drugset / Trial / NCT01763671

Paclitaxel-bevacizumab in Advanced Lung Cancer

NCT01763671 ↗

Phase 3 Completed 166 enrolled French Cooperative Thoracic Intergroup
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2013-05
Primary completion
2015-12
Completion
2017-04

Outcome

Met primary endpoint

paper 5·4 months versus 3·9 months, adjusted hazard ratio (HR) 0·61 (95% confidence interval [CI]: 0·44-0·86); p = 0·005 PMID 32276179 ↗

paper Weekly paclitaxel plus bevacizumab as second- or third-line improves PFS and ORR compared with docetaxel PMID 32276179 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 10 mg/kg Intravenous
Comparator Docetaxel Small molecule 75 mg/m2 Intravenous
Subject Paclitaxel Small molecule 90 mg/m2 Intravenous