A Study Of AG-013736 (Axitinib) Or Bevacizumab (Avastin) In Combination With Paclitaxel And Carboplatin In Patients With Advanced Lung Cancer.

Phase 2 Completed 118 enrolled Pfizer

RandomizedParallel-groupOpen-labelTreatment

Summary

To determine if the addition of AG-013736 to chemotherapy is beneficial in patients with advanced lung cancer who have not been previously treated.

Timeline

Start: 2008-04
Primary completion: 2011-04
Completion: 2012-10

Outcome

Missed primary endpoint

registry Axitinib + Paclitaxel + Carboplatin vs Bevacizumab + Paclitaxel + Carboplatin; p = 0.639; Hazard Ratio (HR) 1.093 (95% CI 0.679 to 1.761) NCT00600821 ↗

paper axitinib/paclitaxel/carboplatin did not improve efficacy versus bevacizumab/paclitaxel/carboplatin PMID 24356624 ↗

Publications

Twelves C, Chmielowska E, Havel L, Popat S, Swieboda-Sadlej A, Sawrycki P, Bycott P, Ingrosso A, Kim S, Williams JA, Chen C, Olszanski AJ, de Besi P, Schiller JH. Randomised phase II study of axitinib or bevacizumab combined with paclitaxel/carboplatin as first-line therapy for patients with advanced non-small-cell lung cancer. Ann Oncol. 2014 Jan;25(1):132-8. doi: 10.1093/annonc/mdt489.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Axitinib	Small molecule	5 mg	Oral
Comparator	Bevacizumab	Monoclonal antibody	15 mg/kg	Intravenous
Background	Carboplatin	Small molecule	6 unknown	Intravenous
Background	Paclitaxel	Small molecule	200 mg/m2	—