Study of LY2181308 in Combination With Docetaxel Versus Docetaxel in Patients With Non-Small Cell Lung Cancer: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Study of LY2181308 in Combination With Docetaxel Versus Docetaxel in Patients With Non-Small Cell Lung Cancer (NCT01107444), a randomized phase 2 study. The primary outcome is Change From Baseline in Tumor Size to the End of Cycle 2.

2. Clinical Question

3. Trial Design

This was a randomized, parallel-group phase 2 trial comparing LY2181308 plus docetaxel with docetaxel alone in people with locally advanced or metastatic non-small cell lung cancer previously treated with first-line chemotherapy. Masking was listed as none, so the study was open-label. The registry lists enrollment of 180 and a completed status. The listed study start was 2010-05, and primary completion was 2011-12.

The primary outcome was change from baseline in tumor size to the end of Cycle 2, with one cycle defined as 21 days. The primary measure was the log ratio of tumor size at the end of Cycle 2 to tumor size at baseline. The analysis population was described as participants who received at least one dose of study drug and had eligible tumor-size measurements at both time points. The reported primary analysis includes 82 participants in the combination arm and 42 in the docetaxel arm. These analysis counts do not represent the full registry enrollment.

Secondary outcomes listed in the registry span tumor response, progression-free and overall survival, adverse events, pharmacokinetics, symptom worsening, and time to response or documented progression. The registry record also lists a response outcome with 114 participants in the combination arm and 48 in the docetaxel arm. The reasons for differences between the endpoint-specific analysis counts are not reported in the registry record.

The original sample-size justification, planned allocation ratio, detailed randomization procedures, and the full statistical analysis plan are not reported in the registry record. Planning figures based on the observed effect are illustrations and should not be read as descriptions of the trial's original design.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Participants who received at least 1 dose of study drug and had tumor size measurements (according to the pre-specified inclusion criteria) at baseline and at the end of Cycle 2.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: Participants who received at least 1 dose of study drug.

6. Primary Endpoint

The registry lists the primary outcome as Change From Baseline in Tumor Size to the End of Cycle 2, measured over Baseline, End of Cycle 2 (1 cycle = 21 days).

The primary endpoint was change from baseline in tumor size to the end of Cycle 2. Tumor size was defined as the sum of the longest diameters of target lesions, measured according to RECIST version 1.1. For each participant, the analysis used the log ratio of the tumor-size sum at the end of Cycle 2 to the sum at baseline. This transforms a relative change into a continuous measure that can be summarized with a mean and standard deviation.

In general, a log ratio expresses how an end measurement relates multiplicatively to a baseline measurement. Values on either side of zero correspond to different directions of change on the original size scale. The endpoint therefore captures early tumor-size change in a way that can be compared between randomized groups. It is not itself a measure of survival, symptoms, or long-term disease control.

The registry reports mean values of 1.06 for LY2181308 plus docetaxel and 1.01 for docetaxel alone. The standard deviations were 0.2 and 0.13, respectively. The primary population required treatment exposure and measurements at both specified time points, so the result pertains to participants meeting those conditions rather than automatically to everyone enrolled. The registry record does not report how missing tumor measurements were handled or whether additional analyses assessed sensitivity to missing observations.

7. Results Posted in the Registry

• Docetaxel: mean 1.01 versus 1.06 on control; difference -0.05 (95% CI -0.11 to 0.01), standardized effect d = -0.28; z-test p = 0.094.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Percent of Participants Having a Partial Response (PR) or a Complete Response (CR)

• Endpoint type: Binary: the percentage of participants with the event (counts rebuilt from the posted percentages and group sizes).
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Docetaxel: 2.1% (1/48) versus 6.1% (7/114) on control; risk difference -4.1 percentage points (95% CI -10.0 to 1.9), risk ratio 0.34 (0.04–2.68); unadjusted two-proportion z-test p = 0.276.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Docetaxel and the control. The interval gives the range of effects that remain compatible with the data.

The registry lists secondary outcomes covering response, progression-free and overall survival, treatment toxicity, pharmacokinetics, symptoms, and timing of response or progression. These outcomes address different aspects of the trial: tumor response and progression describe disease activity, survival outcomes follow time to events, toxicity describes harms, pharmacokinetics characterizes drug exposure, and symptom measures capture a patient-reported dimension. They should not be treated as interchangeable measures of one underlying effect.

The registry includes a numerical result for the response outcome, but the other secondary outcomes are listed without accompanying numerical findings in the record represented in the posted results. Consequently, the direction and precision of a pattern across all secondary outcomes cannot be established from the registry record. The response result should not be taken as confirmation of the primary tumor-size comparison, nor should it be used to infer unreported survival, symptom, safety, or pharmacokinetic findings.

Secondary outcomes can provide supporting context, but they commonly involve multiple questions and may have less statistical weight than a prespecified primary endpoint. If many outcomes are tested without adjustment, the chance of obtaining at least one apparently notable result can increase. The registry record does not report a multiplicity strategy for these outcomes, and the available secondary findings should therefore be interpreted cautiously. Their differing analysis populations and measurement scales also make it inappropriate to combine them informally into a single overall conclusion.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Number of Participants With Characterization of Toxicities as Defined by Common Terminology Criteria for Adverse Events (CTCAE) Coding
• Progression Free Survival (PFS)
• Pharmacokinetics: Area Under the Concentration Curve From Zero to 4 Hours (AUC[0-4]) for LY2181309 and Docetaxel
• Pharmacokinetics: Area Under the Drug Concentration-Time Curve From Zero to Infinity (AUC[0 ∞]) of LY2181309 and Docetaxel
• Overall Survival (OS)
• Time to Worsening of Symptoms as Defined by Lung Cancer Symptom Score (LCSS) Questionnaire
• Time to Objective Tumor Response of Partial Response (PR) or Complete Response (CR)
• Time to Documented Disease Progression

9. Statistical Interpretation

10. Statistical Methods Explained

A continuous endpoint is commonly summarized by a mean and a measure of spread. The mean describes the central value in a group, while the standard deviation describes how dispersed participant measurements are around that group mean. For the primary endpoint, the registry reports the mean log ratio and standard deviation for each treatment arm. The group sizes differ in the primary analysis population, so the precision of each group mean also depends on its number of analyzed participants.

What does the mean difference express?

The recalculated comparison subtracts the combination-arm mean from the docetaxel-arm mean. The estimated difference is -0.05. This is an unadjusted comparison derived from the posted group summaries, not a separately reported adjusted effect estimate. The sign reflects the order of subtraction: a negative value means the docetaxel mean is lower than the combination mean on this endpoint's scale. The estimate is not a percentage change and should not be reinterpreted as one.

What does a confidence interval add?

A confidence interval gives a range of values compatible with the data under the method used to construct it. It is useful for seeing how uncertain an estimate is and whether values on different sides of zero remain plausible for a difference. For this comparison, the recalculated interval extends on both sides of zero. That breadth means the summaries do not pin down the direction of the underlying difference. A confidence interval is not a guarantee that the true value lies within its limits, nor does it describe the range of individual participant outcomes.

How should a p-value be read?

A p-value measures how unusual the observed data, or data more extreme, would be under a specified null model and test procedure. It does not give the probability that the null hypothesis is true, and it is not a measure of the probability that the result occurred by chance. The recalculated unadjusted p-value is 0.094. The registry's reported analysis is described as a one-sided t-test and has p = 0.284. Because the procedures are not identical as reported, the two values should not be treated as interchangeable. Neither p-value conveys effect size or clinical importance.

Why can unequal group sizes matter?

In general, the standard error of a group mean depends on both the variability of participant measurements and the number of observations. A smaller analyzed group tends to contribute less precise information, all else being equal. Here, the primary analysis counts are 82 and 42, and the reported standard deviations are 0.2 and 0.13. These summaries support an unadjusted comparison, but they do not reveal the full distribution of measurements, whether unusual values were influential, or how the analysis addressed participants without measurements.

Why does distribution shape matter?

General statistical interpretation of a mean-based comparison depends on the assumptions or approximations used by the test. The registry labels the sponsor's analysis as a one-sided t-test but does not report its detailed assumptions, diagnostic checks, or any alternative model. The recalculated comparison is based on group-level summaries, not participant-level observations, so it cannot assess distribution shape, outliers, covariate balance, or the influence of individual measurements. No such diagnostic findings are reported in the registry record.

What does over-dispersion mean in general?

Over-dispersion is mainly a concern for outcomes whose variability exceeds what a chosen probability model expects. In general, failing to account for over-dispersion can make standard errors too small and uncertainty look narrower than it is. The primary endpoint is continuous, and the registry reports standard deviations rather than a count-model dispersion parameter. The record does not report an over-dispersion assessment; it would be inappropriate to assume that one was required or performed for the primary analysis.

Why keep reported and recalculated results separate?

The registry's sponsor analysis is an analysis of the trial, whereas the recalculated comparison is a simple unadjusted calculation from posted summary statistics. Summary-statistic calculations cannot reproduce analyses that depend on participant-level data, covariate adjustment, exclusions, or other undocumented choices. The registry gives the sponsor's test type and p-value, but does not report enough detail to fully reproduce that analysis. The recalculated estimate and interval are therefore useful as a transparent descriptive comparison, not a replacement for the sponsor's analysis.

11. Confidence Intervals and Precision

Precision concerns how narrowly the data estimate the between-arm difference. The recalculated mean difference is -0.05, and its confidence interval reaches values below and above zero. This indicates that the summaries leave uncertainty about both the size and direction of the difference. The interval is more informative than the point estimate alone because it shows that the observed estimate is not pinned down to a narrow range.

The analyzed group sizes were 82 for LY2181308 plus docetaxel and 42 for docetaxel alone. The corresponding standard deviations were 0.2 and 0.13. The mean difference and its uncertainty reflect both the observed group separation and variability within each group. The group sizes are not equal, and the smaller analysis group contributes less information than a group of the same variability with more observations would contribute in general.

The confidence interval is a measure of uncertainty in the estimated mean difference, not a prediction interval for an individual participant. It also does not account for possible limitations that cannot be examined from summary statistics, such as missing measurements, departures from model assumptions, or selective availability of outcomes. The registry record does not report enough detail to assess those possibilities.

The recalculated p-value of 0.094 and the interval are complementary summaries of the same unadjusted comparison; neither should be read as proof of no effect. The sponsor-reported p-value of 0.284 comes from a separately described one-sided t-test. Since the registry record does not give all details required to reconcile the analyses, precision should be judged from the recalculated estimate and interval separately from the sponsor's test result.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are illustrations based on the observed effect, not a report of the trial's original sample-size design. For the continuous primary comparison, the figures are participants per arm. At 100% of the observed effect, the illustration gives 203 participants per arm for 80% power and 271 participants per arm for 90% power. At 75% of the observed effect, it gives 360 participants per arm for 80% power and 482 participants per arm for 90% power. At 50% of the observed effect, it gives 810 participants per arm for 80% power and 1,084 participants per arm for 90% power.

In plain language, 80% power means that, under the stated planning assumptions and if the effect used for planning were the true effect, the design would detect that effect in 80% of repeated studies at the stated significance level. The 90% column describes the corresponding target of detecting it in 90% of repeated studies. These are planning probabilities under assumptions, not probabilities that the treatment is effective and not measures of what happened in this trial.

The listed assumptions are a two-sided significance level of 0.05, equal allocation between arms, a normal approximation, and an effect to detect equal to the stated fraction of the observed effect. Smaller target effects require more participants in these illustrations. The original trial's own sample-size justification and assumptions are not reported in the registry record. These figures are not observed power.

For participant-based outcomes, the figures are participants per arm. In general, any time-to-event planning figures are expressed as total events rather than participants per arm. The distinction matters because event totals and enrollment totals are not interchangeable: time-to-event information depends on events occurring, not only on the number of people enrolled.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -0.050; pooled standard deviation σ = 0.180.
2. n = 2 × (1.96 + 0.842)² × 0.180² / -0.050² = 202.4, rounded up to 203 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -0.05                      # observed difference in means
sigma <- 0.179546331752842                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(1107444)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 203 (80% power), 271 (90% power)
 75% of observed effect: n per arm = 360 (80% power), 482 (90% power)
 50% of observed effect: n per arm = 810 (80% power), 1,084 (90% power)
power.t.test: 203.4 
Simulated power at n = 203 per arm: 0.802 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The registry reports the sponsor's primary analysis as a one-sided t-test comparing the two groups, with p = 0.284. Separately, the unadjusted recalculation from the posted group summaries estimates a mean difference of -0.05 and gives p = 0.094. The recalculation is a supplementary comparison based on means, standard deviations, and analysis counts; it is not a reconstruction of the sponsor's participant-level analysis.

These results should be read as distinct rather than combined into one test result. The sponsor's test is explicitly one-sided, while the recalculation is an unadjusted summary-statistic analysis. The registry record does not report enough detail about the sponsor analysis to determine all reasons for the difference between the p-values, including any differences in the analyzed data or test implementation. The sponsor's reported result remains the registry's reported trial analysis; the recalculation offers a transparent additional view of the posted summaries, not a substitute for that analysis.

The registry record does not report the sponsor's confidence interval for the primary comparison, an adjusted effect estimate, or the rationale for the one-sided testing approach. Interpretation should therefore preserve the distinction between the sponsor's reported p-value and the recalculated difference and interval, without treating either as a complete account of the trial's statistical plan.

15. Multiplicity, Missing Data and Analysis Populations

The registry identifies a primary tumor-size endpoint and lists multiple secondary outcomes. It reports one primary analysis and 12 posted secondary outcomes. Testing several outcomes raises a multiplicity question: when many statistical tests are considered, the chance of at least one apparently unusual result can grow. In general, a prespecified adjustment strategy can address this issue, but the registry record does not report whether an adjustment was planned or applied. The original statistical analysis plan and the hierarchy, if any, among secondary outcomes are not reported in the registry record.

The record describes the primary analysis population as participants who received at least one dose of study drug and had tumor measurements at baseline and at the end of Cycle 2. This defines who contributed to the posted primary endpoint summaries, but it does not explain what happened to participants without one or both measurements. The missing-data method, any imputation, and sensitivity analyses for missing primary outcomes are not reported in the registry record. The reasons that some participants lacked endpoint data are also not reported.

Endpoint-specific participant counts differ: the primary endpoint summaries include 82 and 42 participants, whereas the response outcome includes 114 and 48. These differences show that the analyses do not use the same reported counts, but the reasons for the differences are not reported in the registry record. The broader analysis population for each outcome, exclusions after randomization, and handling of unavailable outcome data cannot be inferred from the counts alone.

The registry does not report whether interim analyses were conducted, whether stopping boundaries were used, or whether there were prespecified subgroup analyses for the primary endpoint. The original sample-size justification and the full statistical plan are also not reported. These absences limit assessment of how the posted analyses relate to the planned inferential framework; they do not, by themselves, show that a particular procedure was or was not used.

16. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: febrile neutropenia (8.3%), neutropenia (5.8%), pyrexia (5.8%), atrial fibrillation (5.0%), pneumonia (4.2%).

The registry reports serious adverse events for 65 of 120 participants at risk in the LY2181308-plus-docetaxel group and 24 of 60 at risk in the docetaxel group. For other adverse events, the corresponding figures are 106 of 120 and 44 of 60. These are counts of participants recorded as affected, with the registry's at-risk counts as denominators. They are not measures of the number of separate events, and the record does not explain whether individual participants could contribute to more than one event category.

The listed serious adverse-event terms with their registry percentages include febrile neutropenia at 8.3%, neutropenia at 5.8%, pyrexia at 5.8%, atrial fibrillation at 5.0%, pneumonia at 4.2%, and anaemia at 3.3%. The registry does not report deaths in the posted safety summary. The figures should be read as descriptive safety counts in the recorded groups; the available summary does not establish comparative risk after accounting for follow-up, event timing, or other factors.

These safety counts do not by themselves show causation or allow a complete comparison of the nature, severity, duration, or timing of adverse events. Detailed definitions, exposure-adjusted rates, and fuller participant-level safety analyses are not reported in the registry record.

17. What the Result Does, and Does Not, Mean

The primary result describes the mean log ratio of tumor size at the end of Cycle 2 relative to baseline among participants meeting the stated primary analysis criteria. The group means were 1.06 for the combination and 1.01 for docetaxel alone. The unadjusted recalculation estimates a mean difference of -0.05 for docetaxel relative to the combination, with uncertainty spanning values on either side of zero. This is evidence about an early continuous tumor-size measure in the analyzed participants, not a comprehensive statement about all aspects of the trial.

The result does not establish that the treatments are equivalent, because a non-definitive comparison is not the same as a formal equivalence or non-inferiority analysis. The registry record does not describe an equivalence margin or a non-inferiority framework. Nor does the result establish a clinically important difference: the endpoint is a tumor-size measure at the end of Cycle 2, and the registry does not report a threshold for clinical importance.

The primary endpoint alone cannot determine what happened to overall survival, progression-free survival, symptoms, adverse events, or drug exposure. Those outcomes address distinct questions, and complete numerical findings for them are not reported in the registry record. The posted response outcome does not fill those gaps. Similarly, the safety counts are descriptive and do not by themselves provide a causal comparison.

Randomization supports a comparative trial design, but interpreting the primary result also requires understanding who was included in the analysis and how missing measurements were handled. The record specifies the measurement-based primary population but does not report the full missing-data approach. The appropriate conclusion is therefore limited to the posted estimates and their uncertainty, rather than a broad claim about benefit, lack of benefit, or the balance of outcomes.

18. Why This Trial Matters Statistically

This trial illustrates why a point estimate, a p-value, and a confidence interval answer related but different questions. The mean difference of -0.05 gives the estimated separation on the chosen endpoint scale. The recalculated p-value of 0.094 describes the data relative to a null model under the recalculation's procedure. The confidence interval expresses uncertainty about the range of differences compatible with the data. None of these summaries alone describes clinical importance.

It also demonstrates the importance of distinguishing the sponsor's reported analysis from a calculation based on group-level summaries. The registry reports a one-sided t-test with p = 0.284, while the simple unadjusted recalculation produces a different p-value. Without all details of the sponsor's analysis, those results cannot be reconciled fully. Reporting them separately prevents a supplementary calculation from being mistaken for the trial's own analysis.

Endpoint populations and counts are another statistical consideration. The primary and response outcomes have different reported analysis counts, and the registry does not explain why. Interpretation of results depends on knowing who contributed data to each outcome, how missing information was handled, and whether the analysis followed the planned population. Those details are not all available in the registry record.

Finally, the secondary outcomes span several domains, and multiple outcomes raise questions about multiplicity and selective emphasis. The registry does not report a multiplicity strategy or the complete numerical results for all listed secondary outcomes. These limits show why a single early tumor-size endpoint should be interpreted alongside its precision, analysis population, and the scope of available results rather than as a standalone verdict on every trial question.

19. 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 primary outcome is an early tumor-size measure evaluated at the end of Cycle 2. It does not directly measure survival, symptom improvement, or durable disease control. The registry lists outcomes in those domains, but complete numerical results for most of them are not reported in the registry record. This limits how far the primary endpoint can speak to the broader range of trial questions.

The primary summary includes only participants who received at least one dose and had eligible tumor measurements at both baseline and the end of Cycle 2. The registry does not report the reasons for missing measurements, how missing outcomes were handled, or whether sensitivity analyses were performed. Because the primary analyzed counts are smaller than the enrollment figure, the endpoint summaries should not be treated as summaries of every enrolled participant.

The sponsor's reported test and the unadjusted recalculation are not fully reconcilable from the registry information. The sponsor analysis is identified as a one-sided t-test, but its detailed model, analysis population, and other implementation choices are not reported. The recalculation relies on summary statistics and cannot assess participant-level features such as outliers, covariate patterns, or alternative analysis choices.

The record does not report the original sample-size justification, planned allocation ratio, interim analyses, multiplicity adjustment, or the complete statistical analysis plan. It also does not give a full account of secondary numerical results or detailed safety analyses. These limitations restrict assessment of the complete evidentiary picture, but they do not establish that any specific unreported procedure was omitted.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Study of LY2181308 in Combination With Docetaxel Versus Docetaxel in Patients With Non-Small Cell Lung Cancer — NCT01107444.
• Registry record last updated 2019-09-11; status last verified 2019-08.
• Results first posted 2019-05-24.
• 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.

23. Record Summary

The registry record describes a completed randomized, open-label, parallel-group phase 2 trial of LY2181308 plus docetaxel versus docetaxel alone in previously treated locally advanced or metastatic non-small cell lung cancer. Enrollment was 180. The primary outcome was the log ratio of tumor size at the end of Cycle 2 to baseline among participants with treatment exposure and measurements at both time points.

The primary endpoint means were 1.06 and 1.01, with an unadjusted recalculated mean difference of -0.05 and p = 0.094. The sponsor-reported one-sided t-test had p = 0.284. The confidence interval for the recalculated difference spans zero, reflecting uncertainty about the direction and size of the difference. The registry lists secondary outcomes across response, survival, toxicity, pharmacokinetics, and symptoms, but does not report complete numerical results for those outcomes. Important details on missing data, multiplicity, interim analyses, and the original sample-size design are not reported in the registry record.