Gemcitabine, Docetaxel, and Cetuximab in Patients With Unresectable Advanced Non-Small Cell Lung Cancer

NCT00193453 ↗

Phase 2 Completed 69 enrolled SCRI Development Innovations, LLC Bristol-Myers Squibb · collab

NaSingle-groupOpen-labelTreatment

Summary

This purpose of this study is to evaluate the role of gemcitabine and docetaxel, a well tolerated chemotherapy regimen in the treatment of advanced non-small cell lung cancer (NSCLC), in combination with a novel agent cetuximab.

Timeline

Start: 2005-07
Primary completion: 2009-02
Completion: 2009-12

Outcome

Missed primary endpoint

paper The ORR was 17% (95% CI, 9%-29%). PMID 20439197 ↗

Publications

Results Spigel DR, Greco FA, Thompson DS, Webb C, Rubinsak J, Inhorn RC, Reeves J Jr, Vazquez ER, Lane CM, Burris HA 3rd, Hainsworth JD. Phase II study of cetuximab, docetaxel, and gemcitabine in patients with previously untreated advanced non-small-cell lung cancer. Clin Lung Cancer. 2010 May;11(3):198-203. doi: 10.3816/CLC.2010.n.026.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cetuximab	Monoclonal antibody	250 mg/m2	Intravenous
Subject	Docetaxel	Small molecule	30 mg/m2	Intravenous
Subject	Gemcitabine	Small molecule	1000 mg/m2	Intravenous