the design and analysis assumptions. In a single-group study, the observed outcome has no concurrent treatment-group contrast. Historical or external comparisons would require suitable information and methods; the registry record does not report such a comparison. No effect estimate for the combined regimen relative to another treatment can therefore be read from the posted results.
What can the listed outcome measures establish?
The registry lists objective response rate under RECIST 1.1, overall survival from first study treatment to death from any cause, and patterns of progression in radiated and non-radiated lesions, as well as new lesions. These definitions identify outcome concepts but are not themselves results. The record lists 8 outcome measures and 0 analyses. It does not report the response, survival, or progression estimates, nor does it provide analysis details that would explain how censored observations, event timing, or repeated assessments were handled.
General explanation: Statistical methods should be chosen to match the outcome. Counts, proportions, time-to-event outcomes, and repeated observations require different approaches. A time-to-event analysis, for example, needs information about follow-up and censoring as well as event times. The registry record does not report a statistical analysis plan, model specifications, or methods for missing observations. No particular method should be inferred from the outcome definitions alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 8 outcome measures, including the primary toxicity endpoint and secondary outcomes for response, overall survival, and patterns of progression. It records 0 analyses. The registry record does not report a multiplicity strategy, such as a prespecified hierarchy among outcomes or an adjustment for evaluating several outcomes. Without that information and without posted outcome analyses, the impact of multiple testing cannot be assessed.
General explanation: When several outcomes or comparisons are examined, the chance of at least one apparently notable result arising by chance can increase. A prespecified analysis plan can clarify which outcome is primary, how secondary outcomes are interpreted, and whether statistical testing is adjusted. This general concern does not establish that any result in this trial is false; the posted record does not provide inferential results to evaluate.
Missing-data handling and analysis populations are not reported in the registry record. The record does not explain whether all enrolled participants were included in each outcome, how incomplete follow-up was handled, or how participants who did not complete planned treatment were treated in analyses. It also does not report participant-level outcome data or a flow of enrollment, treatment, and follow-up.
General explanation: Missing observations can affect an estimate when their occurrence is related to participant outcomes or treatment experience. Analysis-population definitions help readers understand which participants contribute to a result. These details are particularly relevant when interpreting a small study, but no assumptions about missingness or population membership should be made in their absence. The enrollment count alone does not show how many participants contributed to each outcome.
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 |
|---|---|---|---|
| Radiation + Chemo-Immunotherapy | 5 | 6 | 83.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Radiation + Chemo-Immunotherapy | 1 of 6 |
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 |
|---|---|
| Radiation + Chemo-Immunotherapy | 6 of 6 |
Most frequent serious adverse event terms
| Event term | Organ system | Radiation + Chemo-Immunotherapy |
|---|---|---|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | 2 of 6 |
| Atrial Fibrillation | Cardiac disorders | 2 of 6 |
| Anemia | Blood and lymphatic system disorders | 1 of 6 |
| Anuric Renal Failure | Renal and urinary disorders | 1 of 6 |
| Colonic Perforation | Gastrointestinal disorders | 1 of 6 |
| Dyspepsia | Gastrointestinal disorders | 1 of 6 |
| Alanine Aminotransferase Increased | Investigations | 1 of 6 |
| Fever | General disorders | 1 of 6 |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | 1 of 6 |
| Periorbital Edema | Eye disorders | 1 of 6 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Radiation + Chemo-Immunotherapy |
|---|---|---|
| Fatigue | General disorders | 4 of 6 |
| Cough | Respiratory, thoracic and mediastinal disorders | 3 of 6 |
| Neuropathy | Nervous system disorders | 3 of 6 |
| Rash Maculo-papular | Skin and subcutaneous tissue disorders | 3 of 6 |
| Back Pain | Musculoskeletal and connective tissue disorders | 2 of 6 |
| Constipation | Gastrointestinal disorders | 2 of 6 |
| Diarrhea | Gastrointestinal disorders | 2 of 6 |
| Dry Mouth | Gastrointestinal disorders | 2 of 6 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 2 of 6 |
| Vomiting | Gastrointestinal disorders | 2 of 6 |
Serious events with the highest arm-level rate: pleural effusion (33.3%), atrial fibrillation (33.3%), anemia (16.7%), anuric renal failure (16.7%), colonic perforation (16.7%).
The registry’s adverse-event record lists 5 participants with serious adverse events among 6 at risk, 6 participants with other adverse events among 6 at risk, and 1 death in the study group. These are descriptive counts. The record does not say that the death was treatment-related, and the count should not be read as a causal finding.
The serious-event terms listed include pleural effusion and atrial fibrillation at 33.3% each, and anemia, anuric renal failure, colonic perforation, and dyspepsia at 16.7% each. Those percentages are recorded as presented; the registry does not specify the denominator or whether the terms count participants or events. They cannot safely be translated into participant counts from the information available.
Seriousness and severity grade are different ways to classify adverse events. A serious event is not necessarily a grade 3 or above toxicity, and a toxicity meeting the primary endpoint’s grade threshold is not necessarily classified as serious. The primary endpoint also requires investigators to judge an event definitely or probably related to treatment. The adverse-event counts do not identify which events met all of those conditions, and the primary endpoint result itself is not reported in the registry record.
With enrollment of 6 and no comparison group, these summaries describe only the recorded experience in this cohort. They do not provide a comparative estimate or a precise characterization of risk across a broader population.
12. What the Result Does, and Does Not, Mean
The registry record establishes that this was a phase II, single-group study of a combined radiotherapy and chemo-immunotherapy approach for newly diagnosed stage IV small cell lung cancer. It records enrollment of 6, a terminated status, the planned treatment sequence, and a primary safety endpoint focused on treatment-related toxicities graded 3 or above. The adverse-event record gives a small set of group-level counts and selected event terms.
Those details do not establish whether the combined approach is more or less effective or safer than another treatment. There was no concurrent comparator, and the record does not report results for the listed response, survival, or progression outcomes. It also does not report the primary endpoint count. The listed adverse-event counts are descriptive and do not establish that treatment caused the events.
The registry’s percentages for selected serious-event terms should be treated cautiously because their denominator and counting basis are not stated. The serious-event category should not be substituted for the primary endpoint’s grade-and-attribution definition. The single death in the record is not accompanied by a stated causal relationship to treatment.
General explanation: A result can be informative about what was observed in a study group while still being insufficient to support a comparative or causal conclusion. Study size, design, outcome definitions, follow-up, and analysis methods all shape how far an observation can be generalized. In this record, the small enrollment and absence of a comparison group limit comparative interpretation, while the absence of posted endpoint analyses prevents assessment of the intended primary outcome.
The proper reading is therefore narrow: the record documents the trial design and selected safety summaries, but does not provide enough outcome information to determine the results of its primary or secondary questions. No conclusion about treatment benefit, lack of benefit, or a definitive safety profile follows from these entries alone.
13. Why This Trial Matters Statistically
This trial raises a useful statistical question: how should outcomes from a small, single-group study be interpreted when the intervention combines several treatment components? The design can record whether events occurred during the study and can describe response or survival if those results are reported. But without a concurrent comparator, the separate contribution of radiotherapy, chemotherapy, and immunotherapy cannot be disentangled from the observed outcomes.
The registry also illustrates why outcome definitions matter. The primary endpoint is a count of toxicities meeting both a severity threshold and an attribution criterion. The adverse-event listing instead reports serious events, other events, and a death. Those summaries may be relevant to safety, but they do not automatically answer the primary endpoint question. Keeping the categories distinct avoids treating different measures as though they were interchangeable.
Enrollment of 6 makes the distinction between a descriptive count and a precise estimate especially important. Each participant’s experience contributes substantially to the group summary, and the record does not provide uncertainty intervals. The selected adverse-event percentages also lack a stated denominator and counting convention. Statistical interpretation must reflect those limits rather than give the figures more precision than the record supports.
Finally, a registered outcome is not the same as a reported result. The listed response, survival, and progression outcomes indicate areas the study intended to assess, but analyses are not listed. The primary toxicity endpoint is defined but has no posted value. This difference matters for researchers reading trial records: design information can clarify the question, while missing results leave the question unanswered in the public record.
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.
Several limitations specific to this record constrain interpretation. The study enrolled 6 participants and had a single-group design, so the posted information cannot support a randomized comparison. The status is terminated, but the reason for termination is not reported in the registry record. It is not possible to determine from the record whether termination followed recruitment difficulties, a safety concern, a change in priorities, or another circumstance.
The primary endpoint is defined, but its observed value is not reported in the registry record. The record also lists 8 outcome measures and 0 analyses, leaving the stated secondary questions without posted results. For the adverse-event terms, the registry gives percentages but does not state their denominator or counting basis. That ambiguity limits interpretation of the percentages.
The record does not report the grading system for the primary toxicity endpoint, how repeated toxicities were counted, or how treatment attribution was determined. It also does not specify whether the adverse-event summaries refer to events, affected participants, or distinct event episodes in every category. The primary endpoint and adverse-event summaries should therefore not be combined or treated as equivalent.
Participant characteristics, treatment completion, follow-up by outcome, missing-data methods, analysis populations, and the statistical analysis plan are not reported in the registry record. These omissions prevent assessment of how representative the enrolled group was, how complete outcome ascertainment was, or whether analyses followed a prespecified approach. The planned regimen in the brief summary does not establish what each participant actually received.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Trial With Chemotherapy, Immunotherapy, and Radiotherapy for Patients With Newly Diagnosed Stage IV Small Cell Lung Cancer — NCT04951115.
- Registry record last updated 2024-11-26; status last verified 2024-11.
- Results first posted 2024-11-26.
- 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
The registry describes a phase II, single-group trial of stereotactic body radiotherapy with platinum-etoposide chemotherapy and durvalumab for untreated, newly diagnosed stage IV small cell lung cancer. The planned sequence included radiation therapy for five days, followed by chemotherapy and durvalumab for 4 cycles, with possible continued durvalumab until disease progression. Enrollment was 6, and the study is listed as terminated.
The primary endpoint was the number of toxicities graded 3 or above judged definitely or probably related to treatment, within a timeframe of up to 29 months. Its result is not reported in the registry record. The adverse-event listing records serious events affecting 5 of 6 participants at risk, other events affecting 6 of 6, and 1 death, alongside selected serious-event terms with reported percentages.
Response, survival, and progression are listed as secondary outcomes, but analyses are not listed. The design and posted safety counts support limited descriptive interpretation; they do not provide a concurrent comparison or establish treatment causation.