NCT00087711

A Randomized Phase 3 Trial of Pemetrexed and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

A Randomized Phase 3 Trial of ALIMTA and Cisplatin Versus GEMZAR and Cisplatin in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,713 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized Phase 3 study comparing pemetrexed and cisplatin combination to gemcitabine and cisplatin for the treatment of Non Small Cell Lung Cancer (NCSLC). Gemcitabine plus cisplatin is currently the standard of care for NSCLC. It is thought that pemetrexed plus cisplatin may be as effective and may have fewer side effects than the standard of care.

Conditions

• Non Small Cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	pemetrexed	500 mg/m2, IV q 21 days x 6 cycles
DRUG	gemcitabine	1250 mg/m2, IV, day 1 and 8 q 21 days x 6 cycles
DRUG	cisplatin	75 mg/m2, IV, q 21 days x 6 cycles

Timeline

• Start date: 2004-07-01
• Primary completion: 2007-01-01
• Completion: 2008-03-01
• First posted: 2004-07-16
• Last updated: 2019-09-12

Locations

134 sites across 27 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Denmark, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Mexico, Netherlands, Poland, Portugal, Puerto Rico, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom