title: A Multicenter Double-blind Phase II Study of Metformin With Gefitinib as First-line Therapy of Locally Advanced Non-Small-cell Lung Cancer.
abstract: We present the rationale and study design of the CGMT (combined gefitinib and metformin therapy) trial (www.ClinicalTrials.gov Identifier: NCT01864681), which is aimed at treating locally advanced non-small-cell lung cancer. The CGMT trial is a multicenter, phase II randomized, double-blinded, and placebo-controlled study, which is designed to evaluate the safety and efficacy of metformin in combination with gefitinib as first-line therapy in patients presenting with stage IIIb-IV non-small-cell lung cancer expressing the epidermal growth factor receptor mutant. Two therapies are proposed for this trial. The first regimen is comprised of gefitinib plus metformin. The second therapy is comprised of gefitinib plus placebo. The primary objective of this trail is to compare the progression-free survival rate at year 1 of the study. The secondary objective of this trial is to compare the 2-year overall survival, the 2-year progression-free survival, the objective response rate, and the disease-control rate, and to evaluate the relative safety of both therapies. Based on the statistical design, we plan to enroll approximately 200 patients.
authors.affiliation: Department of Respiration, Daping Hospital, Third Military Medical University, P.R. China.
authors.forename: Kun-Lin
authors.initials: KL
authors.lastname: Li
authors.affiliation: Department of Respiration, Daping Hospital, Third Military Medical University, P.R. China.
authors.forename: Li
authors.initials: L
authors.lastname: Li
authors.affiliation: Sichuan International Studies University, P.R. China.
authors.forename: Peng
authors.initials: P
authors.lastname: Zhang
authors.affiliation: Department of Respiration, Daping Hospital, Third Military Medical University, P.R. China.
authors.forename: Jun
authors.initials: J
authors.lastname: Kang
authors.affiliation: Department of Respiration, Daping Hospital, Third Military Medical University, P.R. China.
authors.forename: Yu-Bo
authors.initials: YB
authors.lastname: Wang
authors.affiliation: Department of Respiration, Daping Hospital, Third Military Medical University, P.R. China.
authors.forename: Heng-Yi
authors.initials: HY
authors.lastname: Chen
authors.affiliation: Department of Respiration, Daping Hospital, Third Military Medical University, P.R. China. Electronic address: heyong8998@126.com.
authors.forename: Yong
authors.initials: Y
authors.lastname: He
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002681:China; D004311:Double-Blind Method; D005260:Female; D000077156:Gefitinib; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008687:Metformin / Q000627:therapeutic use*; D008875:Middle Aged; D009367:Neoplasm Staging; D011799:Quinazolines / Q000627:therapeutic use*; D012107:Research Design; D016019:Survival Analysis; D055815:Young Adult
chemical_list: D011799:Quinazolines; D008687:Metformin; D000077156:Gefitinib
keywords: EGFR-TKI; Gefitnib; Metformin; NSCLC; Resistance