title: Study protocol: systematic review and meta-analysis of randomized controlled trials in first-line treatment of squamous non-small cell lung cancer.
abstract: BACKGROUND
  There is a high unmet need for effective treatments for patients with squamous non-small cell lung cancer (NSCLC). Eli Lilly and Company is conducting a phase III, randomized, multicenter, open-label study of gemcitabine plus cisplatin plus necitumumab (GC + N) versus gemcitabine plus cisplatin (GC) for the first-line treatment of patients with stage IV squamous NSCLC. Given GC is not the only treatment commonly used for the treatment of squamous NSCLC, this study was designed to compare the survival, toxicity, and quality of life outcomes of current treatment strategies for squamous NSCLC in the first-line setting.
  
  
  METHODS
  A systematic review and meta-analysis (including indirect comparisons) of treatments used in squamous NSCLC will be conducted to assess the clinical efficacy (overall and progression-free survival), health-related quality of life (HRQoL), and safety (grade 3-4 toxicity) of GC + N compared to other treatments used in squamous NSCLC. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines will be followed for all aspects of this study. A systematic literature review will be conducted to identify randomized controlled trials evaluating chemotherapy treatment in first-line NSCLC. Eligible articles will be restricted to randomized controlled trials (RCTs) among chemotherapy-naïve advanced NSCLC cancer patients that report outcome data (survival, toxicity, or quality of life) for patients with squamous histology. Following data extraction and validation, data consistency and study heterogeneity will be assessed. A network meta-analysis will be conducted based on the available hazard ratios for overall and progression-free survival, odds ratios for published toxicity data, and mean difference of HRQoL scales. Sensitivity analyses will be conducted.
  
  
  CONCLUSIONS
  This is a presentation of the study protocol only. Results and conclusions are pending completion of this study.
  
  
  BACKGROUND
  PROSPERO CRD42014008968.
authors.forename: Amy M
authors.initials: AM
authors.lastname: DeLozier
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Brown
authors.forename: Fanni
authors.initials: F
authors.lastname: Natanegara
authors.forename: Luping
authors.initials: L
authors.lastname: Zhao
authors.forename: Zhanglin Lin
authors.initials: ZL
authors.lastname: Cui
authors.forename: Stephen L
authors.initials: SL
authors.lastname: Able
authors.forename: Lee
authors.initials: L
authors.lastname: Bowman
authors.forename: Joseph
authors.initials: J
authors.lastname: Treat
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA. hess_lisa_m@lilly.com.
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Hess
mesh_terms: D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D015996:Survival Rate; D000078202:Systematic Reviews as Topic; D000093542:Gemcitabine; D015201:Meta-Analysis as Topic
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D003841:Deoxycytidine; C527969:necitumumab; D002945:Cisplatin; D000093542:Gemcitabine