A Study of Erlotinib (Tarceva) After Surgery With or Without Adjuvant Chemotherapy in Non-Small Cell Lung Carcinoma (NSCLC) Patients Who Have Epidermal Growth Factor Receptor (EGFR) Positive Tumors

Phase 3 Completed 1252 enrolled OSI Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a study to evaluate the effectiveness of erlotinib compared with a placebo sugar pill following complete surgical removal of the tumor with or without chemotherapy after surgery in Stage IB-IIIA NSCLC patients.

Timeline

Start: 2006-09
Primary completion: 2013-04
Completion: 2014-06

Outcome

Missed primary endpoint

registry Erlotinib vs Placebo; p = 0.3235; Hazard Ratio (HR) 0.90 (95% CI 0.741 to 1.104); Log Rank NCT00373425 ↗

registry Erlotinib vs Placebo; p = 0.5620; Hazard Ratio (HR) 0.94 (95% CI 0.780 to 1.144); Log Rank NCT00373425 ↗

paper There was no statistically significant difference in DFS (median, 50.5 months for erlotinib and 48.2 months for placebo; hazard ratio, 0.90; 95% CI, 0.74 to 1.10; P = .324). PMID 26324372 ↗

Publications

Kelly K, Altorki NK, Eberhardt WE, O'Brien ME, Spigel DR, Crino L, Tsai CM, Kim JH, Cho EK, Hoffman PC, Orlov SV, Serwatowski P, Wang J, Foley MA, Horan JD, Shepherd FA. Adjuvant Erlotinib Versus Placebo in Patients With Stage IB-IIIA Non-Small-Cell Lung Cancer (RADIANT): A Randomized, Double-Blind, Phase III Trial. J Clin Oncol. 2015 Dec 1;33(34):4007-14. doi: 10.1200/JCO.2015.61.8918. Epub 2015 Aug 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Erlotinib	Small molecule	150 mg	Oral