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 Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Previously Treated Advanced Non-small Cell Lung Cancer (NCT01620190), a na phase 2 study. The primary outcome is Overall Response Rate (Complete and Partial Response) Defined by RECIST 1.1 Criteria.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01620190 |
| Phase | Phase 2 |
| Condition | Recurrent Non-Small Cell Lung Carcinoma, Stage IV Non-Small Cell Lung Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 26 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Washington |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned patients with advanced non-small cell lung cancer. Its official title specifies patients with EGFR mutations or a durable response to an EGFR tyrosine kinase inhibitor following front-line therapy with an EGFR tyrosine kinase inhibitor. The primary endpoint population was narrower: participants had to meet eligibility criteria, receive at least one dose of study intervention, and have at least one post-baseline assessment. The registry record does not report the number meeting that endpoint definition.
Intervention
Participants received paclitaxel albumin-stabilized nanoparticle formulation, identified in the study description as Abraxane. The treatment description specifies an intravenous infusion over 30 minutes on days 1, 8, and 15, with courses repeating every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory biomarker analysis was also listed as an intervention.
Comparator
There was no comparison group. The study is registered as a single-group study with allocation recorded as not applicable and no masking. Consequently, the registry does not support a direct comparison of this treatment with another treatment or with a control group.
Primary question
The primary question was what proportion of eligible, treated, assessable participants achieved a complete or partial response under RECIST 1.1 criteria. The endpoint description states that a response proportion and 95% confidence interval would be calculated. The response count, proportion, and confidence interval are not reported in the registry record.
3. Trial Design
This was a phase II, single-group study sponsored by the University of Washington. The registry lists an enrollment of 26 and a completed status. The study start date was 2012-12-02, and the primary completion date was 2017-10-24. Allocation was not applicable, and masking was none. These features describe a study without a concurrent randomized control group; they do not establish how participants were selected or whether the treatment was compared with any external evidence.
The treatment arm received paclitaxel albumin-stabilized nanoparticle formulation intravenously over 30 minutes on days 1, 8, and 15. Courses were scheduled to repeat every 28 days unless disease progression or unacceptable toxicity occurred. The record also lists laboratory biomarker analysis. It does not report further details about the biomarker procedures or how biomarker findings were intended to affect treatment or analysis.
The primary outcome was overall response rate, defined as the count of participants with complete or partial response by RECIST 1.1. Assessments were planned every two cycles, beginning from the date of first study therapy and continuing until documented progression, death, unacceptable toxicity, withdrawal of consent, or up to 60 weeks. The primary endpoint population included participants who met eligibility criteria, received at least one dose, and had at least one post-baseline assessment.
Secondary outcomes included toxicity within a clinically significant category defined as neutropenia, neutropenic fever, or neuropathy; overall survival; grade 3 or higher toxicity; and time to progression. The record lists five outcome measures overall. It does not report a control arm, an allocation procedure, or an analysis plan establishing how results for these outcomes would be compared or jointly interpreted.
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: Twenty-six patients were consented and treated.
Overall Study
| Stage | Treatment (Paclitaxel Albumin-stabilized Nanoparticle Formula) |
|---|---|
| STARTED | 26 |
| COMPLETED | 26 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: All participants who met eligibility criteria and received at least one dose of study intervention and at least one assessment post-baseline.
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: Baseline participant measures are based on total eligible, consented, and treated patients.
| Characteristic | Unit | Treatment (Paclitaxel Albumin-stabilized Nanoparticle Formula) |
|---|---|---|
| Participants analysed | 26 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 12 |
| Age, Categorical: >=65 years | Participants | 14 |
| Age, Continuous | years | 65 (52 to 81) |
| Sex: Female, Male: Female | Participants | 18 |
| Sex: Female, Male: Male | Participants | 8 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 26 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 10 |
| 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 | 15 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | Participants | 26 |
6. Primary Endpoint
The registry lists the primary outcome as Overall Response Rate (Complete and Partial Response) Defined by RECIST 1.1 Criteria, measured over Assessed every two cycles from date of first study therapy until documented disease progression, date of death, unacceptable toxicity, or withdrawal of patient consent, whichever occurs first, assessed up to 60 weeks..
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
Overall response rate describes the proportion of participants whose tumors met criteria for complete or partial response. In this study, response was defined using RECIST 1.1. The endpoint description says the response proportion and a 95% confidence interval would be calculated. The registry record does not report the response count, proportion, or interval, so the magnitude and precision of the primary result cannot be read from the posted record.
As a general statistical concept, a response proportion condenses participant-level classifications into a measure of how common response was in the defined analysis population. A confidence interval expresses uncertainty around an estimated proportion: it identifies a range of values compatible with the observed data under the method’s assumptions. It is not a guarantee that the true value lies in that range, nor does it by itself establish a comparison with another treatment.
Response is used as a tumor-activity endpoint because it records whether participants met prespecified criteria for tumor shrinkage. It does not by itself describe how long a response lasted, how long participants lived, or the balance of benefits and harms. The registry separately lists overall survival and time to progression as secondary outcomes. Their results are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a planned single-group assessment of response in participants with advanced non-small cell lung cancer. Its primary endpoint was the proportion with complete or partial response by RECIST 1.1 among eligible participants who received at least one dose and had at least one post-baseline assessment. Although the endpoint description says a response proportion and 95% confidence interval would be calculated, neither is reported in the registry record. The primary outcome therefore cannot be quantified from the posted results.
The enrollment listed is 26, but that number should not be treated as the primary endpoint denominator. The endpoint population has additional eligibility, treatment, and assessment requirements, and the number meeting them is not reported. Without the response count and its denominator, it is not possible to characterize the observed response frequency or its statistical precision. There is also no reported result for the secondary outcomes of overall survival, time to progression, or the specified toxicity measures.
The safety information is distinct from the missing response result. In the treatment group, 26 participants were listed at risk for serious adverse events and 1 participant was listed as affected. For other adverse events, 26 were listed at risk and 11 as affected. The registry reports 6 deaths and lists hypotension at 3.8% among the top serious adverse event terms. These entries do not establish the causes of deaths, whether events were related to treatment, or whether participants counted in one category also appear in another. The record does not report the event-level detail needed to resolve those questions.
Because there is no comparator group, the design cannot estimate a treatment contrast against another intervention or control condition. General statistical interpretation of a single-group result is limited to describing outcomes among the analyzed participants; differences from outcomes in other settings may reflect differences in participants, care, follow-up, or measurement. No causal conclusion about comparative effects follows from the design alone.
The registry lists zero analysis entries. That means no analysis results are posted in those registry entries; it does not demonstrate that analyses were never conducted. The statistical analysis plan, including any prespecified methods beyond the endpoint description, is not reported in the registry record. In particular, the record does not establish how incomplete assessments, deviations, or multiple outcomes were handled. The most defensible reading is therefore descriptive: the registry documents the study design, endpoint definition, and selected safety counts, but it does not post the primary efficacy estimate or enough detail to assess its precision or comparative meaning.
9. Statistical Methods Explained
The primary endpoint is a binary participant-level outcome: a participant either met the RECIST 1.1 definition of complete or partial response, or did not. The registry describes the intended summary as a response proportion with a 95% confidence interval. The result itself is not reported in the registry record, so no estimate or interval can be interpreted.
What does a response proportion summarize?
As a general statistical explanation, a proportion is the number of participants with the outcome divided by the number of participants included in the analysis. Its interpretation depends on defining both the outcome and the analysis population. Here, the record defines the endpoint population as eligible participants who received at least one dose and had at least one post-baseline assessment. It does not report how many participants met those conditions or how many achieved response. The enrollment of 26 is not a substitute for that denominator unless the record confirms that every enrolled participant was included, which it does not.
What does a confidence interval add?
In general, a confidence interval communicates the sampling uncertainty around an estimate. For a response proportion, the width depends in part on the number of participants contributing endpoint information and on the observed response pattern. A narrower interval indicates greater precision under the method’s assumptions; a wider interval indicates less precision. An interval is not a measure of clinical importance and does not convert a single-group estimate into a treatment comparison. The planned 95% confidence interval is described, but its limits are not reported.
Why does the analysis population matter?
The endpoint definition excludes participants who did not meet eligibility requirements, did not receive a dose, or lacked a post-baseline assessment. This makes the analysis population dependent on treatment exposure and follow-up information. As a general consideration, excluding participants without an assessment can affect interpretation if the availability of assessment is related to prognosis, toxicity, or other factors. The registry does not report how many participants were excluded for these reasons, why assessments were missing, or whether any alternative analysis populations were used. It is therefore not possible to assess the consequences of missing endpoint data.
What can a single-group design estimate?
As a general statistical concept, a single-group study can describe outcomes within the participants who were observed. It does not directly estimate the difference between treatment and control outcomes because no concurrent comparator is registered. Comparisons with historical expectations would require a specified external benchmark and assumptions about comparability; neither is reported in the registry record. The listed allocation of not applicable and masking of none are consistent with a nonrandomized, unmasked single-group design, but the record does not provide further detail about conduct or analysis.
How should safety counts be interpreted?
Safety entries are counts of participants recorded as affected within the listed treatment group. The record gives 26 at risk and 1 affected for serious adverse events, and 26 at risk and 11 affected for other adverse events. These are not the same measure as the primary response proportion. The record also lists 6 deaths and identifies hypotension at 3.8% among the top serious adverse event terms. It does not report the causes of death, the relationship of events to treatment, or participant-level overlap among categories. General interpretation should therefore keep these figures descriptive and avoid treating them as comparative estimates.
What is known about the analysis plan?
The registry lists zero analysis entries. The endpoint description specifies a response proportion and 95% confidence interval, but it does not provide a fuller statistical plan. Details such as the estimator used for the interval, treatment of missing assessments, prespecified subgroup analyses, or interim analyses are not reported in the registry record. The record also does not report a sample-size justification. General statistical explanations can clarify what these methods would mean, but cannot establish which procedures were actually used beyond the details explicitly recorded.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists five outcome measures: the primary overall response rate and secondary measures covering clinically significant toxicity, overall survival, grade 3 or higher toxicity, and time to progression. It describes the primary response endpoint and its intended 95% confidence interval, but does not report results for that endpoint or for the secondary outcomes. The registry record does not report a multiplicity strategy describing how the interpretation of several outcomes would be coordinated.
As a general statistical concept, multiplicity arises when several hypotheses or outcomes are examined. Repeated testing can increase the chance of at least one apparently notable result arising by chance, depending on the analyses and decision rules. Methods to address multiplicity can include prespecifying a hierarchy or adjusting inference, but the record does not state whether any such approach was planned or used. It would be inappropriate to infer a method from the list of outcomes alone.
The registry lists zero analysis entries. This indicates that results are not posted in those analysis entries; it does not establish that no analyses were performed. The statistical analysis plan, any interim analyses, and any rules for selecting analyses are not reported in the registry record.
The primary endpoint population requires eligibility, treatment exposure, and at least one post-baseline assessment. The number meeting this definition and the handling of participants without assessments are not reported. As a general matter, missing outcome data can affect both the denominator and the interpretation of a proportion, especially if missingness is related to participant outcomes. The registry record does not describe reasons for missing data, imputation, sensitivity analyses, or alternative analysis populations. Accordingly, neither multiplicity nor missing-data procedures can be evaluated from the posted information.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Treatment (Paclitaxel Albumin-stabilized Nanoparticle Formula) | 1 | 26 | 3.8% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Treatment (Paclitaxel Albumin-stabilized Nanoparticle Formula) | 6 of 26 |
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 |
|---|---|
| Treatment (Paclitaxel Albumin-stabilized Nanoparticle Formula) | 11 of 26 |
Most frequent serious adverse event terms
| Event term | Organ system | Treatment (Paclitaxel Albumin-stabilized Nanoparticle Formula) |
|---|---|---|
| Hypotension | Vascular disorders | 1 of 26 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Treatment (Paclitaxel Albumin-stabilized Nanoparticle Formula) |
|---|---|---|
| Peripheral Neuropathy | Nervous system disorders | 6 of 26 |
| Fatigue | General disorders | 4 of 26 |
| Neutrophil count decreased | Investigations | 4 of 26 |
| White blood cell decreased | Investigations | 2 of 26 |
Serious events with the highest arm-level rate: hypotension (3.8%).
The registry reports one treatment group, with 26 participants listed at risk for serious adverse events and 1 listed as affected. For other adverse events, 26 were listed at risk and 11 as affected. The record lists 6 deaths and identifies hypotension at 3.8% among the top serious adverse event terms. These are descriptive registry entries, not comparisons with another group.
As a general interpretation point, a participant count and an event-term percentage may refer to different levels of summary. The record does not provide enough detail to determine whether the hypotension percentage represents participants or events, or to reconstruct its denominator. The listed counts also do not show whether participants overlap across serious events, other events, and deaths. They should not be added together.
The record does not report causes of death, event timing, severity detail beyond the listed categories, or whether events were considered related to treatment. It also does not report the detailed results for the secondary toxicity outcomes. These figures therefore describe recorded safety counts but do not establish attribution or a comparative safety profile.
12. What the Result Does, and Does Not, Mean
The record establishes that a phase II single-group study evaluated paclitaxel albumin-stabilized nanoparticle formulation in patients with previously treated advanced non-small cell lung cancer, with response defined by RECIST 1.1. It also records the planned treatment schedule, the endpoint population criteria, and selected safety counts. These details clarify what the study set out to examine and what information was entered in the registry.
The record does not report the primary response count, response proportion, or 95% confidence interval. It therefore does not permit a numerical description of the primary endpoint or its precision. Enrollment of 26 does not establish the endpoint denominator, because the registry-defined analysis population also required treatment and a post-baseline assessment. Results for the listed secondary outcomes are not reported either.
Even if a response estimate were available, a single-group estimate would describe outcomes in the analyzed participants rather than a contrast with another treatment. Without a concurrent comparator, differences from another population or study could reflect factors other than treatment. The registry also does not report a fuller analysis plan, missing-data procedures, or a sample-size justification. Those gaps limit assessment of how robustly the results were intended to be analyzed.
The safety entries provide counts in the treatment group, including serious adverse events, other adverse events, deaths, and a listed serious event term. They do not identify causes of death or establish whether events were attributed to treatment. The posted information thus supports a limited description of study conduct and recorded safety counts, but not a conclusion about comparative effects, the precision of the primary result, or the balance of outcomes.
13. Why This Trial Matters Statistically
This study illustrates why a registry’s design and analysis population matter when reading a clinical outcome. The primary response endpoint was not defined simply for everyone enrolled: it applied to eligible participants who received at least one dose and had at least one post-baseline assessment. Without the count meeting that definition, enrollment cannot be assumed to be the response denominator. This distinction is important whenever a registry describes an outcome population that is narrower than total enrollment.
The record also demonstrates the limits of interpreting a single-group study. Such a design can describe outcomes among participants who received the study treatment, but it does not provide a concurrent treatment contrast. This matters when readers are tempted to interpret an outcome as evidence of comparative benefit or harm. The design and the posted results must be kept separate: the record states what was studied, but it does not post the primary response estimate or confidence interval.
Safety information calls for similar care. Counts of participants affected, death counts, and a reported event term are different summaries and cannot be combined or interpreted as treatment-attributable without additional information. Here, the registry does not report event causes, treatment relationship, or overlap among categories.
Finally, the record lists multiple outcomes but does not report the analysis plan, missing-data handling, or multiplicity strategy. These omissions do not prove that such procedures were absent from the study; they mean the registry record does not document them. For biostatistical reading, recognizing the boundary between a stated endpoint, a posted result, and an unreported method is essential to avoid overstating what the evidence establishes.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The principal limitation for interpreting efficacy is that the registry record does not report the primary response result. Although it specifies the response definition and planned confidence interval, there is no posted response count, proportion, interval, or endpoint denominator. The enrollment of 26 cannot fill that gap because the analysis population required eligibility, at least one dose, and at least one post-baseline assessment.
The single-group design has no concurrent comparator, so the record cannot support a direct treatment contrast. Allocation is listed as not applicable and masking as none. The registry does not report a fuller analysis plan, sample-size justification, interim analyses, or methods for missing assessments. It also does not report how the five outcome measures were handled jointly for statistical inference.
Safety interpretation is limited by the level of detail posted. The record gives counts for serious and other adverse events, a death count, and a top serious adverse event term, but does not report event timing, causes of death, treatment attribution, or participant-level overlap between categories. The registry does not provide detailed results for the specified toxicity outcomes, overall survival, or time to progression.
These are limitations of what is documented in the registry record. They do not establish that unreported procedures or analyses were not conducted; they mean that those details cannot be evaluated from the posted information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Previously Treated Advanced Non-small Cell Lung Cancer — NCT01620190.
- Registry record last updated 2021-07-16; status last verified 2021-06.
- Results first posted 2021-07-16.
- 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
NCT01620190 is a completed phase II, single-group study sponsored by the University of Washington, with enrollment listed as 26. It examined paclitaxel albumin-stabilized nanoparticle formulation in advanced non-small cell lung cancer. The registered primary endpoint was overall response rate by RECIST 1.1, defined as complete or partial response, with a planned response proportion and 95% confidence interval.
The endpoint population required eligibility, at least one dose, and at least one post-baseline assessment. The registry record does not report the primary response result, its denominator, or the listed secondary outcome results. Safety entries include 1 participant affected by a serious adverse event, 11 affected by other adverse events, 6 deaths, and hypotension at 3.8% among the top serious adverse event terms. Comparative interpretation and detailed assessment of analysis methods are limited because no comparator is registered and several analysis details are not reported.