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 First-Line Treatment of A Comparison of 2 Treatments in Elderly Patients With Advanced NSCLC (NCT00456261), a randomized phase 2 study. The primary outcome is Time to Progression (TTP), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00456261 |
| Phase | Phase 2 |
| Condition | Lung Cancer |
| Allocation | Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 110 |
| Arms in the primary outcome | 2 |
| Lead sponsor | SCRI Development Innovations, LLC |
| Results posted | Yes |
2. Clinical Question
Population
Elderly patients with advanced non-small cell lung cancer were the population of interest. The registry describes an intent-to-treat efficacy set and says all patients were analyzed for response using RECIST v1.0. The specific age threshold used to define elderly is not reported in the registry record.
Intervention
One treatment cohort received bevacizumab, pemetrexed, and gemcitabine. The recorded regimen gives bevacizumab 10mg/kg, pemetrexed 500 mg/m2, and gemcitabine 1500 mg/m2 on day 1 and day 15 of each 28-day cycle.
Comparator
The other cohort received bevacizumab, pemetrexed, and carboplatin. Its recorded regimen gives bevacizumab 15mg/kg, pemetrexed 500 mg/m2, and carboplatin AUC=5 on day 1 of each 21-day cycle. Both cohorts were randomized.
Primary question
The primary question was how long patients remained alive without documented disease progression after treatment began. The registry reports median time to progression for each cohort with a 95% confidence interval. A sponsor-reported comparative hazard ratio or other formal primary-endpoint comparison is not reported in the registry record.
This is a comparison of two combination regimens, not a comparison of bevacizumab with no bevacizumab: bevacizumab and pemetrexed appear in both recorded treatment combinations, while gemcitabine and carboplatin distinguish the cohorts. Since the regimens also use different schedules and bevacizumab doses, the contrast is between the complete assigned regimens; the posted results cannot isolate the contribution of one drug or schedule.
The registry identifies the study as randomized and phase II, with 110 participants enrolled. The two posted primary-outcome cohorts each have 55.0 participants. The trial addresses a specific population and treatment setting; its reported results should be read in that context rather than assumed to apply to people outside the enrolled population or to other treatment settings.
3. Trial Design
This was a randomized phase II study with no masking. It compared bevacizumab/pemetrexed/gemcitabine with bevacizumab/pemetrexed/carboplatin as first-line treatment for elderly patients with advanced non-small cell lung cancer. The registry lists 110 participants as enrolled and the study status as completed. The recorded start was 2007-03, and primary completion was 2010-02.
The first cohort received bevacizumab 10mg/kg by vein, followed by pemetrexed 500 mg/m2 and gemcitabine 1500 mg/m2. The regimen was scheduled on day 1 and day 15 of each 28-day cycle. The second cohort received bevacizumab 15mg/kg, pemetrexed 500 mg/m2, and carboplatin AUC=5 on day 1 of each 21-day cycle. The descriptions specify intravenous administration. The descriptions in the registry record are truncated after wording about treatment continuation, so the continuation rules and full treatment-duration details are not reported in the registry record.
The primary endpoint was time to progression (TTP), measured from treatment initiation to documented progression. The registry states that progression was assessed using RECIST v1.0 and gives a timeframe ending at progression, last study contact, or the start of other therapy, up to 18 months. The listed analysis population is the intent-to-treat efficacy set, and the registry says all patients were analyzed for response by RECIST v1.0.
Overall response rate and overall survival were listed as secondary outcomes. Posted numerical secondary results are available for overall response rate. Numerical results for overall survival are not reported in the registry record. The registry does not report a masking procedure, a sample-size justification, or a detailed protocol for statistical analyses beyond the endpoint descriptions and results that are posted.
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.
Combination Therapy
| Stage | Bevacizumab/Pemetrexed/Gemcitabine | Bevacizumab/Pemetrexed/Carboplatin |
|---|---|---|
| STARTED | 55 | 55 |
| COMPLETED | 3 | 29 |
| NOT COMPLETED | 52 | 26 |
Maintenance Therapy
| Stage | Bevacizumab/Pemetrexed/Gemcitabine | Bevacizumab/Pemetrexed/Carboplatin |
|---|---|---|
| STARTED | 3 | 29 |
| COMPLETED | 3 | 29 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: All patients were analyzed for a response by RECIST v1.0. Intent to treat efficacy analysis set.
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 | Bevacizumab/Pemetrexed/Gemcitabine | Bevacizumab/Pemetrexed/Carboplatin | Total |
|---|---|---|---|---|
| Participants analysed | 55 | 55 | 110 | |
| Age, Continuous | years | 76 (70 to 89) | 77 (70 to 88) | 77 (70 to 89) |
| Sex: Female, Male: Female | Participants | 26 | 29 | 55 |
| Sex: Female, Male: Male | Participants | 29 | 26 | 55 |
| Region of Enrollment: United States | participants | 55 | 55 | 110 |
6. Primary Endpoint
The registry lists the primary outcome as Time to Progression (TTP), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease, measured over From the date of treatment initiation until the date of first documented PD or date of last study contact or date of other therapy begins up to 18 months.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | months |
| Endpoint classification | Time-to-Event Analysis |
Time to progression measures the interval between the start of treatment and the date of progressive disease. The registry defines progression using RECIST v1.0: it can involve an increase in the sum of the longest diameters of target lesions relative to the smallest recorded sum, unequivocal progression of non-target lesions, or the appearance of new lesions. The record gives the endpoint timeframe as treatment initiation until documented progression, last study contact, or the start of other therapy, up to 18 months.
A time-to-event endpoint is useful when the outcome is not simply whether progression ever occurred, but when it occurred. A median describes the time by which half of the analyzed group has experienced the event, subject to the analysis and follow-up approach. It does not describe each participant’s course, nor does it mean that all participants progressed at the median time. Participants who have not had a documented event by their last observation may contribute information up to that point; standard time-to-event methods can account for such incomplete follow-up through censoring.
The registry reports median TTP of 4.7 months for bevacizumab/pemetrexed/gemcitabine, with a 95% confidence interval from 3.8 to 5.8 months. For bevacizumab/pemetrexed/carboplatin, the median is 10.2 months, with a 95% confidence interval from 6.3 to 12.7 months. These are arm-specific estimates. A formal comparative primary-endpoint analysis is not reported in the registry record, so the medians and their intervals should not be treated as a reported test of the difference between regimens.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary results are arm-specific median times to progression. The median is 4.7 months for bevacizumab/pemetrexed/gemcitabine, with a 95% confidence interval of 3.8 to 5.8 months. For bevacizumab/pemetrexed/carboplatin, the median is 10.2 months, with a 95% confidence interval of 6.3 to 12.7 months. The estimates describe the observed time-to-progression experience in the two randomized cohorts, as analyzed in the registry record.
The confidence intervals communicate uncertainty around each arm’s estimated median. They are not ranges containing the outcomes of all participants, and they do not directly provide a confidence interval for the difference between arms. The record does not post a sponsor-reported hazard ratio, a comparative confidence interval, or a primary-endpoint p-value. Therefore, the arm-specific estimates alone do not establish the statistical significance of a between-regimen contrast. A formal comparison would need to account for the time-to-event data and its analysis, rather than simply compare the two medians.
The registry also posts overall response rate results. Each arm has a reported response rate of 35.0%, with a 95% confidence interval from 23.0% to 49.0%. The recalculated unadjusted risk difference is 0.0, with an interval that spans both negative and positive values, and the unadjusted p-value is 1.0. This is a simple comparison based on the posted response counts; it is not a substitute for a prespecified sponsor analysis. The registry lists no reported analyses for this secondary result.
The primary and secondary outcomes describe different aspects of the observed data. TTP measures time until disease progression, whereas overall response rate records the proportion experiencing an objective benefit as defined for that endpoint. Equal posted response-rate estimates do not imply equal time-to-progression patterns, just as different arm-specific TTP medians do not establish a comparative effect without a reported analysis of that endpoint.
These findings should be interpreted as descriptive posted results from a randomized phase II trial, not as a definitive estimate for every patient or setting. The registry record does not report the detailed statistical plan, the method used to calculate the primary confidence intervals, or a sponsor-reported comparative primary analysis. Overall survival is listed as a secondary outcome, but its numerical results are not reported in the registry record. The available results therefore do not provide a complete account of every listed outcome or every aspect of the primary comparison.
9. Statistical Methods Explained
Randomization assigns participants to treatment groups by chance. In general, this can reduce systematic differences between groups at the point of assignment, although randomization does not guarantee that every characteristic will be balanced in a particular trial. The registry identifies this study as randomized, with no masking. It lists 110 participants enrolled and 55.0 in each cohort for the posted primary endpoint. The allocation procedure and any stratification factors are not reported in the registry record.
What does a median time-to-event estimate describe?
For a time-to-event outcome, each participant contributes information about the time from a defined starting point until an event or last known observation. In this trial the starting point is treatment initiation, and the event is documented progressive disease. The registry describes progression assessment using RECIST v1.0. In general, a median time is the point at which the estimated event-time distribution reaches its midpoint. It is a group summary, not a prediction for an individual participant and not a statement that every participant experienced progression at that time.
Some participants may not have a recorded progression by the end of their observed follow-up, or may leave observation for another reason. In time-to-event analysis, such observations are commonly censored: they contribute information up to the last time the event status is known, without being treated as if the event occurred then. The registry timeframe permits follow-up until progression, last study contact, or the start of other therapy, up to 18 months. The detailed censoring rules and analysis method are not reported in the registry record, so the exact implementation cannot be assessed from the posted information.
How should the confidence intervals be read?
A confidence interval expresses uncertainty about an estimated quantity under the statistical method used. The 95% confidence intervals accompanying the two median TTP estimates are arm-specific intervals. They describe uncertainty in each estimated median; they are not individual-level ranges and do not directly give uncertainty for a contrast between arms. A comparison would ordinarily require an estimate of the between-arm effect and its uncertainty, such as a sponsor-reported hazard ratio with a confidence interval, or another suitable time-to-event comparison. Such a primary-endpoint comparison is not reported in the registry record.
Confidence intervals can be more informative than a binary declaration of statistical significance because they show the range of estimates compatible with the analysis. Their interpretation nevertheless depends on the model, assumptions, data completeness, and analysis population. The registry record does not give enough detail to evaluate all of those elements for the primary outcome.
What does the binary comparison mean?
Overall response rate is a binary outcome at the participant level: a participant either meets the response definition or does not. The registry reports 35.0% in each arm, with a 95% confidence interval from 23.0% to 49.0% for each. A recalculated unadjusted risk difference expresses the difference between the two observed proportions on an absolute scale. The estimate is 0.0, and its interval spans values on either side of zero. The unadjusted p-value is 1.0. A p-value describes how compatible the observed data are with a specified null hypothesis under the calculation’s assumptions; it is not the probability that a treatment works, nor does it measure the size or clinical importance of an effect.
The registry lists no reported sponsor analyses for this secondary endpoint. The recalculated result is an unadjusted calculation from posted summary statistics, not evidence of a prespecified analysis or adjustment for other factors. It should be distinguished from the sponsor’s own analysis when one is reported. In this record, no sponsor-reported comparative analysis for the primary endpoint is available.
Why can time-to-event comparisons be different from median comparisons?
Two groups’ time-to-event curves can differ in ways that are not fully represented by their medians. A common time-to-event summary, the hazard ratio, compares event rates over follow-up under assumptions about how that relative contrast behaves. The registry record does not post a sponsor-reported hazard ratio for TTP, so one should not infer or calculate one from the two medians. In general, the validity of a hazard-ratio summary depends on the analysis plan and the behavior of hazards over time. The method used for a primary comparison is not reported in the registry record.
Over-dispersion is a general concern when data vary more than a statistical model expects; it can make standard errors and confidence intervals too small if the extra variability is ignored. It is not possible to determine from the posted TTP summaries whether over-dispersion was relevant or how it was addressed. For a time-to-event endpoint, censoring, event timing, and the chosen model are more directly central considerations. The registry record does not report diagnostics or sensitivity analyses.
What can planning illustrations tell readers?
Sample-size calculations are planning exercises, not observed trial outcomes. The record’s planning assumptions describe an illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. For time-to-event calculations, the stated convention is to report a total number of events; for other endpoints, the convention is participants per arm. These assumptions describe an illustration and do not establish that they were the trial’s original design assumptions. A numerical planning result or the trial’s own sample-size justification is not reported in the registry record. Such illustrations are not observed power and should not be read as evidence about the probability that the trial detected an effect.
10. Multiplicity, Missing Data and Analysis Populations
Multiplicity arises when a study evaluates several outcomes or makes several statistical comparisons. Each additional test creates another opportunity for an apparently notable result, even if no real difference exists. Statistical plans can address this by defining a primary hypothesis, setting an outcome hierarchy, or adjusting the interpretation of multiple tests. The registry lists TTP as the primary outcome and ORR and OS as secondary outcomes, but a multiplicity strategy is not reported in the registry record. The posted unadjusted ORR comparison should therefore not be treated as if it were protected by a documented adjustment.
Missing data and incomplete follow-up can affect interpretation in different ways. For TTP, participants may have follow-up that ends before documented progression; time-to-event methods generally use censoring rather than treating the last observation as an event. The registry describes a timeframe that includes last study contact and the start of other therapy, but detailed rules for censoring, missing assessments, and sensitivity analyses are not reported in the registry record. This makes it difficult to assess how those situations were handled.
The record describes an intent-to-treat efficacy analysis set and says all patients were analyzed for response by RECIST v1.0. It reports 55.0 participants in each primary-outcome cohort and reports the same cohort sizes for the response-rate comparison. However, detailed participant flow, exclusions, missing outcome counts, and endpoint-specific analysis denominators are not reported in the registry record. It is therefore not possible to independently determine from the record whether every enrolled participant contributed to each estimate or how missing response assessments were classified.
The registry record also does not report a detailed statistical analysis plan, a primary-endpoint comparative model, or a sample-size justification. These omissions limit assessment of whether the reported analyses match prespecified procedures and how robust the results are to alternative assumptions. They do not invalidate the posted estimates, but they constrain the strength and scope of conclusions that can be drawn from them.
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 |
|---|---|---|---|
| Bevacizumab/Pemetrexed/Gemcitabine | 33 | 55 | 60.0% |
| Bevacizumab/Pemetrexed/Carboplatin | 21 | 55 | 38.2% |
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 |
|---|---|
| Bevacizumab/Pemetrexed/Gemcitabine | 55 of 55 |
| Bevacizumab/Pemetrexed/Carboplatin | 55 of 55 |
Most frequent serious adverse event terms
| Event term | Organ system | Bevacizumab/Pemetrexed/Gemcitabine | Bevacizumab/Pemetrexed/Carboplatin |
|---|---|---|---|
| Infection - Pneumonia | Infections and infestations | 7 of 55 | 1 of 55 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 3 of 55 | 3 of 55 |
| Thrombosis/Thrombus/Embolism | Vascular disorders | 3 of 55 | 1 of 55 |
| Death - disease progression NOS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 2 of 55 | 2 of 55 |
| Pulmonary - COPD Exacerbation | Respiratory, thoracic and mediastinal disorders | 1 of 55 | 2 of 55 |
| Febrile neutropenia | Infections and infestations | 2 of 55 | 1 of 55 |
| Neutrophils | Immune system disorders | 3 of 55 | 0 of 55 |
| CNS Cerebrovascular ischemia | Nervous system disorders | 2 of 55 | 1 of 55 |
| Dehydration | Gastrointestinal disorders | 1 of 55 | 2 of 55 |
| Infection - Sepsis | Infections and infestations | 2 of 55 | 0 of 55 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Bevacizumab/Pemetrexed/Gemcitabine | Bevacizumab/Pemetrexed/Carboplatin |
|---|---|---|---|
| Fatigue | General disorders | 46 of 55 | 48 of 55 |
| Hemoglobin | Blood and lymphatic system disorders | 45 of 55 | 45 of 55 |
| Leukocytes | Blood and lymphatic system disorders | 39 of 55 | 47 of 55 |
| Neutrophils | Blood and lymphatic system disorders | 39 of 55 | 42 of 55 |
| Platelets | Blood and lymphatic system disorders | 30 of 55 | 40 of 55 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 34 of 55 | 29 of 55 |
| Nausea | Gastrointestinal disorders | 29 of 55 | 29 of 55 |
| Anorexia | Gastrointestinal disorders | 25 of 55 | 26 of 55 |
| Proteinuria | Renal and urinary disorders | 22 of 55 | 28 of 55 |
| Infection - NOS | Infections and infestations | 30 of 55 | 17 of 55 |
Serious events with the highest arm-level rate: infection - pneumonia (12.7%), thrombosis/thrombus/embolism (5.5%), dyspnea (5.5%), neutrophils (5.5%), infection - sepsis (3.6%).
The registry reports serious adverse events among participants in each treatment cohort. In the bevacizumab/pemetrexed/gemcitabine cohort, 33 of 55 participants were recorded as affected by a serious adverse event. In the bevacizumab/pemetrexed/carboplatin cohort, the corresponding count was 21 of 55. The record also lists other adverse events as affecting all 55 participants in each cohort. These categories should be read as registry counts, not as estimates of comparative risk adjusted for follow-up or participant characteristics.
The listed serious-event terms include Infection - Pneumonia at 12.7%, Thrombosis/Thrombus/Embolism at 5.5%, Dyspnea at 5.5%, Neutrophils at 5.5%, Infection - Sepsis at 3.6%, and Death - disease progression NOS at 3.6%. The registry’s serious-event listing does not, by itself, establish that treatment caused an event. The record does not report a comparative statistical analysis of these safety outcomes, and deaths are not separately reported in the adverse-event group summaries.
Differences in counts should be interpreted cautiously. The posted figures do not describe event timing, duration, severity grading for every event, repeated events within a participant, or exposure-adjusted rates. The registry record also does not report enough detail to determine how adverse events were collected or whether follow-up differed between cohorts. These limitations make the figures useful as descriptive safety reporting, but not as a complete comparative safety analysis.
12. What the Result Does, and Does Not, Mean
The registry reports a median TTP of 4.7 months for bevacizumab/pemetrexed/gemcitabine and 10.2 months for bevacizumab/pemetrexed/carboplatin. The accompanying 95% confidence intervals describe uncertainty around each cohort’s median. These posted summaries show the observed arm-specific estimates, but they do not supply a sponsor-reported comparative test or effect estimate for the primary endpoint.
The results do not establish that one regimen is superior, inferior, or equivalent to the other. A difference between two point estimates is not itself a statistical comparison, and the primary confidence intervals are not an interval for the difference between regimens. The randomized design is relevant to the intended comparison, but interpretation still depends on the full analysis, follow-up, and prespecified statistical methods, several of which are not reported in the registry record.
The response-rate estimates are 35.0% in both cohorts. That descriptive similarity does not show that all other outcomes were similar, and it does not determine how long participants remained without progression. Overall survival is listed as a secondary endpoint, but its numerical results are not reported in the registry record. The available safety counts likewise describe reported events and cannot establish that an event was caused by a regimen or provide a full comparison of safety.
The trial’s scope is the enrolled population and these two specific combinations, schedules, and doses. The registry describes elderly patients with advanced non-small cell lung cancer but does not report the age criterion defining elderly. The available results should not be generalized automatically to other populations, regimens, or treatment settings. Nor do the posted outcomes provide an individual prognosis. They are group-level statistical summaries from a phase II study.
In practical terms, the record supplies useful descriptive estimates and intervals, but it leaves important questions unanswered: the sponsor-reported comparative primary analysis, the overall-survival results, detailed missing-data handling, and the broader prespecified statistical plan are not reported. Those gaps limit how far the findings can support a comparative conclusion.
13. Why This Trial Matters Statistically
This trial is statistically informative because it illustrates the distinction between reporting an outcome in each randomized cohort and reporting a formal comparison between cohorts. For TTP, the registry posts a median and confidence interval for each regimen, but no sponsor-reported comparative primary analysis. Readers should not treat separate arm estimates as if they were a direct estimate of the treatment contrast.
The study also shows why endpoints that sound related can lead to different summaries. TTP is a time-to-event measure, whereas response rate is a proportion. The posted response rates are identical, but that fact does not erase the different arm-specific TTP medians. Each endpoint captures a different aspect of the observed clinical course, and interpretation requires attention to its definition and statistical method.
Uncertainty matters as much as the point estimate. Confidence intervals around the medians and response rates indicate that estimates are not exact. A formal comparison would need its own effect estimate and uncertainty, using an appropriate analysis of the endpoint. Since that comparative primary result is not reported, the registry supports description more strongly than a claim about a difference between regimens.
The record also highlights the importance of analysis transparency. The trial is identified as randomized and its primary and secondary outcomes are named, but detailed analysis methods, multiplicity procedures, missing-data handling, and the original sample-size justification are not reported. These details help determine how confirmatory a result is and whether readers can assess robustness. The planning assumptions listed in the record are illustrations based on observed effects, not proof of the study’s original design or observed power.
For clinical researchers and biostatisticians, the central lesson is to distinguish outcome definition, arm-level estimation, comparative inference, and planning calculations. These are related but separate pieces of evidence. Keeping them separate prevents descriptive summaries from being overstated as definitive treatment comparisons.
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.
Several limitations are specific to the information posted for this trial. The primary endpoint has arm-specific medians and confidence intervals, but the registry does not report the sponsor’s comparative primary analysis, such as a hazard ratio or a comparative confidence interval. The method used to estimate the medians and intervals is not described in detail. This prevents readers from evaluating the primary comparison using the full time-to-event analysis.
The registry names overall survival as a secondary outcome but does not report numerical results for it. It also lists overall response rate, but no sponsor-reported analyses accompany the result. The simple unadjusted recalculation is useful for describing the posted counts, but it cannot substitute for a prespecified analysis. A multiplicity strategy is not reported, so secondary findings should be interpreted cautiously.
The analysis population is described as intent to treat, and the record states that all patients were analyzed for response by RECIST v1.0. However, participant flow, endpoint-specific denominators, missing assessments, censoring details, and sensitivity analyses are not reported in the registry record. These omissions matter for both a binary endpoint and a time-to-event endpoint, because incomplete observation and assessment can influence the estimates.
The trial compares complete regimens that differ in both the included third drug and certain administration details. The posted results cannot isolate the effect of gemcitabine versus carboplatin from other regimen differences. The arm descriptions are truncated after their continuation wording, and complete treatment-duration rules are not reported. The age threshold used for elderly is also not reported.
Finally, the record does not report a detailed statistical analysis plan or original sample-size justification. The phase II findings and available summaries should therefore be interpreted within the narrow scope of the trial rather than as a comprehensive or definitive comparison.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: First-Line Treatment of A Comparison of 2 Treatments in Elderly Patients With Advanced NSCLC — NCT00456261.
- Registry record last updated 2022-05-03; status last verified 2022-04.
- Results first posted 2013-02-27.
- 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
NCT00456261 is a completed randomized phase II trial sponsored by SCRI Development Innovations, LLC. It enrolled 110 elderly patients with advanced non-small cell lung cancer and compared bevacizumab/pemetrexed/gemcitabine with bevacizumab/pemetrexed/carboplatin. Masking was listed as none.
The primary endpoint was time to progression by RECIST v1.0. The registry reports arm-specific median estimates with 95% confidence intervals, but a sponsor-reported comparative primary analysis is not reported in the registry record. Overall response rate is posted as a secondary outcome, while numerical overall-survival results are not reported. Serious adverse-event counts and selected event terms are also listed; they are descriptive and do not establish causation or provide a complete comparative safety analysis.
Important analysis details—including the primary comparative method, multiplicity handling, detailed missing-data rules, and the trial’s sample-size justification—are not reported in the registry record.