Vincent K Lam1, Vassiliki Papadimitrakopoulou. 1. Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, Texas, USA.
Abstract
PURPOSE OF REVIEW: Contemporary advances in the understanding of the molecular and immunologic basis of metastatic lung cancer have firmly changed its treatment paradigm to a personalized, biomarker-driven approach. However, the majority of lung-cancer patients [especially lung squamous cell carcinoma (LUSC)] still do not have effective targeted therapeutic options. Master protocols, such as Lung-MAP, represent an innovative clinical trial approach designed to accelerate evaluation of novel biomarker-driven therapies. RECENT FINDINGS: Lung-MAP is an umbrella trial for advanced LUSC and has been active since 2014. Cumulative experience from this overarching, multi-institution master protocol has demonstrated that centralized, real-time biomarker screening is feasible and substudy modularity is essential for protocol adaptability in a rapidly changing treatment landscape. In addition, screening and efficacy results from Lung-MAP affirm that LUSC has several putative drivers but remains difficult to effectively treat with targeted therapy. SUMMARY: Master protocols are a feasible and efficient approach for evaluating biomarker-driven therapies in lung cancer. As we begin to target less common genomic and immunotherapy subtypes, centrally coordinated clinical trial designs such as Lung-MAP are necessary to rapidly deliver effective therapies to patients, whereas also maximizing the quality of research data obtained.
PURPOSE OF REVIEW: Contemporary advances in the understanding of the molecular and immunologic basis of metastatic lung cancer have firmly changed its treatment paradigm to a personalized, biomarker-driven approach. However, the majority of lung-cancerpatients [especially lung squamous cell carcinoma (LUSC)] still do not have effective targeted therapeutic options. Master protocols, such as Lung-MAP, represent an innovative clinical trial approach designed to accelerate evaluation of novel biomarker-driven therapies. RECENT FINDINGS: Lung-MAP is an umbrella trial for advanced LUSC and has been active since 2014. Cumulative experience from this overarching, multi-institution master protocol has demonstrated that centralized, real-time biomarker screening is feasible and substudy modularity is essential for protocol adaptability in a rapidly changing treatment landscape. In addition, screening and efficacy results from Lung-MAP affirm that LUSC has several putative drivers but remains difficult to effectively treat with targeted therapy. SUMMARY: Master protocols are a feasible and efficient approach for evaluating biomarker-driven therapies in lung cancer. As we begin to target less common genomic and immunotherapy subtypes, centrally coordinated clinical trial designs such as Lung-MAP are necessary to rapidly deliver effective therapies to patients, whereas also maximizing the quality of research data obtained.
Authors: Taofeek K Owonikoko; Mary W Redman; Lauren A Byers; Fred R Hirsch; Philip C Mack; Lawrence H Schwartz; Jeffrey D Bradley; Thomas E Stinchcombe; Natasha B Leighl; Tareq Al Baghdadi; Primo Lara; Jieling Miao; Karen Kelly; Suresh S Ramalingam; Roy S Herbst; Vassiliki Papadimitrakopoulou; David R Gandara Journal: Clin Lung Cancer Date: 2021-01-10 Impact factor: 4.785
Authors: Jay J H Park; Ellie Siden; Michael J Zoratti; Louis Dron; Ofir Harari; Joel Singer; Richard T Lester; Kristian Thorlund; Edward J Mills Journal: Trials Date: 2019-09-18 Impact factor: 2.279
Authors: Ellie G Siden; Jay Jh Park; Michael J Zoratti; Louis Dron; Ofir Harari; Kristian Thorlund; Edward J Mills Journal: Contemp Clin Trials Commun Date: 2019-07-04