At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating bevacizumab [Avastin], cisplatin, and 1 other intervention for Non-Squamous Non-Small Cell Lung Cancer. Completed, enrolled 376 participants across 91 sites in 12 countries.
Detailed 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.
Study Details
Timeline
Interventions
7.5mg/kg iv on day 1 of each 3-week cycle
75mg/m2 iv on day 1 of each 3-week cycle
500mg/m2 iv on day 1 of each 3-week cycle