drugset / Trial / NCT00363415
Study of Pemetrexed and Carboplatin Compared With Etoposide Carboplatin to Treat Extensive-Stage Small Cell Lung Cancer
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2006-08
- Primary completion
- 2008-06
- Completion
- 2008-06
Outcome
Missed primary endpoint
paper pemetrexed-carboplatin was inferior to etoposide-carboplatin for overall survival PMID 19720897 ↗
registry MEDIAN Pemetrexed + Carboplatin: 8.1 (7.3 to 9.1) months NCT00363415 ↗
registry p <0.01; Hazard Ratio (HR) 1.56 (95% CI 1.27 to 1.92); Log Rank NCT00363415 ↗
Publications
- Ventz S, Khozin S, Louv B, Sands J, Wen PY, Rahman R, Comment L, Alexander BM, Trippa L. The design and evaluation of hybrid controlled trials that leverage external data and randomization. Nat Commun. 2022 Oct 2;13(1):5783. doi: 10.1038/s41467-022-33192-1.
- Socinski MA, Smit EF, Lorigan P, Konduri K, Reck M, Szczesna A, Blakely J, Serwatowski P, Karaseva NA, Ciuleanu T, Jassem J, Dediu M, Hong S, Visseren-Grul C, Hanauske AR, Obasaju CK, Guba SC, Thatcher N. Phase III study of pemetrexed plus carboplatin compared with etoposide plus carboplatin in chemotherapy-naive patients with extensive-stage small-cell lung cancer. J Clin Oncol. 2009 Oct 1;27(28):4787-92. doi: 10.1200/JCO.2009.23.1548. Epub 2009 Aug 31.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Etoposide | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |
| Background | Carboplatin | Small molecule | 5 unknown | Intravenous |