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 Tecemotide Following Concurrent Chemo-radiotherapy for Non-small Cell Lung Cancer (NCT02049151), a randomized phase 3 study. The primary outcome is Overall Survival.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02049151 |
| Phase | Phase 3 |
| Condition | Carcinoma, Non-Small-Cell Lung |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 35 |
| Arms in the primary outcome | n/a |
| Lead sponsor | EMD Serono |
| Results posted | Yes |
2. Clinical Question
Population
The trial enrolled subjects with unresectable stage III non-small cell lung cancer who had stable disease or an objective response following primary concurrent chemo-radiotherapy. The primary-outcome description defines the Safety Analysis Set as subjects who took at least one dose of trial treatment, including tecemotide or placebo and cyclophosphamide or saline. The registry record does not report further eligibility details or baseline characteristics.
Intervention
The tecemotide group is identified in the safety results as tecemotide (L-BLP25) plus cyclophosphamide. The registry describes the study as evaluating tecemotide after completed concurrent chemo-radiotherapy. Dosing schedules, treatment duration and details of how cyclophosphamide was used are not reported in the registry record.
Comparator
The comparison group is identified as placebo plus saline. The trial is described as randomized, double-blind and placebo-controlled. The record does not give the allocation sequence, concealment procedures, or details about which trial roles were masked, despite listing quadruple masking.
Primary question
The central question was whether overall survival differed between subjects assigned to tecemotide and subjects assigned to matching placebo after concurrent chemo-radiotherapy. Overall survival was defined as time from randomization to death, with follow-up assessed maximum up to 16 months. The primary analysis was not performed because the study and tecemotide program were prematurely terminated. The registry therefore does not report an estimated treatment comparison.
3. Trial Design
This was a multicenter, randomized, double-blind, placebo-controlled Phase III trial with a parallel-group model. The registry lists quadruple masking. Its stated purpose was to compare overall survival for tecemotide versus matching placebo in subjects with unresectable stage III non-small cell lung cancer who had completed concurrent chemo-radiotherapy and demonstrated stable disease or an objective response. The safety group labels identify the treatment combinations as tecemotide plus cyclophosphamide and placebo plus saline.
The registry reports enrollment of 35 and a status of terminated. The recorded start is 2014-03, and primary completion is recorded as 2015-07. These dates describe the trial record; they do not establish how long each subject was followed. The primary outcome timeframe says that overall survival was assessed maximum up to 16 months from randomization. The record does not report the treatment assignment ratio, the number assigned to each group, or the number who completed follow-up.
The registry lists secondary outcomes covering time to symptom progression, progression-free survival, time to progression, and treatment-emergent adverse events. The adverse-event categories include serious events, NCI-CTC Grade 3/4 events, events leading to permanent discontinuation, events leading to death, and injection-site reactions. Listing an outcome does not establish that its analysis was completed. The registry reports no analyses, and the primary analysis was not performed following premature termination of the study and tecemotide program based on negative results in EM. The meaning of EM is not reported in the registry record.
Randomization and masking are design features intended to limit bias in treatment assignment and outcome assessment. They do not, by themselves, establish that a treatment difference can be estimated reliably. In this trial, termination and the absence of a primary analysis mean that the design description cannot substitute for a comparative result. The registry record does not report the sample-size justification, detailed statistical plan, or the procedures used to implement randomization and masking.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: 50 subjects were screened for eligibility; 15 excluded (mainly due to non-fulfillment of inclusion or exclusion criteria) and 35 subjects were randomized. Three subjects were randomized but were not treated.
Overall Study
| Stage | Tecemotide (L-BLP25) + Cyclophosphamide | Placebo + Saline |
|---|---|---|
| STARTED | 15 | 17 |
| COMPLETED | 15 | 17 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Safety Analysis Set included all subjects who had taken at least one dose of trial treatment (tecemotide \[L-BLP25\] or placebo), including cyclophosphamide or saline. Analysis was not performed due to the premature termination of this study and the tecemotide program based on negative results in EMR 63325-009 (NCT00960115).
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: Safety Analysis Set included all subjects who had taken at least one dose of trial treatment (tecemotide \[L-BLP25\] or placebo), including cyclophosphamide or saline.
| Characteristic | Unit | Tecemotide (L-BLP25) + Cyclophosphamide | Placebo + Saline | Total Title |
|---|---|---|---|---|
| Participants analysed | 15 | 17 | 32 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 5 | 10 | 15 |
| Age, Categorical: >=65 years | Participants | 10 | 7 | 17 |
| Age, Continuous: Age Continuous | years | 66.2 (SD 5.99) | 63.9 (SD 10.45) | 65.0 (SD 8.60) |
| Sex: Female, Male: Female | Participants | 2 | 7 | 9 |
| Sex: Female, Male: Male | Participants | 13 | 10 | 23 |
6. Primary Endpoint
The registry lists the primary outcome as Overall Survival, measured over Time from date of randomization until death, assessed maximum up to 16 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | subjects |
| Endpoint classification | Binary Endpoint |
Overall survival measures the time from randomization until death. In this trial, the timeframe specifies assessment maximum up to 16 months. The registry says the outcome was presented in terms of the number of subjects who died and the number of censored subjects. Censoring means that the event time is not observed for a subject during the available follow-up; it is not equivalent to recording a death at the end of follow-up.
Overall survival is used in clinical trials because death is a clearly defined event and the endpoint captures time until that event rather than only whether it occurred by a particular visit. A time-to-event analysis can incorporate differing follow-up durations and censored observations, provided the analysis methods and assumptions are appropriate. This is a general explanation of the endpoint, not a description of an analysis completed in this study.
The primary-outcome description states that the analysis was not performed because of premature termination of the study and tecemotide program. Accordingly, the registry record does not report the number of deaths or censored subjects by group, a survival estimate, a treatment-effect estimate, or its uncertainty. The endpoint definition explains what the trial intended to measure; it does not provide evidence about the observed comparison.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The main statistical point is that the registry specifies an overall-survival endpoint but reports no primary analysis. The record explicitly says that analysis was not performed following premature termination of the study and tecemotide program. It also reports zero analyses. Consequently, there is no posted between-group estimate of overall survival to interpret, and no reported confidence interval or primary-outcome significance test.
The enrollment entry is 35, but enrollment alone does not show how many subjects were assigned to each group, received treatment, or contributed follow-up to a particular outcome. The safety figures give group-specific numbers at risk for adverse-event reporting, but those figures are not a substitute for the primary endpoint data. In particular, they do not establish a survival difference. The registry also does not report a hazard ratio, median survival, survival probabilities, or a count of deaths by group.
Without a treatment-effect estimate and a measure of its precision, readers cannot judge whether the primary comparison was compatible with a range of beneficial, harmful, or negligible effects. A confidence interval, in general, describes the statistical uncertainty around an estimate under the assumptions of the analysis. No confidence interval for overall survival is reported in the registry record. The absence of a reported estimate is not evidence that the groups had the same outcome; it means the registry does not supply a completed comparison for this endpoint.
The stated reason for not performing the analysis refers to premature termination of the study and tecemotide program based on negative results in EM. The registry does not explain what EM refers to or provide a detailed account of the decision. That statement should not be expanded into a claim about the outcome of this trial. The record does not say that its own primary comparison demonstrated either a benefit or a lack of benefit.
The safety entries describe participants affected by events within the listed groups. They are descriptive counts, not a randomized efficacy comparison and not adjusted estimates. The serious-event terms include pneumonia and several other named events, but the registry does not report an inferential analysis for these data. Counts and percentages can help describe what was recorded, but without fuller context, analysis details, and uncertainty estimates they do not establish that an event was caused by a particular treatment or that event risks differed between groups.
Thus, the posted information is best read as a trial design and limited safety record with an unreported primary analysis. The intended question is clear, but the record does not supply the survival results needed to answer it statistically.
9. Statistical Methods Explained
The registry describes a randomized, parallel-group, placebo-controlled Phase III design. Random assignment is intended, in general, to make treatment groups comparable with respect to measured and unmeasured baseline factors on average. It does not guarantee balance in a small realized sample, nor does it remove the need to report how the randomization was conducted and analyzed. The registry record does not report the allocation sequence, allocation ratio, or implementation details.
What does masking contribute?
The record lists the trial as double-blind and also records quadruple masking. Masking is intended to reduce the influence of treatment knowledge on behavior, care, outcome assessment, and reporting. The registry does not identify which roles were masked, how masking was maintained, or whether it was ever compromised. The design label alone cannot establish the success of masking.
How is overall survival analyzed in general?
Overall survival is a time-to-event outcome: the event is death, and the time origin is randomization. The registry says that the planned presentation included the number of deaths and censored subjects. In a general time-to-event analysis, subjects with incomplete event follow-up contribute information up to their last known time without the event, rather than being treated as if they had died. The validity of such methods depends on assumptions about censoring and on sufficiently complete follow-up information. The registry record does not report the censoring rules, the survival estimator, the model, or the method used for a treatment comparison.
Common time-to-event approaches can describe survival over follow-up or compare groups while accounting for event timing. A hazard ratio is one possible summary, but its interpretation depends on the model and assumptions. These are general methods, not methods that can be attributed to this trial: the primary analysis was not performed, and the record does not report a treatment-effect estimate. It also does not report survival curves, numbers at risk over time, or a confidence interval for an overall-survival comparison.
What does a confidence interval add?
In general, a confidence interval expresses the statistical precision of an estimate under the analysis assumptions. A relatively broad interval signals less precision than a narrow interval, and the interval can show which values remain compatible with the data and model. It is not a substitute for the estimate itself or for assessing the design and data quality. No overall-survival confidence interval is reported in the registry record, so precision for the intended primary comparison cannot be assessed.
What can counts and event percentages establish?
Adverse-event counts describe how many participants in a group were recorded as affected. They are useful for understanding what was reported, but a count is not automatically a risk comparison. Differences in follow-up, exposure, event ascertainment, and chance can matter. A formal comparison would require a defined estimand and analysis method, as well as uncertainty reporting. The registry lists affected and at-risk counts for serious and other events, plus selected serious-event terms. It does not report inferential comparisons for those entries.
Over-dispersion is a general issue for some count outcomes: observed variability can exceed what a simple statistical model assumes, which can make standard errors too small if the model is not adapted. That concern does not establish that over-dispersion affected this trial. The primary outcome is time to death, and the registry does not report a count-model analysis or an over-dispersion assessment.
What do the planning assumptions mean?
The registry describes sample-size illustrations as planning calculations based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation; it says that time-to-event illustrations use a total event count and other illustrations use participants per arm. Such illustrations are not observed power and are not evidence that a completed comparison exists. The record does not report the trial's own sample-size justification. Because the primary analysis was not performed, the registry does not report an overall-survival effect estimate with which to assess the intended calculation.
No full statistical analysis plan, interim-analysis plan, multiplicity procedure, missing-data strategy, or covariate-adjustment method is reported in the registry record. These omissions matter because analysis choices determine how the intended estimand is translated into an estimate and how uncertainty is quantified. They also prevent readers from checking whether the analyses followed a prespecified plan. The available design details identify the broad trial structure, but they do not reconstruct the analysis that was never reported.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists overall survival as the primary outcome and lists secondary outcomes for symptom progression, progression-free survival, time to progression, and several adverse-event categories. When a trial evaluates multiple outcomes or multiple comparisons, multiplicity can increase the chance of a false-positive finding if each is tested without an appropriate strategy. This is a general statistical concern. The registry record does not report a multiplicity adjustment or other plan for handling the family of outcomes. Since no analyses are reported, there are no posted significance tests to assess in light of multiplicity.
The primary-outcome population is described as the Safety Analysis Set: subjects who took at least one dose of tecemotide or placebo, including cyclophosphamide or saline. That is the population definition stated for the outcome, but the analysis was not performed. The registry does not report the number in that set by group or describe other analysis populations, such as an intention-to-treat population.
The outcome definition includes censored subjects, but the record does not explain how loss to follow-up, incomplete outcome records, or other missing data would have been handled. Censoring is a feature of time-to-event data, not a complete description of missing-data procedures. The registry record also does not report sensitivity analyses, imputation methods, or assumptions about missingness. These details cannot be inferred from the endpoint definition or from the trial's design labels.
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 |
|---|---|---|---|
| Tecemotide (L-BLP25) + Cyclophosphamide | 4 | 15 | 26.7% |
| Placebo + Saline | 1 | 17 | 5.9% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Tecemotide (L-BLP25) + Cyclophosphamide | 14 of 15 |
| Placebo + Saline | 13 of 17 |
Most frequent serious adverse event terms
| Event term | Organ system | Tecemotide (L-BLP25) + Cyclophosphamide | Placebo + Saline |
|---|---|---|---|
| Pneumonia | Infections and infestations | 3 of 15 | 1 of 17 |
| Atrial fibrillation | Cardiac disorders | 1 of 15 | 0 of 17 |
| Autoimmune thyroiditis | Endocrine disorders | 1 of 15 | 0 of 17 |
| Pseudomonal sepsis | Infections and infestations | 1 of 15 | 0 of 17 |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 15 | 1 of 17 |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 0 of 15 | 1 of 17 |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 1 of 15 | 0 of 17 |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 1 of 15 | 0 of 17 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Tecemotide (L-BLP25) + Cyclophosphamide | Placebo + Saline |
|---|---|---|---|
| Fatigue | General disorders | 3 of 15 | 3 of 17 |
| Nausea | Gastrointestinal disorders | 2 of 15 | 2 of 17 |
| Diarrhoea | Gastrointestinal disorders | 1 of 15 | 2 of 17 |
| Fall | Injury, poisoning and procedural complications | 1 of 15 | 2 of 17 |
| Decreased appetite | Metabolism and nutrition disorders | 1 of 15 | 2 of 17 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 2 of 15 | 1 of 17 |
| Back pain | Musculoskeletal and connective tissue disorders | 2 of 15 | 1 of 17 |
| Hypoaesthesia | Nervous system disorders | 1 of 15 | 2 of 17 |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 2 of 15 | 1 of 17 |
| Pain | General disorders | 0 of 15 | 2 of 17 |
Serious events with the highest arm-level rate: pneumonia (20.0%), atrial fibrillation (6.7%), autoimmune thyroiditis (6.7%), pseudomonal sepsis (6.7%), pleural effusion (6.7%).
The safety entries report serious adverse events for the tecemotide (L-BLP25) plus cyclophosphamide group as 4 affected among 15 at risk, and for the placebo plus saline group as 1 affected among 17 at risk. For other adverse events, the entries report 14 affected among 15 at risk in the tecemotide group and 13 among 17 in the placebo group. These are participant counts, not an adjusted comparison or proof that treatment caused an event. The record does not provide uncertainty estimates or a formal safety comparison.
The selected serious-event terms include pneumonia at 20.0%, and atrial fibrillation, autoimmune thyroiditis, pseudomonal sepsis, pleural effusion, and pneumothorax, each at 6.7%. The registry does not provide event counts for each term in the listed summary, nor does it explain whether participants could contribute more than one term. The death entries are null, so the record does not report group-specific counts of deaths attributed to adverse events in that field. These safety summaries should be read as descriptive reports, not as estimates of comparative risk.
12. What the Result Does, and Does Not, Mean
The trial record documents a randomized, masked, placebo-controlled Phase III study intended to compare overall survival after concurrent chemo-radiotherapy in subjects with unresectable stage III non-small cell lung cancer. It also documents that the study was terminated and that the planned primary analysis was not performed. These registry entries establish the trial's intended question and the incompleteness of its posted efficacy results; they do not establish the direction or size of an overall-survival difference.
The absence of a reported comparison must not be interpreted as evidence that tecemotide and placebo produced equivalent outcomes. Equivalence or non-inferiority conclusions require a defined design and suitable analysis, neither of which is reported as completed. Conversely, the lack of a primary result does not demonstrate that tecemotide improved overall survival. No treatment-effect estimate or uncertainty interval is reported for the primary endpoint.
The termination statement says that the study and tecemotide program ended prematurely based on negative results in EM. The registry does not identify the meaning of EM or report the underlying findings in that statement. It therefore cannot be used as a substitute for this trial's missing primary analysis. The record does not report why the individual trial was terminated in greater detail, or whether a separate analysis informed the decision.
The adverse-event entries provide limited descriptive information about affected participants and selected serious-event terms. They do not establish causal attribution or a reliable treatment-group difference. The record also does not report full follow-up, detailed exposure, or uncertainty for those comparisons. Overall, this record describes a study that set out to evaluate a clinically important time-to-event endpoint but does not provide the completed efficacy analysis needed to estimate that endpoint's treatment contrast.
13. Why This Trial Matters Statistically
This trial is statistically instructive because it separates a clearly stated clinical question from the evidence needed to answer it. The design specifies randomization, masking, a placebo comparator, a target population, and overall survival as the primary endpoint. Those elements clarify what investigators intended to compare. They do not create an outcome estimate when the planned analysis was not performed.
Termination makes transparent reporting especially important. Readers need to distinguish trial status, enrollment, safety descriptions, and an analyzed primary outcome. An enrollment figure is not a substitute for group-specific outcome data; an endpoint definition is not a result; and selected adverse-event summaries do not answer a survival question. The record's explicit statement that the primary analysis was not performed prevents an unsupported interpretation of the intended comparison as a completed finding.
The record also illustrates why precision matters. A treatment-effect estimate without uncertainty can be difficult to interpret, while the absence of both estimate and interval leaves no statistical basis for judging the range of effects compatible with the trial's data. Here, no primary comparison is reported at all. The design labels and event summaries cannot fill that gap.
For biostatisticians and clinical researchers, the case highlights the importance of reporting analysis populations, missing-data procedures, censoring rules, multiplicity handling, and a prespecified statistical plan. These details are not reported in the registry record. Their absence limits independent assessment of the intended analysis, while the premature termination further limits what can be concluded from the posted information. The statistical lesson is not a treatment conclusion; it is the need to keep design intent, descriptive safety data, and analyzed efficacy evidence distinct.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The principal limitation is that the overall-survival analysis was not performed. The registry therefore does not report group-specific deaths or censored subjects, a survival estimate, a treatment contrast, or uncertainty for the primary endpoint. This prevents direct statistical evaluation of the trial's central question.
The registry reports enrollment of 35, but does not report group assignment counts for the efficacy population, baseline characteristics, follow-up completeness, or the number of subjects contributing to each outcome. The safety entries provide their own at-risk counts, but they do not replace those missing efficacy details. The record also does not report the sample-size justification, the statistical analysis plan, an analysis population actually used for the primary comparison, or procedures for censoring and missing data.
The trial is marked terminated, with primary completion recorded as 2015-07. The record does not give a detailed account of the termination decision. Its statement about negative results in EM is not expanded, and the meaning of EM is not reported in the registry record. The safety summary is limited to participant counts and selected serious-event terms; it does not report formal comparisons, precision estimates, or event-specific counts for the listed terms. These limitations constrain interpretation of both efficacy and safety information and should not be resolved by assumptions about unreported methods or outcomes.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Tecemotide Following Concurrent Chemo-radiotherapy for Non-small Cell Lung Cancer — NCT02049151.
- Registry record last updated 2017-08-23; status last verified 2017-07.
- Results first posted 2017-03-30.
- 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
This is a multicenter, randomized, double-blind, placebo-controlled Phase III trial of tecemotide after concurrent chemo-radiotherapy in subjects with unresectable stage III non-small cell lung cancer who had stable disease or an objective response. The registry lists a parallel-group design, quadruple masking, enrollment of 35, and terminated status. The recorded start is 2014-03, with primary completion recorded as 2015-07.
Overall survival, defined from randomization until death and assessed maximum up to 16 months, was the primary outcome. The registry states that the analysis was not performed following premature termination of the study and tecemotide program. It lists secondary progression and safety outcomes and includes descriptive adverse-event figures, but reports no analyses. The primary treatment comparison and its precision are not reported in the registry record.