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 Docetaxel & Oxaliplatin in Combination With Bevacizumab as First-Line Treatment in Subjects With Non-Small Cell Lung Cancer (NSCLC) (NCT00356122), a non-randomized phase 2 study. The primary outcome is Progression-free Survival (PFS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00356122 |
| Phase | Phase 2 |
| Condition | Non-Small Cell Lung Cancer |
| Allocation | Non-Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 53 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Sanofi |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled people with non-small cell lung cancer described as unresectable locally advanced and/or recurrent Stage IIIB, or metastatic Stage IV, with non-squamous cell histology. The treatment description refers to participants with advanced, recurrent, or metastatic disease. The primary outcome population was all participants registered to receive study treatment; the registry record does not report further eligibility details in the registry record described.
Intervention
The intervention combined docetaxel, oxaliplatin and bevacizumab as first-line treatment. The arm description says participants received the combination for Cycles 1-6, every 3 weeks, followed by maintenance bevacizumab every 3 weeks. The study’s brief summary describes the drugs as investigational in this combination and states that the three drugs are FDA approved.
Comparator
There was no separate comparator arm. The registry describes a non-randomized, single-group study with no masking. Consequently, the record does not provide a randomized between-group estimate of the treatment’s effect, and it cannot support a like-for-like comparison against another treatment group within this study.
Primary question
The primary endpoint was progression-free survival (PFS), measured in months. The study asked how long participants remained alive without documented progressive disease after registration. The endpoint definition counts progression or death from any cause, whichever occurred first. The registry record does not report the observed median PFS or its 95% confidence interval, so the numerical result for this primary question is not reported in the registry record.
3. Trial Design
This was a completed Phase II, multicenter study of a three-drug regimen for first-line treatment of non-small cell lung cancer. The record identifies Sanofi as sponsor, reports enrollment of 53, and gives a study start of 2006-07 and primary completion of 2010-08. The study status is completed.
The design was non-randomized, unmasked, and single-group. The registry lists one treatment arm: Docetaxel/Oxaliplatin/Bevacizumab. Participants received docetaxel followed by oxaliplatin and then bevacizumab during Cycles 1-6, every 3 weeks, followed by maintenance bevacizumab every 3 weeks. A control group, allocation concealment, or masked assessment is not reported in the registry record.
These design features shape what can be learned. A single-group study describes outcomes among participants who received the regimen, but it does not create a randomized comparison with a different treatment. Without such a comparison, observed changes or outcomes cannot by themselves separate treatment effects from the course of disease, participant characteristics, or other influences. The registry record does not report the protocol’s sample-size justification, a statistical analysis plan, or interim analyses.
The primary outcome was PFS, and the registry also lists objective response rate, time-to-treatment failure, overall survival, and treatment-related toxicities as secondary outcomes. Although the record identifies five outcome measures, numerical results for the primary endpoint are not reported in the registry record. The record also reports no analyses in its analysis-count information, and no numerical hazard ratio is included in the registry record for this analysis.
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: Of the 85 participants screened for this study, 32 were screen-failures. 53 participants were registered to receive treatment in this study, however, one participant did not receive any study medication. All 53 participants entered the follow-up period, even if they discontinued treatment.
TREATMENT
| Stage | Docetaxel/Oxaliplatin/Bevacizumab |
|---|---|
| STARTED | 53 |
| COMPLETED | 8 |
| NOT COMPLETED | 45 |
Reasons for not completing this period:
| Reason | Docetaxel/Oxaliplatin/Bevacizumab |
|---|---|
| Lack of Efficacy | 26 |
| Adverse Event | 10 |
| Subject's request | 4 |
| Other | 4 |
| Did not receive study medication | 1 |
FOLLOW-UP
| Stage | Docetaxel/Oxaliplatin/Bevacizumab |
|---|---|
| STARTED | 53 |
| COMPLETED | 12 |
| NOT COMPLETED | 41 |
Reasons for not completing this period:
| Reason | Docetaxel/Oxaliplatin/Bevacizumab |
|---|---|
| Death | 37 |
| Lost to Follow-up | 2 |
| Other | 2 |
Analysis population for the primary outcome, as defined in the registry: All participants registered to receive study treatment
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 | Docetaxel/Oxaliplatin/Bevacizumab |
|---|---|---|
| Participants analysed | 53 | |
| Age Continuous | years | 61.10 (SD 11.07) |
| Age, Customized: <65 years | participants | 28 |
| Age, Customized: >=65 years | participants | 25 |
| Sex: Female, Male: Female | Participants | 15 |
| Sex: Female, Male: Male | Participants | 38 |
| Weight | kilograms | 76.530 (SD 17.793) |
| Height | Centimeters | 169.80 (SD 9.57) |
| Body Surface Area (BSA) | Square meters | 1.875 (SD 0.252) |
6. Primary Endpoint
The registry lists the primary outcome as Progression-free Survival (PFS), measured over Baseline to PFS (up to 24 months after the first treatment).
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | Months |
| Endpoint classification | Time-to-Event Analysis |
Progression-free survival measures the time from registration until the earliest of documented progressive disease or death from any cause. In this study, progression was defined by at least a 20% increase in the sum of the longest diameters of target lesions compared with the smallest sum recorded since treatment began, or by the appearance of one or more new lesions. The stated timeframe was baseline to PFS, up to 24 months after the first treatment.
PFS is a time-to-event endpoint: it records how long participants remain without the event defined by the study. It combines progression and death into one outcome, so the endpoint does not separately describe the timing or frequency of each event. A median PFS, when reported, describes the time by which the estimated proportion remaining progression-free has reached the midpoint. A confidence interval communicates uncertainty around an estimate; it is not a guarantee that the true value lies within the interval.
The registry identifies the primary population as all participants registered to receive study treatment. However, the median PFS and its 95% confidence interval are not reported in the registry record. The endpoint definition and analysis population are available, but the numerical primary result is not.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the study’s design and intended primary outcome, but it does not give the numerical PFS result. It identifies PFS as a median in months with a 95% confidence interval, yet the median estimate and interval are not reported in the registry record. No hazard ratio or other numerical estimate of PFS is included in the registry record for this analysis. It is therefore not possible to describe the observed duration of PFS or the precision of that estimate from this record.
The study enrolled 53 participants, while the adverse-event record lists 52 participants at risk in its treatment group. These are distinct figures serving different record purposes. The adverse-event entry says 17 of 52 participants experienced a serious adverse event and 51 of 52 experienced an other adverse event. The listed serious-event terms include pneumonia at 7.7%, abdominal pain at 5.8%, and febrile neutropenia, supraventricular tachycardia, diarrhoea and sepsis at 3.8% each. These entries describe events recorded for the treatment group; they do not provide a comparison with an untreated or alternative-treatment group.
For a single-group study, an outcome estimate would describe the observed course among participants treated in the study. It would not, by itself, quantify what would have happened to comparable participants under another treatment. General statistical interpretation distinguishes an outcome observed in a group from a causal treatment effect estimated through a suitable comparison. The non-randomized, single-group design does not supply a randomized control comparison.
The registry record lists objective response rate, time-to-treatment failure and overall survival as secondary outcomes, as well as treatment-related toxicities. Numerical results for those outcomes are not reported in the registry record in the registry record for this analysis. No p-value, adjusted or unadjusted comparative estimate, or sponsor-reported hazard ratio is reported. Accordingly, there is no basis in this record for judging statistical evidence against a null hypothesis or for comparing treatment effects across groups.
The appropriate reading is therefore limited: the registry describes a completed Phase II study of a specified regimen, its primary endpoint definition, and selected adverse-event counts and terms. It does not report the primary endpoint estimate needed to characterize PFS, nor a comparison that would quantify the regimen’s effect relative to another treatment. Absence of a reported estimate is not evidence that an outcome did or did not occur; it means the corresponding result is not reported in the registry record.
9. Statistical Methods Explained
The statistical details available in the registry record are limited. The study is identified as Phase II, non-randomized, unmasked, and single-group. Its primary endpoint is a median time-to-event measure with a 95% confidence interval. The registry entries available for this analysis do not include the estimated median, interval limits, event count, censoring details, or a numerical hazard ratio. The registry record does not report the protocol’s statistical analysis plan, interim analyses, or sample-size justification.
What does a time-to-event endpoint represent?
General explanation: A time-to-event analysis uses both whether an event occurred and the time until that event. Participants who have not experienced the event by the end of observation may contribute follow-up without being counted as having had the event. This is commonly called censoring. Because participants can have different follow-up durations, time-to-event methods are designed to use available follow-up rather than treating every participant as if observation ended at the same moment. The registry’s PFS definition specifies the event as documented progressive disease or death from any cause, whichever occurs first. It does not report the censoring rules or details of the time-to-event estimation method.
How should a median and confidence interval be read?
General explanation: A median time-to-event estimate is a summary of the distribution of event times. It is not the average time for every participant, and it does not say that all participants experience an event at that time. A confidence interval expresses statistical uncertainty around an estimate under the assumptions of the method used. A wider interval generally indicates less precision than a narrower interval, although precision also depends on the analysis and data. Here, the registry identifies a 95% confidence interval as the planned or reported dispersion measure, but its numerical limits and the median itself are not reported in the registry record. Thus, neither the magnitude nor precision of PFS can be assessed from the available result information.
What does the single-group design allow?
General explanation: A single-group study can describe outcomes observed among participants receiving a regimen. A randomized comparison is different: random assignment is intended to make treatment groups comparable, on average, with respect to measured and unmeasured factors at baseline. Without a comparison group, an outcome in the treated group cannot establish what would have occurred to similar participants without that regimen or under a different regimen. The study’s non-randomized, single-group design therefore limits causal interpretation. A comparison with outside experience would require details and assumptions that are not reported in the registry record.
What do the planning assumptions mean?
The record describes a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. For time-to-event outcomes, the stated planning quantity is a total number of events using the Schoenfeld approach; other planning quantities are expressed as participants per arm. These are planning illustrations, not observed study outcomes and not observed power. The registry entries available for this analysis do not include the calculated planning values or an effect estimate from which to interpret them. The illustration also assumes two arms, whereas the actual registry design is single-group; it should not be read as the study’s actual randomized design or as evidence that the study had a particular probability of detecting an effect.
Why does over-dispersion matter in general?
General explanation: Over-dispersion occurs when outcome variability is greater than a statistical model expects. If a model assumes less variability than is present, uncertainty may be understated and tests may be too optimistic. Analysts may use models that account for extra variability when the outcome and data structure call for them. The registry entries do not identify an over-dispersion adjustment or a model for count outcomes. It would not be appropriate to infer that such a method was or was not used.
In general, statistical interpretation also depends on the analysis population, handling of missing observations, endpoint assessment procedures, and prespecified analysis choices. Those details are not reported in the registry record. The numerical primary result is likewise absent, so no recalculated estimate or comparison with a sponsor analysis can be described.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary outcome, PFS, and secondary outcomes that include objective response rate, time-to-treatment failure, overall survival, and treatment-related toxicities. Testing or estimating several outcomes raises a general multiplicity issue: when many statistical questions are considered, the chance of at least one apparently notable result can increase if each is assessed independently. Prespecified priorities and appropriate adjustment methods can help readers understand how multiple outcomes were handled. The registry record does not report a multiplicity strategy, a hierarchy among secondary outcomes, or whether any adjustment was used.
Missing-data handling is also not reported in the registry record. For a time-to-event endpoint, the method for censoring participants who have not had an event by the end of follow-up is important, as are the rules for incomplete follow-up and endpoint assessment. The record defines PFS and gives its timeframe, but does not describe censoring rules, loss to follow-up, missing endpoint information, or sensitivity analyses addressing missingness.
The primary population is described as all participants registered to receive study treatment. The record does not provide further detail on analysis populations, such as whether eligibility or treatment receipt affected inclusion in particular outcome analyses. It also does not report an interim-analysis plan. These omissions do not establish that such procedures were absent from the study; they mean their details are not reported in the registry record. Because the numerical PFS result and related analysis details are unavailable, the robustness of the primary analysis cannot be evaluated from the registry entries.
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 |
|---|---|---|---|
| Docetaxel/Oxaliplatin/Bevacizumab | 17 | 52 | 32.7% |
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 |
|---|---|
| Docetaxel/Oxaliplatin/Bevacizumab | 51 of 52 |
Most frequent serious adverse event terms
| Event term | Organ system | Docetaxel/Oxaliplatin/Bevacizumab |
|---|---|---|
| PNEUMONIA | Infections and infestations | 4 of 52 |
| ABDOMINAL PAIN | Gastrointestinal disorders | 3 of 52 |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | 2 of 52 |
| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | 2 of 52 |
| DIARRHOEA | Gastrointestinal disorders | 2 of 52 |
| SEPSIS | Infections and infestations | 2 of 52 |
| DEHYDRATION | Metabolism and nutrition disorders | 2 of 52 |
| ATRIAL FIBRILLATION | Cardiac disorders | 1 of 52 |
| INTESTINAL PERFORATION | Gastrointestinal disorders | 1 of 52 |
| LARGE INTESTINE PERFORATION | Gastrointestinal disorders | 1 of 52 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Docetaxel/Oxaliplatin/Bevacizumab |
|---|---|---|
| FATIGUE | General disorders | 37 of 52 |
| DIARRHOEA | Gastrointestinal disorders | 33 of 52 |
| NAUSEA | Gastrointestinal disorders | 32 of 52 |
| ALOPECIA | Skin and subcutaneous tissue disorders | 24 of 52 |
| VOMITING | Gastrointestinal disorders | 21 of 52 |
| ANOREXIA | Metabolism and nutrition disorders | 15 of 52 |
| INSOMNIA | Psychiatric disorders | 14 of 52 |
| CONSTIPATION | Gastrointestinal disorders | 13 of 52 |
| PYREXIA | General disorders | 12 of 52 |
| COUGH | Respiratory, thoracic and mediastinal disorders | 12 of 52 |
Serious events with the highest arm-level rate: pneumonia (7.7%), abdominal pain (5.8%), febrile neutropenia (3.8%), supraventricular tachycardia (3.8%), diarrhoea (3.8%).
The adverse-event record lists 52 participants at risk in the Docetaxel/Oxaliplatin/Bevacizumab group. It reports 17 participants with a serious adverse event and 51 with an other adverse event. The serious-event terms listed most prominently are pneumonia at 7.7%, abdominal pain at 5.8%, and febrile neutropenia, supraventricular tachycardia, diarrhoea and sepsis at 3.8% each. The registry lists no death count in this adverse-event entry.
These figures describe recorded events in the treatment group. They do not compare event rates with a control group, since the study was single-group. The record does not provide event definitions, severity grades beyond the serious-event classification, exposure-adjusted rates, or detailed timing and duration in the registry record for this analysis. A participant may also experience more than one event; the listed figures should not be treated as mutually exclusive categories or added together.
The registry’s distinction between serious and other adverse events is a reporting classification, not a statement about whether every event was caused by treatment. The reported counts and terms should be read as safety observations from this study, without a comparative estimate of excess risk.
12. What the Result Does, and Does Not, Mean
The registry record documents a completed, single-group Phase II study of docetaxel, oxaliplatin and bevacizumab as first-line treatment for non-small cell lung cancer. It describes the treatment schedule, defines PFS, identifies the population for the primary outcome, and records selected adverse-event information. It also lists secondary outcome categories.
The record does not report the median PFS or its 95% confidence interval. Therefore, the primary endpoint’s observed magnitude and precision cannot be described in the registry record. Numerical results for the listed secondary outcomes are not reported in the registry record in the registry record for this analysis. No numerical hazard ratio or comparative treatment estimate is included.
Even if a group-level outcome estimate were available, the study’s non-randomized, single-group design would describe outcomes among treated participants rather than establish a treatment effect relative to a control. A like-for-like randomized comparison is not present. Statistical concepts such as a confidence interval can describe uncertainty around an estimate, but they cannot remedy the absence of a reported estimate or create a missing comparison.
The adverse-event record reports serious and other events among participants in the treatment group, together with selected serious-event terms and percentages. Those observations do not establish how event frequency would compare under another regimen, and the record does not provide a control group for that purpose. The absence of detail about missing data, analysis populations and multiplicity also limits assessment of how outcomes were analyzed.
In short, the record supports description of the study design and some safety observations, but not a numerical conclusion about PFS or a causal comparison of treatments. A result not reported in the registry record should not be interpreted as either a favorable or unfavorable result.
13. Why This Trial Matters Statistically
This study illustrates why design and reporting details matter alongside the name of an endpoint. PFS is defined clearly enough in the registry to identify the event being studied: documented progressive disease or death from any cause, whichever comes first. Yet the registry entries available for this analysis do not include the median PFS or its 95% confidence interval. Without those values, readers cannot assess the observed time-to-event estimate or its precision.
The design also matters for interpretation. A non-randomized, single-group study can provide descriptive evidence about outcomes among participants who received a regimen. It does not provide an internal randomized comparison with another treatment. This distinction is essential: a group’s observed outcome and a treatment effect relative to an alternative are different statistical quantities.
The registry also makes visible the difference between planning information and observed results. Its sample-size assumptions describe a planning illustration based on an observed effect and an assumed two-arm allocation. Those assumptions are not observed outcomes, and planning sample sizes are not observed power. The actual study is listed as single-group, so the illustration should not be mistaken for the trial design.
Finally, safety counts are useful descriptions but do not supply comparative risk estimates. The reported event counts and terms can be read as observations in the treated group; a control group would be needed for a direct internal comparison. The record’s omissions around outcome estimates, analysis populations, missing data, and multiplicity show why registry entries need to be read for both what they report and what they leave unreported.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The principal limitation is that the primary endpoint’s numerical result is not reported in the registry record. Although PFS is defined as a median in months with a 95% confidence interval, neither the estimate nor the interval is available in the registry record. Numerical results for the secondary outcomes are also not reported in the registry record in the registry record.
The study is a non-randomized, single-group trial with no separate comparator. Its results therefore cannot provide a randomized, like-for-like comparison against another treatment. The record does not report a statistical analysis plan, sample-size justification, interim analyses, multiplicity handling, missing-data procedures, censoring rules, or detailed analysis-population definitions. Their absence from the record does not establish that these procedures were not used; their details are not reported in the registry record.
The adverse-event information is limited to counts at risk and affected, selected serious-event terms with percentages, and a null death entry. Detailed event definitions, timing, duration, severity beyond the serious classification, and comparative safety estimates are not reported in the registry record in the registry record for this analysis. The enrollment figure and the adverse-event at-risk count are not the same figure, and the record does not explain the difference in the registry record.
The study’s stated planning illustration assumes two arms despite the actual single-group design. Its calculated planning values are not included in the registry record, and the illustration should not be interpreted as observed power or as a description of the trial’s actual allocation.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Docetaxel & Oxaliplatin in Combination With Bevacizumab as First-Line Treatment in Subjects With Non-Small Cell Lung Cancer (NSCLC) — NCT00356122.
- Registry record last updated 2011-10-17; status last verified 2011-08.
- Results first posted 2011-09-16.
- 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
This completed Phase II study evaluated docetaxel, oxaliplatin and bevacizumab as first-line treatment for non-small cell lung cancer. It was multicenter, non-randomized, unmasked and single-group, with enrollment of 53. The primary endpoint was median PFS, defined from registration to documented progression or death from any cause, whichever occurred first.
The median PFS and its 95% confidence interval are not reported in the registry record. The record lists secondary outcomes and reports adverse-event counts for 52 participants at risk in the treatment group, including 17 with a serious adverse event and 51 with an other adverse event. Without a comparator, the record does not provide an internal randomized treatment comparison.