{"id":9898,"date":"2024-04-29T17:07:38","date_gmt":"2024-04-29T15:07:38","guid":{"rendered":"https:\/\/www.icta.fr\/case-studies\/lung-cancer-patients-treated-with-a-new-pd-1-imp-a-longitudinal-prospective-observational-multicentric-study-in-france\/"},"modified":"2026-01-14T10:25:05","modified_gmt":"2026-01-14T09:25:05","slug":"lung-cancer-patients-treated-with-a-new-pd-1-imp-a-longitudinal-prospective-observational-multicentric-study-in-france","status":"publish","type":"casclients","link":"https:\/\/www.icta.fr\/fr\/cas-clients\/lung-cancer-patients-treated-with-a-new-pd-1-imp-a-longitudinal-prospective-observational-multicentric-study-in-france\/","title":{"rendered":"Lung cancer patients treated with a new PD-1 IMP: A longitudinal, prospective, observational, multicentric study in France"},"content":{"rendered":"\n
<\/div>
\n

OBJECTIVES<\/h3>\n\n\n\n
\n
\n

CO-PRIMARY OBJECTIVES<\/h4>\n\n\n\n

<\/p>\n\n\n\n

    \n
  • To describe socio-demographic and clinical characteristics of patients<\/li>\n\n\n\n
  • To describe treatment effectiveness (i.e OS) at 36 months<\/li>\n<\/ul>\n\n\n\n

    <\/p>\n\n\n\n

    <\/p>\n\n\n\n

    EXPLORATORY OBJECTIVES<\/strong><\/p>\n\n\n\n

    To examine the prognostic association between the OS at 36 months and the characteristics of the patients<\/p>\n<\/div>\n\n\n\n

    \n

    SECONDARY OBJECTIVES<\/h4>\n\n\n\n

    <\/p>\n\n\n\n

      \n
    • To estimate the OS at 12 and 24 months<\/li>\n\n\n\n
    • To evaluate the incidence, severity and management of IMP adverse event (AE) and adverse drug reactions (ADR) at 36 months<\/li>\n\n\n\n
    • To estimate intermediate endpoints (progression-free survival and objective response rate) at several timepoints<\/li>\n\n\n\n
    • To describe QoL and working status at several timepoints<\/li>\n\n\n\n
    • To describe the management of patients, treatment patterns, and variations in treatment patterns at several timepoints<\/li>\n\n\n\n
    • To describe the evolution over the 36-month follow-up period of major clinical parameters<\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n\n\n
      \n
      \n

      SCIENTIFIC and DATA vALORISATION<\/h3>\n\n\n\n
        \n
      • Three poster presentations at major conferences<\/li>\n\n\n\n
      • Two publications<\/li>\n\n\n\n
      • Excellent recognition of the Scientific Community regarding the extend and quality of the study database, useful for future research.<\/li>\n<\/ul>\n<\/div>\n\n\n\n
        \n

        Key factors of success<\/strong><\/h3>\n\n\n\n
          \n
        • Strong and long-term involvement of ICTA\u2019s collaborators (58 in total)<\/li>\n\n\n\n
        • Strong involvement of the Scientific Committee<\/li>\n\n\n\n
        • Regular communication: internally, with the centres and the Sponsor<\/li>\n\n\n\n
        • ICTA\u2019s ability to develop specific iTools in a short time upon Sponsor’s request<\/li>\n\n\n\n
        • ICTA\u2019s expertise in data management and AE management<\/li>\n\n\n\n
        • Flexibility and adaptability to deadlines by ICTA.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n\n\n
          \n
          \n

          LESSONS LEARNED to speed up the start-up phase of the next study<\/h3>\n\n\n\n
            \n
          • The value of close communication between ICTA, the Sponsor and any third parties (e.g. Scientific Committee and regional expert physicians) with regular teleconference meetings.<\/li>\n\n\n\n
          • To well define the Sponsor\u2019s expectations in terms of objectives, statistical analyses and results presentation.<\/li>\n\n\n\n
          • The importance to validate all study documents and make sure that they were perfectly understood by the Sponsor and the Scientific Committee.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n\n\n

            CHALLENGES<\/h3>\n\n\n\n
            KEY CHALLENGES<\/th>ICTA’s SOLUTIONS<\/th>ICTA’s ACHIEVEMENTS<\/th><\/tr><\/thead>
            . High number of physicians to be contacted<\/strong><\/strong>
            (\u00b12,500) and enrolled (\u00b1 250) in order to recruit 1,500 patients


            <\/td>            		. Involvement of regional expert physicians for site initiation and eCRF training
            . Close follow-up of sites by CRO


            <\/td>            		\u00b7\u00a0 205 sites<\/strong> and 261 physicians agreed<\/strong> to participate and 146 and 186 respectively were active<\/strong>
            \u00b7\u00a0 1,495 patients were recruited<\/strong>
            \u25b6 Recruitment ended 5 months earlier<\/strong> than the Sponsor\u2019s expectations<\/td><\/tr>
            . High amount of data to be collected\/managed<\/strong>
            In particular high number of AE\/ADRs to be handled and reconciled with Sponsor PV<\/strong><\/strong>


            <\/td>            		. Development of a customed eCRF restricted to \u201cmust-have\u201d data for an easier data collection and reduced burden
            . Hotline for site support
            . Close follow-up of sites by CRO
            . Close follow-up of AEs by both vigilance departments<\/td>            		. 12,900 visits checked remotely<\/strong>
            . >6,700 questionnaires entered<\/strong> in the database
            . >16,500 treatments<\/strong> coded
            . \u00b112,400 AE<\/strong> forms collected and treated

            <\/td><\/tr>
            . Many different statistical analyses <\/strong>(planned in the statistical analysis plan (SAP)<\/strong>
            . Several requests of additional analyses <\/strong>(not planned in the SAP)
            . Multiple Sponsor reviews of the SAP, TFLs and CSR<\/strong>



            <\/td>            		. Anticipation and organization
            . SAP completed with additional analyses
            . Update of the statistical program and associated QC
            . Timing management of each 5 interim analyses and final analysis (update of the SAP, new version of TFLs)
            . Several teleconference meetings to understand the Sponsor\u2019s expectations<\/td>            		. Adaptability and flexibility of ICTA to keep the timelines & deadlines
            . TFLs of > 4,000 pages<\/strong>
            . TFLs addendum of > 600 pages
            . Enabling data valorisation through a clinical report study (CSR)
            . First exhaustive database providing long-term real life data in this disease<\/strong>

            <\/td><\/tr><\/tbody><\/table><\/figure>\n<\/div><\/section>\n\n\n\n
              \n
            • <\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":15,"featured_media":10787,"template":"","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","inline_featured_image":false,"_uag_custom_page_level_css":"","kk_blocks_editor_width":"","_kiokenblocks_attr":"","_kiokenblocks_dimensions":"","footnotes":""},"categories":[],"class_list":["post-9898","casclients","type-casclients","status-publish","has-post-thumbnail","hentry"],"acf":[],"uagb_featured_image_src":{"full":["https:\/\/www.icta.fr\/wp-content\/uploads\/lung-cancer.jpg",493,247,false],"thumbnail":["https:\/\/www.icta.fr\/wp-content\/uploads\/lung-cancer-128x88.jpg",128,88,true],"medium":["https:\/\/www.icta.fr\/wp-content\/uploads\/lung-cancer-300x150.jpg",300,150,true],"medium_large":["https:\/\/www.icta.fr\/wp-content\/uploads\/lung-cancer.jpg",493,247,false],"large":["https:\/\/www.icta.fr\/wp-content\/uploads\/lung-cancer.jpg",493,247,false],"1536x1536":["https:\/\/www.icta.fr\/wp-content\/uploads\/lung-cancer.jpg",493,247,false],"2048x2048":["https:\/\/www.icta.fr\/wp-content\/uploads\/lung-cancer.jpg",493,247,false],"post-thumbnail":["https:\/\/www.icta.fr\/wp-content\/uploads\/lung-cancer.jpg",493,247,false],"wpm_taille_1":["https:\/\/www.icta.fr\/wp-content\/uploads\/lung-cancer-364x247.jpg",364,247,true],"wpm_taille_slider":["https:\/\/www.icta.fr\/wp-content\/uploads\/lung-cancer-240x145.jpg",240,145,true],"gform-image-choice-sm":["https:\/\/www.icta.fr\/wp-content\/uploads\/lung-cancer.jpg",300,150,false],"gform-image-choice-md":["https:\/\/www.icta.fr\/wp-content\/uploads\/lung-cancer.jpg",400,200,false],"gform-image-choice-lg":["https:\/\/www.icta.fr\/wp-content\/uploads\/lung-cancer.jpg",493,247,false]},"uagb_author_info":{"display_name":"Manon ROBERT","author_link":"https:\/\/www.icta.fr\/fr\/author\/mrobert-icta21\/"},"uagb_comment_info":0,"uagb_excerpt":null,"_links":{"self":[{"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/casclients\/9898","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/casclients"}],"about":[{"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/types\/casclients"}],"author":[{"embeddable":true,"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/users\/15"}],"version-history":[{"count":1,"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/casclients\/9898\/revisions"}],"predecessor-version":[{"id":9899,"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/casclients\/9898\/revisions\/9899"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/media\/10787"}],"wp:attachment":[{"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/media?parent=9898"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/categories?post=9898"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}