NCT00961415

AVAPERL1 Study: A Study of Avastin (Bevacizumab) With or Without Pemetrexed as Maintenance Therapy After Avastin in First Line in Patients With Non-Squamous Non-Small Cell Lung Cancer

Open-label Study of Bevacizumab Maintenance Therapy (AVASTIN®) With or Without Pemetrexed After First-line Chemotherapy With Bevacizumab-cisplatin-pemetrexed in Patients With Advanced, Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer (NSCLC)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 376 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This open-label study will assess the efficacy and safety of Avastin with or without pemetrexed as maintenance therapy in patients with advanced, metastatic or recurrent non-small cell lung cancer. In Part 1, patients will receive 4 cycles of treatment with Avastin (7.5mg/kg iv) plus cisplatin (75mg/m2 iv) plus pemetrexed (500mg/m2 iv) on day 1 of each 3-week cycle. In Part 2, patients responding to treatment will be randomized to receive further treatment cycles of Avastin (7.5mg/kg iv every 3 weeks) with or without pemetrexed (500mg/m2 iv every 3 weeks). Anticipated time on study treatment is until disease progression. Target sample size is \<500 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	75mg/m2 iv on day 1 of each 3-week cycle
DRUG	pemetrexed	500mg/m2 iv on day 1 of each 3-week cycle

Timeline

• Start date: 2009-08-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2009-08-19
• Last updated: 2016-02-22
• Results posted: 2016-02-22

Locations

91 sites across 12 countries: France, Germany, Greece, Italy, Netherlands, Russia, South Korea, Spain, Sweden, Switzerland, Turkey (Türkiye), United Arab Emirates