NCT01763671

Paclitaxel-bevacizumab in Advanced Lung Cancer

Phase III Study Comparing the Efficacy of Paclitaxel-bevacizumab With Docetaxel in 2nd or 3rd Line of Treatment of Non Squamous Non Small Cells Lung Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: Intergroupe Francophone de Cancerologie Thoracique · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study objective is to evaluate the efficacy of paclitaxel-bevacizumab comparing to docetaxel. Docetaxel is a standard treatment of 2nd or 3rd line in lung cancer. It was validated by numerous clinical trials but sometimes toxicities are difficult to manage. Bevacizumab is an antiangiogenic treatment which was validated by numerous clinical trials in association with platinum in first ligne. Different clinical and preclinical data suggest that there could exist a synergy between paclitaxel and bevacizumab. This association is already used in metastatic breast cancer, it permits almost to double the response rate and progression free survival. In lung cancer, the association was evaluated by two retrospective studies which demonstrated a benefit with a favourable safety profile.

Conditions

• Non-squamous Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel	75 mg/m² IV on day one of 21 days cycle Number of Cycles: until progression or unacceptable toxicity develops.
DRUG	Paclitaxel	90 mg/m² IV on day 1, 8 and 15 of 28 days cycle Number of Cycles: until progression or unacceptable toxicity develops.
DRUG	Bevacizumab	10 mg/kg IV on day 1 and 15 of 28 days cycle Number of Cycles: until progression or unacceptable toxicity develops.

Timeline

• Start date: 2013-05-01
• Primary completion: 2015-12-01
• Completion: 2017-04-01
• First posted: 2013-01-09
• Last updated: 2023-03-14

Locations

55 sites across 1 country: France