Trial · NCT00363415
Study of Pemetrexed and Carboplatin Compared With Etoposide Carboplatin to Treat Extensive-Stage Small Cell Lung Cancer
NCT00363415, Phase 3, Completed, Eli Lilly and Company; results first posted 2009-10-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Pemetrexed and Carboplatin Compared With Etoposide Carboplatin to Treat Extensive-Stage Small Cell Lung Cancer. Trials, record NCT00363415. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00363415
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Pemetrexed and Carboplatin Compared With Etoposide Carboplatin to Treat Extensive-Stage Small Cell Lung Cancer
- NCT number
- NCT00363415
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 908 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Small Cell Lung Cancer
- Interventions
- pemetrexed, etoposide, carboplatin
- First posted
- 2006-08-15
- Last updated
- 2009-10-28
- Results first posted
- 2009-10-06
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | baseline to date of death from any cause (up to 19.6 months) | Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact. |
| Secondary | Overall Survival (Subgroups) | baseline to date of death from any cause (up to 19.6 months) | The effects of individual baseline factors (sex, race, Eastern Cooperative Oncology Group (ECOG) performance, region, lactate dehydrogenase (LDH), age, number of metastatic sites, and history of brain metastases) on overall survival are reported. For two subgroups - LDH\<=upper limit of normal and brain metastases=yes, the upper limits of the 95% confidence interval were not calculable for the etoposide+carboplatin group - instead the number of participants in these two subgroups are presented as a post-hoc outcome measure. |
| Secondary | Progression Free Survival | baseline to measured progressive disease (up to 14.7 months) | The period from study entry until disease progression, death or date of last contact. |
| Secondary | Change From Baseline to Each Cycle in Functional Assessment of Cancer Therapy - Lung (FACT-L) | baseline and 6 cycles (21-day cycles) | FACT-L measures following domains of health-related quality of life (HR-QL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of lung cancer. Total scores range from 0 to 136, with higher scores representing better HR-QL. A clinically meaningful change is considered to be 5 points. |
| Secondary | Overall Survival (Subgroups: LDH<=Upper Limit of Normal and History of Brain Metastases=Yes) | baseline to date of death due to any cause (up to 19.6 months) | The effects of individual baseline factors (lactate dehydrogenase (LDH) and history of brain metastases) on overall survival are reported. The Upper Limits of the 95% Confidence Intervals were not calculable for these factors in the Etoposide+Carboplatin group. The number of participants in these subgroup are instead presented as a Post-Hoc Outcome Measure. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | baseline to date of death from any cause (up to 19.6 months) | Number of participants with events. In the pemetrexed+carboplatin group, 242 participants were censored. In the etoposide+carboplatin group, 288 participants were censored. | months | MEDIAN |
| SECONDARY | Overall Survival (Subgroups) | baseline to date of death from any cause (up to 19.6 months) | Number of randomized participants. | months | MEDIAN |
| SECONDARY | Progression Free Survival | baseline to measured progressive disease (up to 14.7 months) | All randomized participants. Number of participants censored: 113 in Pemetrexed+Carboplatin; 150 in Etoposide+Carboplatin. | months | MEDIAN |
| SECONDARY | Change From Baseline to Each Cycle in Functional Assessment of Cancer Therapy - Lung (FACT-L) | baseline and 6 cycles (21-day cycles) | Number of randomized participants with baseline and non-missing value at respective cycle. | units on a scale | MEAN |
| SECONDARY | Overall Survival (Subgroups: LDH<=Upper Limit of Normal and History of Brain Metastases=Yes) | baseline to date of death due to any cause (up to 19.6 months) | The upper limit of the 95% Confidence Intervals (CI) were not calculable for these two subgroups in the etoposide+carboplatin group so medians and lower limits of the 95% CI are not presented. A post-hoc outcome measure table provides the number of participants in each subgroup. | months | MEDIAN |
| POST_HOC | Number of Participants in Subgroups: LDH<=Upper Limit of Normal and History of Brain Metastases=Yes | baseline to date of death due to any cause (up to 19.6 months) | Number of randomized participants. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Pemetrexed + Carboplatin | 8.1 | 95% Confidence Interval 7.3 to 9.1 | months | |
| Overall Survival | Etoposide + Carboplatin | 10.6 | 95% Confidence Interval 9.7 to 11.6 | months | |
| Overall Survival (Subgroups) | Pemetrexed + Carboplatin | Sex: Male (n=325, n=330) | 8.2 | 95% Confidence Interval 7.2 to 9.1 | months |
| Overall Survival (Subgroups) | Etoposide + Carboplatin | Sex: Male (n=325, n=330) | 10.4 | 95% Confidence Interval 9.3 to 11.5 | months |
| Overall Survival (Subgroups) | Pemetrexed + Carboplatin | Sex: Female (n=128, n=125) | 8.1 | 95% Confidence Interval 7.2 to 9.7 | months |
| Overall Survival (Subgroups) | Etoposide + Carboplatin | Sex: Female (n=128, n=125) | 11.6 | 95% Confidence Interval 10.3 to 13.0 | months |
| Overall Survival (Subgroups) | Pemetrexed + Carboplatin | Race: Caucasian (n=391, n=379) | 8.2 | 95% Confidence Interval 7.6 to 9.4 | months |
| Overall Survival (Subgroups) | Etoposide + Carboplatin | Race: Caucasian (n=391, n=379) | 11.2 | 95% Confidence Interval 9.9 to 12.0 | months |
| Overall Survival (Subgroups) | Pemetrexed + Carboplatin | Race: Non-Caucasian (n=62, n=76) | 7.1 | 95% Confidence Interval 5.7 to 9.1 | months |
| Overall Survival (Subgroups) | Etoposide + Carboplatin | Race: Non-Caucasian (n=62, n=76) | 8.7 | 95% Confidence Interval 7.2 to 14.9 | months |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pemetrexed + Carboplatin | 453 | |
| Overall Study | STARTED | Etoposide + Carboplatin | 455 | |
| Overall Study | Received at Least One Dose of Study Drug | Pemetrexed + Carboplatin | 433 | |
| Overall Study | Received at Least One Dose of Study Drug | Etoposide + Carboplatin | 447 | |
| Overall Study | COMPLETED | Pemetrexed + Carboplatin | 92 | |
| Overall Study | COMPLETED | Etoposide + Carboplatin | 206 | |
| Overall Study | NOT COMPLETED | Pemetrexed + Carboplatin | 361 | |
| Overall Study | NOT COMPLETED | Etoposide + Carboplatin | 249 |
Source ClinicalTrials.gov
Adverse events468
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Pemetrexed + Carboplatin | 135 | 433 | 175 |
| other | Anaemia | Blood and lymphatic system disorders | Etoposide + Carboplatin | 155 | 447 | 200 |
| other | Leukopenia | Blood and lymphatic system disorders | Pemetrexed + Carboplatin | 33 | 433 | 67 |
| other | Leukopenia | Blood and lymphatic system disorders | Etoposide + Carboplatin | 86 | 447 | 179 |
| other | Neutropenia | Blood and lymphatic system disorders | Pemetrexed + Carboplatin | 82 | 433 | 141 |
| other | Neutropenia | Blood and lymphatic system disorders | Etoposide + Carboplatin | 252 | 447 | 524 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pemetrexed + Carboplatin | 61 | 433 | 117 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Etoposide + Carboplatin | 94 | 447 | 151 |
| other | Coronary artery disease | Cardiac disorders | Pemetrexed + Carboplatin | 23 | 433 | 23 |
| other | Coronary artery disease | Cardiac disorders | Etoposide + Carboplatin | 24 | 447 | 24 |
1 to 10 of 468Source ClinicalTrials.gov
See all 468 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pemetrexed + Carboplatin | ||
| Total, all-cause mortality | Etoposide + Carboplatin | ||
| Total, other adverse events | Pemetrexed + Carboplatin | 425 | |
| Total, other adverse events | Etoposide + Carboplatin | 438 | |
| Total, serious adverse events | Pemetrexed + Carboplatin | 150 | |
| Total, serious adverse events | Etoposide + Carboplatin | 134 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00363415
GET https://conductscience.org/api/trials/v1/NCT00363415/results?page=2