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 Safety and Efficacy Clinical Study of SNS-595 for Second-Line Therapy in Patients With Advanced NSCLC (NCT00252382), a na phase 2 study. The primary outcome is Objective Tumor Response Rate.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00252382 |
| Phase | Phase 2 |
| Condition | Carcinoma, Non-Small-Cell Lung |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 31 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Sunesis Pharmaceuticals |
| Results posted | Yes |
2. Clinical Question
The clinical question was whether SNS-595, given as second-line chemotherapy, was associated with objective tumor responses in patients with advanced non-small cell lung cancer (NSCLC). The registry identifies objective tumor response rate as the primary outcome, assessed using RECIST criteria. It does not give the number or proportion of participants with a response, so the response result itself cannot be described from this record.
Population
Patients with advanced NSCLC who had received prior therapy and were being considered for second-line therapy. The registry records an enrollment of 31 and names the efficacy analysis population for the primary endpoint. Further eligibility details and the number included in that analysis population are not reported in the registry record.
Intervention
The intervention was SNS-595 injection. The treatment description specifies 48 mg/m2 once every 21 days for up to 6 cycles as second-line therapy. The registry lists the study as open-label, so masking was not used. Actual treatment exposure, dose modifications, and the number of cycles received are not reported in the registry record.
Comparator
There was no separate control group: the design is recorded as single-group, with allocation marked as not applicable. Accordingly, the study does not provide a concurrent treatment comparison. Response and safety observations in the treated group cannot by themselves distinguish treatment effects from other influences on outcomes.
Primary question
The primary question concerned objective tumor response over a stated timeframe of 168 days. Under the registry’s RECIST description, complete response involves disappearance of all target lesions, while partial response requires at least a 30% decrease in the sum of the longest diameters of target lesions. The record gives no response count, rate, confidence interval, or analysis result.
3. Trial Design
The registry describes a phase 2, open-label, multicenter clinical study of intravenous SNS-595 as second-line chemotherapy for advanced NSCLC. Its design is single-group, and allocation is listed as not applicable. There is no randomized comparator or other control arm in the record, so the study is not a like-for-like comparison of treatment strategies.
The specified regimen was 48 mg/m2 of SNS-595 injection once every 21 days for up to 6 cycles. The primary outcome was objective tumor response rate, with a timeframe of 168 days. Best overall response is listed as a secondary outcome. The registry identifies 31 participants as the enrollment, but does not report the number who started treatment, completed treatment, or were evaluated for each outcome.
The study status is completed. Its recorded start date is 2005-12-27 and its primary completion date is 2007-03-05. Sunesis Pharmaceuticals is listed as the sponsor. These registry entries describe the study’s administrative and treatment framework; they do not establish how much treatment participants received or how complete outcome follow-up was.
The record lists two outcome measures and no analysis results. It does not report the study’s sample-size justification, detailed statistical analysis plan, or procedures for monitoring the study while it was underway. The equal-allocation, two-arm assumptions associated with planning illustrations do not describe this trial’s actual single-group design.
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 With 48 mg/m2 of SNS-595 |
|---|---|
| STARTED | 31 |
| COMPLETED | 5 |
| NOT COMPLETED | 26 |
Analysis population for the primary outcome, as defined in the registry: Efficacy Analysis Population
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 | Total |
|---|---|---|
| Participants analysed | 31 | |
| Age, Continuous | years | 60.4 (SD 9.74) |
| Sex: Female, Male: Female | Participants | 11 |
| Sex: Female, Male: Male | Participants | 20 |
| 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 | 3 |
| Race (NIH/OMB): White | Participants | 28 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Objective Tumor Response Rate, measured over 168 days.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is objective tumor response rate, expressed in the registry as a count of participants and assessed in the efficacy analysis population. The outcome description uses RECIST criteria assessed by CT or MRI. It defines complete response as disappearance of all target lesions and partial response as at least a 30% decrease in the sum of the longest diameters of target lesions. Overall response combines complete and partial response categories.
Response is a binary outcome for each participant under a specified response classification: a participant either meets the criteria for an objective response or does not. A response rate would describe the proportion classified as having a response among the participants included in the relevant analysis. The registry does not report the response count, denominator used, or calculated rate, so none can be stated.
In general, a tumor-response endpoint is used to describe whether participants meet prespecified imaging criteria during a defined assessment period. It can summarize observed tumor shrinkage without, on its own, establishing how outcomes would compare with another treatment or what would have happened without treatment. The registry’s stated endpoint timeframe is 168 days; assessment schedules and rules for handling missing or unevaluable scans are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the study’s purpose and design but does not include the primary endpoint result. It names objective tumor response rate as the primary outcome and describes RECIST-based criteria, yet gives no response count, rate, estimate of uncertainty, or analysis result. Consequently, the recorded information does not allow a quantitative description of observed tumor response in the efficacy analysis population.
The enrollment is 31. That number describes the registry’s enrollment entry; it is not necessarily the denominator for the primary endpoint. The number assessed for response and the number included in the efficacy analysis population are not reported. Without those details and the response count, the response proportion cannot be reconstructed from the registry record.
The study is single-group and open-label. Its results, even if an outcome estimate were available, would describe observations in participants treated under the study regimen rather than a comparative effect against a concurrent control. In general, a single-group study cannot separate treatment-associated outcomes from the natural course of disease, participant selection, other care, or measurement and follow-up influences. This is a design limitation, not a conclusion about what happened to individual participants.
Safety information is recorded separately. The total group lists 6 participants with serious adverse events among 31 at risk, 30 with other adverse events among 31 at risk, and 14 deaths. The registry also lists serious adverse-event terms with percentages. These entries provide safety counts and term listings, but the record does not state timing, individual-level overlap, or whether the deaths were attributed to treatment. They do not supply the missing primary response result.
The registry lists Best Overall Response as a secondary outcome, but no corresponding result is recorded. It also lists no analysis results. Thus, the available record supports description of the planned question, regimen, study structure, and posted safety counts, but not a conclusion about the magnitude or precision of the primary response outcome. A confidence interval or significance test cannot be inferred when the underlying response estimate and analysis are absent.
Any planning illustration based on an observed effect should be read as a hypothetical design calculation, not as evidence of observed power. The registry does not report the primary response effect needed to understand such an illustration in this study. The single-group design also differs from the two-arm equal-allocation assumptions described for those planning calculations.
9. Statistical Methods Explained
The primary outcome is binary: each participant is classified according to whether the RECIST definition of objective response is met. In general, a response rate is the number of participants meeting the response definition divided by the number assessed in the analysis population. The registry identifies the efficacy analysis population but does not report its size or the response count. Therefore, a rate cannot be recovered from the information recorded.
What does a confidence interval describe?
In general, a confidence interval describes the statistical uncertainty around an estimated quantity, such as a response proportion. It is not a range containing a fixed percentage of individual participant outcomes, nor does it address every possible source of bias. Its width depends on the amount of information and the variability in the data, as well as the method used. No interval for the primary endpoint is reported in the registry record, and no interval can be calculated without the endpoint estimate and relevant denominator.
A binary outcome analysis also depends on how participants with missing assessments or unevaluable scans are handled. For example, an analysis plan might specify whether such participants are excluded from the evaluable denominator or assigned a particular outcome classification. That choice can change the estimate’s interpretation. The registry does not report a missing-data rule, the number of participants with missing response assessments, or how unevaluable assessments were treated.
How should a single-group result be understood?
In general, a single-group analysis estimates an outcome within the observed group. It does not estimate a between-group treatment contrast because no concurrent control group is recorded for this study. A response proportion in the treated group would describe the observed classification under the study’s assessment process; it would not by itself quantify how that proportion differs from an alternative treatment or from no treatment. No comparative estimate is available in the registry record.
The open-label design means masking was not used, according to the registry. In general, knowledge of treatment assignment can affect some aspects of conduct or outcome assessment, although imaging criteria provide a defined framework for classifying response. The record does not describe blinded review, independent central assessment, or other measures governing interpretation of scans. Those details should not be assumed.
What do the planning assumptions represent?
The planning assumptions describe a hypothetical two-arm calculation using a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. The stated effect for detection is a fraction of an observed effect. Such calculations concern how a future or hypothetical comparison might be planned under the specified assumptions. They are not observed power and do not establish the precision of the result in this single-group study. The registry does not report the trial’s own sample-size justification or the observed primary response effect needed to interpret an effect-based illustration.
In general, power calculations depend on the assumed effect, outcome variability, significance level, allocation, and analysis method. A planning illustration is conditional on those assumptions; it is not a guarantee that a study will produce a statistically significant result. The equal-allocation assumption has no direct counterpart in the recorded single-group design. The registry also does not report an analysis plan that would explain whether any other sample-size assumptions were used by the investigators.
The primary endpoint is described as a participant count, while the analysis framework and inferential procedure are not reported. The record contains no primary estimate, test statistic, confidence interval, or p-value. It is therefore not possible to assess statistical evidence against a null hypothesis, quantify uncertainty, or compare an inferential result with a threshold. General statistical principles can explain what such measures would mean, but they cannot substitute for absent trial results.
Finally, the safety entries are participant counts and term-specific percentages rather than a comparative safety analysis. In general, counts and percentages describe how often recorded events occurred in the observed group, while a comparison would require an appropriate reference group and compatible ascertainment. This study’s single-group design does not provide such a control. The registry does not report event timing, exposure-adjusted rates, or a causal attribution analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists two outcome measures: objective tumor response rate as the primary outcome and Best Overall Response as a secondary outcome. It does not report how testing or interpretation across outcomes was handled. In general, examining multiple outcomes can increase the chance of finding an apparently notable result by chance if each is treated as a separate confirmatory test. A prespecified multiplicity strategy can address that issue, but no such strategy is reported in the registry record. No outcome analysis results are listed.
The primary endpoint names the efficacy analysis population, but the record does not define its membership or state how participants were selected for it. Enrollment is 31; the number included in the efficacy analysis is not reported. The record also does not give counts for participants who discontinued, were not evaluable, or lacked an assessment.
Missing-data procedures are not reported. For a response endpoint assessed by imaging, missing or unevaluable assessments can affect both the numerator and denominator, depending on the analysis rules. The registry does not say whether participants without an evaluable scan were excluded, classified as nonresponders, or handled in another way. No assumption about that handling can be made from the outcome description alone.
The record does not report an intention-to-treat definition, a per-protocol population, or sensitivity analyses. It identifies an efficacy analysis population but does not provide its operational definition. These omissions limit assessment of how closely the analyzed participants corresponded to all enrolled participants and whether conclusions would be robust to alternative analysis choices.
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 |
|---|---|---|---|
| Total | 6 | 31 | 19.4% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Total | 14 of 31 |
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 |
|---|---|
| Total | 30 of 31 |
Most frequent serious adverse event terms
| Event term | Organ system | Total |
|---|---|---|
| Pneumonia | Infections and infestations | 2 of 31 |
| Febrile neutropenia | Blood and lymphatic system disorders | 1 of 31 |
| Leukopenia | Blood and lymphatic system disorders | 1 of 31 |
| Abdominal pain | Gastrointestinal disorders | 1 of 31 |
| Vomiting | Gastrointestinal disorders | 1 of 31 |
| Pneumonia pneumococcal | Infections and infestations | 1 of 31 |
| Depression | Psychiatric disorders | 1 of 31 |
| Renal failure | Renal and urinary disorders | 1 of 31 |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 1 of 31 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Total |
|---|---|---|
| Fatigue | General disorders | 21 of 31 |
| Nausea | Gastrointestinal disorders | 17 of 31 |
| Anaemia | Blood and lymphatic system disorders | 11 of 31 |
| Constipation | Gastrointestinal disorders | 8 of 31 |
| Abdominal pain | Gastrointestinal disorders | 6 of 31 |
| Vomiting | Gastrointestinal disorders | 6 of 31 |
| Oral candidiasis | Infections and infestations | 6 of 31 |
| Anorexia | Metabolism and nutrition disorders | 6 of 31 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 6 of 31 |
| Neutropenia | Blood and lymphatic system disorders | 5 of 31 |
Serious events with the highest arm-level rate: pneumonia (6.5%), febrile neutropenia (3.2%), leukopenia (3.2%), abdominal pain (3.2%), vomiting (3.2%).
For the total group, the registry records 31 participants at risk for serious adverse events and 6 participants affected. It separately records 31 participants at risk for other adverse events and 30 affected. These are participant counts, not counts of every event occurrence. A participant may experience more than one event, and the registry record does not describe overlap between the categories.
The serious adverse-event term listings include pneumonia at 6.5%, and febrile neutropenia, leukopenia, abdominal pain, vomiting, and pneumonia pneumococcal at 3.2% each. These are term-specific percentages as recorded; the registry does not provide further details on timing, duration, severity grading, or whether individual participants appeared under multiple terms. The percentages should not be added together to form an overall rate.
The total group also lists 14 deaths. The record does not report when the deaths occurred, their causes, or whether they were considered related to treatment. These figures describe recorded safety information in the study group; because there is no control arm, they do not estimate a comparative safety effect or establish causation.
12. What the Result Does, and Does Not, Mean
The study record documents a phase 2 investigation of SNS-595 as second-line therapy for advanced NSCLC, with objective tumor response rate as its primary endpoint. It specifies a regimen and RECIST-based response definitions, and it records enrollment of 31. However, it does not report the primary endpoint’s response count or rate. The key efficacy result therefore cannot be quantified from the registry record.
The absence of a reported response result is not evidence that no responses occurred, and it is not evidence that a response threshold was or was not met. It means the posted registry information does not give the result needed to answer the primary question statistically. Likewise, no confidence interval or p-value is recorded, so neither precision nor statistical significance can be characterized.
The study’s single-group design means there is no concurrent control comparison. General statistical interpretation of an observed rate in one group would be descriptive, not a randomized estimate of the difference attributable to treatment. The open-label designation and the unreported details of outcome assessment and analysis further limit what can be inferred about how the primary result would have been obtained or interpreted.
The safety counts give information about adverse events recorded in the group, including serious adverse events and deaths. They do not establish that treatment caused any event, and the registry does not provide attribution or timing details. Nor can these counts be used to compare safety with another treatment in the absence of a control group.
Overall, the record supports a description of the study’s question, setting, regimen, and some safety observations. It does not support a quantitative efficacy conclusion, a comparative treatment claim, or an assessment of the precision of the primary endpoint. Those limits arise from the results and design information recorded, rather than from a statistical reanalysis of the missing response data.
13. Why This Trial Matters Statistically
This study illustrates the distinction between a clearly named endpoint and a reported endpoint result. The registry defines objective tumor response using RECIST criteria and identifies the analysis population and assessment timeframe, but supplies no response count or rate. A precise endpoint definition is important for reproducibility, yet it cannot replace the result needed to estimate the outcome.
It also illustrates why study design governs interpretation. A single-group study can describe outcomes in its participants, but it does not provide a concurrent estimate of what would have occurred under a comparator. This matters even when the outcome is clinically interpretable: an observed response classification is not itself a randomized treatment contrast. The open-label designation is another design feature relevant to understanding how outcomes were assessed, while details of assessment safeguards are not reported.
Safety reporting makes a related point. Participant counts and event-term percentages are useful descriptions of recorded events, but they are not causal estimates and cannot be compared across treatments from this study alone. Event timing, attribution, and the treatment exposure needed for a fuller safety interpretation are not reported in the registry record.
Finally, the planning assumptions described for hypothetical sample-size illustrations are not a substitute for the trial’s own design rationale or observed analysis. Equal allocation between two arms does not match the recorded single-group design, and planning calculations should not be mistaken for observed power. For biostatistical reading, the central lesson is to separate the stated endpoint, the actual study structure, the planning framework, and the results that are—and are not—recorded.
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 most direct limitation of the registry record is that it contains no primary response result. Although objective tumor response rate is specified, the record gives no response count, denominator, estimate, or measure of uncertainty. Best Overall Response is listed as a secondary outcome, but its result is also not reported. No analysis results are listed.
The design is single-group and open-label, with no concurrent control. Thus, the record cannot support a randomized comparison or a treatment-effect contrast. Enrollment is 31, but the number treated and the number included in each outcome analysis are not reported. The efficacy analysis population is named without a definition or size.
Other details needed to judge the endpoint analysis are absent: the response assessment schedule, handling of missing or unevaluable scans, analysis population rules, and methods for uncertainty estimation or hypothesis testing are not reported in the registry record. It also does not report whether scan assessment was independently reviewed or blinded. These details should not be inferred from the stated RECIST criteria.
The safety entries do not include event timing, duration, exposure-adjusted summaries, or attribution of deaths and adverse events. The single-group design also leaves no concurrent safety comparator. The registry does not report a multiplicity strategy, detailed statistical plan, or sample-size justification. Taken together, these omissions restrict interpretation to the documented design and posted safety counts, without a quantitative assessment of efficacy or a comparative safety conclusion.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Safety and Efficacy Clinical Study of SNS-595 for Second-Line Therapy in Patients With Advanced NSCLC — NCT00252382.
- Registry record last updated 2018-09-24; status last verified 2017-12.
- Results first posted 2017-06-29.
- 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
NCT00252382 is recorded as a completed phase 2, open-label, multicenter, single-group study sponsored by Sunesis Pharmaceuticals. It investigated intravenous SNS-595 as second-line chemotherapy for patients with advanced NSCLC. The registry lists enrollment of 31, a start date of 2005-12-27, and a primary completion date of 2007-03-05.
The regimen was 48 mg/m2 once every 21 days for up to 6 cycles. The primary outcome was objective tumor response rate by RECIST, with a stated timeframe of 168 days; Best Overall Response was listed as a secondary outcome. No outcome analysis results or primary response estimate are recorded. The total group safety entries list 6 participants with serious adverse events, 30 with other adverse events, and 14 deaths; the record does not report attribution or timing.