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 Dosage Schedule Study of Pemetrexed Monochemotherapy for Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) (NCT00370292), a non-randomized phase 2 study. The primary outcome is Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00370292 |
| Phase | Phase 2 |
| Condition | Non Small Cell Lung Cancer |
| Allocation | Non-Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 19 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Eli Lilly and Company |
| Results posted | Yes |
2. Clinical Question
Population
People with locally advanced or metastatic non-small cell lung cancer were the intended population. The primary outcome description specifies participants who received at least one dose of study drug as the analysis population. The registry record reports enrollment of 19 participants, but does not report how many received a dose or contributed measurements at each time point.
Intervention
The study evaluated pemetrexed monochemotherapy. The record lists pemetrexed before and after a protocol amendment as separate intervention labels, but gives no arm descriptions explaining the dosing schedules or what changed with the amendment. The brief summary says treatment could continue for a maximum of 8 cycles.
Comparator
There was no randomized control group. The study is recorded as non-randomized and single-group, with no masking. The two pemetrexed intervention labels refer to periods before and after a protocol amendment; the record does not describe them as randomized groups or provide enough detail to treat them as a like-for-like comparison.
Primary question
The primary outcome concerned mean deoxycytidine kinase (dCK) expression in normal lymphocytes at cycles 1, 2, and 3. Measurements were scheduled before dosing and at specified post-dose times. The stated aim was to assess whether maximum dCK expression occurred at a reproducible time and to consider the interval between pemetrexed and gemcitabine. The primary outcome results are not reported in the registry record.
3. Trial Design
This is a phase 2 pilot study of pemetrexed monochemotherapy in people with locally advanced or metastatic non-small cell lung cancer. The official title describes a pilot intended to define a dosing schedule for a planned randomized phase II trial. That future trial is a stated motivation; it is not the design evaluated by this record.
The registered study is non-randomized, has a single-group model, and has no masking. Enrollment is 19. The record lists pemetrexed before and after a protocol amendment, but provides no arm descriptions and does not state the change made by the amendment. These labels therefore do not establish a controlled comparison between dosing schedules. The record explicitly cautions that the arms are not a like-for-like control comparison.
The brief summary says participants would receive pemetrexed for a maximum of 8 cycles. It also describes monitoring biomolecules involved in the gemcitabine mechanism of action, with the stated aim of optimizing the interval between pemetrexed and gemcitabine. However, the study's listed intervention is pemetrexed monochemotherapy. Details of the amendment and of any particular dosing schedule are not reported in the registry record.
The primary outcome focuses on dCK expression in normal lymphocytes over cycles 1, 2, and 3. The description also mentions hENT expression as a separate outcome. The record lists best objective tumor response as a secondary outcome. It reports 3 outcome measures and 12 analyses, but does not describe the analysis methods or provide the outcome values in the available record.
Because there is no randomized comparator, changes over time or differences between the amendment periods cannot be attributed to pemetrexed with the protections of random allocation. The registry record does not report a protocol-level sample-size justification, or enough detail to reconstruct the intended 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 assignment: Of the 19 enrolled patients, 12 were enrolled before the protocol amendment was made effective (i.e. 2-weekly administration) and 7 were enrolled after the amendment (i.e. 3-weekly administration).
Overall Study
| Stage | Pemetrexed |
|---|---|
| STARTED | 19 |
| COMPLETED | 6 |
| NOT COMPLETED | 13 |
Reasons for not completing this period:
| Reason | Pemetrexed |
|---|---|
| Disease Progression | 4 |
| Adverse Event | 7 |
| Physician Decision | 2 |
Analysis population for the primary outcome, as defined in the registry: All participants who received at least one 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.
| Characteristic | Unit | Pemetrexed - Before Amendment | Pemetrexed - After Amendment | Total |
|---|---|---|---|---|
| Participants analysed | 12 | 7 | 19 | |
| Age Continuous | years | 69.1 (SD 10.34) | 69.4 (SD 6.45) | 69.2 (SD 8.90) |
| Sex: Female, Male: Female | Participants | 3 | 5 | 8 |
| Sex: Female, Male: Male | Participants | 9 | 2 | 11 |
| Region of Enrollment: Italy | participants | 12 | 7 | 19 |
| Disease Stages: Not Known | participants | 0 | 1 | 1 |
| Disease Stages: Stage IA | participants | 2 | 0 | 2 |
| Disease Stages: Stage IB | participants | 1 | 0 | 1 |
| Disease Stages: Stage IIA | participants | 1 | 0 | 1 |
| Disease Stages: Stage IIB | participants | 0 | 1 | 1 |
| Disease Stages: Stage IIIA | participants | 0 | 1 | 1 |
| Disease Stages: Stage IIIB | participants | 3 | 2 | 5 |
| Disease Stages: Stage IV | participants | 5 | 2 | 7 |
| Eastern Cooperative Oncology Group Performance Status: 0 - Fully Active | participants | 4 | 1 | 5 |
| Eastern Cooperative Oncology Group Performance Status: 1 - Ambulatory, Restricted Strenuous Activity | participants | 6 | 5 | 11 |
| Eastern Cooperative Oncology Group Performance Status: 2 - Ambulatory, No Work Activities | participants | 2 | 1 | 3 |
| Histopathological Grade: Not Done | participants | 7 | 2 | 9 |
| Histopathological Grade: G1 - Well-Differentiated | participants | 1 | 1 | 2 |
| Histopathological Grade: G2 - Moderately Differentiated | participants | 2 | 1 | 3 |
| Histopathological Grade: G3 - Poorly Differentiated | participants | 2 | 3 | 5 |
| Previous Anti-Tumor Treatment: No | participants | 5 | 1 | 6 |
| Previous Anti-Tumor Treatment: Yes | participants | 7 | 6 | 13 |
| Previous Surgery: Surgery - No | participants | 4 | 1 | 5 |
| Previous Surgery: Surgery - Yes: Pneumonectomy | participants | 0 | 1 | 1 |
| Previous Surgery: Surgery - Yes: Lobectomy | participants | 3 | 3 | 6 |
| Previous Surgery: Surgery - Yes: Other | participants | 5 | 3 | 8 |
| Previous Surgery: Surgery - Yes: Radical | participants | 5 | 4 | 9 |
| Race/Ethnicity: Caucasian | participants | 12 | 7 | 19 |
| Tumor Type: Adenocarcinoma | participants | 5 | 6 | 11 |
| Tumor Type: Squamous Cell Carcinoma | participants | 5 | 1 | 6 |
| Tumor Type: Other | participants | 2 | 0 | 2 |
| Blood Pressure: Systolic Blood Pressure (SBP) | mmHg | 138.0 (SD 13.17) | 146.9 (SD 21.54) | 141.6 (SD 17.08) |
| Blood Pressure: Diastolic Blood Pressure (DBP) | mmHg | 81.8 (SD 7.97) | 83.6 (SD 9.45) | 82.5 (SD 8.37) |
| Body Surface Area (BSA) | square meters (m^2) | 1.7 (SD 0.17) | 1.7 (SD 0.13) | 1.7 (SD 0.16) |
| Body Temperature | degrees Celsius (°C) | 36.1 (SD 0.58) | 35.9 (SD 0.36) | 36.0 (SD 0.49) |
| Heart Rate | beats per minute (bpm) | 82.9 (SD 14.98) | 78.6 (SD 8.52) | 81.1 (SD 12.58) |
6. Primary Endpoint
The registry lists the primary outcome as Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3, measured over pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | mRNA relative values (ratio with GAPDH) |
| Endpoint classification | Continuous Endpoint |
The primary outcome is mean deoxycytidine kinase (dCK) expression at cycle 1, cycle 2, and cycle 3. The unit is mRNA relative values, expressed as a ratio with GAPDH. The outcome description says expression was measured in normal lymphocytes, using polymerase chain reaction threshold cycles relative to glyceraldehyde 3-phosphate dehydrogenase (GAPDH), a reference gene.
Measurements were scheduled before dosing and at 1, 2, 4, 6, 24, and 48 hours after dosing across the 3 cycles. Repeated measurements across time can describe the timing and pattern of expression after treatment. The stated scientific purpose was to assess whether the timing of maximum dCK expression was reproducible and to inform consideration of the interval between pemetrexed and gemcitabine. This is a biological measurement, not a direct measure of tumor response or patient benefit.
The endpoint is summarized as a mean with standard deviation. In general, a mean describes the central value of the measured observations, while a standard deviation describes their spread around that mean. Interpretation depends on knowing how many participants contributed measurements at each cycle and time point, how missing measurements were handled, and whether the analysis accounted for repeated observations from the same participant. Those details and the primary outcome values are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a biological question: whether dCK expression in normal lymphocytes has a reproducible timing pattern after pemetrexed, and whether the measurements may help inform the interval between pemetrexed and gemcitabine. The primary outcome was measured across multiple post-dose times and treatment cycles, but its numerical results are not reported in the registry record. Consequently, the record does not allow a reader to assess the observed mean expression, its variability, or the size and consistency of any time-related pattern.
The study design also limits what can be concluded from any apparent change. This was a non-randomized, single-group study without masking. The registry lists treatment periods before and after a protocol amendment, but supplies no descriptions of the schedules or the amendment. Any contrast between those periods would therefore be difficult to interpret as an effect of a particular schedule: the record does not establish comparable groups or describe how participants were assigned.
The primary outcome is a laboratory measure in normal lymphocytes. Even if a pattern were reported, it would describe this biomarker under the study conditions. It would not by itself establish a tumor response, a clinical benefit, or an optimal treatment interval. Best objective tumor response is listed as a secondary outcome, but its results are not reported in the registry record either.
The enrollment of 19 indicates the size recorded for the study, not the number with complete primary outcome data. The endpoint's stated population includes participants who received at least one dose, but the record does not report the number treated or the number with evaluable measurements at each time point. This makes it impossible to judge the precision of any particular time-point estimate from the registry record.
The record reports 3 outcome measures and 12 analyses. Without a statistical analysis plan, it is not clear which comparisons were prespecified, how repeated observations were modeled, or how multiple analyses were addressed. The primary outcome is described as a mean with standard deviation, but a method for estimating uncertainty around the mean is not reported. A standard deviation alone describes variation among measurements; it is not the same as a confidence interval for the mean.
The record also gives planning assumptions for sample-size illustrations: two-sided significance level 0.05, equal allocation between two arms, a normal approximation, and target effects expressed as a fraction of the observed effect. These are planning assumptions, not the documented design of this single-group study, and any resulting sample sizes would be illustrations rather than observed power. The registry record does not report its own sample-size justification. No efficacy conclusion or precise estimate can be drawn from the primary outcome because the outcome values and their uncertainty are not reported.
9. Statistical Methods Explained
The primary measure is continuous: dCK expression is represented by mRNA relative values, as a ratio with GAPDH. The registry describes the outcome as a mean with standard deviation. In general, a mean summarizes the central location of measured values, while a standard deviation describes how dispersed those values are around the mean. These summaries answer different questions. A standard deviation concerns variation among observed measurements; a confidence interval, when reported, describes uncertainty about an estimated quantity such as a mean. No confidence interval for the primary outcome is reported in the registry record.
What do repeated measurements contribute?
Measurements were scheduled before dosing and at several post-dose times during cycles 1, 2, and 3. In general, repeated measurements can show how a biomarker varies over time and whether a pattern recurs across cycles. They also create a statistical dependence: measurements from the same participant are usually more alike than measurements from unrelated participants. An analysis that treats every measurement as independent can misstate uncertainty. A suitable repeated-measures approach would account for the within-participant relationship, but the specific method used is not reported in the registry record.
The timing of collection is central to the question described in the registry. A claim about a maximum expression time requires comparing measurements across the scheduled times and interpreting the pattern, not merely reporting an overall average. Reproducibility across cycles also requires a clear comparison of patterns between cycles. The record does not report numerical results, a model for time, or a formal definition of how a maximum or reproducibility was assessed.
What does the reference ratio mean?
The outcome description says threshold cycles from polymerase chain reaction were expressed relative to GAPDH, identified as the reference gene. In general, normalization to a reference gene provides a basis for interpreting target-gene measurements in relation to another measured gene. The reported unit is a relative value rather than an absolute concentration. Interpretation depends on the assay and on how the relative values are summarized. The registry record does not report additional laboratory-processing details or transformation methods.
How should the mean and standard deviation be read?
The mean can be useful for describing the average relative expression in the analyzed observations. The standard deviation conveys how much individual observations vary around that mean. Neither statistic alone describes the full distribution. In general, markedly asymmetric data or a small number of influential observations can make a mean less representative of a typical measurement. The record does not provide distributions, plots, sample counts by time point, or diagnostic checks, so those features cannot be assessed.
Precision also depends on the number of observations contributing to each summary and on their dependence. Although enrollment is 19, that is not necessarily the number of participants with a measurement at every time and cycle. The endpoint population is described as participants who received at least one dose, but treatment counts and completeness of follow-up are not reported in the registry record. No standard errors or confidence intervals are listed for the primary measure.
Why does over-dispersion matter?
In general, over-dispersion means the observed variability is greater than a statistical model assumes. If a model underestimates variability, its uncertainty estimates can be too narrow and its tests can appear more decisive than the data warrant. This concept is relevant when selecting or checking a model for biological measurements, but the registry record does not state that over-dispersion was assessed or report a model for the dCK outcome. It cannot be concluded that over-dispersion occurred in this study.
What do the planning assumptions mean?
The record describes sample-size illustrations based on a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The target effect is specified as a fraction of the observed effect. Such calculations, in general, estimate how many participants per arm might be needed under stated assumptions to detect a target difference. They depend on the effect used as the reference and on assumptions about variability and analysis.
These assumptions do not describe the registered study design: this trial is single-group and non-randomized. The resulting values, where calculated, are planning illustrations rather than observed power or evidence that the study was designed with those assumptions. The registry record does not report the trial's own sample-size justification. The observed effect and numerical sample-size illustrations are not available in the registry record, so no particular planning figure can be interpreted.
What can the analysis support?
Statistical methods can describe the biomarker measurements, estimate uncertainty, and assess patterns over time if the data and analysis plan are available. In general, a p-value assesses compatibility of data with a specified null model; it does not measure the size or clinical importance of an effect. A confidence interval provides a range of values compatible with the data and model, while its width conveys precision. Neither a p-value nor an interval can be interpreted without knowing the model, estimand, and analyzed population. The registry record does not report primary outcome estimates, p-values, confidence intervals, or a complete statistical analysis plan.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome involves measurements at several post-dose times and across cycles 1, 2, and 3. The record also lists hENT expression in the primary outcome description as a separate outcome, and identifies best objective tumor response as a secondary outcome. It reports 3 outcome measures and 12 analyses. These features create the possibility of multiple statistical comparisons. In general, testing many outcomes, times, or cycles can increase the chance of finding an apparently unusual result by chance. A prespecified analysis plan can identify primary comparisons and explain whether adjustment or another multiplicity strategy is used.
The registry record does not report whether the 12 analyses were prespecified, how they relate to the outcome measures, or whether multiplicity was addressed. It does not identify a single primary time-point contrast or explain how comparisons across cycles were handled. Therefore, the statistical meaning of any individual test cannot be evaluated from this record.
The primary outcome description defines its population as participants who received at least one dose of study drug. The record reports enrollment of 19, but does not report how many received treatment, contributed to each measurement, or completed the relevant cycles. It also does not describe missing-data handling, reasons for missing measurements, or whether analyses used all available observations or a restricted complete-case group.
In general, missing measurements can affect both the analysis population and the interpretation of repeated-measures results. The consequences depend on why data are missing and on the analysis method. Because those details are not reported in the registry record, the extent and direction of any missing-data effects cannot be assessed. The record also does not report a formal statistical analysis plan or a protocol-level sample-size justification.
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 |
|---|---|---|---|
| Pemetrexed | 5 | 19 | 26.3% |
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 |
|---|---|
| Pemetrexed | 19 of 19 |
Most frequent serious adverse event terms
| Event term | Organ system | Pemetrexed |
|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | 1 of 19 |
| Cardiac arrest | Cardiac disorders | 1 of 19 |
| Disease progression | General disorders | 1 of 19 |
| Renal colic | Renal and urinary disorders | 1 of 19 |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 1 of 19 |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 1 of 19 |
| Haemorrhage | Vascular disorders | 1 of 19 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Pemetrexed |
|---|---|---|
| Pyrexia | General disorders | 14 of 19 |
| Asthenia | General disorders | 9 of 19 |
| Mucosal inflammation | General disorders | 8 of 19 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 7 of 19 |
| Conjunctivitis | Eye disorders | 6 of 19 |
| Constipation | Gastrointestinal disorders | 6 of 19 |
| Anaemia | Blood and lymphatic system disorders | 5 of 19 |
| Diarrhoea | Gastrointestinal disorders | 5 of 19 |
| Cough | Respiratory, thoracic and mediastinal disorders | 5 of 19 |
| Fatigue | General disorders | 4 of 19 |
Serious events with the highest arm-level rate: thrombocytopenia (5.3%), cardiac arrest (5.3%), disease progression (5.3%), renal colic (5.3%), pulmonary embolism (5.3%).
The adverse-event record lists 19 participants at risk for serious events and 5 affected. It also lists 19 at risk for other events and 19 affected. These are registry counts for the pemetrexed group. They describe events recorded in the study; by themselves, they do not establish that treatment caused an event.
The serious-event terms listed are thrombocytopenia, cardiac arrest, disease progression, renal colic, pulmonary embolism, and respiratory failure. Each term is accompanied by 5.3% in the registry record. These percentages should be read as the record's reported figures, not as evidence about comparative risk: this study has no randomized control group. The record does not give further detail about event timing, severity grading, relatedness assessments, or whether a participant could appear under more than one term.
The deaths field is not reported in the registry record. The adverse-event figures do not replace the missing primary outcome results, and they do not provide a controlled comparison of safety between schedules. They should be interpreted as descriptive counts within the recorded study group.
12. What the Result Does, and Does Not, Mean
The study addresses a biomarker-timing question within a pilot investigation of pemetrexed monochemotherapy in non-small cell lung cancer. It records dCK expression as the primary outcome, measured in normal lymphocytes across treatment cycles and post-dose times. The stated rationale is to assess the timing and reproducibility of maximum expression and inform consideration of the interval between pemetrexed and gemcitabine.
However, primary outcome values are not reported in the registry record. There is therefore no reported mean, standard deviation, or uncertainty estimate with which to judge the pattern, its variability, or its precision. The record also does not report the results for the secondary outcome of best objective tumor response. The available information cannot establish whether a biomarker pattern was observed or what its size might have been.
The design is non-randomized and single-group, with no masking. The intervention labels distinguish pemetrexed before and after a protocol amendment, but the amendment and schedules are not described. Those labels do not establish a randomized comparison, and the registry itself cautions that the arms are not a like-for-like control comparison. Any apparent difference between periods would need cautious interpretation.
Even a clearly measured change in dCK expression would be a finding about a laboratory marker in normal lymphocytes. In general, biomarker measurements do not automatically demonstrate a change in tumor response or clinical outcomes. The registry record does not provide evidence that connects a particular dCK pattern to those outcomes.
The study can be understood as a pilot designed to inform a planned randomized phase II trial, not as that later trial. Its recorded design and missing outcome results mean that conclusions about schedule comparisons, precision, and clinical effects cannot be drawn from the registry record. The reported enrollment and adverse-event counts describe the study record, but do not answer the primary biomarker question.
13. Why This Trial Matters Statistically
This study is statistically notable because its stated goal is about timing, while its primary outcome is a continuous biomarker measured repeatedly within participants. Such data require attention to both the pattern across collection times and the relationship among observations from the same person. A single overall mean would not, on its own, answer whether expression peaks at a reproducible time across cycles.
The pilot context also matters. The official title describes the study as intended to define a schedule for a planned randomized phase II trial. Pilot data can help shape later questions and procedures, but their interpretation depends on the estimates and their uncertainty. Here, primary outcome values and analysis details are not reported in the registry record, so the biomarker pattern cannot be assessed from the record.
The design illustrates a common distinction between a study's motivation and its actual comparison. The record describes two pemetrexed intervention labels separated by a protocol amendment, but identifies the study as non-randomized and single-group and supplies no arm descriptions. A future randomized trial is mentioned, but that does not make this study randomized or establish a controlled comparison between schedules.
Finally, the record lists 12 analyses and 3 outcome measures without describing how comparisons were selected or how multiplicity was handled. A transparent plan would help readers understand which results were confirmatory and how repeated measurements were analyzed. These missing details are especially important for a study with multiple time points, cycles, and biomarker outcomes. The record's limits demonstrate why design details, analysis plans, and complete outcome reporting are essential alongside enrollment and endpoint definitions.
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 record does not include the primary outcome values, so the central biomarker question cannot be evaluated from the recorded results. It also does not report numerical results for best objective tumor response, the listed secondary outcome. Without estimates and measures of uncertainty, neither the size nor precision of an observed pattern can be assessed.
The study is non-randomized, single-group, and unmasked. The record lists pemetrexed before and after a protocol amendment, but does not explain the schedule in either period or the amendment itself. It therefore does not support treating those labels as a randomized comparison. The record explicitly cautions that the arms are not a like-for-like control comparison.
Enrollment is reported as 19, but the number treated and the number with evaluable measurements at each cycle and time point are not reported in the registry record. The primary outcome population is described as participants who received at least one dose. Missing-data reasons and methods are not reported, preventing assessment of completeness and possible selection effects.
The record reports 3 outcome measures and 12 analyses but does not describe a statistical analysis plan, multiplicity handling, or the model used for repeated measurements. It also does not report a protocol-level sample-size justification. The actual dosing schedule, laboratory-processing details, and outcome-specific analysis counts are not reported in the registry record. These limitations restrict interpretation of the biomarker question and any comparison between periods.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Dosage Schedule Study of Pemetrexed Monochemotherapy for Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) — NCT00370292.
- Registry record last updated 2009-10-20; status last verified 2009-10.
- Results first posted 2009-10-12.
- 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
NCT00370292 is a completed phase 2, non-randomized, single-group study of pemetrexed monochemotherapy for locally advanced or metastatic non-small cell lung cancer. Enrollment was 19, and the record lists no masking. The brief summary describes treatment for a maximum of 8 cycles and a biomarker-timing rationale concerning pemetrexed and gemcitabine.
The primary outcome was mean dCK expression in normal lymphocytes at cycles 1, 2, and 3, with measurements scheduled before dosing and at 1, 2, 4, 6, 24, and 48 hours after dosing. The record lists 3 outcome measures and 12 analyses, and identifies best objective tumor response as a secondary outcome. Primary outcome results and the statistical analysis plan are not reported in the registry record.
The intervention labels distinguish periods before and after a protocol amendment, but the schedules are not described. The registry cautions that the periods are not a like-for-like control comparison. Serious adverse-event counts are recorded, but the death count is not reported in the registry record.