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 Dose-Dense Induction/Neoadjuvant Chemotherapy in Locally Advanced Non-Small Cell Lung Cancer (NCT02157116), a na phase 2 study. The primary outcome is Induction Response.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02157116 |
| Phase | Phase 2 |
| Condition | Non-small Cell Lung Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 13 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Duke University |
| Results posted | Yes |
2. Clinical Question
Population
Patients with locally advanced non-small cell lung cancer. The registry record lists the condition as non-small cell lung cancer and gives enrollment as 13; it does not provide further detail about the analyzed population.
Intervention
Dose-dense induction chemotherapy with cisplatin and docetaxel administered every 14 days, with pegfilgrastim. The arm description specifies cisplatin 75mg/m2 IV and docetaxel 75mg/m2 IV on days 1, 15, and 29, and pegfilgrastim 6mg SC on days 2, 16, and 30.
Comparator
There was no comparison group. The registry classifies the study as single-group, with no allocation and no masking. It therefore cannot provide a randomized or concurrent comparison against another chemotherapy schedule or a control treatment.
Primary question
What induction response was observed after treatment, assessed between 2 and 3 weeks after induction using RECIST criteria? Response was defined as complete response, meaning disappearance of all target lesions, or partial response, meaning at least a 30% decrease in the sum of the longest diameter of target lesions. The registry record states that data analysis was not performed because of insufficient accrual.
The study explored a shorter interval between chemotherapy treatments than the every-21-day schedule mentioned in the brief summary. Its central question was whether patients treated with the every-14-day schedule would have a measurable response after induction. The record also describes planned genetic testing of pretreatment specimens to look for signatures that may predict chemotherapy sensitivity or resistance. It does not report results of those genetic analyses.
Because the study had a single treatment group, the clinical question is descriptive rather than comparative. A response observed in this group, if reported, would not by itself establish that the every-14-day schedule produces a different response than another schedule. In this record, even a descriptive response estimate is unavailable: the response analysis was not performed. No conclusion about the frequency of response can be drawn from the registry entry.
3. Trial Design
This was a phase 2 study sponsored by Duke University, titled “Dose-Dense Induction/Neoadjuvant Chemotherapy in Locally Advanced Non-Small Cell Lung Cancer.” The registry lists a single group, “Induction Chemotherapy,” with allocation recorded as NA and masking recorded as none. These design features mean that the study did not assign participants between randomized treatment groups and did not use masking as recorded in the registry. There was no concurrent control arm.
The planned regimen combined cisplatin and docetaxel, each listed at 75mg/m2 intravenously on days 1, 15, and 29. Pegfilgrastim was listed at 6mg subcutaneously on days 2, 16, and 30. The brief summary describes the schedule as every 14 days and contrasts it with the every-21-day administration mentioned for these drugs. The record describes genetic testing on pretreatment specimens as an additional study aim, intended to identify signatures that may predict chemotherapy sensitivity or resistance.
The listed enrollment is 13. The study start is recorded as 2006-05, and primary completion as 2009-10. Its status is terminated. The registry record does not report a reason for termination beyond the primary outcome description’s statement that data analysis was not performed due to insufficient accrual. It does not state how many participants received treatment, completed induction, or contributed specimens.
The primary outcome was induction response assessed between 2 and 3 weeks after induction using RECIST criteria. Secondary outcomes listed include Grade III/IV hematologic adverse events, Grade III/IV non-hematologic adverse events, maintaining hemoglobin between 11-13 g/dL during induction, and overall survival. The record lists six outcome measures in total but does not provide analyzed results for these outcomes. It also does not report a detailed protocol, a statistical analysis plan, or an explanation for the enrollment target.
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 | All Subjects |
|---|---|
| STARTED | 13 |
| COMPLETED | 4 |
| NOT COMPLETED | 9 |
Reasons for not completing this period:
| Reason | All Subjects |
|---|---|
| Withdrawal by Subject | 4 |
| Physician Decision | 3 |
| Failed Screening | 2 |
Analysis population for the primary outcome, as defined in the registry: Due to insufficient accrual, data analysis was not performed.
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 | All Subjects |
|---|---|---|
| Participants analysed | 13 | |
| Age, Customized: <18 years | years | 0 |
| Age, Customized: >= 18 years | years | 13 |
| Sex: Female, Male: Female | Participants | 6 |
| Sex: Female, Male: Male | Participants | 7 |
| 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 | 2 |
| Race (NIH/OMB): White | Participants | 11 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 13 |
6. Primary Endpoint
The registry lists the primary outcome as Induction Response, measured over Between 2 and 3 weeks after induction.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was induction response, assessed between 2 and 3 weeks after induction. Response was defined as either complete response or partial response under RECIST criteria. Complete response meant disappearance of all target lesions. Partial response meant at least a 30% decrease in the sum of the longest diameter of target lesions. This definition uses changes in measured lesions to classify whether a participant’s disease meets the stated response criteria after treatment.
Response is used as an endpoint because it gives a structured way to describe tumor change over a specified assessment period. A prespecified definition also makes response classification less dependent on informal judgment. The timing matters: the endpoint concerns an assessment after induction, not a long-term outcome. It is distinct from overall survival, which is listed as a secondary outcome and concerns time until death.
The registry record does not report a response count, response proportion, or other summary estimate. Instead, it states that analysis was not performed because of insufficient accrual. Consequently, the response endpoint is defined, but its observed value is unavailable in the registry record. The endpoint definition cannot be treated as evidence that any participant experienced a complete or partial response, nor can it establish how precisely a response rate might have been estimated.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive fact is that the registry record does not contain an analyzed induction-response result. It explicitly attributes the absence of analysis to insufficient accrual. As a result, no response estimate, uncertainty interval, or statistical test is available to describe the primary outcome. The record therefore cannot answer how often complete or partial response occurred under the studied regimen.
The enrollment entry is 13, but that figure does not replace an endpoint analysis. Enrollment alone does not establish how many participants received the regimen, had an evaluable assessment, or met the response definition. The registry does not report those analysis details. It would be inappropriate to treat enrollment as the response denominator or to infer a response outcome from it.
The design also limits what a response result could have established. This was a single-group study with no concurrent comparator and no randomized allocation. Even if an observed response summary had been reported, it would describe outcomes in the treated group; it would not isolate the effect of the every-14-day schedule relative to the every-21-day schedule or another treatment. Differences in patient characteristics, assessment, or other care could not be separated from a treatment-schedule effect using a single-group result alone.
The record lists adverse-event outcomes, hemoglobin maintenance, and overall survival as secondary outcomes, but it does not provide analyzed results for them. The adverse-event entry identifies a “Treated Patients” category with zero values in its listed at-risk and affected fields and no serious-event terms. Those registry fields should not be interpreted as proof that no adverse events occurred: the record also indicates that data analysis was not performed, and it does not clarify how the zero entries relate to data collection or outcome availability.
Similarly, there is no posted overall-survival estimate, follow-up summary, or genetic-signature result. The study’s stated interest in genomic predictors is an aim, not a reported finding. No association between a genetic signature and chemotherapy sensitivity or resistance can be inferred from the description of planned testing.
The record’s terminated status and insufficient-accrual statement are important context for interpreting the missing results. They indicate that the planned primary analysis was not reported, but the registry does not give enough detail to establish the precise operational circumstances or the number of participants contributing any specific data. Any planning illustrations derived from an observed effect cannot serve as an alternative trial result or as observed power. In this record, the lack of an analyzed primary outcome prevents a quantitative assessment of response and its precision.
9. Statistical Methods Explained
What does a single-group design establish?
A single-group study describes outcomes among participants receiving the specified regimen. It can provide a structured account of what was observed in that group when outcome data are collected and analyzed. It does not, by itself, provide the counterfactual comparison needed to determine what would have happened to similar participants under a different schedule or treatment. This distinction is especially important when the research question concerns a treatment schedule: without a concurrent comparison group, a reported response cannot show that one interval is better or worse than another.
Here, the registry records a single group and no allocation. The absence of masking is also recorded. These design characteristics are not evidence for or against a particular response; they describe how the study was organized. Because the primary analysis was not performed, there is no response summary on which to base even a descriptive estimate.
What does the RECIST response definition mean?
The primary endpoint classifies response using target-lesion measurements. The registry defines complete response as disappearance of all target lesions and partial response as at least a 30% decrease in the sum of the longest diameter of target lesions. A response endpoint based on a rule like this converts measurements into categories according to a stated threshold. In general, standard definitions support consistent interpretation across assessments, although the registry record does not give detailed assessment procedures or additional response categories.
The endpoint’s assessment window is between 2 and 3 weeks after induction. That timing describes when response was intended to be assessed; it does not mean a result was reported. A definition and assessment window are necessary to interpret an endpoint, but they are not substitutes for participant-level observations or an analysis. The record does not provide the number with complete response, the number with partial response, or the combined response count.
Why do estimates need uncertainty measures?
In general, a response estimate from a study is subject to sampling uncertainty: the observed participants may not represent every similar group of patients. A confidence interval expresses the range of values reasonably compatible with the data under the statistical method used. Its width reflects precision; narrower intervals indicate greater precision, while wider intervals indicate less precision. A point estimate without an uncertainty measure can conceal how much the result might vary.
No response estimate or confidence interval is reported in this registry record. Therefore, there is no basis for describing the precision of the primary outcome. Enrollment of 13 does not make an unavailable estimate precise or imprecise; it only states the enrollment figure recorded by the registry. The record also does not provide an analysis population or outcome denominator from which to assess endpoint-specific information.
What can a p-value establish?
In general, a p-value is calculated under a statistical model and a specified null hypothesis. It describes how compatible the observed data are with that hypothesis, assuming the model and test are appropriate. It is not the probability that a treatment works, and it does not measure the size or clinical importance of an effect. A p-value also cannot compensate for a design without a comparison group when the question is a causal treatment contrast.
No primary-outcome p-value or other test result is reported in the registry record. The record lists no analyses. There is consequently no inferential result to interpret, and no basis to characterize the primary result as statistically significant or not statistically significant.
How should sample-size illustrations be read?
In general, prospective sample-size planning depends on choices such as the outcome, a target effect, variability or event assumptions, significance level, power, and allocation. A planning calculation describes what a future study might require under those assumptions; it is not evidence about the actual study’s outcome. The record’s planning assumptions describe an illustration based on an observed effect and specify a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. For time-to-event planning, the stated quantity is total events; for other outcomes, it is participants per arm.
Those assumptions do not describe this trial’s actual design: it was single-group, with no allocation to two arms. Any planning figures based on an observed effect should be read as illustrations, not as the study’s own sample-size justification or as observed power. The registry does not report the protocol’s sample-size rationale. The primary analysis was not performed, so the record does not supply an analyzed response effect on which to base conclusions about the study’s observed response.
Why do endpoint definitions and analysis plans matter?
In general, specifying an endpoint, its assessment window, and the analysis method before examining results can reduce ambiguity about which outcome is being evaluated and how it will be summarized. A complete analysis plan may also define the analysis population, how missing assessments are handled, and whether adjustments are made when multiple outcomes or comparisons are tested. The registry record gives the primary response definition and assessment timing, but does not report a detailed statistical plan, an analysis population, missing-data methods, or a multiplicity approach. Those omissions prevent a fuller evaluation of the intended inference.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists six outcome measures overall. It identifies induction response as the primary outcome and lists secondary outcomes concerning Grade III/IV hematologic adverse events, Grade III/IV non-hematologic adverse events, maintaining hemoglobin between 11-13 g/dL during induction, and overall survival. The record does not provide analyzed results for these outcomes. It does not report whether additional outcomes or analyses were planned beyond the listed measures.
When a study examines multiple outcomes or performs multiple statistical tests, the chance of at least one apparently notable result can increase. In general, a prespecified multiplicity strategy may address that issue by defining which comparisons are primary or by adjusting the interpretation of multiple tests. The registry record does not report a multiplicity adjustment or a hierarchy for interpreting secondary outcomes. Since no analyses are listed, there are no reported tests for which to assess an adjustment.
The primary endpoint description states that analysis was not performed because of insufficient accrual. The record does not say how missing response assessments were handled, whether any participants were excluded from an analysis, or what analysis population was intended. It also does not report the number of participants who received treatment or had an evaluable response assessment. These details are not reported in the registry record.
The adverse-event entry’s zero values do not resolve these uncertainties. The registry does not explain whether those fields represent collected and analyzed outcome data or how they relate to the stated lack of analysis. The record likewise does not provide missing-data methods or an account of follow-up for overall survival. Interpretations of these outcomes must therefore remain limited to the fact that they were listed, not to unreported results.
11. What the Result Does, and Does Not, Mean
The registry record documents a planned investigation of dose-dense induction chemotherapy for locally advanced non-small cell lung cancer. The treatment schedule used cisplatin and docetaxel every 14 days, with pegfilgrastim, and the primary outcome was defined using RECIST response criteria after induction. These details describe the intervention and the question the study set out to address.
The record does not report an analyzed response result. It states that data analysis was not performed because of insufficient accrual. Therefore, the posted information does not establish the number or proportion of participants who had complete or partial response, nor does it show the precision of a response estimate. It cannot support a conclusion that the regimen did or did not produce a particular response rate.
The study’s single-group design also means that it could not provide a randomized comparison with another schedule or treatment. Even if a response estimate were available, a single-group result would describe outcomes in that group and would not by itself establish a comparative treatment effect. No conclusion about the relative value of the every-14-day and every-21-day schedules can be drawn from this record.
The secondary outcome list and the planned genetic analyses should not be mistaken for results. The registry does not report analyzed adverse-event, hemoglobin, overall-survival, or genomic-signature findings. The zero entries in the adverse-event fields do not establish that no events occurred, given the absence of analysis and the lack of explanation for those entries. The record is best read as documentation of a study’s design and intended outcomes, with the primary analysis unavailable.
12. Why This Trial Matters Statistically
This trial is statistically notable because its registry record makes the distinction between an endpoint definition and an endpoint result consequential. The primary response outcome is clearly described, including the assessment period and the criteria for complete and partial response, yet no analysis was performed. A well-defined outcome can support consistent measurement, but it does not create evidence when the underlying analysis is unavailable.
The study also illustrates the interpretive limits of single-group research. A one-group design can be useful for describing outcomes under a regimen, but it does not provide a concurrent reference group for estimating a comparative effect. This matters when the regimen’s schedule is the focus: a result in one group cannot establish what a different schedule would have produced in comparable participants.
Insufficient accrual adds a further constraint. The registry lists enrollment as 13, but the primary response analysis was not performed. The number enrolled should not be conflated with the number contributing evaluable outcome data, and the record does not provide that denominator. Without an analyzed estimate and an uncertainty measure, the intended response question remains unanswered in the posted results.
The record also lists safety, hemoglobin, survival, and genomic aims without providing analyzed findings. This makes it a useful example of why outcome registration, analysis reporting, and interpretation are distinct parts of the evidence record. Readers can identify what the investigators planned to assess, but cannot treat listed aims or empty analyses as evidence of a finding. Any sample-size illustrations are planning calculations, not observed power or a substitute for the unreported primary analysis.
13. 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 trial-specific limitation is that the registry reports no analysis of the primary response endpoint because of insufficient accrual. It therefore provides no response estimate, response denominator, or uncertainty interval. The enrollment entry of 13 does not resolve the absence of those endpoint data, and the record does not say how many participants received treatment or had an evaluable response assessment.
The single-group design limits comparative interpretation. There was no randomized allocation or concurrent control group, so the study could not directly compare the every-14-day regimen with the every-21-day schedule or another treatment. The record also lists no masking. These design features constrain what a result could establish, independent of the missing analysis.
Important analysis details are not reported in the registry record. These include the planned analysis population, handling of missing response assessments, the statistical analysis plan, and any multiplicity strategy for the outcomes. The record does not provide a detailed account of follow-up or analyzed results for the secondary outcomes. The adverse-event fields contain zero values, but their meaning in the context of the stated lack of analysis is not explained; they should not be taken as evidence that no events occurred.
The study is recorded as terminated, but the registry does not give a detailed explanation of the circumstances beyond the insufficient-accrual statement. It also does not report results of the planned genetic testing. Finally, any planning illustrations described in the record are not the trial’s own design justification and should not be interpreted as observed power. Collectively, these omissions leave the study’s intended clinical response question without a reported quantitative answer.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Dose-Dense Induction/Neoadjuvant Chemotherapy in Locally Advanced Non-Small Cell Lung Cancer — NCT02157116.
- Registry record last updated 2014-07-04; status last verified 2014-06.
- Results first posted 2014-07-04.
- 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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17. Record Summary
The registry identifies NCT02157116 as a phase 2, single-group study sponsored by Duke University. It examined induction/neoadjuvant chemotherapy for locally advanced non-small cell lung cancer using cisplatin and docetaxel on an every-14-day schedule, with pegfilgrastim. Enrollment is listed as 13; the study started in 2006-05, had primary completion in 2009-10, and is recorded as terminated.
The primary endpoint was induction response assessed between 2 and 3 weeks after induction under RECIST criteria. The record states that analysis was not performed because of insufficient accrual. It lists secondary outcomes covering adverse events, hemoglobin maintenance, and overall survival, as well as planned genetic analyses, but does not report analyzed findings for these outcomes. With no response estimate and no concurrent comparator, the registry record does not establish a treatment effect or comparative result.