{"id":174,"date":"2021-06-30T14:32:14","date_gmt":"2021-06-30T14:32:14","guid":{"rendered":"https:\/\/mims.parabolasolution.com\/?page_id=174"},"modified":"2024-02-01T09:01:22","modified_gmt":"2024-02-01T01:01:22","slug":"study-design","status":"publish","type":"page","link":"https:\/\/bms.mimsit.net\/dosing\/1l-metastatic-recurrent-nsclc-with-chemo\/study-design\/","title":{"rendered":"Study design: CheckMate 9LA (NSCLC with chemo)"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"174\" class=\"elementor elementor-174\" data-elementor-settings=\"[]\">\n\t\t\t\t\t\t\t<div class=\"elementor-section-wrap\">\n\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-5d88eb39 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"5d88eb39\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-4ea4398\" data-id=\"4ea4398\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-7de400c elementor-widget elementor-widget-text-editor\" data-id=\"7de400c\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.5.5 - 03-02-2022 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#818a91;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#818a91;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<ul>\n<li>Phase 3 randomized study in patients with recurrent\/metastatic NSCLC<sup>1<\/sup><\/li>\n<li>Primary endpoint: OS<sup>1<\/sup><\/li>\n<li>Secondary endpoints: PFS by BICR<sup>a<\/sup>; ORR by BICR<sup>a<\/sup>; efficacy by tumor PD-L1 expression<sup>1<\/sup><\/li>\n<\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ebbe991 elementor-widget elementor-widget-text-editor\" data-id=\"ebbe991\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><!-- wp:paragraph --><!-- \/wp:paragraph -->\n\n<!-- wp:image {\"id\":644,\"sizeSlug\":\"full\",\"linkDestination\":\"none\",\"className\":\"img-fluid d-none d-md-block\"} --><\/p>\n<figure class=\"wp-block-image size-full img-fluid d-none d-md-block\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-1164 size-full\" src=\"http:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study_design_CheckMate_9LA_NSCLC_with_chemo.png\" alt=\"\" width=\"4120\" height=\"993\" srcset=\"https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study_design_CheckMate_9LA_NSCLC_with_chemo.png 4120w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study_design_CheckMate_9LA_NSCLC_with_chemo-300x72.png 300w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study_design_CheckMate_9LA_NSCLC_with_chemo-1024x247.png 1024w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study_design_CheckMate_9LA_NSCLC_with_chemo-768x185.png 768w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study_design_CheckMate_9LA_NSCLC_with_chemo-1536x370.png 1536w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study_design_CheckMate_9LA_NSCLC_with_chemo-2048x494.png 2048w\" sizes=\"auto, (max-width: 4120px) 100vw, 4120px\" \/><\/figure>\n<p><!-- \/wp:image -->\n\n<!-- wp:image {\"id\":645,\"sizeSlug\":\"full\",\"linkDestination\":\"none\",\"className\":\"img-fluid d-block d-md-none\"} --><\/p>\n<figure class=\"wp-block-image size-full img-fluid d-block d-md-none\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-1166 size-large\" src=\"http:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study_design_CheckMate_9LA_NSCLC_with_chemo_mobile-614x1024.png\" alt=\"\" width=\"614\" height=\"1024\" srcset=\"https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study_design_CheckMate_9LA_NSCLC_with_chemo_mobile-614x1024.png 614w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study_design_CheckMate_9LA_NSCLC_with_chemo_mobile-180x300.png 180w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study_design_CheckMate_9LA_NSCLC_with_chemo_mobile-768x1281.png 768w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study_design_CheckMate_9LA_NSCLC_with_chemo_mobile-921x1536.png 921w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study_design_CheckMate_9LA_NSCLC_with_chemo_mobile-1228x2048.png 1228w, https:\/\/bms.mimsit.net\/dosing\/wp-content\/uploads\/2024\/02\/Study_design_CheckMate_9LA_NSCLC_with_chemo_mobile.png 1785w\" sizes=\"auto, (max-width: 614px) 100vw, 614px\" \/><\/figure>\n<p><!-- \/wp:image --><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6194c5a elementor-widget elementor-widget-text-editor\" data-id=\"6194c5a\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<sup>a<\/sup>Hierarchically statistically tested. <sup>b<\/sup>Determined by the PD-L1 IHC 28-8 pharmDx assay (Dako). <sup>c<\/sup>Patients unevaluable for PD-L1 were stratified to PD-L1 &lt;1% and capped to 10% of all randomized patients. <sup>d<\/sup>NSQ: pemetrexed + cisplatin or carboplatin; SQ: paclitaxel + carboplatin. Figure adapted from Paz-Ares et al. 2021.<sup>1<\/sup>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fb91f59 elementor-widget elementor-widget-text-editor\" data-id=\"fb91f59\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\tALK, anaplastic lymphoma kinase; BICR, blinded independent central review; chemo, chemotherapy; ECOG PS, Eastern Clinical Oncology Group Performance Status; EGFR, epidermal growth factor receptor; IHC, immunohistochemistry; IPI, ipilimumab; NIVO, nivolumab; NSCLC, non-small cell lung cancer; NSQ, non-squamous; ORR, objective response rate; OS, overall survival; PD-L1, programmed death ligand 1; PFS, progression-free survival; QxW, every x weeks; R, randomization; SQ, squamous.\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6627267 elementor-widget elementor-widget-text-editor\" data-id=\"6627267\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>1. Paz-Ares L, et al. <em>Lancet Oncol<\/em> 2021;22:198\u2013211.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Phase 3 randomized study in patients with recurrent\/metastatic NSCLC1 Primary endpoint: OS1 Secondary endpoints: PFS by BICRa; ORR by BICRa; efficacy by tumor PD-L1 expression1 aHierarchically statistically tested. bDetermined by the PD-L1 IHC 28-8 pharmDx assay (Dako). cPatients unevaluable for PD-L1 were stratified to PD-L1 &lt;1% and capped to 10% of all randomized patients. dNSQ: [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":161,"menu_order":20,"comment_status":"closed","ping_status":"closed","template":"page-template3.php","meta":{"footnotes":""},"class_list":["post-174","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/pages\/174","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/comments?post=174"}],"version-history":[{"count":36,"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/pages\/174\/revisions"}],"predecessor-version":[{"id":1180,"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/pages\/174\/revisions\/1180"}],"up":[{"embeddable":true,"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/pages\/161"}],"wp:attachment":[{"href":"https:\/\/bms.mimsit.net\/dosing\/wp-json\/wp\/v2\/media?parent=174"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}