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 Study for Participants With Advanced, Not Amenable to Surgery, or Metastatic Lung Cancer Comparing Treatment With Pemetrexed + Cisplatin + Enzastaurin Versus Pemetrexed + Cisplatin + Placebo (NCT00538681), a randomized phase 2 study. The primary outcome is Part 1: Evaluate Safety [Toxicity, Serious Adverse Events (SAEs) and Reasons for Participant's Discontinuation].
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00538681 |
| Phase | Phase 2 |
| Condition | Lung Cancer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 35 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Eli Lilly and Company |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned chemonaive participants with advanced, unresectable, or metastatic Stage IIIB or IV nonsquamous non-small cell lung cancer. The brief description specifies participants with advanced lung cancer that was not amenable to surgery or was metastatic, and who had received no prior chemotherapy. The primary safety population was all randomized participants who received at least 1 dose of study drug.
Intervention
Part 2 compared pemetrexed and cisplatin together with enzastaurin. Part 1 evaluated the safety of the pemetrexed, cisplatin, and enzastaurin combination. The registry also lists Part 2- Enzastaurin as a group in the adverse-event record, but does not provide additional descriptions of the treatment schedules or doses.
Comparator
The planned Part 2 comparator was pemetrexed and cisplatin together with placebo. The adverse-event record lists a Part 2- Placebo group and a separate Part 2- Pemetrexed + Cisplatin group. The registry record does not explain the relationship between that separately listed group and the planned comparison.
Primary question
The recorded primary outcome asks about Part 1 safety: toxicity, serious adverse events, and reasons for participant discontinuation. The brief description identifies efficacy comparison as the main objective of Part 2, but the posted primary outcome is not an efficacy endpoint. The registry lists secondary outcomes including response, overall survival, disease control, symptom worsening, and biomarkers.
These are related but distinct questions. Safety counts describe participants with recorded events in the listed groups; they do not, by themselves, estimate a treatment effect. An efficacy comparison would require outcome results and a defined analysis comparing the randomized Part 2 groups. Such results and analyses are not reported in the registry record.
3. Trial Design
The registry identifies this as a randomized, triple-masked, parallel Phase 2 study. Enrollment was 35, and the study status is terminated. The record lists a start of 2007-09 and a primary completion of 2008-11. It does not report why the study was terminated, or whether the planned study conduct changed after it began.
The study had two parts, according to its brief description. Part 1 was intended to evaluate safety of pemetrexed, cisplatin, and enzastaurin. Part 2 was intended to compare that combination with pemetrexed, cisplatin, and placebo, with Part 2 participants limited to those with nonsquamous non-small cell lung cancer. The official title describes the population as chemonaive participants with advanced, unresectable, or metastatic disease. The registry does not report how participants were assigned between the parts, the allocation ratio, or further details of the masking procedures.
The adverse-event record lists Part 1- Cohort 1 and Part 1- Cohort 2, alongside Part 2- Enzastaurin, Part 2- Placebo, and Part 2- Pemetrexed + Cisplatin. The record does not describe the treatment distinction between the two Part 1 cohorts, nor explain the separately listed Part 2 group receiving pemetrexed and cisplatin. These labels should therefore be read as registry group labels, not as evidence of a particular dose schedule or study sequence.
The primary outcome specifies a safety follow-up spanning Cycle 1 (28-day cycle), Cycles 2, 3, 4, 5, and 6 (21-day cycles), and 30-day follow up. The reported primary population is all randomized participants who received at least 1 dose of study drug. The registry does not state a protocol-based sample-size justification, a target enrollment for each part, or the number of participants who completed follow-up.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Part 1- Cohort 1 | Part 1- Cohort 2 | Part 2- Enzastaurin | Part 2- Placebo |
|---|---|---|---|---|
| STARTED | 9 | 4 | 11 | 11 |
| Received ≥1 Dose of Any Study Drug | 9 | 4 | 11 | 11 |
| COMPLETED | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 9 | 4 | 11 | 11 |
Reasons for not completing this period:
| Reason | Part 1- Cohort 1 | Part 1- Cohort 2 | Part 2- Enzastaurin | Part 2- Placebo |
|---|---|---|---|---|
| Progressive Disease | 7 | 0 | 1 | 0 |
| Sponsor Decision | 1 | 3 | 8 | 9 |
| Adverse Event | 1 | 1 | 1 | 0 |
| Death | 0 | 0 | 1 | 1 |
| Investigator Decision | 0 | 0 | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: All randomized participants who received at least 1 dose of study drug.
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: All randomized participants who received at least 1 dose of any study drug.
| Characteristic | Unit | Part 1- Cohort 1 | Part 1- Cohort 2 | Part 2- Enzastaurin | Part 2- Placebo | Other | Total |
|---|---|---|---|---|---|---|---|
| Participants analysed | 9 | 4 | 11 | 10 | 1 | 35 | |
| Age, Continuous | years | 58.3 (SD 9.32) | 61.2 (SD 6.85) | 58.6 (SD 9.62) | 59.5 (SD 9.39) | 49.1 (SD NA) | 58.8 (SD 8.88) |
| Sex: Female, Male: Female | Participants | 1 | 2 | 6 | 6 | 1 | 16 |
| Sex: Female, Male: Male | Participants | 8 | 2 | 5 | 4 | 0 | 19 |
| Race/Ethnicity, Customized: Caucasian | Participants | 9 | 4 | 11 | 10 | 1 | 35 |
| Region of Enrollment: Belgium | Participants | 4 | 1 | 1 | 4 | 0 | 10 |
| Region of Enrollment: Poland | Participants | 0 | 0 | 4 | 4 | 1 | 9 |
| Region of Enrollment: Germany | Participants | 5 | 3 | 6 | 2 | 0 | 16 |
| Type of Carcinoma: Adenocarcinoma: Lung | Participants | 7 | 3 | 1 | 4 | 0 | 15 |
| Type of Carcinoma: Carcinoma Large Cell: Lung | Participants | 1 | 0 | 3 | 2 | 0 | 6 |
| Type of Carcinoma: Squamous Cell Carcinoma: Lung | Participants | 1 | 1 | 0 | 0 | 0 | 2 |
| Type of Carcinoma: Carcinoma Non-Small Cell: Lung | Participants | 0 | 0 | 2 | 1 | 0 | 3 |
| Type of Carcinoma: Adenocarcinoma, Bronchioalveolar | Participants | 0 | 0 | 5 | 3 | 1 | 9 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-Fully Active | Participants | 1 | 1 | 4 | 3 | 0 | 9 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status: 1-Ambulatory, work of a light or sedentary nature | Participants | 8 | 3 | 7 | 7 | 1 | 26 |
6. Primary Endpoint
The registry lists the primary outcome as Part 1: Evaluate Safety [Toxicity, Serious Adverse Events (SAEs) and Reasons for Participant's Discontinuation], measured over Cycle 1 (28-day cycle), Cycles 2, 3, 4, 5, and 6 (21-day cycles) and 30-day follow up.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The recorded primary outcome is Part 1 safety, covering toxicity, serious adverse events (SAEs), and reasons for discontinuation. Toxicity was assessed using Common Terminology Criteria for Adverse Events (CTCAE v3.0). The record describes discontinuations due to SAEs or other non-serious adverse events, and specifies follow-up through Cycle 1 (28-day cycle), Cycles 2, 3, 4, 5, and 6 (21-day cycles), and 30-day follow up.
The endpoint is expressed as participants, with the parameter described as a count of participants. In practical terms, safety counts indicate how many participants in a group were recorded as having the relevant event or discontinuation. Counts need their group denominators for interpretation: the same count can convey different information when the number of participants at risk differs. The adverse-event record supplies group-specific at-risk and affected counts for serious and other adverse events.
General: Safety outcomes are used to describe the kinds and frequency of harms observed during study treatment and follow-up. Such information is important even when a study is not designed or reported with a comparative efficacy estimate. A count of participants with an event does not establish that treatment caused the event. The registry description says that SAEs and other non-serious adverse events regardless of causality are detailed in the Reported Adverse Event module. No single summary measure combines all the listed safety components, and no analysis of the primary outcome is reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary outcome is a safety assessment in Part 1, rather than a reported statistical comparison of the Part 2 treatments. The registry record lists the intended Part 2 efficacy comparison, but it contains no analysis entries. Consequently, the posted information does not provide an estimated treatment difference, confidence interval, or significance test for efficacy or for the primary safety outcome.
The safety record lists 9 participants at risk in Part 1- Cohort 1, with 5 affected by serious events and 9 affected by other events. Part 1- Cohort 2 lists 4 at risk, with 0 affected by serious events and 4 by other events. In Part 2- Enzastaurin, 11 were at risk, with 2 affected by serious events and 8 by other events. Part 2- Placebo lists 10 at risk, with 4 affected by serious events and 8 by other events. Part 2- Pemetrexed + Cisplatin lists 1 at risk, with 0 affected by serious events and 1 by other events.
These are descriptive participant counts, not adjusted comparisons. The registry does not report statistical tests for these groups or establish whether the groups are comparable for a particular safety contrast. The separately listed Part 2- Pemetrexed + Cisplatin group has a very small recorded denominator, so its count should be understood as a description of that record rather than a stable estimate of event frequency. More generally, small denominators make observed counts sensitive to the experience of individual participants.
The serious-event terms listed are Pericardial effusion, Abdominal pain, Ileus paralytic, Blood amylase increased, Haematuria, and Dyspnoea exertional, each at 11.1%. The registry does not identify a treatment group for each listed term in the information available, so those percentages should not be assigned to a particular arm. Death counts are not reported in the registry record.
General: A confidence interval expresses the range of effect estimates compatible with the data under a statistical model, and helps show precision as well as direction. Without an estimate and its uncertainty, a reader cannot judge how precisely a group contrast is known. The posted counts support a limited descriptive reading of recorded events, but they do not establish that one regimen has a higher or lower safety risk than another. They also do not answer the planned efficacy question.
9. Statistical Methods Explained
The registry describes a randomized, triple-masked, parallel Phase 2 study. It identifies a count-based primary safety outcome, but lists no statistical analyses. The distinction between design features, outcome definitions, and analysis results matters: design labels explain how the study was organized, while an analysis plan would specify how observations were to be compared and interpreted. The latter is not reported in the registry record.
What does randomization contribute?
General: Randomization assigns participants to study groups through a chance-based process. When it is implemented as planned, it can reduce systematic differences between groups at entry, supporting a fair comparison. It does not guarantee that groups will be identical, especially in a small study, and it does not replace reporting the actual analysis population or accounting for missing outcomes. The registry identifies random allocation but does not state the allocation ratio or provide details of the randomization procedure.
What does masking mean?
The registry labels the study triple-masked. General: Masking is intended to reduce the influence of knowing a participant's assigned treatment on aspects of care, outcome assessment, or study conduct. The label alone does not identify which roles were masked, how masking was maintained, or whether it was broken. Those details are not reported in the registry record.
How should event counts be understood?
The primary endpoint is reported as participants, and the adverse-event record gives the number at risk and the number affected in each listed group. General: A participant count is a direct descriptive measure, but it depends on the event definition, the observation period, and the population included. The number at risk provides a denominator that helps put an affected count in context. Counts do not show when an event occurred, whether a participant had multiple events, or how event severity was distributed unless those details are separately reported.
The primary outcome description refers to toxicity graded under CTCAE v3.0, SAEs, and discontinuations due to SAEs or other non-serious adverse events. It also says that summaries of SAEs and other non-serious adverse events regardless of causality are located in the Reported Adverse Event module. The group-level serious and other affected counts should therefore be read as registry safety summaries, not as a causal attribution to study treatment.
Why are uncertainty estimates useful?
General: A point estimate gives a single summary of an observed contrast, while a confidence interval conveys uncertainty around that estimate. For event counts, uncertainty can be substantial when the number of participants is limited. A statistical test addresses compatibility with a specified null hypothesis under its assumptions; a p-value alone does not measure the size or clinical importance of an effect. No confidence intervals, p-values, or comparative estimates for the primary outcome are reported in the registry record.
What can the planning illustration establish?
The registry describes a planning illustration based on a fraction of an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It distinguishes participants per arm for non-time-to-event outcomes from total events for time-to-event outcomes. A planning illustration based on an observed effect is not the trial's protocol-based sample-size justification, and it is not observed power. The registry does not report the protocol's sample-size justification. No numerical planning result is reported in the record, so a required sample size cannot be interpreted from these details alone.
General: Sample-size calculations depend on assumptions about the effect to detect, variability or event frequency, allocation, and the chosen error rate. Changing those assumptions can change the resulting planning target. Such calculations describe a design scenario; they do not show whether a study's findings are statistically persuasive after data are collected.
What analysis details remain unavailable?
The registry does not report an analysis population for the Part 2 efficacy outcomes, a missing-data approach, covariate adjustment, handling of repeated events, or a statistical model for the count outcome. It also does not report an interim-analysis plan or multiplicity procedure. These omissions mean that the posted record cannot support reconstruction of a sponsor analysis or assessment of its assumptions. The appropriate interpretation is limited to the outcome definitions and descriptive safety counts that are recorded.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists several Part 2 secondary outcomes: safety and toxicity; participants with a complete or partial response; overall survival; duration of disease control and response; time to worsening of symptoms; and biomarkers of disease state and their correlation to clinical outcome. It reports 8 outcome measures, but lists no analyses. The record does not specify which outcomes were confirmatory, how they were ordered, or whether any adjustment for multiple testing was planned.
General: When several outcomes or comparisons are examined, the chance of at least one apparently notable result can increase if each is evaluated separately. A prespecified hierarchy or a multiplicity adjustment can help define how evidence across outcomes should be interpreted. No such procedure is reported in the registry record. Since no inferential results are listed, there is also no posted multiplicity-adjusted or unadjusted finding to interpret.
The primary safety population is described as all randomized participants who received at least 1 dose of study drug. The registry does not identify an analysis population for Part 2 efficacy, explain how participants who did not receive treatment were handled, or describe the number included in each outcome analysis. It does not report missing-data methods, imputation, censoring rules, or follow-up completeness. The stated primary outcome timeframe is Cycle 1 (28-day cycle), Cycles 2, 3, 4, 5, and 6 (21-day cycles) and 30-day follow up, but the record does not provide participant-level completion information.
These gaps matter because analyses can differ according to who is included and how unavailable outcomes are handled. General: Excluding participants with missing outcomes may distort a comparison if missingness is related to health status or treatment experience. Methods for handling missing data require assumptions, which should be stated and examined. Without analysis details, the reported event counts can be read descriptively, but cannot be taken as a complete account of all planned analyses.
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 |
|---|---|---|---|
| Part 1- Cohort 1 | 5 | 9 | 55.6% |
| Part 1- Cohort 2 | 0 | 4 | 0.0% |
| Part 2- Enzastaurin | 2 | 11 | 18.2% |
| Part 2- Placebo | 4 | 10 | 40.0% |
| Part 2- Pemetrexed + Cisplatin | 0 | 1 | 0.0% |
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 |
|---|---|
| Part 1- Cohort 1 | 9 of 9 |
| Part 1- Cohort 2 | 4 of 4 |
| Part 2- Enzastaurin | 8 of 11 |
| Part 2- Placebo | 8 of 10 |
| Part 2- Pemetrexed + Cisplatin | 1 of 1 |
Most frequent serious adverse event terms
| Event term | Organ system | Part 1- Cohort 1 | Part 1- Cohort 2 | Part 2- Enzastaurin | Part 2- Placebo | Part 2- Pemetrexed + Cisplatin |
|---|---|---|---|---|---|---|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 1 of 9 | 0 of 4 | 0 of 11 | 1 of 10 | 0 of 1 |
| Pericardial effusion | Cardiac disorders | 1 of 9 | 0 of 4 | 0 of 11 | 0 of 10 | 0 of 1 |
| Tachyarrhythmia | Cardiac disorders | 0 of 9 | 0 of 4 | 0 of 11 | 1 of 10 | 0 of 1 |
| Abdominal pain | Gastrointestinal disorders | 1 of 9 | 0 of 4 | 0 of 11 | 0 of 10 | 0 of 1 |
| Duodenal ulcer | Gastrointestinal disorders | 0 of 9 | 0 of 4 | 0 of 11 | 1 of 10 | 0 of 1 |
| Ileus paralytic | Gastrointestinal disorders | 1 of 9 | 0 of 4 | 0 of 11 | 0 of 10 | 0 of 1 |
| Appendicitis | Infections and infestations | 0 of 9 | 0 of 4 | 0 of 11 | 1 of 10 | 0 of 1 |
| Candidiasis | Infections and infestations | 0 of 9 | 0 of 4 | 0 of 11 | 1 of 10 | 0 of 1 |
| Lung infection | Infections and infestations | 0 of 9 | 0 of 4 | 1 of 11 | 0 of 10 | 0 of 1 |
| Blood amylase increased | Investigations | 1 of 9 | 0 of 4 | 0 of 11 | 0 of 10 | 0 of 1 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Part 1- Cohort 1 | Part 1- Cohort 2 | Part 2- Enzastaurin | Part 2- Placebo | Part 2- Pemetrexed + Cisplatin |
|---|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | 5 of 9 | 3 of 4 | 3 of 11 | 5 of 10 | 0 of 1 |
| Fatigue | General disorders | 7 of 9 | 3 of 4 | 3 of 11 | 0 of 10 | 0 of 1 |
| Vomiting | Gastrointestinal disorders | 4 of 9 | 2 of 4 | 3 of 11 | 2 of 10 | 0 of 1 |
| Constipation | Gastrointestinal disorders | 2 of 9 | 3 of 4 | 3 of 11 | 0 of 10 | 0 of 1 |
| Oedema peripheral | General disorders | 6 of 9 | 1 of 4 | 1 of 11 | 0 of 10 | 0 of 1 |
| Anorexia | Metabolism and nutrition disorders | 3 of 9 | 1 of 4 | 1 of 11 | 2 of 10 | 0 of 1 |
| Alopecia | Skin and subcutaneous tissue disorders | 2 of 9 | 1 of 4 | 1 of 11 | 2 of 10 | 1 of 1 |
| Stomatitis | Gastrointestinal disorders | 2 of 9 | 0 of 4 | 2 of 11 | 1 of 10 | 0 of 1 |
| Chest pain | General disorders | 5 of 9 | 0 of 4 | 0 of 11 | 0 of 10 | 0 of 1 |
| Faeces discoloured | Gastrointestinal disorders | 2 of 9 | 2 of 4 | 0 of 11 | 0 of 10 | 0 of 1 |
Serious events with the highest arm-level rate: pericardial effusion (11.1%), abdominal pain (11.1%), ileus paralytic (11.1%), blood amylase increased (11.1%), haematuria (11.1%).
The serious adverse-event counts are listed by registry group. Part 1- Cohort 1 has 5 participants affected among 9 at risk; Part 1- Cohort 2 has 0 among 4. Part 2- Enzastaurin has 2 among 11, Part 2- Placebo has 4 among 10, and Part 2- Pemetrexed + Cisplatin has 0 among 1. The corresponding counts for other adverse events are 9 among 9, 4 among 4, 8 among 11, 8 among 10, and 1 among 1, respectively.
These are numbers of participants recorded as affected, not counts of every event occurrence. The registry description says the adverse-event summaries include events regardless of causality, so an event's appearance in these counts does not establish that study treatment caused it. Each denominator is important, particularly for the group with 1 participant at risk; the recorded count in that group offers very little information about the frequency that might be expected in a broader population.
The listed serious-event terms are Pericardial effusion, Abdominal pain, Ileus paralytic, Blood amylase increased, Haematuria, and Dyspnoea exertional, each reported as 11.1%. The registry does not connect those terms to a specific group in the available record. Deaths are not reported in the registry record. The counts are descriptive and are not accompanied by comparative statistical analyses.
12. What the Result Does, and Does Not, Mean
The registry record establishes that the study was a randomized, triple-masked, parallel Phase 2 trial with an intended safety assessment in Part 1 and an intended efficacy comparison in Part 2. It identifies the primary safety outcome, the assessment timeframes, the safety population definition, and group-level counts for serious and other adverse events. Those details make it possible to describe what was recorded in the listed groups.
The record does not establish the relative efficacy of pemetrexed and cisplatin with enzastaurin versus pemetrexed and cisplatin with placebo. Although Part 2 was intended to compare those regimens, no comparative efficacy analysis is listed. The record also does not report an estimated contrast, confidence interval, or statistical test for the primary safety outcome. The event counts therefore should not be treated as proof of a difference or similarity between regimens.
Nor do the counts establish that an event was caused by treatment. The registry describes adverse-event summaries regardless of causality. The serious-event terms and their listed percentages do not identify a specific group in the available record, and the death counts are not reported. Safety counts also do not describe event timing or the full clinical course of participants.
General: A lack of a reported statistical result is not evidence that there was no effect. It means that the record does not supply the estimate and uncertainty needed to assess the direction or precision of an effect. Likewise, an observed difference in raw counts, without a suitable analysis and clear comparison population, is not by itself evidence of a treatment effect. The study's terminated status does not explain why it ended or what conclusions its investigators reached; that reason is not reported in the registry record.
13. Why This Trial Matters Statistically
This record illustrates why trial design, endpoint choice, and analysis reporting must be read together. The study has a randomized, masked, parallel design, but its primary endpoint is a safety assessment in Part 1, while its brief description identifies an efficacy comparison as the main objective of Part 2. Keeping those objectives distinct prevents safety summaries from being mistaken for efficacy results.
The safety data also show why denominators matter. The listed groups range from a denominator of 1 in Part 2- Pemetrexed + Cisplatin to 11 in Part 2- Enzastaurin. Counts from groups with very different amounts of information should not be compared as though they had equal precision. General: In small groups, the experience of a single participant can have a large influence on an observed count; uncertainty estimates help communicate that limitation when they are reported.
The record is also a useful example of the limits of registry reporting. It names multiple secondary outcomes but lists no statistical analyses. The analysis population for Part 2, missing-data handling, multiplicity approach, and detailed statistical plan are not reported. These omissions restrict what can be concluded even when outcome definitions and some event counts are available.
Finally, the planning assumptions described in the record should be kept separate from evidence about the completed study. A planning illustration is not an observed result and does not substitute for a reported analysis. Clear reporting of estimates, uncertainty, analysis populations, and limitations is necessary for readers to evaluate how much the findings can support.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry status is terminated, but the reason for termination is not reported in the registry record. The record does not explain whether termination affected enrollment, follow-up, or the planned analyses. Enrollment is listed as 35, but the number randomized to each part and the number completing the scheduled safety follow-up are not reported.
The Part 1 group labels identify Cohort 1 and Cohort 2 without describing how their treatments differed. The adverse-event record also lists a Part 2- Pemetrexed + Cisplatin group separately from the Part 2- Enzastaurin and Part 2- Placebo groups, without explaining its role in the design. That ambiguity limits interpretation of group-to-group comparisons. In addition, the adverse-event terms are not linked to specific groups in the available record.
The primary outcome combines toxicity, SAEs, and discontinuation reasons, but the registry does not report a single statistical summary or comparative analysis of those components. No analyses are listed. Details about event timing, repeated events, outcome missingness, censoring, or analysis populations beyond the primary safety population are not reported. Death counts are also not reported in the registry record.
The registry gives a safety follow-up timeframe and identifies CTCAE v3.0, but does not provide enough analysis detail to assess adjustment, multiplicity, or the handling of incomplete observations. It does not report the protocol-based sample-size justification. The planning illustration described in the record should not be taken as the study's own design justification or as observed power. Together, these limitations mean that the posted information supports descriptive reading of selected safety counts, but not a full reconstruction of the trial's planned or completed statistical analyses.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study for Participants With Advanced, Not Amenable to Surgery, or Metastatic Lung Cancer Comparing Treatment With Pemetrexed + Cisplatin + Enzastaurin Versus Pemetrexed + Cisplatin + Placebo — NCT00538681.
- Registry record last updated 2020-11-05; status last verified 2020-10.
- Results first posted 2020-11-05.
- 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
NCT00538681 is a randomized, triple-masked, parallel Phase 2 study sponsored by Eli Lilly and Company. It enrolled 35 participants and is listed as terminated. The record gives a start of 2007-09 and a primary completion of 2008-11. The study concerned chemonaive participants with advanced, unresectable, or metastatic nonsquamous non-small cell lung cancer.
Part 1 was intended to assess the safety of pemetrexed, cisplatin, and enzastaurin. Part 2 was intended to compare that combination with pemetrexed, cisplatin, and placebo. The recorded primary outcome is Part 1 safety, covering toxicity, SAEs, and reasons for discontinuation. The record lists group-level counts for serious and other adverse events, but no statistical analyses. The reason for termination, efficacy comparisons, and several analysis details are not reported in the registry record.