Phase 3 Study of Bavituximab Plus Docetaxel Versus Docetaxel Alone in Patients With Late-stage Non-squamous Non-small-cell Lung Cancer

Summary

The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to the standard chemotherapy drug docetaxel, will improve the results of the treatment for non-small-cell lung cancer.

Timeline

Start

2013-12

Primary completion

2017-03

Completion

2017-03

Outcome

Missed primary endpoint

paper (HR 1.06; 95% CI 0.88-1.29; P = 0.533). PMID 29767677 ↗

paper The combination of bavituximab plus docetaxel is not superior to docetaxel in patients with previously treated advanced NSCLC. PMID 29767677 ↗

Publications

• Gerber DE, Horn L, Boyer M, Sanborn R, Natale R, Palmero R, Bidoli P, Bondarenko I, Germonpre P, Ghizdavescu D, Kotsakis A, Lena H, Losonczy G, Park K, Su WC, Tang M, Lai J, Kallinteris NL, Shan JS, Reck M, Spigel DR. Randomized phase III study of docetaxel plus bavituximab in previously treated advanced non-squamous non-small-cell lung cancer. Ann Oncol. 2018 Jul 1;29(7):1548-1553. doi: 10.1093/annonc/mdy177.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bavituximab	Monoclonal antibody	3 mg/kg	—
Background	Docetaxel	Small molecule	—	—

Indications