This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Safety and Efficacy Study of Carboplatin, Paclitaxel, Bevacizumab and CA4P in Non-Small Cell Lung Cancer (NCT00653939), a randomized phase 2 study. The primary outcome is Progression Free Survival (PFS) in the Intent-to-Treat Population.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00653939 |
| Phase | Phase 2 |
| Condition | Tumors |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 63 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Mateon Therapeutics |
| Results posted | Yes |
2. Clinical Question
Population
People with chemotherapy-naïve stage IIIB or IV non-squamous non-small cell lung cancer were eligible for the study. The primary outcome was specified for the intent-to-treat population. The registry records enrollment of 63 participants.
Intervention
The experimental regimen added fosbretabulin, also known as CA4P, to carboplatin, paclitaxel and bevacizumab. During up to six 21-day cycles, fosbretabulin was scheduled on Days 7, 14 and 21. The study summary describes maintenance bevacizumab with or without CA4P for eligible participants who completed the initial cycles without progression.
Comparator
The comparator was carboplatin, paclitaxel and bevacizumab, without fosbretabulin during the initial treatment cycles. Participants without progression after six cycles could continue bevacizumab maintenance.
Primary question
Among participants in the intent-to-treat population, what median progression-free survival was reported for each regimen? The posted results give medians and 95% confidence intervals, rather than a direct estimate of the between-arm contrast or a sponsor-reported hazard ratio.
The study was randomized, used parallel groups and had no masking. Its central comparison asks whether the addition of fosbretabulin was associated with a different pattern of progression-free survival when used alongside the shared chemotherapy and bevacizumab regimen. The registry lists 31 participants in the chemotherapy-plus-bevacizumab arm and 32 in the arm that also received fosbretabulin. These are the arm sizes recorded with the posted primary outcome.
The study also listed tumor response, overall survival and several categories of grade 3 or 4 toxicity as secondary outcomes. Those outcomes provide context for the range of questions investigated, but the primary question is narrower: the time-to-event outcome of progression-free survival in the intent-to-treat population. The registry record does not report a sponsor-estimated hazard ratio for this comparison.
3. Trial Design
This was a phase II, randomized, parallel-arm study with no masking. The registry lists a total enrollment of 63 and reports 31 participants in the chemotherapy-plus-bevacizumab arm and 32 in the arm that added fosbretabulin. The registry record does not report the method used to generate or conceal the random allocation sequence.
Both arms received carboplatin, paclitaxel and bevacizumab during up to six 21-day cycles. The listed doses were carboplatin AUC 6, paclitaxel 200 mg/m2 and bevacizumab 15 mg/kg, administered intravenously on Day 1. In the fosbretabulin arm, fosbretabulin 60 mg/m2 was scheduled on Days 7, 14 and 21 for up to six cycles. The comparator arm did not include fosbretabulin during these cycles.
The registry summary describes a maintenance phase for participants who completed the first six cycles without disease progression. It states that maintenance involved bevacizumab alone or bevacizumab plus CA4P, according to the assigned regimen. The arm description for the fosbretabulin group is cut off in the registry record, so further details of its maintenance schedule are not reported in the registry record.
The study focused on chemotherapy-naïve stage IIIB or IV non-squamous non-small cell lung cancer. Its primary outcome was progression-free survival in the intent-to-treat population, with a timeframe described as six 21-day cycles. The registry lists tumor response, overall survival using a multivariate Cox regression model, and grade 3 or 4 chemistry, hematology and coagulation toxicities as secondary outcomes. It lists six outcome measures, while five secondary outcomes are posted in the record.
The study status is completed. The registry record lists a start date of 2008-03 and primary completion in 2011-07. It does not report whether the study was designed to establish a definitive treatment effect, nor does it provide a sample-size justification. The posted group summaries should therefore be read as results of this phase II study, without attributing a particular design objective beyond what the record states.
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 | Arm 1: Chemotherapy+Bevacizumab | Arm 2: Active Comparator+Fosbretabulin |
|---|---|---|
| STARTED | 31 | 32 |
| COMPLETED | 19 | 17 |
| NOT COMPLETED | 12 | 15 |
Reasons for not completing this period:
| Reason | Arm 1: Chemotherapy+Bevacizumab | Arm 2: Active Comparator+Fosbretabulin |
|---|---|---|
| Adverse Event | 1 | 3 |
| Withdrawal by Subject | 3 | 3 |
| Physician Decision | 4 | 0 |
| Disease Progression | 2 | 3 |
| Other | 2 | 6 |
Analysis population for the primary outcome, as defined in the registry: Intent-to-Treat
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 | Arm 1: Chemotherapy+Bevacizumab | Arm 2: Active Comparator+Fosbretabulin | Total |
|---|---|---|---|---|
| Participants analysed | 29 | 31 | 60 | |
| Age, Continuous | years | 63.5 (SD 9.5) | 61.0 (SD 9.4) | 62.2 (SD 9.5) |
| Sex: Female, Male: Female | Participants | 17 | 12 | 29 |
| Sex: Female, Male: Male | Participants | 12 | 19 | 31 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 23 | 27 | 50 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 6 | 4 | 10 |
| Region of Enrollment: United States | participants | 29 | 31 | 60 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0 - Fully active | participants | 16 | 16 | 32 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 1 - Restricted in physically strenuous activity | participants | 13 | 15 | 28 |
| Surgery Performed: Yes | participants | 5 | 4 | 9 |
| Surgery Performed: No | participants | 24 | 27 | 51 |
| Prior Surgery Due to NSCLC: Yes | participants | 3 | 2 | 5 |
| Prior Surgery Due to NSCLC: No | participants | 26 | 29 | 55 |
| Subject Given Radiation Therapy: Yes | participants | 5 | 4 | 9 |
| Subject Given Radiation Therapy: No | participants | 23 | 27 | 50 |
| Subject Given Radiation Therapy: Information Missing | participants | 1 | 0 | 1 |
| Prior Radiation Due to NSCLC: Yes | participants | 4 | 4 | 8 |
| Prior Radiation Due to NSCLC: No | participants | 25 | 27 | 52 |
| Stage of Disease at Study Entry: IIIB | participants | 4 | 2 | 6 |
| Stage of Disease at Study Entry: IV | participants | 25 | 29 | 54 |
6. Primary Endpoint
The registry lists the primary outcome as Progression Free Survival (PFS) in the Intent-to-Treat Population, measured over Six 21-day cycles.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | months |
| Endpoint classification | Time-to-Event Analysis |
Progression-free survival (PFS) is a time-to-event outcome: it describes the time until disease progression or death, according to the endpoint definition used in a study. The registry defines progression using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0. Its description identifies progression as a 20% increase in the longest diameter of target lesions, the appearance of one or more new non-target lesions, or progression of non-target lesions since treatment started.
The primary outcome is reported as a median in months for the intent-to-treat population. A median time-to-event value is the time by which half of the relevant observed or estimated event-time distribution has occurred, subject to the study’s analysis and censoring procedures. It is not the average time, and it does not state how long every participant remained free of progression.
Time-to-event outcomes are useful when the timing of an event matters and participants may have different follow-up durations. The median offers a central summary that is relatively direct to interpret, while a confidence interval communicates uncertainty around that estimate. The posted results give a median and 95% confidence interval for each arm. The registry record does not report the censoring details or the method used to estimate the medians.
The primary outcome timeframe is described as six 21-day cycles. This does not mean that the reported medians are limited to six cycles; the registry record does not clarify how that timeframe relates to the duration of outcome follow-up. The outcome definition also does not provide enough detail to infer how deaths without documented progression were handled. Those analysis details are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted median progression-free survival is 9.3 months in the chemotherapy-plus-bevacizumab arm, with a 95% confidence interval from 4.4 to 11.5 months. In the arm that also received fosbretabulin, the median is 8.6 months, with a 95% confidence interval from 5.0 to 10.2 months. The registry lists 31 participants and 32 participants, respectively, for these outcome groups.
These arm-specific estimates describe the observed time-to-event summaries as recorded. The confidence intervals communicate uncertainty in each median estimate; they are not ranges that contain the outcomes of all participants, nor do they directly give the uncertainty in the difference between arms. The intervals overlap. That observation alone is not a formal test of the treatment comparison, and it cannot establish whether the arms differ statistically.
The record does not post a hazard ratio, confidence interval for an arm-to-arm contrast, or p-value for the primary outcome. It also does not give event counts or a survival-curve comparison for PFS. Consequently, the two medians do not by themselves quantify the relative rate of progression or death over follow-up, and they do not provide a complete picture of how the event patterns may have differed at other times.
Because the study was randomized, the arm comparison is framed as a comparison of assigned regimens. However, the registry record does not describe the allocation procedure, follow-up completeness, censoring, adherence, or handling of missing outcome information. Without those details and a sponsor-reported comparative estimate, the posted medians should be interpreted as descriptive arm results rather than a standalone estimate of the causal effect of adding fosbretabulin.
The primary outcome was specified for the intent-to-treat population, which generally aims to retain participants in their randomized groups for analysis. The record does not clarify the precise analysis set or explain whether all randomized participants contributed to the posted median estimates. The outcome timeframe is listed as six 21-day cycles, but the record does not explain whether this denotes the treatment period, the assessment period or another timing convention.
The study also listed response, overall survival and toxicity outcomes. The presence of those outcomes does not establish that they were analyzed with a particular adjustment for multiple testing, or that all planned results were posted. The registry lists five secondary outcomes and six outcome measures. A complete interpretation of the study would require the prespecified analysis methods and additional outcome details, which are not reported in the registry record.
Overall, the posted PFS results supply a median and its 95% confidence interval for each randomized arm. They do not supply the formal comparative estimate needed to state the magnitude or statistical precision of the between-arm contrast. The numbers describe the registry’s reported results; they should not be translated into a claim that either regimen does or does not work.
9. Statistical Methods Explained
Progression-free survival is analyzed as a time-to-event outcome because the endpoint concerns when progression or another defined event occurs. Unlike a simple count at a fixed visit, a time-to-event analysis can account for participants whose follow-up ends before the event is observed, using censoring methods. The registry record does not report the censoring rules, follow-up duration, or the statistical method used for its median estimates, so the exact analysis cannot be reconstructed from the posted summaries.
What does a median time-to-event estimate mean?
A median is a central point in the estimated event-time distribution: half of that distribution lies on either side of the median. It is not a mean, and it is not a statement that every participant experienced the event at that time. For PFS, the posted median is 9.3 months for chemotherapy plus bevacizumab and 8.6 months for the regimen that also included fosbretabulin. Each estimate is accompanied by a 95% confidence interval, which conveys uncertainty around that arm’s median under the analysis assumptions.
A confidence interval for one arm’s median is not a confidence interval for the difference between two arms. Comparing arm-specific intervals informally is not a substitute for a direct contrast, because the uncertainty of a contrast depends on the joint comparison and its analysis. Here, the registry record does not post a comparative hazard ratio, an interval for the arm difference, or a primary-outcome p-value. It is therefore not possible to state the statistical precision of the between-arm comparison from the posted medians alone.
Why is a hazard ratio often used?
In general, a hazard ratio compares the event rates between groups over follow-up, conditional on remaining event-free up to each time. It can use information across the follow-up period rather than reducing each group’s result to a single median. Its interpretation depends on the model and assumptions, including whether the relative event rates are sufficiently stable over time. The registry lists overall survival as a secondary outcome analyzed using a multivariate Cox regression model, but it does not post a hazard ratio for the primary PFS outcome. No hazard ratio should be inferred from the reported medians.
General statistical explanations do not establish which model the investigators used for PFS. The registry record does not report whether a proportional-hazards assumption was assessed, what covariates were used for any PFS model, or whether a log-rank test was performed. Those methods should not be assumed from the outcome type alone.
What does randomization contribute?
In general, random assignment is intended to make treatment groups comparable, on average, with respect to measured and unmeasured baseline characteristics. That supports a comparison by assigned group, especially when analysis follows the intent-to-treat principle. Randomization does not guarantee that every characteristic is balanced in a study, and it does not remove the need to describe the allocation method, outcome follow-up and analysis population. The study is identified as randomized, but the randomization procedure and its implementation are not reported in the registry record.
The primary population is named as intent-to-treat. In general, an intent-to-treat analysis retains participants in their assigned groups even if treatment changes or stops. The registry record does not define its implementation, state how many participants were included in the PFS analysis, or describe treatment discontinuations and crossovers. Therefore, the label alone does not answer every question about the actual analysis set.
How should the planning illustrations be understood?
Any sample-size illustrations associated with the posted results are planning scenarios based on the observed effect, not observed power. The stated assumptions are a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation; the effect to detect is described as a fraction of the observed effect. For time-to-event outcomes, the illustration uses a total number of events, while other outcomes use participants per arm. These are general planning concepts, not evidence that the trial was originally designed with those assumptions.
The registry record does not report the study’s sample-size justification or the assumptions used by investigators when planning enrollment. An illustration based on the observed effect cannot establish what power the completed trial had, and it should not be interpreted as an observed result. It also does not replace a confidence interval or a formal comparative estimate. No planning values beyond the stated assumptions are used in this interpretation.
Why do event counts and follow-up matter?
Time-to-event estimates depend on the observed event information and the handling of participants whose event status is not known through the end of follow-up. More events can make an estimate more informative, while substantial censoring or incomplete follow-up can limit precision. These are general considerations. The registry record does not post PFS event counts or enough follow-up detail to assess how they affected the reported medians and confidence intervals.
For the same reason, the posted arm sizes should not be treated as the number of participants who necessarily experienced an event or contributed complete follow-up. They are the group sizes listed alongside the outcome. Distinguishing enrollment, analysis populations, and event counts is essential for understanding time-to-event evidence, and the registry record does not provide every such detail for this outcome.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary outcome, progression-free survival, and five posted secondary outcomes: best overall tumor response rate, overall survival using a multivariate Cox regression model, and grade 3 or 4 chemistry, hematology and coagulation toxicities. It also records six outcome measures. The registry record does not explain the relationship between the number of outcome measures and the number of posted secondary outcomes, or whether additional planned outcomes were not posted.
When a study evaluates several outcomes, the chance of finding at least one apparently notable result can increase if each is tested separately. General methods for addressing this include prespecifying a hierarchy or adjusting for multiple comparisons. The registry record does not report whether any multiplicity strategy was planned or used. No conclusion about adjustment can be drawn from the list of outcomes alone.
The primary outcome population is named as intent-to-treat, but the registry record does not provide a participant flow, the number included in each outcome analysis, or the number with missing PFS assessments. It does not report reasons for missing observations, censoring details, or an approach to missing data. These gaps limit assessment of whether the posted estimates could be affected by incomplete follow-up or differences in outcome ascertainment.
The record also does not report the prespecified statistical analysis plan, interim analyses, or a sample-size justification. These details are important for understanding how the analyses were selected and how precisely the study was expected to estimate its outcomes. Their absence from the registry record does not prove that no such plans existed; it means they are not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Arm 1: Chemotherapy+Bevacizumab | 16 | 29 | 55.2% |
| Arm 2: Active Comparator+Fosbretabulin | 16 | 31 | 51.6% |
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 |
|---|---|
| Arm 1: Chemotherapy+Bevacizumab | 29 of 29 |
| Arm 2: Active Comparator+Fosbretabulin | 31 of 31 |
Most frequent serious adverse event terms
| Event term | Organ system | Arm 1: Chemotherapy+Bevacizumab | Arm 2: Active Comparator+Fosbretabulin |
|---|---|---|---|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | 1 of 29 | 3 of 31 |
| Febrile Neutropenia | Blood and lymphatic system disorders | 0 of 29 | 2 of 31 |
| Neutropenia | Blood and lymphatic system disorders | 1 of 29 | 1 of 31 |
| Myocardial Ischaemia | Cardiac disorders | 0 of 29 | 2 of 31 |
| Pneumonia | Infections and infestations | 2 of 29 | 0 of 31 |
| Back Pain | Musculoskeletal and connective tissue disorders | 1 of 29 | 1 of 31 |
| Metastases to Meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 29 | 2 of 31 |
| Delirium | Psychiatric disorders | 2 of 29 | 0 of 31 |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | 1 of 29 | 1 of 31 |
| Anaemia | Blood and lymphatic system disorders | 1 of 29 | 0 of 31 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Arm 1: Chemotherapy+Bevacizumab | Arm 2: Active Comparator+Fosbretabulin |
|---|---|---|---|
| Fatigue | General disorders | 25 of 29 | 18 of 31 |
| Neutropenia | Blood and lymphatic system disorders | 14 of 29 | 25 of 31 |
| Neuropathy | Nervous system disorders | 19 of 29 | 15 of 31 |
| Anaemia | Blood and lymphatic system disorders | 20 of 29 | 13 of 31 |
| Nausea | Gastrointestinal disorders | 20 of 29 | 13 of 31 |
| Thrombocytopenia | Blood and lymphatic system disorders | 18 of 29 | 13 of 31 |
| Hypertension | Vascular disorders | 13 of 29 | 17 of 31 |
| Alopecia | Skin and subcutaneous tissue disorders | 16 of 29 | 13 of 31 |
| Diarrhoea | Gastrointestinal disorders | 17 of 29 | 11 of 31 |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 16 of 29 | 11 of 31 |
Serious events with the highest arm-level rate: pulmonary embolism (9.7%), pneumonia (6.9%), delirium (6.9%), febrile neutropenia (6.5%), myocardial ischaemia (6.5%).
For serious adverse events, the registry lists 29 participants at risk in the chemotherapy-plus-bevacizumab arm, with 16 affected. In the arm that added fosbretabulin, it lists 31 participants at risk, with 16 affected. These are arm-specific counts as recorded; they should not be treated as counts of individual event episodes, because the record does not clarify whether a participant could contribute more than one serious event.
The registry also lists other adverse events for 29 participants at risk and 29 affected in the first arm, and 31 at risk and 31 affected in the fosbretabulin arm. These figures are separate from the serious adverse event figures. The registry record does not give further definitions or details that would clarify the precise event-level counting rules.
Listed serious adverse event terms include pulmonary embolism at 9.7%, pneumonia at 6.9%, delirium at 6.9%, febrile neutropenia at 6.5%, myocardial ischaemia at 6.5%, and metastases to meninges at 6.5%. The record does not specify an arm assignment for these percentages in the posted term list, so they should not be attributed to a particular arm. Death counts are not reported in the registry record.
These summaries describe reported safety events; they do not establish that a treatment caused an event. Interpretation depends on event definitions, observation time, exposure and the completeness of reporting, details that are not fully reported in the registry record.
12. What the Result Does, and Does Not, Mean
The posted results describe median progression-free survival in two randomized arms receiving a shared chemotherapy and bevacizumab regimen, with fosbretabulin added in one arm. The reported medians are 9.3 months and 8.6 months, with separate 95% confidence intervals. These values give a summary of the time-to-event experience recorded for each arm, but they do not capture every feature of the event-time distributions.
The results do not provide a direct estimate of the relative effect of the regimens. In particular, the registry record does not report a PFS hazard ratio, confidence interval for the arm-to-arm contrast, or p-value. The two arm-specific medians cannot be converted into those quantities without additional data and assumptions. Nor do the confidence intervals for each median answer whether the arms differ statistically.
The results also do not show how outcomes varied across participant subgroups, whether treatment effects changed over time, or how the outcome was affected by incomplete follow-up. Those details are not reported in the registry record. The primary outcome is named as intent-to-treat, but the record does not fully describe the analysis population or missing-data procedures.
Safety findings should be read as recorded event counts and listed terms, not as proof of causation or as a complete assessment of comparative risk. The registry presents serious and other adverse events separately, but does not provide all contextual information needed to interpret event timing, exposure, or possible differences in reporting.
More broadly, this is a completed phase II study. Its posted results describe the study’s reported outcomes; they do not, on their own, establish a definitive treatment effect or settle the value of either regimen. A conclusion about treatment benefit or lack of benefit would go beyond the information in the registry record. The most defensible reading is descriptive: the record reports arm-specific medians and confidence intervals, plus selected safety summaries, while important comparative and analytical details are not reported.
13. Why This Trial Matters Statistically
This study illustrates a common statistical challenge in randomized clinical research: an outcome can be clinically and analytically important while the registry provides only arm-specific summaries. A median progression-free survival and its confidence interval are useful descriptions, but readers seeking a treatment comparison also need a direct estimate of the contrast and its uncertainty.
Time-to-event outcomes are particularly sensitive to how follow-up and censoring are handled. The median does not describe the whole survival pattern, and it may not capture differences that occur at other points in follow-up. A hazard ratio, survival curves, event counts and clear follow-up information can each contribute to interpretation, but the registry record does not report a PFS hazard ratio, event counts or detailed censoring methods.
The trial also illustrates why registry completeness matters. The primary population is identified as intent-to-treat, yet the exact analysis set and missing-data approach are not reported. The record identifies multiple secondary outcomes but does not report a multiplicity strategy. These are not merely technical details: they help readers understand how much confidence to place in the estimates and how to distinguish planned analyses from exploratory findings.
Finally, the presence of sample-size planning illustrations based on observed effects should be distinguished from the original trial design. Such illustrations can help frame future research, but they are not observed power and do not show what the investigators anticipated when planning this phase II study. The registry record does not report the original sample-size justification. Keeping these distinctions clear helps prevent descriptive results from being read as stronger comparative evidence than the posted information supports.
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 registry record leaves several trial-specific limitations unresolved. It does not report the randomization sequence or allocation concealment method, and the study had no masking. The absence of masking may matter for outcomes that involve judgment or reporting, although the record does not describe how outcome assessment was conducted.
The primary outcome is described as PFS using RECIST Version 1.0, but the record does not report the assessment schedule, assessor blinding, censoring rules, or the method used to estimate the median. The timeframe is listed as six 21-day cycles, without clarifying its relationship to the full duration of PFS follow-up. The record also does not state how death without documented progression was handled in the primary analysis.
Although the outcome is designated for the intent-to-treat population, the exact analysis population and participant flow are not reported. The record does not give PFS event counts, follow-up completeness, reasons for missing assessments, or a missing-data strategy. It also does not post a comparative PFS hazard ratio or other direct arm contrast. These omissions restrict assessment of the precision and robustness of the treatment comparison.
Several secondary outcomes are listed, but the record does not report a multiplicity approach or explain why six outcome measures are recorded while five secondary outcomes are posted. The sample-size justification and any interim analyses are not reported in the registry record. The arm description for fosbretabulin maintenance is incomplete, which limits reconstruction of the full treatment schedule after the initial cycles. These limitations concern the available registry detail and should not be taken to establish that the study did not address them elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Safety and Efficacy Study of Carboplatin, Paclitaxel, Bevacizumab and CA4P in Non-Small Cell Lung Cancer — NCT00653939.
- Registry record last updated 2015-02-09; status last verified 2015-01.
- Results first posted 2015-02-09.
- 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
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18. Record Summary
This completed phase II trial was randomized, parallel-arm and unmasked. It enrolled 63 participants with chemotherapy-naïve stage IIIB or IV non-squamous non-small cell lung cancer. The primary outcome was median progression-free survival in the intent-to-treat population, defined using RECIST Version 1.0.
The registry reports median PFS of 9.3 months (95% confidence interval 4.4 to 11.5) for carboplatin, paclitaxel and bevacizumab, and 8.6 months (95% confidence interval 5.0 to 10.2) for the same regimen with fosbretabulin. It does not report a PFS hazard ratio or a direct comparative estimate.
Serious adverse events affected 16 participants in each arm, with 29 and 31 participants listed at risk, respectively. The record also lists selected serious-event terms and percentages. Details of the PFS analysis, missing data, multiplicity and original sample-size justification are not reported in the registry record.