drugset / Trial / NCT00538681
Study for Participants With Advanced, Not Amenable to Surgery, or Metastatic Lung Cancer Comparing Treatment With Pemetrexed + Cisplatin + Enzastaurin Versus Pemetrexed + Cisplatin + Placebo
RandomizedParallel-groupTriple-blindTreatment
Summary
This study is intended for participants with advanced, not amenable to surgery, or metastatic lung cancer who have not received any prior chemotherapy. The study will be conducted in 2 parts: * Part 1 is intended to evaluate safety of pemetrexed + cisplatin + enzastaurin combination chemotherapy * Part 2 whose main objective is to compare the efficacy of pemetrexed + cisplatin + enzastaurin versus pemetrexed + cisplatin + placebo. Participants to be included in Part 2 are those with Nonsquamous Non-Small Cell Lung Cancer (NSCLC).
Timeline
- Start
- 2007-09
- Primary completion
- 2008-11
- Completion
- 2008-11
Outcome
Outcome not reported
Stopped: “Terminated due to lack of efficacy demonstrated in relevant participant population in other clinical trials.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | enzastaurin | Small molecule | 500 mg | Oral |
| Background | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Background | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |