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 Feasibility Study of Pemetrexed in Combination With Cisplatin or Carboplatin as Adjuvant Treatment of Non-Small Cell Lung Cancer (NCT00269152), a randomized phase 2 study. The primary outcome is The Feasibility of Post-Surgery Chemotherapy.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00269152 |
| Phase | Phase 2 |
| Condition | Non-Small Cell Lung Cancer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 122 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Eli Lilly and Company |
| Results posted | Yes |
2. Clinical Question
Population
Participants with completely resected stage Ib or IIa/IIb non-small cell lung cancer. The primary-outcome population was defined as participants enrolled, randomized, and treated with at least one dose of study drug, classified by the treatment received.
Intervention
Pemetrexed combined with cisplatin, intended as adjuvant chemotherapy after surgery. The study examined feasibility of completing the planned treatment cycles without ongoing severe toxicity.
Comparator
Pemetrexed combined with carboplatin. The registry describes a randomized, parallel comparison of the two combinations, but does not report treatment dosing details in the record.
Primary question
Could participants complete 4 treatment cycles without remaining toxicities at Grade 3 or higher, assessed 30 days after the last infusion? This is a feasibility question, not a direct estimate of comparative cancer control.
The study focused on whether either chemotherapy combination could be delivered after complete resection within the specified cycle schedule and toxicity criterion. Its registry description identifies a feasibility measure based on treatment completion, rather than a primary endpoint framed as a survival comparison. The record describes a two-stage design conducted independently for each treatment arm, with the possibility of stopping an arm early for lack of feasibility. It does not report whether either arm was stopped early.
The clinical comparison is between pemetrexed plus cisplatin and pemetrexed plus carboplatin. Because both groups received pemetrexed, the study was not a comparison of pemetrexed against no pemetrexed. Nor does the stated primary endpoint itself establish which combination better controls cancer: it measures treatment completion under a specified toxicity condition. The registry lists survival and disease-free survival outcomes separately among the secondary outcomes.
The record does not report a single primary-outcome result that permits a direct summary of completion between the arms. It notes that the primary outcome has several categories or time points and is not reduced to one comparison. The clinical question can therefore be described from the design and endpoint definition, but a comparative answer based on the posted primary results is not reported in the registry record.
3. Trial Design
This was a randomized, open-label, parallel Phase 2 feasibility study of pemetrexed combined with cisplatin or carboplatin as adjuvant chemotherapy for non-small cell lung cancer. The brief description identifies it as multicenter. Participants had completely resected stage Ib or IIa/IIb disease. The registry enrollment is 122. Study status is completed; the recorded start is 2005-12 and primary completion is 2007-11.
The two treatment arms were pemetrexed plus cisplatin and pemetrexed plus carboplatin. Random allocation means assignment was intended to use chance rather than clinician or participant choice. The record does not report the sequence-generation method, allocation concealment, or the allocation ratio. The study was unmasked, so participants and study personnel were not described as blinded to the assigned treatment. The parallel model means participants were assigned to a treatment arm rather than crossing between the two combinations.
The registry describes an independent two-stage design for each arm, allowing early stopping for lack of feasibility. This design feature concerns whether treatment delivery meets the study’s feasibility criteria; it is not evidence that an arm actually stopped. Whether stopping occurred is not reported in the registry record. Detailed stage-specific boundaries and their operating characteristics are also not reported.
The primary-outcome population was the safety population: participants enrolled, randomized, and treated with at least one dose of study drug, summarized according to treatment received. This is narrower than simply describing everyone enrolled, because the definition requires treatment exposure. The registry enrollment number should not be treated as the analyzed denominator for every endpoint. The arm-specific denominators reported for adverse events differ, and the primary-outcome result is not reduced to a single comparison in the registry record.
Specific drug doses, administration procedures, eligibility details beyond the stated disease and resection criteria, and the statistical analysis plan are not reported in the registry record. The design supports a feasibility assessment of the two combinations in this study population; it does not, by itself, establish comparative effectiveness or applicability to populations not described in the record.
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 | Pemetrexed + Cisplatin | Pemetrexed + Carboplatin |
|---|---|---|
| STARTED | 63 | 59 |
| COMPLETED | 45 | 49 |
| NOT COMPLETED | 18 | 10 |
Reasons for not completing this period:
| Reason | Pemetrexed + Cisplatin | Pemetrexed + Carboplatin |
|---|---|---|
| Adverse Event | 9 | 3 |
| Withdrawal by Subject | 7 | 3 |
| Physician Decision | 2 | 3 |
| Protocol Violation | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: Number of participants in safety population, that is, number of participants enrolled, randomized and treated with at least one dose of study drug (presented by treatment received arm).
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 + Cisplatin | Pemetrexed + Carboplatin | Total |
|---|---|---|---|---|
| Participants analysed | 63 | 59 | 122 | |
| Age, Continuous | years | 60.6 (SD 7.7) | 58.9 (SD 7.2) | 59.7 (SD 7.5) |
| Sex: Female, Male: Female | Participants | 14 | 18 | 32 |
| Sex: Female, Male: Male | Participants | 49 | 41 | 90 |
| Race/Ethnicity, Customized: Caucasian | participants | 62 | 58 | 120 |
| Race/Ethnicity, Customized: African | participants | 1 | 1 | 2 |
| Region of Enrollment: France | participants | 12 | 8 | 20 |
| Region of Enrollment: Spain | participants | 7 | 8 | 15 |
| Region of Enrollment: Germany | participants | 44 | 43 | 87 |
| Curative Surgery Used: Pneumonectomy | participants | 9 | 9 | 18 |
| Curative Surgery Used: Lobectomy | participants | 46 | 46 | 92 |
| Curative Surgery Used: Bi-lobectomy | participants | 8 | 4 | 12 |
| Smoking History: Yes | participants | 56 | 56 | 112 |
| Smoking History: No | participants | 7 | 3 | 10 |
| Stage of Disease Prior to Tumor Resection: Stage Ia | participants | 0 | 1 | 1 |
| Stage of Disease Prior to Tumor Resection: Stage Ib | participants | 27 | 26 | 53 |
| Stage of Disease Prior to Tumor Resection: Stage IIa | participants | 6 | 5 | 11 |
| Stage of Disease Prior to Tumor Resection: Stage IIb | participants | 30 | 25 | 55 |
| Stage of Disease Prior to Tumor Resection: Stage IIIa | participants | 0 | 1 | 1 |
| Stage of Disease Prior to Tumor Resection: Unknown: could have been either Stage IIIb or IV | participants | 0 | 1 | 1 |
| Tumor Type at Initial Pathological Diagnosis: Adenocarcinoma of the Lung | participants | 27 | 23 | 50 |
| Tumor Type at Initial Pathological Diagnosis: Squamous Carcinoma of the Lung | participants | 24 | 20 | 44 |
| Tumor Type at Initial Pathological Diagnosis: Non-Small Cell Lung Cancer | participants | 5 | 4 | 9 |
| Tumor Type at Initial Pathological Diagnosis: Mixed Cell (Squamous/Adeno) Carcinoma of Lung | participants | 0 | 5 | 5 |
| Tumor Type at Initial Pathological Diagnosis: Large Cell Carcinoma of Lung | participants | 5 | 7 | 12 |
| Tumor Type at Initial Pathological Diagnosis: Bronchoalveolar Carcinoma | participants | 2 | 0 | 2 |
6. Primary Endpoint
The registry lists the primary outcome as The Feasibility of Post-Surgery Chemotherapy, measured over every 21-day cycle for 4 cycles up to 30 days after last infusion.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the feasibility of post-surgery chemotherapy. It counts participants who completed 4 treatment cycles without remaining toxicities at Grade 3 or higher, assessed 30 days after the last infusion. The stated schedule refers to every 21-day cycle for 4 cycles, with assessment up to 30 days after the last infusion. The endpoint population is participants who were enrolled, randomized, and treated with at least one dose of study drug, presented by treatment received.
This endpoint is useful in a feasibility study because it combines treatment delivery with a toxicity condition. Completion alone would not reflect whether treatment remained tolerable under the study’s definition; toxicity alone would not show whether the planned cycles were completed. The endpoint therefore asks whether participants could get through the specified course without the defined ongoing toxicity at the assessment time.
It is not a measure of tumor response, recurrence, or survival. Those outcomes are distinct and are listed separately as secondary outcomes in the registry. Nor does the endpoint capture every possible dimension of treatment burden: the record does not describe a broader quality-of-life measure within this primary definition.
The registry record does not report a single primary-outcome comparison. It indicates that the primary outcome has several categories or time points and is not reduced to one comparison. The endpoint definition can therefore be interpreted, but the record does not support a single numerical summary of how the arms compared on it.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted record describes the design and endpoint criteria, but it does not report a single primary-outcome comparison for feasibility. The primary endpoint concerns completion of treatment cycles without remaining toxicity at Grade 3 or higher at the specified assessment. Since the record identifies several categories or time points and does not reduce them to one comparison, no overall arm-to-arm estimate for that endpoint can be stated from the posted results.
The adverse-event figures offer descriptive safety information. Serious adverse events were reported for 18 of 64 participants in the pemetrexed-plus-cisplatin arm and 5 of 54 in the pemetrexed-plus-carboplatin arm. The record also lists other adverse events for 61 of 64 and 52 of 54 participants, respectively. These are counts within each arm’s reported risk group, not an adjusted comparison. The registry does not report a statistical test or confidence interval for these counts, and the figures alone do not establish that the treatments caused the events.
The listed serious-event terms include dyspnoea, nausea, vomiting, pulmonary embolism, febrile neutropenia, and neutropenia, with percentages recorded for each. Those percentages are descriptive entries. The registry record does not report the denominator used for each term percentage, so they should not be treated as directly comparable event rates without that context. Participants may also have experienced more than one event; the term listings should not be added together to infer a number of affected participants.
Overall survival at 3 years, disease-free survival at 3 years, and overall survival at 6 years are listed as secondary outcomes, along with Grade III/IV adverse events. The registry record does not report numerical survival or disease-free survival results in the registry record for this account. Their inclusion as outcomes is not evidence of a particular result.
The study’s randomized design makes the two combinations the intended comparison, but a clear interpretation depends on outcome estimates, uncertainty, and analysis details. Those are not reported for the primary feasibility comparison in the registry record. The findings that can be stated are consequently limited to the endpoint definition and the descriptive adverse-event counts and terms, not a claim that either regimen is better, safer, or more effective.
9. Statistical Methods Explained
For a feasibility endpoint, the basic statistical question is how often participants meet the study’s completion criterion. Here, that criterion joins completion of the planned cycles with the absence of remaining Grade 3 or higher toxicities at the specified follow-up assessment. The registry defines the population as participants who were enrolled, randomized, and treated with at least one dose, and says results are presented by treatment received. The record does not report a single summary comparison across the primary endpoint’s categories or time points.
What does randomization contribute?
Random assignment is intended to make treatment groups comparable, on average, with respect to both measured and unmeasured baseline characteristics. This helps a randomized comparison estimate the effect of assignment to the study treatments, provided the analysis follows an appropriate plan and outcome data are handled appropriately. Randomization does not guarantee that observed groups are identical, especially in a feasibility study, and it does not remove uncertainty from a limited amount of information. The registry does not report the randomization procedure or concealment details, so those features cannot be evaluated from this record.
The primary endpoint is described by treatment received rather than solely by original assignment. Such a population definition can differ from an intention-to-treat analysis, which generally analyzes participants according to randomized assignment regardless of treatment received. Neither approach is automatically suitable for every question; the choice depends on the estimand and prespecified analysis plan. The registry record does not report an intention-to-treat analysis or explain how participants who did not receive assigned treatment were handled.
How should counts and percentages be read?
A count describes the number of participants meeting a stated event definition. A percentage expresses that count relative to a denominator, but interpretation depends on exactly who is included in that denominator and how missing observations are treated. The serious adverse-event entries give both affected-participant counts and at-risk denominators by arm. The listed serious-event-term percentages do not have their denominators stated in the record, so their precision and comparability cannot be assessed from the percentages alone.
A confidence interval, in general, describes the range of values compatible with an estimate under the statistical model and sampling assumptions. It communicates precision as well as the direction and size of an estimate. A narrow interval indicates greater precision than a wide interval, while either interval can still be affected by bias, missing data, or model misspecification. No confidence interval for the primary feasibility comparison is reported in the registry record, so the precision of an arm difference cannot be evaluated.
A hypothesis test, in general, measures how incompatible observed data are with a specified null model. A p-value does not state the probability that a treatment works, and it does not quantify the size or clinical importance of a difference. The registry record does not report a primary comparison test or p-value in the material available for this account. The absence of a reported test should not be interpreted as evidence that groups were equivalent.
Why does the two-stage design matter?
The registry describes a two-stage feasibility design carried out independently for each arm, with the possibility of early stopping for lack of feasibility. In general, staged designs can allow a study to reassess whether continuing recruitment or treatment in an arm is justified by the observed feasibility data. The stopping rules and decision boundaries must be specified in advance to interpret the resulting estimates and any selection caused by stopping. Those details, and whether an arm actually stopped, are not reported in the registry record.
Early stopping can also affect how much information is available for later outcomes. A feasibility decision is not the same as a conclusion about survival or disease control. The registry’s two-stage description is therefore relevant to how the trial was intended to proceed, but it does not establish that a stopping boundary was reached or that the treatments differed.
What does a planning illustration mean?
The registry’s stated planning assumptions describe an illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. The effect to detect is described as a fraction of the observed effect. Such an illustration is a planning exercise, not the trial’s original design justification and not observed power. A sample-size calculation based on an observed effect depends on that effect estimate and its uncertainty; it should not be read as an independent confirmation of the result. The registry does not report the trial’s sample-size justification in the record.
More generally, power is a design concept: it is the probability that a specified statistical procedure rejects a null hypothesis under a particular assumed effect and model. After data collection, a post hoc calculation labeled observed power does not substitute for an estimate with a confidence interval. The registry’s stated planning assumptions should therefore be kept separate from the observed endpoint results, which are not reduced to a single primary comparison.
Finally, statistical significance and feasibility are different concepts. A feasibility study can be informative about whether a treatment course was completed under defined conditions, even when it is not designed or reported as a definitive test of survival benefit. Conversely, a feasibility result does not establish that the course improves cancer outcomes. The registry record does not report a complete statistical plan linking all endpoints, populations, missing-data rules, and multiplicity procedures.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists the primary feasibility outcome and secondary outcomes that include Grade III/IV adverse events, overall survival at 3 years, disease-free survival at 3 years, and overall survival at 6 years. Considering several outcomes or assessment times raises multiplicity: the more questions analyzed, the greater the chance that at least one result appears notable by chance if each is tested separately. In general, a prespecified hierarchy or adjustment can help control this issue. The registry record does not report a multiplicity strategy, endpoint hierarchy, or statistical analysis plan, so it is not possible to determine how multiple comparisons were intended to be interpreted.
Missing-data handling is also important. Participants may lack an endpoint assessment because of withdrawal, treatment discontinuation, an unavailable visit, or another reason. These situations can affect feasibility and safety summaries differently. The registry record does not report the amount or pattern of missing primary-outcome data, the reasons for missingness, or the method used to handle missing observations. No assumption about missing participants should be inferred from the reported arm denominators.
The primary population is defined as participants enrolled, randomized, and treated with at least one dose, summarized by treatment received. This is a safety-population definition. The registry record does not report whether an intention-to-treat population was also analyzed, how participants were assigned for analyses if treatment received differed from assignment, or which population was used for the secondary outcomes.
These reporting gaps limit assessment of robustness. A reader cannot determine from this record whether estimates would change under alternative missing-data assumptions, whether outcomes were prespecified in a statistical hierarchy, or whether the same population was used across endpoints. Such information is not reported in the registry record.
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 + Cisplatin | 18 | 64 | 28.1% |
| Pemetrexed + Carboplatin | 5 | 54 | 9.3% |
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 + Cisplatin | 61 of 64 |
| Pemetrexed + Carboplatin | 52 of 54 |
Most frequent serious adverse event terms
| Event term | Organ system | Pemetrexed + Cisplatin | Pemetrexed + Carboplatin |
|---|---|---|---|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 5 of 64 | 0 of 54 |
| Nausea | Gastrointestinal disorders | 4 of 64 | 0 of 54 |
| Vomiting | Gastrointestinal disorders | 3 of 64 | 0 of 54 |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 3 of 64 | 0 of 54 |
| Febrile neutropenia | Blood and lymphatic system disorders | 0 of 64 | 2 of 54 |
| Neutropenia | Blood and lymphatic system disorders | 2 of 64 | 0 of 54 |
| Chest pain | General disorders | 2 of 64 | 0 of 54 |
| Bronchitis | Infections and infestations | 1 of 64 | 1 of 54 |
| Leukopenia | Blood and lymphatic system disorders | 1 of 64 | 0 of 54 |
| Acute myocardial infarction | Cardiac disorders | 1 of 64 | 0 of 54 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Pemetrexed + Cisplatin | Pemetrexed + Carboplatin |
|---|---|---|---|
| Nausea | Gastrointestinal disorders | 40 of 64 | 30 of 54 |
| Fatigue | General disorders | 23 of 64 | 21 of 54 |
| Vomiting | Gastrointestinal disorders | 21 of 64 | 17 of 54 |
| Neutropenia | Blood and lymphatic system disorders | 21 of 64 | 15 of 54 |
| Constipation | Gastrointestinal disorders | 17 of 64 | 8 of 54 |
| Anorexia | Metabolism and nutrition disorders | 10 of 64 | 14 of 54 |
| Asthenia | General disorders | 10 of 64 | 13 of 54 |
| Cough | Respiratory, thoracic and mediastinal disorders | 6 of 64 | 16 of 54 |
| Anaemia | Blood and lymphatic system disorders | 12 of 64 | 8 of 54 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 7 of 64 | 9 of 54 |
Serious events with the highest arm-level rate: dyspnoea (7.8%), nausea (6.2%), vomiting (4.7%), pulmonary embolism (4.7%), febrile neutropenia (3.7%).
The serious adverse-event figures are participant counts within each arm’s stated risk group. The pemetrexed-plus-cisplatin group had 18 of 64 participants with serious adverse events; the pemetrexed-plus-carboplatin group had 5 of 54. The record also lists other adverse events for 61 of 64 and 52 of 54 participants, respectively. These categories should be read as separate descriptive entries; the record does not explain their full operational definitions in the registry record.
The serious-event terms listed include dyspnoea (7.8%), nausea (6.2%), vomiting (4.7%), pulmonary embolism (4.7%), febrile neutropenia (3.7%), and neutropenia (3.1%). The registry record does not report the denominator for each term percentage. Nor does the listing show whether one participant could contribute to more than one term, so the percentages should not be added or interpreted as a total.
These figures do not by themselves establish a comparative safety effect. They are not adjusted for differences in participant characteristics or exposure, and no confidence intervals or tests are reported for the arm-level counts. Adverse-event summaries also do not establish causation: an event occurring during a study is not necessarily caused by study treatment. The record does not provide enough detail to assess event timing, severity beyond the stated categories, or attribution to treatment.
12. What the Result Does, and Does Not, Mean
The registry record supports a description of the study question, its feasibility endpoint, and the reported adverse-event counts. It does not report a single primary-outcome comparison that can establish how the two treatment combinations compared on completing cycles without remaining Grade 3 or higher toxicity. The endpoint definition therefore describes what the investigators intended to assess, not a numerical conclusion about feasibility in either arm.
The safety entries show that serious adverse events were recorded in both groups, and the record lists several serious-event terms with percentages. These descriptive data can help identify what types of events were recorded in the study, but they do not show that one combination has a lower risk than the other. The listed percentages lack stated term-specific denominators in the registry record, while the arm-level counts do have reported risk-group denominators. No adjustment, uncertainty interval, or comparative test is reported for these entries.
The registry also lists survival and disease-free survival outcomes. Their presence does not provide evidence of benefit or harm; numerical results for those outcomes are not reported in the record available for this account. Likewise, a completed study status does not imply that every planned outcome was reported or that the available findings resolve the clinical question.
The scope of interpretation is limited to participants described as having completely resected stage Ib or IIa/IIb non-small cell lung cancer and to the two pemetrexed-containing combinations. The record does not support conclusions about other populations, regimens, or treatment settings. It also does not establish a mechanism, explain why an event occurred, or show that the treatments should be selected in practice.
In short, the registry describes a randomized feasibility study and reports adverse-event summaries, but the posted primary outcome is not presented as one comparative result. The available record can inform how the trial was structured and what was counted; it cannot support a definitive claim of comparative feasibility, safety, or cancer-control benefit.
13. Why This Trial Matters Statistically
This trial is statistically useful as an example of a feasibility question being separated from a definitive treatment-effect question. The primary measure combines treatment completion with a specified toxicity condition. That makes the target of inference different from survival or disease-free survival, which the registry lists as secondary outcomes. A study can be designed to assess whether treatment delivery is workable without establishing whether it improves longer-term outcomes.
The randomized, parallel structure gives a basis for comparing the two pemetrexed combinations. At the same time, the registry describes independent two-stage decision-making for the arms, including possible early stopping for lack of feasibility. This highlights that early stopping rules are part of the design and need to be reported to understand how the study proceeded and how estimates should be interpreted. Whether an arm stopped is not reported in the registry record.
The record also illustrates why population definitions matter. The primary-outcome population includes participants who received at least one dose and is summarized by treatment received. That definition can differ from an analysis based on randomized assignment. Readers need to know which population answers the intended question, how participants with incomplete assessments are handled, and whether the same rules apply across endpoints. Those details are not reported in the registry record.
Finally, descriptive adverse-event counts are not substitutes for comparative estimates with uncertainty. Counts can identify the scale and nature of reported events, but interpretation requires clear denominators, definitions, and analysis methods. The record lists several serious-event terms but does not report term-specific denominators or a formal comparative analysis. This makes the study a useful reminder that transparent reporting is essential for moving from trial design and event listings to a defensible statistical conclusion.
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 primary feasibility outcome is not reduced to a single comparison in the registry record. As a result, the posted information does not support a straightforward numerical contrast between arms for the primary question. The endpoint includes both treatment completion and a toxicity condition assessed after the last infusion, but the record does not provide an overall result for that criterion.
Important design and analysis details are not reported in the registry record, including the randomization procedure, allocation concealment, drug doses, detailed eligibility criteria, primary-outcome analysis method, and statistical analysis plan. The description of a two-stage design does not include its decision boundaries or indicate whether early stopping occurred. These omissions prevent evaluation of several features that affect interpretation.
The primary analysis population is based on treatment received and requires at least one dose. The record does not state whether an intention-to-treat analysis was conducted or how participants who did not receive treatment or lacked endpoint assessments were handled. Missing-data amounts, reasons, and methods are not reported. The listed serious-event-term percentages also lack stated denominators, limiting interpretation of their scale and comparability.
The registry lists survival and disease-free survival outcomes, but their numerical results are not reported in the record available for this account. No confidence intervals or formal tests for the adverse-event comparisons are reported. Consequently, the descriptive safety counts should not be treated as precise comparative estimates, and no conclusion about survival, disease control, or treatment superiority can be drawn from the available information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Feasibility Study of Pemetrexed in Combination With Cisplatin or Carboplatin as Adjuvant Treatment of Non-Small Cell Lung Cancer — NCT00269152.
- Registry record last updated 2015-08-18; status last verified 2015-07.
- Results first posted 2009-06-11.
- 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
NCT00269152 is a completed, randomized, open-label, parallel Phase 2 feasibility study of pemetrexed with cisplatin or carboplatin as adjuvant chemotherapy for completely resected stage Ib or IIa/IIb non-small cell lung cancer. The registry enrollment is 122. The primary endpoint concerns completion of 4 treatment cycles without remaining toxicities at Grade 3 or higher, assessed 30 days after the last infusion. The record describes an independent two-stage design for each arm, with possible early stopping for lack of feasibility.
The primary outcome is not reported as a single comparison. Serious adverse events were reported for 18 of 64 participants in the pemetrexed-plus-cisplatin group and 5 of 54 in the pemetrexed-plus-carboplatin group. The registry lists survival and disease-free survival as secondary outcomes, but their numerical results are not reported in the record available for this account. Analysis methods, missing-data handling, and multiplicity procedures are not reported in the registry record.