Phase 3
N=908
Study of Pemetrexed and Carboplatin Compared With Etoposide Carboplatin to Treat Extensive-Stage Small Cell Lung Cancer
Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00363415 ↗Enrolled (actual)
908
Serious AEs
—
Results posted
Oct 2009
Primary outcome: Primary: Overall Survival — 8.1; 10.6 months — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- pemetrexed (Drug); etoposide (Drug); carboplatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
8.1; 10.6 | <0.01 sig |
| SECONDARY Overall Survival (Subgroups) |
8.2; 10.4; 8.1; 11.6; 8.2; 11.2 | <0.001 sig |
| SECONDARY Progression Free Survival |
3.8; 5.4 | — |
| SECONDARY Change From Baseline to Each Cycle in Functional Assessment of Cancer Therapy - Lung (FACT-L) |
87.42; 87.79; -0.22; 1.55; 0.17; 1.73 | — |
| SECONDARY Overall Survival (Subgroups: LDH<=Upper Limit of Normal and History of Brain Metastases=Yes) |
— | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of extensive stage small cell lung cancer (SCLC)
- Capable of self-care but may be unable to carry out any work activities.
- No prior anticancer therapy for SCLC
Exclusion Criteria
- have previously participated in a study involving pemetrexed
- have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication
Data sourced from ClinicalTrials.gov (NCT00363415). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.