A Study of Tarceva (Erlotinib) in Combination With Avastin (Bevacizumab) in Patients With Advanced Non-Small Cell Lung Cancer.

NCT00531960 ↗

Phase 2 Completed 124 enrolled Hoffmann-La Roche

RandomizedParallel-groupOpen-labelTreatment

Summary

This 2 arm study will compare the efficacy and safety of Tarceva plus Avastin, and chemotherapy plus Avastin, in the first-line treatment of patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva 150mg p.o. daily plus Avastin 15mg/kg i.v. every 3 weeks, or standard platinum-based chemotherapy (4-6 cycles) plus Avastin. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Timeline

Start: 2008-01
Primary completion: 2010-01
Completion: 2010-01

Publications

Ciuleanu T, Tsai CM, Tsao CJ, Milanowski J, Amoroso D, Heo DS, Groen HJ, Szczesna A, Chung CY, Chao TY, Middleton G, Zeaiter A, Klingelschmitt G, Klughammer B, Thatcher N. A phase II study of erlotinib in combination with bevacizumab versus chemotherapy plus bevacizumab in the first-line treatment of advanced non-squamous non-small cell lung cancer. Lung Cancer. 2013 Nov;82(2):276-81. doi: 10.1016/j.lungcan.2013.08.002. Epub 2013 Aug 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carboplatin	Small molecule	6 unknown	Intravenous
Subject	Cisplatin	Other / unclassified	80 mg/m2	Intravenous
Subject	Erlotinib	Small molecule	150 mg	Oral
Subject	Gemcitabine	Small molecule	1250 mg/m2	Intravenous
Subject	Paclitaxel	Small molecule	200 mg/m2	Intravenous
Background	Bevacizumab	Monoclonal antibody	15 mg/kg	Intravenous

A Study of Tarceva (Erlotinib) in Combination With Avastin (Bevacizumab) in Patients With Advanced Non-Small Cell Lung Cancer.

Summary

Timeline

Publications

Drugs

Indications