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 Clinical Trial of Durvalumab (MEDI4736) as 1st Line Therapy in Advanced Non-small Cell Lung Cancer Patients (NCT02879617), a na phase 2 study. The primary outcome is Overall Survival (OS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02879617 |
| Phase | Phase 2 |
| Condition | Non-Small Cell Lung Cancer NSCLC |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 47 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Academic Thoracic Oncology Medical Investigators Consortium |
| Results posted | Yes |
2. Clinical Question
Population
Patients with advanced non-small cell lung cancer and ECOG performance status 2. The registry describes 47 enrolled participants. The primary endpoint population is narrower: participants evaluable for safety and efficacy who received at least one dose and did not withdraw before the second treatment cycle for reasons other than disease progression or toxicity.
Intervention
Durvalumab as first-line therapy. The arm description specifies 1500 mg administered intravenously on day 1 of every 28 day cycle.
Comparator
There is no comparator arm. The trial is identified as single-group, with allocation listed as NA and masking as none. It is not a randomized comparison.
Primary question
The primary endpoint is overall survival: the median time from treatment start to death from any cause, measured in months, with a 95% confidence interval and a timeframe of up to 30 months. The registry record does not report the median or its confidence interval, so the endpoint’s numerical result cannot be interpreted from the record.
In practical terms, the study asks how overall survival was characterized among the specified participants receiving durvalumab in this clinical setting. Because every participant was assigned to the same treatment group, the design cannot estimate a treatment-versus-control contrast. Any observed survival would describe outcomes in this enrolled group; it would not, by itself, establish what would have occurred under another treatment or under no treatment.
The registry also lists progression-free survival, response, and outcomes by PD-L1 expression among secondary outcomes. Numerical results for these outcomes are not reported in the registry record. The central statistical question is therefore limited: what estimate of median overall survival and what uncertainty interval were recorded? The record names the endpoint but supplies neither value.
3. Trial Design
This is a phase II, single-group clinical trial of durvalumab as first-line therapy for advanced non-small cell lung cancer in patients with ECOG performance status 2. The registry lists enrollment as 47 and identifies the trial status as completed. The listed start date is 2017-04-04, and the primary completion date is 2022-06-04.
The intervention is durvalumab, described as 1500 mg given intravenously on day 1 of every 28 day cycle. The trial has no comparator arm: allocation is listed as NA, masking as none, and the model as single group. These design features matter when interpreting the endpoint. Survival observations in a single group can describe the cohort, but there is no concurrent control group in this design to support a randomized between-group treatment effect.
The primary endpoint is median overall survival, with a 95% confidence interval and a timeframe described as up to 30 months. The endpoint definition measures time from treatment start to death from any cause. The designated population includes participants evaluable for safety and efficacy who received at least one dose and did not withdraw before the second treatment cycle for reasons other than disease progression or toxicity. How many enrolled participants met that definition is not reported in the registry record.
Secondary outcomes include progression-free survival, progression-free survival at specified timepoints, outcomes by PD-L1 expression status, and overall response rate. Although the record lists 23 outcome measures, it lists zero analyses. Numerical results, details of outcome-specific analysis populations, and further protocol or statistical-plan details are not reported in the registry record. The completed status indicates the trial is recorded as completed; it does not supply the missing endpoint estimates.
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 | Durvalumab |
|---|---|
| STARTED | 47 |
| COMPLETED | 47 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: Patients evaluable for safety and efficacy that received at least one dose of the treatment who did not withdraw for reasons other than disease progression or toxicity before second treatment cycle.
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 treated patients.
| Characteristic | Unit | Durvalumab |
|---|---|---|
| Participants analysed | 47 | |
| Age, Continuous | years | 76.4 (SD 9.3) |
| Sex: Female, Male: Female | Participants | 20 |
| Sex: Female, Male: Male | Participants | 27 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 7 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 39 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| 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 | 46 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Smoking Status: Former | Participants | 36 |
| Smoking Status: Current | Participants | 10 |
| Smoking Status: Never | Participants | 1 |
| Histology: ADENOCARCINOMA, METASTATIC, NOS | Participants | 7 |
| Histology: ADENOCARCINOMA, N/A | Participants | 2 |
| Histology: ADENOCARCINOMA, NOS | Participants | 16 |
| Histology: BASALOID SQUAMOUS CELL CARCINOMA | Participants | 1 |
| Histology: METASTATIC ADENOSQUAMOUS CARCINOMA | Participants | 2 |
| Histology: NEOPLASM, MALIGNANT | Participants | 2 |
| Histology: NON-SMALL CELL CA | Participants | 5 |
| Histology: PLEOMORPHIC CARCINOMA | Participants | 1 |
| ECOG Performance Status = 2 | Participants | 47 |
| Disease Stage: STAGE IIIB | Participants | 6 |
| Disease Stage: STAGE IV | Participants | 38 |
| Disease Stage: STAGE IVB | Participants | 3 |
6. Primary Endpoint
The registry lists the primary outcome as Overall Survival (OS), measured over Up to 30 months.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | months |
| Endpoint classification | Time-to-Event Analysis |
The primary endpoint is overall survival, defined as the time from the start of treatment to death from any cause. The registry specifies a median in months and a 95% confidence interval, with a timeframe of up to 30 months. The stated endpoint population consists of participants evaluable for safety and efficacy who received at least one dose and did not withdraw before the second treatment cycle for reasons other than disease progression or toxicity.
In general, a median time-to-event is a way to describe the middle of the observed or estimated event-time distribution. It is useful when follow-up times vary or when some participants have not yet had the event by the end of observation. Unlike a mean, the median does not require averaging all event times. The registry record does not state the estimation procedure or explain how censoring was handled.
A confidence interval expresses uncertainty around an estimated quantity. In general, a narrower interval indicates greater precision, while a wider interval indicates less precision. It is not a range that guarantees where an individual participant’s survival time will fall. Here, neither the median estimate nor its 95% confidence interval is reported in the registry record, so the endpoint’s magnitude and precision cannot be assessed. The stated timeframe of up to 30 months identifies the endpoint’s recorded observation horizon; it does not establish how long any particular participant was followed.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies overall survival as the primary endpoint and gives its definition, unit, confidence-interval type, timeframe, and intended population. It does not report a median overall-survival estimate or its 95% confidence interval. Consequently, the primary endpoint’s observed value and precision are not available for interpretation from this record. The timeframe of up to 30 months is not itself a survival result.
The record lists 23 outcome measures and zero analyses. It names secondary outcomes including progression-free survival, progression-free survival at specified timepoints, outcomes by PD-L1 expression status, and overall response rate. Numerical results for these outcomes are not reported in the registry record. No sponsor-reported hazard ratios or corresponding estimates are included in the record. Without endpoint estimates, uncertainty intervals, and analysis details, it is not possible to describe the size or precision of any survival or response finding.
The study is single group, with no comparator arm. This means its design can describe outcomes among the participants treated in the study, but it cannot directly compare those outcomes with a concurrent control group. A numerical survival estimate, if reported, would be an estimate for the defined cohort under the study’s conditions. It would not by itself identify the difference attributable to treatment, because the design does not observe a randomized comparison.
Enrollment is listed as 47, but the number included in the primary endpoint population is not reported in the registry record. The endpoint definition excludes certain participants who withdrew before the second treatment cycle, while requiring at least one dose and evaluability for safety and efficacy. Without the number analyzed and details on follow-up, censoring, or missing outcome data, the contribution of those features to the estimate cannot be assessed.
Safety information is reported separately as counts of participants affected and percentages for selected serious adverse-event terms. Those figures describe events recorded in the trial; they do not establish that durvalumab caused them. They also do not substitute for the missing efficacy endpoint estimates. Overall, the record supports a description of the design and the outcomes intended for assessment, but it does not provide the numerical primary result needed to judge its magnitude or statistical precision.
9. Statistical Methods Explained
The registry describes a phase II, single-group study and identifies median overall survival as the primary endpoint. It does not provide the numerical endpoint result, an analysis procedure, or a sponsor-reported hazard ratio. The explanations below describe general statistical concepts and distinguish them from what the registry record documents.
What does a single-group design estimate?
In general, a single-group study records outcomes among participants receiving the study intervention. It can estimate or describe outcomes in that group, subject to the analysis and follow-up methods used. It does not create a concurrent randomized comparison. As a result, it cannot use a between-arm contrast to separate an intervention effect from other differences that might influence outcomes. The registry identifies this study as single group, with allocation listed as NA and masking listed as none.
This distinction is important for interpreting survival. A median overall-survival estimate would characterize the time-to-death distribution for the endpoint population, if reported. It would not, on its own, show how that survival compares with a different treatment or with no treatment. No control-group survival estimate is reported in the registry record.
What does a median time-to-event measure?
Overall survival is a time-to-event outcome: the event is death from any cause, and the registry defines the time origin as treatment start. In general, time-to-event methods can use information from participants who have not experienced the event by the end of their available observation, provided the analysis handles their follow-up appropriately. Such participants are commonly described as censored. The registry record does not report its censoring rules, the estimator used, or the amount of follow-up available for individual participants.
In general, a median time-to-event identifies the middle of the event-time distribution as estimated by the selected method. It is different from a mean, which averages event times. The record specifies that the endpoint is a median in months, but the estimate itself is not reported. It also does not report whether the median was reached during observation.
How should the confidence interval be read?
In general, a confidence interval communicates uncertainty around an estimate under the assumptions of the statistical method used. A 95% confidence interval gives a range of values compatible with the data and method at the stated confidence level; it is not a prediction interval for individual outcomes. Precision is assessed in part by the interval’s width. Because neither endpoint bound is reported, the precision of this trial’s primary estimate cannot be evaluated.
The registry specifies a 95% confidence interval for the median but does not state how it was calculated. It would be inappropriate to infer the interval method or reconstruct an interval without the necessary event and follow-up information. The record also does not report a numerical estimate from which to assess whether the interval includes any particular benchmark.
What would a hazard ratio mean?
In general, a hazard ratio compares event rates over time between groups under a time-to-event model. Its interpretation depends on the comparison, model, and assumptions. A hazard ratio is not the same quantity as a median survival time, and it does not directly state how long an individual will live. For a single-group study, a comparative hazard ratio would require a defined reference or external comparison. No sponsor-reported hazard ratio or reference group is reported in the registry record, so no hazard-ratio interpretation is available.
How do the planning assumptions differ from trial results?
The registry describes planning illustrations based on a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It states that the effect to detect is a specified fraction of the observed effect. For time-to-event illustrations, the planning quantity is total events; for other outcomes, it is participants per arm. These are planning assumptions, not observed outcomes and not evidence of observed power. The registry record does not report numerical planning counts or the observed effect values used for those illustrations.
These hypothetical assumptions do not change the actual trial design, which is single group rather than a two-arm randomized comparison. Planning illustrations should not be read as the trial’s enrollment target, actual sample size per arm, or a retrospective measure of how likely the study was to detect an effect. Sample-size illustrations are prospective calculations under specified assumptions; they do not replace the observed estimate and its uncertainty.
When a recalculation from posted summary statistics is available, it is an unadjusted calculation and may differ from the sponsor’s analysis. No such numerical comparison or discrepancy is reported in the registry record. There is therefore no recalculated result to compare with a sponsor estimate in this account.
Why does dispersion matter for event counts?
In general, a statistical model for counts may assume a particular relationship between the average count and its variability. Over-dispersion means the observed variability is greater than the model assumes. If it is ignored, standard errors and confidence intervals can be too small, making results appear more precise than they are. The registry record does not describe count models or report a count-outcome analysis, so over-dispersion cannot be assessed as a feature of this trial’s reported results.
More broadly, interpreting any statistical estimate requires knowing the endpoint definition, analysis population, estimation method, and handling of incomplete follow-up. The record specifies some endpoint features, but the numerical primary result and several analysis details are not reported in the registry record. That absence limits conclusions about both effect magnitude and precision.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 23 outcome measures, including overall survival as the primary endpoint and several secondary outcomes. These include progression-free survival, progression-free survival at specified timepoints, outcomes by PD-L1 expression status, and overall response rate. It lists zero analyses, and numerical results for these outcomes are not reported in the registry record.
When a study assesses multiple endpoints or multiple subgroup and timepoint comparisons, the chance of at least one apparently unusual result can increase. In general, multiplicity procedures can address this by controlling the interpretation or testing of a family of comparisons. The registry record does not report a multiplicity adjustment, testing hierarchy, or statistical plan that would establish how such comparisons were intended to be handled. It also does not report interim analyses or stopping rules.
The primary endpoint population is defined as participants evaluable for safety and efficacy who received at least one dose and did not withdraw before the second treatment cycle for reasons other than disease progression or toxicity. The record does not report how many of the 47 enrolled participants met that definition, or give outcome-specific analysis-population counts. It does not describe missing-data procedures, censoring rules, or the completeness of follow-up. These details are relevant because time-to-event estimates depend on how available observation is incorporated, and because exclusions or missing outcomes can affect which participants contribute to an analysis.
Enrollment of 47 should not be assumed to equal the number analyzed for every endpoint. The registry’s stated population definition makes clear that the primary analysis population may be restricted, but its size is not reported in the registry record.
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 |
|---|---|---|---|
| Durvalumab | 26 | 47 | 55.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Durvalumab | 40 of 47 |
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 |
|---|---|
| Durvalumab | 45 of 47 |
Most frequent serious adverse event terms
| Event term | Organ system | Durvalumab |
|---|---|---|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 11 of 47 |
| Lung infection | Infections and infestations | 10 of 47 |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 8 of 47 |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 5 of 47 |
| Atrial fibrillation | Cardiac disorders | 4 of 47 |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 4 of 47 |
| Anemia | Blood and lymphatic system disorders | 2 of 47 |
| Cardiac arrest | Cardiac disorders | 2 of 47 |
| Non-cardiac chest pain | General disorders | 2 of 47 |
| Urinary tract infection | Infections and infestations | 2 of 47 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Durvalumab |
|---|---|---|
| Anemia | Blood and lymphatic system disorders | 30 of 47 |
| Hypoalbuminemia | Metabolism and nutrition disorders | 26 of 47 |
| Lymphocyte count decreased | Investigations | 23 of 47 |
| Fatigue | General disorders | 20 of 47 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 18 of 47 |
| Hyponatremia | Metabolism and nutrition disorders | 17 of 47 |
| Proteinuria | Renal and urinary disorders | 15 of 47 |
| Hypertension | Vascular disorders | 15 of 47 |
| Alkaline phosphatase increased | Investigations | 14 of 47 |
| Sinus tachycardia | Cardiac disorders | 13 of 47 |
Serious events with the highest arm-level rate: dyspnea (23.4%), lung infection (21.3%), hypoxia (17.0%), pleural effusion (10.6%), atrial fibrillation (8.5%).
The registry reports 47 participants at risk in the durvalumab group. It records 26 participants affected by serious adverse events, 45 affected by other adverse events, and 40 deaths. The listed serious adverse-event terms and percentages are dyspnea, 23.4%; lung infection, 21.3%; hypoxia, 17.0%; pleural effusion, 10.6%; atrial fibrillation, 8.5%; and respiratory failure, 8.5%.
These counts and percentages are descriptive safety information. They do not establish that the treatment caused an event, and the death count should not be read as a count of deaths caused by treatment. The registry record does not report event timing, severity detail beyond the serious-event classification, exposure-adjusted rates, or a comparison group. It also does not give counts for each listed serious-event term. Percentages for different terms should not be added to estimate the number of participants affected; in general, a participant may have more than one event, and the record does not specify overlap among these terms.
Serious and other adverse events are separate reported categories. The figures describe what was recorded in the trial and provide context about the observed safety experience, not a causal comparison or a complete account of risk relative to another treatment.
12. What the Result Does, and Does Not, Mean
The registry record describes a completed phase II, single-group trial enrolling 47 patients with advanced non-small cell lung cancer and ECOG performance status 2. Participants received durvalumab as first-line therapy. The primary endpoint is defined as median overall survival from treatment start to death from any cause, with a 95% confidence interval and a timeframe of up to 30 months.
What the record does not provide is the numerical median or its confidence interval. It also does not report numerical results for the listed secondary outcomes. Therefore, the magnitude of the primary endpoint and the precision of any estimate cannot be evaluated from the registry record. A timeframe of up to 30 months is not a substitute for an observed result, and completed status does not convey whether an endpoint estimate was favorable, unfavorable, or uncertain.
The single-group design also limits what any survival estimate could establish. A result from this cohort would describe outcomes among the analyzed participants, but without a concurrent comparator it would not provide a randomized estimate of the difference between durvalumab and another approach. The record does not report a comparative hazard ratio or other between-group effect estimate.
The safety figures describe reported adverse events and deaths in the trial group. They do not by themselves establish causation or comparative safety. Taken together, the available registry information supports an account of the trial design, endpoint definitions, and selected safety counts. It does not support a conclusion about the size or certainty of an overall-survival result, or a treatment effect relative to a comparator.
13. Why This Trial Matters Statistically
This trial is statistically notable for the alignment between its question and its design: it evaluates outcomes in a defined clinical group receiving one intervention, without a randomized comparator. That design can provide descriptive evidence about the enrolled cohort, but it cannot directly estimate a treatment contrast. Distinguishing those aims helps prevent a single-group outcome from being interpreted as a controlled effect.
The population is also specifically characterized by advanced non-small cell lung cancer and ECOG performance status 2. The endpoint population has an additional evaluability and treatment-exposure definition. Those details matter because the population to which a reported estimate applies is determined not just by the enrollment count, but also by who contributes to the endpoint analysis. The number meeting that endpoint definition is not reported in the registry record.
Overall survival is a time-to-event endpoint, for which both the estimate and its precision are important. The registry identifies a median and a 95% confidence interval as the primary summary, but reports neither numerical value. This is a useful reminder that naming an endpoint and a statistical summary does not make the result interpretable without the estimate, uncertainty interval, and analysis context.
The record lists many outcome measures but no analyses. Without numerical results or a reported plan for handling multiple outcomes, readers cannot evaluate the consistency of findings across endpoints or how multiple comparisons were interpreted. The trial therefore illustrates why design, population, endpoint definitions, analysis reporting, and uncertainty all need to be considered together when reading clinical-trial statistics.
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 main trial-specific limitation for statistical interpretation is the absence of numerical endpoint results in the registry record. Although overall survival is identified as the primary endpoint and a 95% confidence interval is specified, neither the median nor its interval is reported. Numerical results for the secondary outcomes are also not reported. The record lists zero analyses, so it does not allow an assessment of the estimated effects or their precision.
The trial is single group and has no comparator arm. This prevents a randomized between-group comparison and limits causal interpretation of any observed outcome. Masking is listed as none. Enrollment is 47, but the number included in the primary endpoint population is not reported; the endpoint definition excludes some early withdrawals for reasons other than progression or toxicity.
The registry does not report the estimation method, censoring rules, follow-up distribution, missing-data procedures, or details of the statistical plan. It also does not report a multiplicity approach for the 23 listed outcome measures. The stated timeframe of up to 30 months does not reveal how much observation was available for each participant.
The population is specific to advanced non-small cell lung cancer and ECOG performance status 2, so results, if available, would apply most directly to the defined study group rather than automatically to other populations. The registry reports selected safety counts and serious-event percentages but does not provide event-level timing, exposure-adjusted rates, or a comparator. These gaps restrict both safety comparisons and interpretation of the relationship between treatment and reported events.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Clinical Trial of Durvalumab (MEDI4736) as 1st Line Therapy in Advanced Non-small Cell Lung Cancer Patients — NCT02879617.
- Registry record last updated 2024-01-05; status last verified 2024-01.
- Results first posted 2023-10-24.
- 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 record identifies NCT02879617 as a completed phase II, single-group trial of durvalumab as first-line therapy for advanced non-small cell lung cancer in patients with ECOG performance status 2. Enrollment is listed as 47. The intervention is described as 1500 mg intravenously on day 1 of every 28 day cycle.
Overall survival is the primary endpoint, defined as median time from treatment start to death from any cause, with a 95% confidence interval and a timeframe of up to 30 months. The numerical median and confidence interval are not reported in the registry record. Secondary outcomes are listed, but numerical results are not reported; the record lists zero analyses.
The design has no comparator arm, and the record lists selected adverse-event counts and serious-event percentages. Those safety data are descriptive and do not establish causation. The available record supports a description of the design and outcome definitions, but not a numerical interpretation of the primary endpoint or a controlled treatment-effect estimate.