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 Chemoradiation Plus Durvalumab Followed by Surgery Followed by Adjuvant Durvalumab in Patients With Surgically Resectable Stage III (N2) Non-Small Cell Lung Cancer (NCT03871153), a na phase 2 study. The primary outcome is Pathologic Complete Response Rate.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03871153 |
| Phase | Phase 2 |
| Condition | Non Small Cell Lung Cancer, Stage III Non-small-cell Lung Cancer |
| Allocation | Not applicable (single group) |
| Design model | Sequential |
| Masking | None (open label) |
| Enrollment | 7 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Greg Durm, MD |
| Results posted | Yes |
2. Clinical Question
Population
Medically operable patients with surgically resectable stage III (N2) non-small cell lung cancer were the intended population. The registry record states that 4 subjects completed surgery and were evaluable for the primary endpoint.
Intervention
The treatment strategy combined concurrent chemoradiation with durvalumab, followed by surgery for eligible patients and planned adjuvant durvalumab for those who remained eligible after surgery. The listed chemotherapy drugs were carboplatin and paclitaxel.
Comparator
There was no separate control group. This was an open-label, single-arm study, so the treatment strategy was not compared within the trial against a different regimen or usual care.
Primary question
The primary endpoint was the pathological complete response rate, defined as no evidence of viable cancer in the surgical specimen at surgery. The registry record does not report the number of evaluable participants who had this response or the resulting rate.
Statistically, the study asks for a descriptive estimate of pathological complete response among the participants who reached surgery and could be evaluated. That question is narrower than whether the full treatment strategy improves outcomes compared with another approach. Without a control group, any observed response could not be contrasted with a concurrent alternative within this study.
The sequence of treatment also matters to interpretation. The endpoint is assessed in a surgical specimen, so it applies to participants who underwent surgery, not automatically to everyone enrolled. The registry record identifies 4 evaluable surgical participants, while enrollment was 7. It does not report the endpoint result or a full account of why participants were not included in the evaluable group.
3. Trial Design
This was a Phase II, open-label, multi-institutional, single-arm study. The registry lists allocation as not applicable and masking as none. Its sequential model reflects the planned treatment pathway: chemoradiation and durvalumab first, surgery afterward for eligible participants, then adjuvant durvalumab for those who remained eligible.
The registry describes the induction treatment as carboplatin, paclitaxel, durvalumab, and radiation. Participants without progressive disease who remained surgical candidates were to undergo resection 4-12 weeks after induction therapy. After resection, participants who remained eligible were to receive adjuvant durvalumab every 4 weeks for 6 cycles, beginning 4-12 weeks after surgery. These descriptions concern the planned pathway; the registry record does not establish that every enrolled participant received every planned treatment component.
Enrollment was 7. The recorded study start was 2019-08-02, primary completion was 2021-10-30, and status is terminated. The reason for termination is not reported in the registry record. The status alone does not establish why the study ended or whether termination was related to safety, recruitment, logistics, or results.
There is no randomized or concurrent control arm. The design can describe outcomes and adverse events among participants treated in this study, but it cannot isolate the effect of the regimen from other influences or support a direct treatment comparison. The primary endpoint was assessed at surgery, and the primary endpoint population is described as 4 subjects who completed the surgical procedure and were evaluable for pathological complete response.
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 | Treatment |
|---|---|
| STARTED | 6 |
| COMPLETED | 6 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: 4 Subjects completed the surgical procedure and were evaluable for Pathologic Complete Response
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 | Treatment |
|---|---|---|
| Participants analysed | 6 | |
| Age, Continuous | years | 66 (45 to 77) |
| Sex: Female, Male: Female | Participants | 3 |
| Sex: Female, Male: Male | Participants | 3 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 5 |
| 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 |
| Baseline ECOG: ECOG = 0 | Participants | 3 |
| Baseline ECOG: ECOG = 1 | Participants | 3 |
6. Primary Endpoint
The registry lists the primary outcome as Pathologic Complete Response Rate, measured over 3 months.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the pathological complete response rate, with the outcome expressed as a count of participants. It is defined as a lack of evidence of viable cancer in the surgical specimen at the time of surgery, with a stated timeframe of 3 months. This is a tissue-based endpoint assessed after the preoperative treatment and at resection.
Pathological response can describe what is found in the removed tissue after treatment. It differs from an imaging response or a time-to-event endpoint: it is based on examination of the surgical specimen, rather than a later event such as recurrence or death. In general, such an endpoint can provide a direct measure of residual viable cancer in the tissue that was removed. That description does not by itself establish longer-term benefit.
The endpoint applies to participants who underwent surgery and could be evaluated. The registry record identifies 4 such participants, but does not report how many had a pathological complete response, the rate, or an uncertainty interval. Consequently, the primary endpoint's result and its precision cannot be assessed from the registry information. It is also not reported whether the endpoint was assessed using a blinded pathology review or a particular analysis procedure.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The trial enrolled 7 participants and was terminated. Its primary endpoint population was smaller: the registry record says 4 subjects completed surgery and were evaluable for pathological complete response. That distinction is central. A response rate for this endpoint would describe the evaluable surgical participants, not necessarily everyone who entered the study or began induction treatment.
The registry record gives the endpoint definition and timeframe but does not report the response count or rate. It also reports no analyses. There is therefore no registry-reported primary endpoint estimate to interpret, and no basis in this record for stating the observed frequency of pathological complete response. A numerical estimate, confidence interval, or hypothesis test should not be inferred from the evaluable population size alone.
Even if a response count were available, the single-arm design would limit the conclusions. A proportion in treated participants can describe what occurred in that group, but there is no concurrent control group to show what would have occurred under another treatment strategy. Differences in patient characteristics, disease course, selection for surgery, and other factors could not be separated from a treatment effect through a randomized comparison in this study.
The pathway also selects the primary endpoint population through events after enrollment. Surgery was planned for participants without progressive disease who remained candidates, and the primary endpoint was evaluable only after surgery. Thus, the endpoint does not directly capture the complete experience of all enrolled participants. The registry record does not report a full participant flow or explain the difference between enrollment and the evaluable surgical group.
The recorded status is terminated, but the reason is not reported in the registry record. Termination should not be interpreted as evidence that the regimen was ineffective, harmful, or successful. The adverse-event summary reports 2 participants affected by serious events among 6 at risk and 6 affected by other events among 6 at risk, with 1 death recorded. Those counts require careful attention to the stated denominators and do not establish causation or an overall safety rate for all enrolled participants.
Overall, the registry provides design details, the intended treatment sequence, and some endpoint and safety counts, but limited efficacy results. The small evaluable surgical population and absence of a comparator constrain precision and causal interpretation. The record does not report enough endpoint information to quantify the primary result.
9. Statistical Methods Explained
Statistical methods determine how outcomes are summarized, which participants contribute to each analysis, and how uncertainty is described. The registry record lists 4 outcome measures and 0 analyses. It does not report a detailed statistical analysis plan, a primary endpoint result, or an uncertainty interval. The design and endpoint description allow some general statistical context, but not reconstruction of analyses that are absent from the record.
What does a count endpoint represent?
The primary endpoint is a count of participants meeting the definition of pathological complete response. For a rate, the count would be considered relative to the number of participants evaluated for that outcome. The registry identifies 4 participants who completed surgery and were evaluable, but does not state how many met the response definition. No rate can therefore be read from the record. The count endpoint should also not be confused with the enrollment total of 7: enrollment and endpoint evaluability describe different groups.
In general, a confidence interval expresses the range of values compatible with the observed data under a specified statistical method. For a proportion based on a small group, the interval can be wide, reflecting substantial uncertainty. The registry does not report a confidence interval or the method that would be used to calculate one for the primary endpoint. Without the response count, neither the estimate nor its interval can be reproduced from the stated evaluable group size.
How does the single-arm design affect inference?
A single-arm trial estimates outcomes in participants who received the study strategy. It does not provide an internal comparison group. In general, a control group helps distinguish outcomes associated with the intervention from outcomes that might have occurred under another strategy or through the natural course of disease. Because this study had no comparator, a descriptive outcome would not establish a causal difference between treatment options.
The trial is described as sequential: treatment decisions and eligibility for later stages followed the induction phase. The primary endpoint requires surgery, so the analysis population is conditioned on reaching surgery and being evaluable. This matters because participants who do not reach that stage cannot contribute a surgical specimen endpoint in the same way. The record does not report a complete accounting of participants at each stage or a planned method for handling participants without an evaluable specimen.
What can be learned from the planning assumptions?
The registry describes a planning illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The intended effect is expressed as a stated fraction of the observed effect. The registry further distinguishes planning outputs for time-to-event outcomes from those for other outcomes. These are planning assumptions, not a report of the trial's own design justification or a description of an analysis conducted in this single-arm study.
In general, a sample-size calculation estimates how many participants would be needed under specified assumptions to detect a target effect with a chosen level of statistical power. A planning illustration is conditional on those assumptions and is not evidence that a study had a particular probability of finding a result. It is not observed power. Here, the displayed assumptions describe a hypothetical equal-allocation comparison, while the actual study is single-arm. The registry record does not report the protocol's sample-size justification, and no sample-size conclusion should be attributed to the original study on the basis of the planning illustration.
Over-dispersion is a general concern when outcome variation exceeds what a simple statistical model assumes. If present, it can make standard errors and intervals too small under an unsuitable model. The registry does not report whether over-dispersion was assessed or whether it is relevant to any analysis in this trial. Similarly, the record does not identify a model used for the primary endpoint, a covariate-adjustment strategy, or a method for estimating uncertainty.
What is not available for statistical review?
The record lists 0 analyses and does not report the primary response count, an interval, a hypothesis test, or adjusted estimates. It also does not report interim analyses, a stopping rule, or the detailed statistical plan. These omissions prevent assessment of whether analyses followed prespecified procedures, how missing outcomes were handled, and whether any results were adjusted for multiple testing. The information supports a description of the design and available counts, not a reconstruction of unreported statistical results.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 4 outcome measures, including pathological complete response, pathological N0 rate, adverse events, and disease-free survival. It lists 0 analyses. The record does not report a multiplicity strategy, such as whether outcomes were arranged in a testing hierarchy or whether any adjustment was planned. Without that information and without reported hypothesis tests, the effect of multiple outcome assessment on statistical error rates cannot be evaluated.
Missing-data procedures are not reported in the registry record. The primary endpoint is assessed from a surgical specimen, and the record identifies 4 subjects who completed surgery and were evaluable. It does not provide a complete participant flow or explain why other enrolled participants are not in that evaluable group. No imputation approach, sensitivity analysis, or rule for handling participants without an evaluable specimen is reported.
The record also does not define analysis populations beyond the statement about the 4 evaluable surgical participants. Enrollment was 7, while the safety summary uses 6 participants at risk. The relationship among these groups is not reported in the registry record, so the denominators should not be treated as interchangeable. No intention-to-treat analysis or per-protocol analysis is reported.
Interim analyses, stopping rules, and the reason for termination are not reported in the registry record. These absences limit assessment of outcome selection, participant disposition, and the prespecification of analyses.
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 |
|---|---|---|---|
| Treatment | 2 | 6 | 33.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Treatment | 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 |
|---|---|
| Treatment | 6 of 6 |
Most frequent serious adverse event terms
| Event term | Organ system | Treatment |
|---|---|---|
| APPENDICITIS | Infections and infestations | 1 of 6 |
| HYPOKALEMIA | Metabolism and nutrition disorders | 1 of 6 |
| LUNG INFECTION | Infections and infestations | 1 of 6 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Treatment |
|---|---|---|
| FATIGUE | General disorders | 6 of 6 |
| NAUSEA | Gastrointestinal disorders | 5 of 6 |
| CONSTIPATION | Gastrointestinal disorders | 4 of 6 |
| ESOPHAGITIS | Gastrointestinal disorders | 4 of 6 |
| COUGH | Respiratory, thoracic and mediastinal disorders | 3 of 6 |
| ANEMIA | Blood and lymphatic system disorders | 2 of 6 |
| ANOREXIA | Metabolism and nutrition disorders | 2 of 6 |
| DIARRHEA | Gastrointestinal disorders | 2 of 6 |
| DIZZINESS | Nervous system disorders | 2 of 6 |
| DYSPNEA | Respiratory, thoracic and mediastinal disorders | 2 of 6 |
Serious events with the highest arm-level rate: appendicitis (16.7%), hypokalemia (16.7%), lung infection (16.7%).
The safety summary is for the Treatment group. It reports 6 participants at risk for serious adverse events, with 2 affected, and 6 at risk for other adverse events, with 6 affected. It also records 1 death. The registry lists appendicitis, hypokalemia, and lung infection among the top serious terms, each at 16.7%.
These are counts and listed percentages, not a complete account of event timing, severity beyond the serious-event classification, or attribution. The registry record does not report whether the events were judged related to treatment, whether participants could contribute to more than one event category, or how the death relates to the listed adverse events. The serious-event terms should therefore be read as reported event categories, not as proof of causation.
The safety denominator of 6 differs from the enrollment of 7 and from the 4 participants evaluable for the primary endpoint. The registry record does not explain this difference. The adverse-event figures should not be extrapolated to participants outside the stated risk group or treated as a comparative safety estimate, since the study had no control arm.
12. What the Result Does, and Does Not, Mean
The registry record describes a treatment sequence for medically operable patients with surgically resectable stage III (N2) non-small cell lung cancer and identifies pathological complete response as the primary endpoint. It reports that 4 subjects completed surgery and were evaluable for that endpoint. However, it does not report the response count or rate. The main efficacy result therefore cannot be quantified from the registry record.
The study's single-arm structure is important. It can describe outcomes among participants who received the study strategy, but it does not provide a like-for-like comparison with another regimen. Even a reported response proportion would not, by itself, establish that the strategy caused the observed outcome or performed better than an alternative.
The endpoint is measured in surgical tissue and applies to participants who reached surgery and had an evaluable specimen. It does not automatically describe all enrolled participants, all participants who began treatment, or longer-term outcomes. Disease-free survival is listed as a secondary outcome, but no analysis is reported. The record therefore does not establish a long-term outcome from that measure.
The safety summary records adverse-event counts, including serious events and a death, but does not report attribution or the relationship between the death and particular events. These figures are not a comparative estimate and cannot establish whether treatment caused an event. The study's terminated status also has no reported explanation and should not be treated as an outcome finding.
In sum, the available registry information supports a careful description of study design, participant counts, endpoint definition, and selected safety figures. It does not support a numerical conclusion about pathological complete response, a causal treatment claim, or a comparison with another treatment strategy.
13. Why This Trial Matters Statistically
This trial illustrates why the population attached to an endpoint matters. Enrollment was 7, whereas the primary endpoint description concerns 4 subjects who completed surgery and were evaluable. A surgical pathology outcome is necessarily tied to the availability of a specimen, so it does not automatically represent every participant enrolled in a sequential treatment strategy. Clear participant flow is essential for understanding who contributes to each estimate.
It also shows the limits of a single-arm Phase II design. Such a study can describe feasibility-related outcomes, response counts, and adverse events in the treated group, but it has no internal control against which to estimate a comparative treatment effect. Design and outcome details can be informative even when causal conclusions are not supported.
The registry record further distinguishes endpoint definitions from endpoint results. It defines pathological complete response and gives its timeframe, but does not state the observed response count or rate. A precise definition is not a substitute for a reported estimate, and the number evaluable alone cannot supply the missing result.
Finally, the study's terminated status and safety counts require context. The reason for termination and event attribution are not reported. Statistical interpretation depends not only on numbers, but also on transparent reporting of participant disposition, analysis methods, uncertainty, and the relationship between outcomes and treatment. Those elements determine what readers can responsibly infer from a small, noncomparative study.
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 for interpreting efficacy is that the registry record does not report the primary endpoint count or rate. Although it states that 4 surgical participants were evaluable, there is no reported estimate or uncertainty interval. The primary endpoint result therefore cannot be assessed quantitatively.
The single-arm design has no control group, and the study is open label. It cannot support a direct comparison with another treatment strategy. The record also does not report a statistical analysis plan, sample-size justification for the original trial, interim analyses, or a method for estimating uncertainty.
Participant accounting is incomplete in the information reported. Enrollment was 7, 4 subjects were evaluable for the primary endpoint, and 6 were at risk in the safety summary. The registry record does not explain the movement among these populations or report full reasons for non-evaluability. The reason for termination is also not reported.
For safety, the record provides event counts and selected serious-event terms, but does not report attribution, event timing, or how the death relates to the events. These data cannot establish causation. The listed secondary outcomes do not have reported analyses, limiting interpretation beyond the primary endpoint information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Chemoradiation Plus Durvalumab Followed by Surgery Followed by Adjuvant Durvalumab in Patients With Surgically Resectable Stage III (N2) Non-Small Cell Lung Cancer — NCT03871153.
- Registry record last updated 2023-11-01; status last verified 2023-10.
- Results first posted 2023-11-01.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT03871153 is a Phase II, open-label, multi-institutional, single-arm study of concurrent chemoradiation and durvalumab followed by surgery and planned adjuvant durvalumab in medically operable patients with surgically resectable stage III (N2) non-small cell lung cancer. Enrollment was 7; the registry lists the status as terminated.
The primary endpoint was pathological complete response, defined as no viable cancer in the surgical specimen at surgery. The registry identifies 4 subjects who completed surgery and were evaluable, but does not report the response count or rate. It lists 4 outcome measures and 0 analyses. Safety figures include 2 serious-event-affected participants among 6 at risk, 6 participants affected by other events among 6 at risk, and 1 death. The reason for termination and detailed analysis methods are not reported in the registry record.