Trial Of CP-751, 871 And Erlotinib In Refractory Lung Cancer: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Trial Of CP-751, 871 And Erlotinib In Refractory Lung Cancer (NCT00673049), a randomized phase 3 study. The primary outcome is Overall Survival.

2. Clinical Question

3. Trial Design

This was a randomized, open-label, Phase 3, parallel-group trial sponsored by Pfizer. The registry lists enrollment of 583 and a status of terminated. The start is recorded as 2008-05, with primary completion recorded as 2011-03. The reason for termination is not reported in the registry record, so the status alone does not explain why the trial ended or whether the decision was related to efficacy, safety, recruitment, or another consideration.

The two primary comparison arms were figitumumab plus erlotinib and erlotinib alone. The registry lists 293 participants in the combination arm and 290 in the erlotinib arm for the overall-survival and progression-free-survival summaries. Randomization supports a between-group comparison, while the open-label design means treatment assignment was not masked. Whether particular assessments or analyses were protected from knowledge of assignment is not reported in the registry record.

The primary analysis population included all randomized participants, regardless of treatment received. This intent-to-treat approach preserves the randomized group assignment for the principal comparison. It is distinct from describing only people who completed treatment or followed the regimen as planned; such alternative populations and their analyses are not reported in the registry record.

Overall survival was assessed from randomization until death, with censoring at last contact for participants who were alive. The registry describes assessment every cycle until disease progression and then every four weeks until death, up to 30.65 months. Secondary outcomes included progression-free survival, objective response, pharmacokinetic measures for figitumumab, anti-drug antibodies, circulating tumor cells expressing IGF-1R, and quality-of-life measures. The registry record does not report the original sample-size justification, detailed allocation procedures, or a full statistical analysis plan.

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 Progression on Erlotinib

Reasons for not completing this period:

After Progression on Erlotinib

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Full (intent-to-treat) analysis set, which included all participants randomized regardless of treatment received.

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.

6. Primary Endpoint

The registry lists the primary outcome as Overall Survival, measured over Baseline, assessed every cycle until disease progression and then every 4 weeks until death, up to 30.65 months.

Overall survival is the time from randomization to death from any cause. Participants who were alive at their last contact were censored at that contact, meaning their exact subsequent survival time was not observed in the analysis. The registry describes follow-up assessments every cycle until disease progression and every four weeks thereafter until death, with the reported timeframe extending up to 30.65 months.

Overall survival is used because it captures a direct outcome—how long participants live after randomization—rather than relying only on a measure of tumor response or disease progression. It also avoids attributing a cause to death: deaths from any cause count toward the endpoint. In a randomized comparison, the endpoint can be analyzed across assigned groups while accounting for the fact that some participants have not died by their last recorded contact.

The median is the time by which half of the estimated survival experience has reached the event, under the time-to-event analysis. It is a summary of the survival distribution, not a statement that every participant lived for that duration. The hazard ratio compares the event rates over follow-up under the model and analysis used; it is not a ratio of the two medians. General statistical interpretation requires considering the hazard ratio and its confidence interval alongside the medians, censoring, follow-up, and analysis method. Details of the survival model beyond the registry’s stated log-rank method are not reported in the registry record.

7. Results Posted in the Registry

• Figitumumab + Erlotinib vs Erlotinib: hazard ratio 1.09 (95% CI 0.91–1.31), reported p = 0.350 (as reported in the registry).

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.

Progression Free Survival (PFS)

• Endpoint type: Time to event: compared as a hazard ratio.
• Test: Hazard ratio as reported by the sponsor (Log Rank); it was not recalculated.
• Result:
  • Figitumumab + Erlotinib vs Erlotinib: hazard ratio 1.07 (95% CI 0.90–1.29), reported p = 0.426 (as reported in the registry).
• Interpretation:
  • The 95% confidence interval includes no difference (a ratio of 1), so these data do not show a statistically significant difference between Figitumumab + Erlotinib vs Erlotinib and the control. The interval gives the range of effects that remain compatible with the data.

Percentage of Participants With Objective Response

• 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:
  • Erlotinib: 3.8% (11/290) versus 5.5% (16/293) on control; risk difference -1.7 percentage points (95% CI -5.1 to 1.7), risk ratio 0.69 (0.33–1.47); unadjusted two-proportion z-test p = 0.338.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Erlotinib and the control. The interval gives the range of effects that remain compatible with the data.

The posted secondary findings cover two different kinds of outcomes: progression-free survival is time-to-event, while objective response is a proportion. Their comparative estimates do not clearly separate the treatment groups from the respective null references. This is broadly consistent with the primary result in the limited sense that the posted comparisons do not provide clear statistical evidence of a difference; it does not establish that all outcomes are identical or that any possible effect is absent.

These outcomes address different aspects of the disease course and should not be treated as interchangeable with overall survival. Progression-free survival concerns time to progression or another endpoint event as defined by the study, while objective response concerns whether a response was recorded. The registry gives outcome names and assessment schedules but does not report detailed endpoint definitions or response criteria beyond the descriptions in the record.

The other listed secondary outcomes include figitumumab pharmacokinetic measures, anti-drug antibodies, circulating tumor cells expressing IGF-1R, and quality-of-life measures. Their numerical findings are not reported in the registry record. Without those results, their direction, magnitude, and precision cannot be assessed.

Secondary outcomes are often numerous and may be exploratory. General statistical explanation: when many outcomes are tested, the chance of at least one apparently notable result from random variation can increase. An unadjusted p-value does not account for testing across a family of outcomes. The registry record does not report a multiplicity adjustment or a prespecified hierarchy for interpreting these secondary results. They therefore carry less confirmatory weight than the designated primary endpoint and should be read as supporting or exploratory evidence rather than independent proof of an effect.

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

• Progression Free Survival (PFS)
• Percentage of Participants With Objective Response
• Maximum Observed Plasma Concentration (Cmax) for Figitumumab
• Minimum Observed Plasma Trough Concentration (Cmin) for Figitumumab
• Percentage of Participants Reporting Positive for Total Anti-drug Antibodies (ADA)
• Counts of Circulating Tumor Cell (CTC) Expressing Positive Insulin-Like Growth Factor 1 Receptor (IGF-1R)
• Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility at Cycles 2, 3, Then Every Other Cycle and EOT (21-28 Days After Last Dose)
• Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) at Cycles 2, 3, and Then Every Odd Cycle Starting With Cycle 5 and EOT (21-28 Days After Last Dose)

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is time-to-event data: each participant contributes a time from randomization until death or, if still alive at last contact, a censored observation. Censoring is not the same as observing a death at the last contact. It indicates that the event time is known only to be later than the last recorded observation. Time-to-event methods use the available follow-up while accounting for this incomplete event-time information.

What does the median describe?

A median survival time is a point on the estimated survival distribution. It describes when the estimated proportion remaining alive reaches the midpoint, rather than the average duration or an individual participant’s expected survival. The registry reports medians separately by arm, with 95% confidence intervals. Those intervals express uncertainty around each arm’s median; comparing whether the intervals overlap is not a substitute for the reported between-arm analysis.

What does a hazard ratio describe?

A hazard ratio is a relative measure of the event hazard between groups over follow-up. A value of 1 is the no-difference reference for the relative hazard. Values on either side indicate different relative directions, but interpretation also depends on the confidence interval and the analysis assumptions. A hazard ratio is not a difference between median survival times and should not be converted into one. For this trial, the sponsor reported a hazard ratio from a log-rank analysis. The registry does not provide further detail about the model specification or diagnostics.

What is the role of the log-rank test?

In general, a log-rank test compares the event-time experience of groups across follow-up, using the timing of events and the participants still at risk over time. It is a test of evidence against a null comparison, not a measure of effect size. The hazard ratio and its confidence interval give information about the estimated relative effect and its uncertainty. A p-value alone does not show whether an effect is large, clinically important, or estimated precisely.

How should confidence intervals and p-values be read?

In general, a confidence interval gives a range of values compatible with the data and analysis at the stated confidence level. It helps show how much uncertainty surrounds an estimate. For a hazard ratio, the no-difference reference is 1; for a difference in response rates, it is 0. When an interval includes its null reference, the data do not clearly rule out that reference at the corresponding confidence level. This does not prove no effect, nor does it establish equivalence. The registry reports p-values for the sponsor’s comparisons, but does not report an equivalence or noninferiority framework.

Why can event-time results differ from simple summaries?

General explanation: time-to-event methods account for when events occur and for censoring, whereas a single median or a simple count does not preserve all that timing information. Participants may have different follow-up durations. The hazard ratio summarizes a relative comparison across observed follow-up, while the median provides a central point in each arm’s estimated event-time distribution. The two summaries answer related but distinct questions.

How is the response outcome analyzed?

Objective response is a binary outcome, represented as a percentage of participants in each arm. The registry reports a sponsor comparison using a chi-squared method and a difference in response rates, together with a confidence interval and p-value. General explanation: a difference in proportions is an absolute contrast, while a risk ratio or odds ratio is a relative contrast. These measures can have different numerical values and interpretations. The registry’s reported comparative analysis should be distinguished from unadjusted recalculations based on posted summary information.

Response assessments were scheduled at baseline and specified follow-up visits, continuing at intervals until disease progression, with the registry describing a maximum timeframe of 29.7 months. Assessment schedules and endpoint definitions affect what a response measure represents. The registry describes the outcome as the percentage with objective response but does not provide further response criteria in the record.

Why does over-dispersion matter in general?

General explanation: over-dispersion occurs when observed variation is greater than a statistical model assumes. If it is present but ignored, standard errors can be too small and confidence intervals or tests can appear more decisive than warranted. It is especially relevant to count outcomes and some clustered or repeated-measure settings. The posted primary analysis is time-to-event, and the registry record does not report an over-dispersion assessment or a model adjustment for it. It should not be assumed that such an issue did or did not affect these results.

The record identifies the full intent-to-treat analysis set for overall survival and states the log-rank method for the comparison. It does not report the full analysis plan, detailed handling of missing observations beyond censoring alive participants at last contact, or whether interim analyses were conducted. Those details cannot be inferred from the posted estimates.

11. Confidence Intervals and Precision

The overall-survival median estimates are 5.7 months for figitumumab plus erlotinib and 6.2 months for erlotinib. Their respective 95% confidence intervals are 4.8 to 6.7 months and 5.8 to 7.2 months. These intervals communicate uncertainty about each arm’s median. They should not be used as though they were a confidence interval for the difference between arms.

The comparative overall-survival estimate is a hazard ratio of 1.091, with a 95% confidence interval from 0.909 to 1.310. The interval includes the no-difference reference of 1 and spans values on either side of it. Consequently, the estimate does not precisely establish the direction of a relative hazard difference. The p-value of 0.35 is consistent with the lack of a clear statistical distinction from the null reference, but it does not measure the probability that the null is true or quantify clinical importance.

In general, wider confidence intervals indicate less precision and narrower intervals indicate greater precision, conditional on the analysis and its assumptions. Precision is not the same as validity: a narrow interval would not address bias from design or measurement, and a wide interval does not prove that no effect exists. The registry does not report a target precision or a clinically important threshold for overall survival. It is therefore not possible to judge from the interval alone whether the remaining uncertainty is acceptable for a clinical decision.

The reported confidence intervals describe uncertainty in the estimates, not the range of outcomes for individual participants. They also do not account for every possible source of uncertainty, such as unreported analysis choices or missing information about the trial’s original design assumptions.

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 display translates an observed effect into illustrative sample-size requirements under stated assumptions. For overall survival and progression-free survival, figures are total events, not participants per arm. For the objective-response comparison, figures are participants per arm. These are different quantities and should not be compared as though they had the same denominator.

The planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set as a stated fraction of the observed effect. For time-to-event outcomes, the event totals use the Schoenfeld approach. The original trial’s own design assumptions and sample-size justification are not reported in the registry record; these planning calculations are not a reconstruction of that original design.

The 80% power column means the illustrative number of events or participants needed for an analysis to have an 80% chance of detecting the specified effect under the stated assumptions, if that effect is present. The 90% power column uses a higher target chance of detection and therefore generally requires more information. These are design concepts, not guarantees about an individual study’s result.

The rows that plan for 75% or 50% of the observed effect represent smaller effects than planning for 100% of the observed effect. Smaller effects are harder to distinguish from random variation, so they require more events or participants under the same assumptions. These figures are planning illustrations, not observed power. They do not describe the probability that the completed trial’s result is correct, and they do not establish whether the trial was adequately powered under its original design.

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

d is the total number of events needed (Schoenfeld's formula) with 1:1 allocation and proportional hazards.

Worked calculation for this trial

1. Hazard ratio HR = 1.091, so ln(HR) = 0.0871.
2. d = 4 × (1.96 + 0.842)² / [ln(1.091)]² = 4,138.9, rounded up to 4,139 events in total 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
hr <- 1.091                              # observed hazard ratio
events_needed <- function(power, frac = 1) ceiling(round(4 * (z_a + qnorm(power))^2 / log(hr^frac)^2, 6))   # Schoenfeld, 1:1 allocation
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: events = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(events_needed(0.80, f), big.mark = ","), format(events_needed(0.90, f), big.mark = ",")))

# Simulation: given d total events under proportional hazards, events in the treatment arm are Binomial(d, hr / (1 + hr)).
# The score (log-rank type) statistic is (D1 - d / 2) / sqrt(d / 4).
set.seed(673049)
d    <- events_needed(0.80)
reps <- 20000
D1 <- rbinom(reps, d, hr / (1 + hr))
z  <- (D1 - d / 2) / sqrt(d / 4)
cat(sprintf("Simulated power with %s events: %.3f (%d replicates)\n", format(d, big.mark = ","), mean(abs(z) > z_a), reps))

Output from running the code

100% of observed effect: events = 4,139 (80% power), 5,541 (90% power)
 75% of observed effect: events = 7,359 (80% power), 9,851 (90% power)
 50% of observed effect: events = 16,556 (80% power), 22,164 (90% power)
Simulated power with 4,139 events: 0.801 (20000 replicates)

The simulation uses the fact that, with d events in total and proportional hazards, the number of events in the treatment arm is binomial. It is an approximation that conditions on the total number of events, and it should land close to the target power.

14. Analyses Reported by the Sponsor

For overall survival, the registry reports the sponsor’s own log-rank analysis as a hazard ratio of 1.091, with a 95% confidence interval from 0.909 to 1.310 and p = 0.35. The time-to-event interpretation uses this reported hazard ratio rather than a recalculation from arm-level medians. Medians and their confidence intervals do not contain enough information to recreate the full event-time comparison.

For progression-free survival, the sponsor-reported log-rank hazard ratio is 1.075, with a 95% confidence interval from 0.898 to 1.287 and p = 0.426. For objective response, the sponsor reports a chi-squared comparison of the difference in response rates: 1.668, with a 95% confidence interval from -1.7 to 5.1 and p = 0.338. These are the registry’s comparative analyses, distinct from simple comparisons of the arm-specific summaries.

The registry’s discrepancy indicator is false, so no discrepancy between a recalculation and the sponsor analysis is flagged. An unadjusted recalculation can be useful for checking or illustrating summary data, but it does not replace the sponsor’s analysis or reproduce analyses that require participant-level event times. The sponsor’s reported analysis remains the reference for interpreting the trial’s stated comparative tests.

15. Multiplicity, Missing Data and Analysis Populations

Multiplicity refers to the increased chance of false-positive findings when several hypotheses are tested. This trial lists overall survival as the primary endpoint and several secondary outcomes, including progression-free survival, objective response, pharmacokinetic outcomes, antibody status, circulating tumor cells, and quality of life. The registry record does not report whether the analyses were adjusted for multiple comparisons, whether a hierarchy or gatekeeping procedure was planned, or which secondary outcomes were intended to be confirmatory.

The primary overall-survival comparison is the central result identified by the registry. Secondary p-values should not be interpreted as though each were the sole prespecified test. Without a reported multiplicity strategy, a nominal p-value for a secondary analysis may overstate the strength of evidence when considered among many possible tests. This does not make the secondary results unusable; it limits how strongly they can support a confirmatory claim.

The record identifies the full intent-to-treat analysis set for overall survival: all participants randomized, regardless of treatment received. That definition helps clarify which participants belong in the primary comparison. The registry does not report detailed methods for missing data in the secondary outcomes, nor does it provide a complete account of exclusions or analysis populations for each endpoint. For overall survival, it states that participants alive at last contact were censored at that contact. The assumptions and details governing censoring beyond that statement are not reported in the registry record.

The original sample-size justification, interim analysis plan, and complete statistical analysis plan are not reported in the registry record. Therefore, the record does not establish whether interim looks were planned, how they may have affected error control, or what sample-size target was used during trial design. The separate planning illustrations use stated assumptions but do not supply those missing historical design details.

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 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: disease progression (54.2%), general physical health deterioration (6.0%), dehydration (4.8%), pneumonia (4.1%), diarrhoea (3.8%).

The serious adverse event summaries report participants at risk and participants affected for each listed group. For figitumumab plus erlotinib, 289 were at risk and 204 were affected. For erlotinib, 290 were at risk and 153 were affected. A further group labelled Erlotinib, Then Figitumumab lists 83 at risk and 63 affected. These are counts, not percentages; no group-level percentages are calculated.

The registry also lists other adverse-event counts: 265 affected among 289 at risk for figitumumab plus erlotinib, 265 among 290 at risk for erlotinib, and 79 among 83 at risk for Erlotinib, Then Figitumumab. These summaries do not by themselves identify event severity, timing, duration, or whether an event was judged related to treatment. Death counts are not reported in the registry record.

The leading listed serious-event terms are disease progression (54.2%), general physical health deterioration (6.0%), dehydration (4.8%), pneumonia (4.1%), diarrhoea (3.8%), and dyspnoea (3.8%). The record does not provide enough context in these figures to infer arm-specific frequencies for these terms or to make a causal comparison. Serious adverse event counts should be interpreted alongside definitions, exposure, follow-up, and attribution information, which are not fully reported in this summary.

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

The primary result is an uncertain comparative estimate for overall survival. The reported hazard ratio is 1.091, and its 95% confidence interval includes the no-difference reference. The median estimates are 5.7 months for the combination and 6.2 months for erlotinib alone, but those medians are separate summaries and do not replace the sponsor’s comparative analysis. The posted data do not clearly establish a difference in overall survival between the randomized groups.

That conclusion is narrower than saying the treatments are equivalent. Equivalence requires a prespecified margin and an analysis designed to determine whether the plausible difference lies within that margin; such a framework is not reported in the registry record. Likewise, a result that does not clearly distinguish the groups does not prove that neither regimen has an effect. It means the available comparison leaves uncertainty about the relative effect.

The results also do not determine whether a possible difference is clinically important. The registry record does not state a threshold for a clinically meaningful change in survival or report a benefit-harm analysis that combines efficacy and safety. The serious adverse event summaries provide counts and listed terms, but they do not alone establish causation or comparative safety.

Interpretation is specific to the enrolled population: people with advanced non-small cell lung cancer of non-adenocarcinoma histology. The results should not be generalized automatically to other cancer histologies or populations. The trial was open label, and the reason it was terminated is not reported in the registry record. These registry entries are relevant context, but neither identifies the cause of the outcome nor explains the termination.

Overall, the registry supports a cautious reading: the sponsor-reported primary comparison does not show a clear difference, while its confidence interval leaves room for uncertainty. The finding is not proof of no effect, equivalence, or a particular clinical recommendation.

18. Why This Trial Matters Statistically

This trial illustrates why a treatment comparison should be read through its estimand and analysis rather than through arm medians alone. Overall survival is a time-to-event outcome, with censoring for participants still alive at last contact. The sponsor’s log-rank hazard ratio is the reported comparative analysis; the medians are useful arm-level descriptions but are not themselves the treatment contrast.

It also demonstrates the role of precision. The hazard-ratio interval crosses the no-difference reference, so the point estimate cannot be treated as a definitive direction of effect. A p-value does not resolve the uncertainty or communicate the full range of plausible effects. The interval is essential to judging how much the data constrain the relative comparison.

The trial’s several secondary outcomes show why outcome families require care. Different endpoint types can contribute complementary information, but multiple unadjusted comparisons can make isolated findings less persuasive. The registry record does not report a multiplicity strategy, reinforcing the distinction between a designated primary endpoint and secondary analyses.

Finally, the planning illustrations distinguish event requirements for time-to-event outcomes from per-arm participant requirements for response. They also show how the required information rises when planning to detect a smaller effect. Those illustrations are not observed power and do not reveal the trial’s original design assumptions. Keeping these distinctions clear helps prevent a planning calculation, a subgroup count, or an arm-specific summary from being mistaken for the primary comparative result.

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 registry record is concise and does not report the reason the trial was terminated. It also does not give the original sample-size justification, the complete statistical analysis plan, or any interim-analysis details. As a result, the rationale behind the trial’s design choices and the context for its termination cannot be assessed from the record.

The study was open label, with no masking listed. Knowledge of treatment assignment can influence some aspects of care, reporting, or assessment, although the registry summary does not establish that any such influence occurred. The record does not describe whether outcome assessors were masked or how potential effects of open-label conduct were addressed.

The registry specifies the intent-to-treat population for overall survival and explains censoring for participants alive at last contact. It does not provide the full participant flow, detailed missing-data handling for each endpoint, or a complete description of follow-up by arm. The primary outcome timeframe extends up to 30.65 months, but the summary alone does not provide a detailed account of event timing or the number of participants remaining under observation over time.

Only some secondary outcome results are numerically reported in the record. Findings for the listed pharmacokinetic, antibody, circulating-tumor-cell, and quality-of-life outcomes are not reported there, limiting an assessment of the overall pattern across all planned outcomes. The registry also does not report multiplicity handling or a clinically meaningful threshold for the primary result.

The serious adverse event summary provides affected counts and selected terms but does not include full event narratives, attribution, timing, or death counts. These limitations constrain interpretation of both efficacy and safety. They do not establish that the missing information would change the conclusions; they identify what the registry record does not allow readers to evaluate.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Trial Of CP-751, 871 And Erlotinib In Refractory Lung Cancer — NCT00673049.
• Registry record last updated 2013-07-24; status last verified 2013-07.
• Results first posted 2013-07-24.
• 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 describes a randomized, open-label, Phase 3, parallel-group trial of figitumumab plus erlotinib versus erlotinib alone in advanced non-small cell lung cancer of non-adenocarcinoma histology. Enrollment is listed as 583, and the status is terminated. The primary endpoint was overall survival in the full intent-to-treat analysis set.

The sponsor-reported overall-survival hazard ratio was 1.091, with a 95% confidence interval from 0.909 to 1.310 and p = 0.35. The interval includes the no-difference reference, leaving uncertainty about the comparative effect. The record also reports progression-free survival and objective response results; other listed secondary outcome findings are not reported in the registry record.

The registry does not report the reason for termination, original design assumptions, complete analysis plan, or multiplicity strategy. The posted results support a cautious interpretation and do not establish equivalence or a clinically important difference.