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The expansion of molecularly guided drugs and immune-modulating treatments offers new options, but FDA leadership stresses that evaluating safety and efficacy requires faster clinical-study models. Lung-MAP is proposed as a sustainable master protocol infrastructure to match biomarker-defined patients to targeted substudies and enable efficient, collaborative development.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":40,"@type":76,"position":81},"https://docshare.wps.com/document/research-report/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/novel-approach-to-accelerate-lung-cancer-research-lung-map-and-the-potential-of-public-private-partnerships/326639/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/novel-approach-to-accelerate-lung-cancer-research-lung-map-and-the-potential-of-public-private-partnerships/326639.png","ImageObject",300,407,{"name":92,"@type":93},"Jiven","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-11-04","2026-09-21",true,{"@type":102,"interactionType":103,"userInteractionCount":39},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What clinical-study challenge does the FDA highlight for NSCLC targeted therapy?","Question",{"text":112,"@type":113},"Safety and efficacy evaluations would be slowed without new models for conducting clinical studies, so a comprehensive approach is recommended to identify best candidates and run studies more efficiently.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"What is the primary objective of Lung-MAP?",{"text":117,"@type":113},"To evaluate overall survival of biomarker-selected patients receiving standard of care versus experimental targeted therapy.",{"name":119,"@type":110,"acceptedAnswer":120},"How does Lung-MAP handle patients who do not match an existing biomarker-driven substudy?",{"text":121,"@type":113},"A continuously available “non-match” immunotherapy-based substudy ensures an available option for any enrolled patient as part of their care.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},326639,1789977704,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":39,"category_name":40,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":39,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":19,"language":139,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":67,"update_tm":143,"read_time":52,"preview_page_count":4},1099513958607,"https://ap-avatar.wpscdn.com/avatar/100002390cf8733938c?x-image-process=image/resize,m_fixed,w_180,h_180&k=1778829742770036399","Novel Approach to Accelerate Lung Cancer Research: Lung-MAP and the Potential of Public-Private Partnerships  \nRoy S. Herbst1, Charles D. Blanke2, and Ellen V. Sigal3  \nABSTRACT  \n◥  \nThe National Cancer Institute recently found that death rates for non–small cell lung cancer (NSCLC) have been reduced by over 6% overall in recent years. This reduction in mortality has been accompanied by an average increase in overall survival and largely credited to the therapeutic advancements for the effective treatment of NSCLC. Numerous molecular alterations have been identified in NSCLC that have enabled the development of new drugs capable of targeting these changes and efficiently kill cancerous cells. New treatments to modulate patients’ immune systems have been shown to be effective in stimulating natural immune cells to have an improved anti-cancer effect. While these types of approaches to treat cancer are providing new options for patients, leadership from the Food and Drug Administration (FDA) recognized that the  \nexpansion of targeted therapy in NSCLC presented significant promise, but evaluation of the safety and efficacy of these new drugs would be slowed if new models for conducting clinical studies were not identified. Specifically, the FDA recommended that a comprehensive approach be implemented to identify the patients that are the best candidates for these, and other new treatments based upon the molecular characteristics of their tumors, and more efficiently conduct the clinical studies necessary to evaluate the safety andefficacy ofnew drugs. To address this growing challenge, leadinglung cancer experts and stakeholders across academia, government, industry, and patient advocacy came together to design a clinical research approach that could serve as a sustainable infrastructure for new lung cancer treatments called the Lung Cancer Master Protocol.  \nIntroduction  \nOver 230,000 Americans are diagnosed with lung cancer each year and it remains the leading cause of cancer death (1) . However, over the past several years, notable progress has been made. Researchers from the NCI recently found that death rates for non–small cell lung cancer (NSCLC), the subtype of lung cancer that comprises approximately three quartersofall lung cancers, have been reduced by over6%overall in recent years (2) . This reduction in mortality has been accompanied by an average increase in overall survival times and largely credited to the therapeutic advancements for the effective treatment of NSCLC. Numerous molecular alterations have been identified in NSCLC that have enabled the development of new drugs capable of targeting these changes andefficiently kill cancerous cells. In addition, new treatments to modulate patients’ immune systems have been shown tobe effective in stimulating natural immune cells to have an improved anticancer effect (3, 4) .  \nWhile these types of approaches to treat cancer are providing new options for patients, leadership from the Food and Drug Administration (FDA) recognized that the expansion of targeted therapy in NSCLC presented significant promise, but evaluation of the safety  \n1Yale Cancer Center and Smilow Cancer Hospital, New Haven, Connecticut. 2SWOG Cancer Research Network, Oregon Health & Science University and Knight Cancer Institute, Portland, Oregon. 3Friends of Cancer Research, Washington, District of Columbia.  \nCorresponding Author: Roy S. Herbst, Yale School of Medicine, Yale Cancer  \nCenter, New Haven, CT 06520 . E-mail: [roy.herbst@yale.edu](roy.herbst@yale.edu)[ ](roy.herbst@yale.edu)[Clin Cancer Res 2024](Clin Cancer Res 2024);[30:29](30:29)–[32](32)  \n[doi:](doi: 10.1158/1078-0432.CCR-23-2690)[ 10.1158/1078-0432.CCR-23-2690](doi: 10.1158/1078-0432.CCR-23-2690)  \nThis open access article is distributed under the Creative Commons AttributionNonCommercial-NoDerivatives 4 . 0 International (CC BY-NC-ND 4 . 0) license.  \n􀀁2023The Authors;Published by the American Association for Cancer Research  \nand efficac","cbCairT9JCppmqnO","https://ap.wps.com/l/cbCairT9JCppmqnO","pdf",170555,"English","# Abstract\n# Introduction\n# Background","[{\"question\":\"What clinical-study challenge does the FDA highlight for NSCLC targeted therapy?\",\"answer\":\"Safety and efficacy evaluations would be slowed without new models for conducting clinical studies, so a comprehensive approach is recommended to identify best candidates and run studies more efficiently.\"},{\"question\":\"What is the primary objective of Lung-MAP?\",\"answer\":\"To evaluate overall survival of biomarker-selected patients receiving standard of care versus experimental targeted therapy.\"},{\"question\":\"How does Lung-MAP handle patients who do not match an existing biomarker-driven substudy?\",\"answer\":\"A continuously available “non-match” immunotherapy-based substudy ensures an available option for any enrolled patient as part of their care.\"}]","Novel Approach to Accelerate Lung Cancer Research: Lung-MAP and the Potential of Public-Private Partnerships | PDF",1789974957]