NCT00440414

Trial of Pemetrexed Versus Erlotinib in Pretreated Patients With Non Small Cell Lung Cancer (NSCLC)

A Multicenter Randomized Phase III Study of Pemetrexed Versus Erlotinib in Patients With Pretreated Advanced Non-Small-Cell Lung Cancer (NSCLC)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Hellenic Oncology Research Group · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The second-line treatment in advanced NSCLC has been currently proved effective in prolonging overall survival and improving quality of life. Both pemetrexed and erlotinib have been approved for second-line treatment of NSCLC . Erlotinib is a valuable option for the treatment of advanced NSCLC, especially for elderly patients, due to convenience of administration and safety profile. The role of comprehensive geriatric assessment in treatment efficacy and tolerance is an area of investigation.

Detailed description

This trial will compare the efficacy of pemetrexed versus erlotinib in pretreated patients with advanced NSCLC.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Erlotinib (Tarceva)	Erlotinib at the dose of 150 mg orally once a day continually until progression
DRUG	Pemetrexed (Alimta)	Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks for 6 consecutive cycles

Timeline

• Start date: 2006-04-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2007-02-27
• Last updated: 2010-08-19

Locations

9 sites across 1 country: Greece