A Phase 3 interventional study of pemetrexed and etoposide in Small Cell Lung Cancer, sponsored by Eli Lilly and Company. Completed at 189 sites in 26 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-10-28.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
This study is a Phase 3, global, multi-center, open-label study of patients with extensive-stage small cell lung cancer. Eligible patients will be randomly assigned to receive either pemetrexed plus carboplatin or etoposide plus carboplatin. It is anticipated that pemetrexed plus carboplatin will offer similar survival benefits as compared to etoposide plus carboplatin.
1,234 studies on the registry are indexed under Small Cell Lung Carcinoma; 350 are open to participants now.
This study's enrollment of 908 is above the median of 56 across 1,058 interventional studies indexed under Small Cell Lung Carcinoma.
Browse Small Cell Lung Carcinoma studies →Eli Lilly and Company is the lead sponsor of 2,095 studies on the registry; 142 are open to participants now.
Of its 535 completed or terminated interventional studies of FDA-regulated products, 356 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Drug: pemetrexed · Drug: carboplatin
Drug: etoposide · Drug: carboplatin
500 mg/m2, intravenous (IV), every 21 days x 6 cycles
Also known as: LY231514, Alimta
100 mg/m2, intravenous (IV), days 1-3 x 6 cycles
Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
Overall Survival
Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
Time frame: baseline to date of death from any cause (up to 19.6 months)
Overall Survival (Subgroups)
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.
Time frame: baseline to date of death from any cause (up to 19.6 months)
Progression Free Survival
The period from study entry until disease progression, death or date of last contact.
Time frame: baseline to measured progressive disease (up to 14.7 months)
Change From Baseline to Each Cycle in Functional Assessment of Cancer Therapy - Lung (FACT-L)
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.
Time frame: baseline and 6 cycles (21-day cycles)
Overall Survival (Subgroups: LDH<=Upper Limit of Normal and History of Brain Metastases=Yes)
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.
Time frame: baseline to date of death due to any cause (up to 19.6 months)
| Milestone | Pemetrexed + Carboplatin | Etoposide + Carboplatin |
|---|---|---|
| Started | 453 | 455 |
| Received at least one dose of study drug | 433 | 447 |
| Completed | 92 | 206 |
| Not completed | 361 | 249 |
| Withdrew: Progressive disease | 196 | 107 |
| Withdrew: Sponsor decision | 67 | 31 |
| Withdrew: Death | 32 | 29 |
| Withdrew: Adverse event | 24 | 15 |
| Withdrew: Physician decision | 18 | 35 |
| Withdrew: Entry criteria not met | 11 | 10 |
| Withdrew: Withdrawal by subject | 9 | 15 |
| Withdrew: Lost to follow-up | 3 | 3 |
| Withdrew: Protocol violation | 1 | 4 |
Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
| months | Pemetrexed + Carboplatin | Etoposide + Carboplatin |
|---|---|---|
| Overall Survival | 8.1 (7.3 to 9.1) | 10.6 (9.7 to 11.6) |
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.
| months | Pemetrexed + Carboplatin | Etoposide + Carboplatin |
|---|---|---|
| Sex: Male (n=325, n=330) | 8.2 (7.2 to 9.1) | 10.4 (9.3 to 11.5) |
| Sex: Female (n=128, n=125) | 8.1 (7.2 to 9.7) | 11.6 (10.3 to 13.0) |
| Race: Caucasian (n=391, n=379) | 8.2 (7.6 to 9.4) | 11.2 (9.9 to 12.0) |
| Race: Non-Caucasian (n=62, n=76) | 7.1 (5.7 to 9.1) | 8.7 (7.2 to 14.9) |
| ECOG: 0 or 1 (n=398, n=398) | 8.5 (7.8 to 9.4) | 11.3 (10.1 to 12.0) |
| ECOG: 2 (n=54, n=55) | 6.2 (3.7 to 7.3) | 5.2 (3.9 to 9.5) |
| Region: United States (n=92, n=83) | 8.1 (7.3 to 9.8) | 11.3 (9.3 to 12.9) |
| Region: European Union (n=279, n=278) | 8.5 (7.2 to 9.7) | 11.2 (9.5 to 12.9) |
| Region: Intercontinential Region (n=82, n=94) | 7.2 (6.1 to 8.6) | 9.9 (8.5 to 11.9) |
| LDH: >Upper Limit of Normal (n=276, n=273) | 7.2 (6.5 to 8.3) | 9.3 (8.0 to 10.4) |
| Age: <= 65 years (n=267, n=275) | 8.4 (7.5 to 9.7) | 11.5 (10.3 to 12.9) |
| Age: >65 years (n=186, n=180) | 7.7 (7.1 to 9.0) | 9.7 (8.7 to 11.3) |
| Number Metastatic Sites: <=2 (n=172, n=204) | 10.0 (8.6 to 13.5) | 11.5 (10.1 to 13.2) |
| Number Metastatic Sites: >=3 (n=273, n=246) | 7.7 (7.2 to 8.2) | 10.3 (9.3 to 11.3) |
| History of Brain Metastases: No (n=410, n=412) | 8.2 (7.3 to 9.1) | 10.6 (9.5 to 11.6) |
The period from study entry until disease progression, death or date of last contact.
| months | Pemetrexed + Carboplatin | Etoposide + Carboplatin |
|---|---|---|
| Progression Free Survival | 3.8 (3.5 to 4.2) | 5.4 (5.2 to 5.7) |
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.
| units on a scale | Pemetrexed + Carboplatin | Etoposide + Carboplatin |
|---|---|---|
| Baseline (n=384, n=383) | 87.42 ± 15.40 | 87.79 ± 16.63 |
| Cycle 1 Change from Baseline (n=270, n=275) | -0.22 ± 12.48 | 1.55 ± 11.11 |
| Cycle 2 Change from Baseline (n=283, n=310) | 0.17 ± 13.72 | 1.73 ± 12.73 |
| Cycle 3 Change from Baseline (n=225, n=277) | 0.06 ± 14.61 | 1.70 ± 13.98 |
| Cycle 4 Change from Baseline (n=199, n=259) | -0.14 ± 15.28 | 1.69 ± 13.42 |
| Cycle 5 Change from Baseline (n=140, n=203) | 0.27 ± 16.34 | 1.94 ± 14.06 |
| Cycle 6 Change from Baseline (n=98, n=146) | 0.34 ± 17.56 | 3.73 ± 14.97 |
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.
No measurements were reported for this outcome.
Number of participants with Low Density Lipoprotein \<=upper limit of normal and the number of participants with a history of brain metastases. This post-hoc outcome replaces the one for Overall Survival (Subgroups: LDH\<=Upper Limit of Normal and History of Brain Metastases=Yes).
| participants | Pemetrexed + Carboplatin | Etoposide + Carboplatin |
|---|---|---|
| LDH: <=Upper Limit of Normal | 167 | 169 |
| History of Brain Metastases: Yes | 43 | 41 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pemetrexed + Carboplatin | — | — | — |
| Etoposide + Carboplatin | — | — | — |
| Event | Pemetrexed + Carboplatin | Etoposide + Carboplatin |
|---|---|---|
| PneumoniaInfections and infestations | 20/433 | 15/447 |
| NeutropeniaBlood and lymphatic system disorders | 11/433 | 19/447 |
| AnaemiaBlood and lymphatic system disorders | 18/433 | 7/447 |
| ThrombocytopeniaBlood and lymphatic system disorders | 15/433 | 7/447 |
| NauseaGastrointestinal disorders | 15/433 | 2/447 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 15/433 | 15/447 |
| Febrile neutropeniaBlood and lymphatic system disorders | 7/433 | 14/447 |
| DiarrhoeaGastrointestinal disorders | 11/433 | 3/447 |
| VomitingGastrointestinal disorders | 11/433 | 4/447 |
| DehydrationMetabolism and nutrition disorders | 6/433 | 4/447 |
| Event | Pemetrexed + Carboplatin | Etoposide + Carboplatin |
|---|---|---|
| NeutropeniaBlood and lymphatic system disorders | 82/433 | 252/447 |
| CoughRespiratory, thoracic and mediastinal disorders | 210/433 | 221/447 |
| HypertensionVascular disorders | 180/433 | 172/447 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 178/433 | 182/447 |
| FatigueGeneral disorders | 153/433 | 182/447 |
| NauseaGastrointestinal disorders | 166/433 | 159/447 |
| AlopeciaSkin and subcutaneous tissue disorders | 27/433 | 156/447 |
| AnaemiaBlood and lymphatic system disorders | 135/433 | 155/447 |
| ConstipationGastrointestinal disorders | 135/433 | 124/447 |
| Chest painGeneral disorders | 98/433 | 114/447 |
| Age, Customized(participants) | Pemetrexed + Carboplatin | Etoposide + Carboplatin | Total |
|---|---|---|---|
| <=65 years | 267 | 275 | 542 |
| >65 years | 186 | 180 | 366 |
| Sex: Female, Male(Participants) | Pemetrexed + Carboplatin | Etoposide + Carboplatin | Total |
|---|---|---|---|
| Female | 128 | 125 | 253 |
| Male | 325 | 330 | 655 |
| Region of Enrollment(participants) | Pemetrexed + Carboplatin | Etoposide + Carboplatin | Total |
|---|---|---|---|
| United States | 92 | 83 | 175 |
| Portugal | 9 | 7 | 16 |
| Taiwan | 11 | 12 | 23 |
| Greece | 7 | 8 | 15 |
| Spain | 16 | 21 | 37 |
| Russian Federation | 30 | 16 | 46 |
| Italy | 7 | 8 | 15 |
| India | 12 | 14 | 26 |
| France | 19 | 10 | 29 |
| Australia | 21 | 19 | 40 |
| South Africa | 0 | 1 | 1 |
| Netherlands | 17 | 17 | 34 |
| China | 14 | 18 | 32 |
| Korea, Republic of | 17 | 15 | 32 |
| Turkey | 15 | 13 | 28 |
| Austria | 5 | 14 | 19 |
| United Kingdom | 16 | 18 | 34 |
| Hungary | 19 | 13 | 32 |
| Argentina | 2 | 6 | 8 |
| Belgium | 12 | 17 | 29 |
| Brazil | 4 | 7 | 11 |
| Poland | 29 | 34 | 63 |
| Romania | 20 | 23 | 43 |
| Germany | 58 | 59 | 117 |
| New Zealand | 1 | 2 | 3 |
| Eastern Cooperative Oncology Group Performance Status(participants) | Pemetrexed + Carboplatin | Etoposide + Carboplatin | Total |
|---|---|---|---|
| 0 - Fully Active | 133 | 121 | 254 |
| 1 - Ambulatory, Restricted Strenuous Activity | 265 | 277 | 542 |
| 2 - Ambulatory, No Work Activities | 54 | 55 | 109 |
| 3 - Partially Confined to Bed, Limited Self Care | 1 | 0 | 1 |
| Not Reported | 0 | 2 | 2 |
| History of Brain Metastases(participants) | Pemetrexed + Carboplatin | Etoposide + Carboplatin | Total |
|---|---|---|---|
| No | 410 | 412 | 822 |
| Yes | 43 | 41 | 84 |
| Not Reported | 0 | 2 | 2 |
| Race/Ethnicity(participants) | Pemetrexed + Carboplatin | Etoposide + Carboplatin | Total |
|---|---|---|---|
| Caucasian | 391 | 379 | 770 |
| East Asian | 43 | 49 | 92 |
| West Asian | 12 | 12 | 24 |
| African | 5 | 8 | 13 |
| Hispanic | 1 | 5 | 6 |
| Aboriginal and/or Torres Strait Islander | 0 | 2 | 2 |
| Native American | 1 | 0 | 1 |
Showing the first 100 of 189 sites across 26 countries.
The record gives a start of Aug 2006, a primary completion of Jun 2008 and a completion of Jun 2008. It does not say whether these dates are actual or estimated.
Results were first posted in Oct 2009, 1 year 4 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pemetrexed