NCT01077713

A Study of Avastin (Bevacizumab) in Combination With Gemcitabine With or Without Cisplatin in First-Line Treatment of Elderly Patients With Non-Small Cell Lung Cancer

Randomised Phase II Trial of Bevacizumab (AVASTIN®) in Combination With Gemcitabine or Attenuated Doses of Cisplatin and Gemcitabine as First-line Treatment of Elderly Patients With Advanced Non-squamous Non-small Cell Lung Cancer - EAGLES

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

This 2 arm study will evaluate the efficacy and safety of Avastin + gemcitabine, and Avastin + gemcitabine + attenuated doses of cisplatin, as first line treatment in elderly patients with non-squamous non-small cell lung cancer. Patients will be randomised to receive either Avastin 7.5mg/kg iv on day 1 + gemcitabine 1200mg/m2 on days 1-8 of each 3 week cycle, or Avastin 7.5mg/kg iv on day 1 + cisplatin 60mg/m2 on day 1 + gemcitabine 1000mg/m2 on days 1-8 of each 3 week cycle. After 6 cycles of combination therapy, all patients will continue to receive Avastin monotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.

Conditions

• Non-Squamous Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	bevacizumab [Avastin]	7.5mg/kg iv on day 1 of each 3 week cycle
DRUG	cisplatin	60mg/m2 on day 1 of each 3 week cycle
DRUG	gemcitabine	1200mg/m2 on days 1-8 of each 3 week cycle
DRUG	gemcitabine	1000mg/m2 on days 1-8 of each 3 week cycle

Timeline

• Start date: 2010-02-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2010-03-01
• Last updated: 2015-10-08
• Results posted: 2015-10-08

Locations

26 sites across 1 country: Italy