Primary Institution	University of Colorado
Participating Institution	Multicenter (n=174)

Cancer Indication	lung cancer
Clinical Indication	non-small cell lung cancer (nsclc), advanced (Stage IIIb) or metastatic (Stage IV), recurrent
Clinical Status	Phase III (begin 6/01, closed 7/03, completed 05) USA
Clinical Trial Title	A Randomized, Double-Blinded, Phase III Clinical Trial of Carboplatin and Paclitaxel with or Without Erlotinib in Treating Chemotherapy-Naive Patients with Stage IIIb or Stage IV Non-Small Cell Lung Cancer
Trial Acronym	TRIBUTE
Clinical Trial Objective	To determine the safety, efficacy, and survival for these regimens.
Protocol ID	OSI2298g; MSKCC-01122, NCT00047736
Protocol Link	Link to Protocol
Protocol Description	Patients are randomized to one of two treatment arms. Treatment in Arm I consists of IV paclitaxel over 3 hours and IV carboplatin over 15-30 minutes on day 1 and oral erlotinib daily on days 1-21. Treatment in Arm II consists of paclitaxel and carboplatin as in Arm I and oral placebo on days 1-21. Treatment is repeated every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression before the sixth course discontinue chemotherapy but continue treatment with erlotinib or placebo.
Administration Route	intravenous (IV) • PO
Target	Microtubules • Epidermal growth factor (EGF) receptor (EGFr, ErbB-1, ErbB1, HEr-1, HEr1)
Enrollment	1059 (erlotinib=526; placebo=533)
Toxicity	Adding erlotinib to chemotherapy was generally well tolerated. AE that occurred more often with erlotinib included diarrhea and rash. In updated results (6/04), erlotinib with carboplatin/paclitaxel and carboplatin/paclitaxel alone were comparable in terms of overall AE (erlotinib/carboplatin/paclitaxel =99.5%, carboplatin/paclitaxel=99.5%) and SAE were comperable except for rash and diarrhea (erlotinib/carboplatin/paclitaxel =47.7%, carboplatin/paclitaxel=43.2%). There was an imbalance in the SAE designated by the reporting investigator as leading to death (erlotinib/carboplatin/paclitaxel=53; carboplatin/paclitaxel=27). Only 5/80 fatal SAE were partially related to trial drug by the reporting investigators.
Result Summary
Result - Overall Response	erlotinib=21.5%, placebo=19.3%
Result - Median TTP	erlotinib=5.1 months, placebo=4.9 months
Result - Overall Survival	erlotinib=10.8 months, placebo=10.6 months
Author's Conclusions	These results indicate that although erlotinib with carboplatin and paclitaxel did not confer an advantage in OS over carboplatin alone in all patients, the addition of erlotinib to carboplatin and paclitaxel significantly improved survival of never smokers. This result is consistent with data from previous trials of EGFr-inhibitors and warrants confirmation in a randomized trial.
Reference	Hirsch FR, etal, Clin Cancer Res, 1 Oct 2008;14(19):6317-23; fred.hirsch@UCHSC.edu • Herbst R, etal, ASCO04, Abs. 7011; Miller V, etal, ASCO04, Abs. 7061
Current as of	June 30, 2010