Non Small Cell Lung Cancer Clinical Trial
Official title:
A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to determine if telisotuzumab vedotin works better than docetaxel and to assess how safe telisotuzumab vedotin is in adult participants with NSCLC who have previously been treated. Change in disease activity and adverse events will be assessed. Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC. Participants will be randomly assigned a treatment of Teliso-V or Docetax at an 1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin or IV infusion of docetaxel. Approximately 698 adult participants with c-Met overexpressing NSCLC will be enrolled in the study in approximately 250 sites worldwide. Participants will receive IV telisotuzumab vedotin every 2 weeks or docetaxel every 3 weeks until meeting study drug discontinuation criteria. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Status | Recruiting |
Enrollment | 698 |
Est. completion date | March 21, 2028 |
Est. primary completion date | June 7, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Participants must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory using the VENTANA MET (SP44) RxDx assay. - Archival or fresh tumor material must be submitted for assessment of c-Met levels during the Pre-Screening period. Tumor material from the primary tumor site and/or metastatic sites are allowed. - If a participant was prescreened for Study M14-239 but did not enroll, tumor material previously submitted for Study M14-239 may be used for Study M18-868 Pre-Screening upon confirmation from AbbVie that sufficient evaluable tumor material is available (Except China). - A histologically documented non-squamous cell NSCLC that is locally advanced or metastatic. - A known epidermal growth factor receptor (EGFR) activating mutation status. - Actionable alterations in genes other than EGFR . - Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. - An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1. - Have received no more than 1 line of prior systemic cytotoxic chemotherapy in the locally advanced or metastatic setting. - Neoadjuvant and adjuvant systemic cytotoxic chemotherapy will count as a prior line for eligibility purposes if progression occurred within 6 months of the end of therapy. - Have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC: - Participants WITHOUT an actionable gene alteration: must have progressed on (or be considered ineligible for) platinum-based chemotherapy and immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy). - Participants WITH an actionable gene alteration for which immune checkpoint inhibitor therapy is not standard of care (e.g., anaplastic lymphoma kinase [ALK] translocation): must have progressed on (or be considered ineligible for) anti-cancer therapy targeting driver gene alterations and platinum-based chemotherapy. - Participants with actionable gene alterations for which immune checkpoint inhibitor is standard of care must have also progressed on (or be considered ineligible for) immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy). - Must be considered appropriate for docetaxel therapy based on the assessment of the treating physician. - Participants with metastases to the central nervous system (CNS) are eligible only after definitive therapy (such as surgery or radiotherapy) is provided and: - There is no evidence of progression of CNS metastases at least 2 weeks after definitive therapy. - They are asymptomatic and off or on a stable or reducing dose of systemic steroids and/or anticonvulsants for at least 2 weeks prior to first dose of telisotuzumab vedotin. Exclusion Criteria: - Participants with adenosquamous histology. - Actionable epidermal growth factor receptor (EGFR) activating mutations. - Participants who have received prior c-Met-targeted antibodies, prior telisotuzumab vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of monomethylauristatin E.. - Participants who have received prior docetaxel therapy. - A history of other malignancies except: - Malignancy treated with curative intent and with no known active disease present for >=2 years before the first dose of study drug and felt to be at low risk for recurrence by investigator. - Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. - Adequately treated carcinoma in situ without current evidence of disease. - A history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. A history of prior radiation pneumonitis in the radiation field (fibrosis) is permitted. - Unresolved adverse event (AE) >= Grade 2 from prior anticancer therapy, except for alopecia or anemia. - Major surgery within 21 days prior to the first dose of telisotuzumab vedotin. - Clinically significant condition(s) as listed in the protocol. |
Country | Name | City | State |
---|---|---|---|
Argentina | Centro Médico Austral /ID# 239860 | Ciudad Autonoma Buenos Aires | Ciudad Autonoma De Buenos Aires |
Argentina | Cenit /Id# 239880 | Ciudad Autonoma de Buenos Aire | Ciudad Autonoma De Buenos Aires |
Argentina | Hospital Britanico de Buenos Aires /ID# 231495 | Ciudad Autonoma de Buenos Aire | Ciudad Autonoma De Buenos Aires |
Argentina | Centro de Investigaciones Clinicas Clinica Viedma S.A. /ID# 232339 | Viedma | Rio Negro |
Australia | Barwon Health /ID# 241920 | Geelong | Victoria |
Australia | Austin Health /ID# 247507 | Heidelberg | Victoria |
Austria | Landeskrankenhaus Feldkirch /ID# 250333 | Feldkirch | Vorarlberg |
Austria | Ordensklinikum Linz GmbH Elisabethinen /ID# 240967 | Linz | Oberoesterreich |
Austria | Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 232467 | Salzburg | |
Austria | Klinik Floridsdorf /ID# 230608 | Vienna | Wien |
Austria | Klinik Penzing /ID# 230700 | Vienna | Wien |
Austria | Medizinische Universitaet Wien /ID# 230615 | Vienna | Wien |
Austria | Klinikum Wels-Grieskirchen GmbH /ID# 249000 | Wels | Oberoesterreich |
Belgium | Institut Jules Bordet /ID# 246770 | Anderlecht | |
Belgium | Algemeen Ziekenhuis klina /ID# 239853 | Brasschaat | |
Belgium | Grand Hopital de Charleroi /ID# 234178 | Charleroi | Hainaut |
Belgium | Universitair Ziekenhuis Antwerpen /ID# 239971 | Edegem | Antwerpen |
Belgium | AZ Maria Middelares /ID# 246768 | Gent | |
Belgium | Jessa Ziekenhuis /ID# 246766 | Hasselt | |
Belgium | Hospital La Louviere Site Jolimont - Helora /ID# 246771 | La Louvière | Hainaut |
Belgium | CHU de Liège /ID# 246772 | Liège | Liege |
Belgium | UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 246769 | Namur | |
Brazil | Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 233247 | Barretos | Sao Paulo |
Brazil | Irmandade da Santa Casa de Misericordia de Porto Alegre /ID# 233249 | Porto Alegre | Rio Grande Do Sul |
Brazil | Instituto D'or de Pesquisa e Ensino /ID# 233245 | Rio de Janeiro | |
Brazil | Instituto Nacional de Cancer (INCA) /ID# 231509 | Rio de Janeiro | |
Brazil | Ensino e Terapia de Inovacao - Clinica AMO /ID# 231604 | Salvador | Bahia |
Brazil | Casa de Saúde Santa Marcelina /ID# 231605 | Sao Paulo | |
Brazil | Instituto de Ensino e Pesquisas Sao Lucas /ID# 247417 | Sao Paulo | |
Bulgaria | Complex Oncology Center - Burgas /ID# 240532 | Burgas | |
Bulgaria | Complex Cancer Center Plovdiv /ID# 234106 | Plovdiv | |
Bulgaria | University Multiprofile Hospital for Active Treatment Sofiamed /ID# 234108 | Sofiya | Sofia |
Bulgaria | UMHAT Sveta Marina /ID# 234112 | Varna | |
Canada | CISSS de la Monteregie /ID# 239081 | Greenfield Park | Quebec |
Chile | Icegclinic /Id# 231212 | La Florida | Region Metropolitana De Santiago |
Chile | Fundacion Arturo Lopez Perez /ID# 231151 | Providencia | Region Metropolitana De Santiago |
Chile | Sociedad Oncovida /ID# 231152 | Providencia | Region Metropolitana De Santiago |
Chile | Sociedad Prosalud Montes y Orlandi /ID# 231154 | Providencia | Region Metropolitana De Santiago |
Chile | Clinica Universidad Catolica del Maule /ID# 231294 | Talca | Maule |
China | Affiliated Hospital of Hebei University /ID# 239586 | Baoding | Hebei |
China | Beijing Cancer Hospital /ID# 231923 | Beijing | Beijing |
China | Beijing Chest Hospital, Capital Medical University /ID# 232202 | Beijing | Beijing |
China | Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 233175 | Beijing | Beijing |
China | Jilin Cancer Hospital /ID# 244702 | Changchun | Jilin |
China | Hunan Cancer Hospital /ID# 231943 | Changsha | Hunan |
China | Sichuan Cancer Hospital /ID# 239707 | Chengdu | Sichuan |
China | West China Hospital, Sichuan University /ID# 233703 | Chengdu | Sichuan |
China | The First Affiliated Hospital of Chongqing Medical University /ID# 251592 | Chongqing | Chongqing |
China | The Second Affiliated Hospital of Dalian Medical University /ID# 239755 | Dalian | Liaoning |
China | Fujian Provincial Cancer Hospital /ID# 243134 | Fuzhou | Fujian |
China | The First Affiliated Hospital of Guangzhou Medical University /ID# 238591 | Guangzhou | Guangdong |
China | People's Hospital of Guizhou Province /ID# 243614 | Guiyang | Guizhou |
China | The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 232032 | Hangzhou | Zhejiang |
China | Zhejiang Cancer hospital /ID# 242476 | Hangzhou | Zhejiang |
China | Harbin Medical University Cancer Hospital /Id# 231941 | Harbin | Heilongjiang |
China | Anhui Medical University - Anhui Chest Hospital /ID# 231899 | Hefei | Anhui |
China | The Affiliated Hospital of Inner Mongolia Medical University /ID# 242179 | Huhehaote | Inner Mongolia |
China | Jinan Central Hospital /ID# 231895 | Jinan | Shandong |
China | Shandong Cancer Hospital /ID# 251506 | Jinan | Shandong |
China | Yunnan Cancer Hospital /ID# 251388 | Kunming | Yunnan |
China | Taizhou Hospital of Zhejiang Province /ID# 232021 | Linhai | Zhejiang |
China | LinYi Cancer Hospital /ID# 239713 | Linyi | Shandong |
China | The First Affiliated Hospital of Nanchang University /ID# 231934 | Nanchang | Jiangxi |
China | The Second Affiliated Hospital of Nanchang University /ID# 231935 | Nanchang | Jiangxi |
China | Nanjing Drum Tower Hospital /ID# 231791 | Nanjing | Jiangsu |
China | Affiliated Cancer Hospital of Guangxi Medical University /ID# 231855 | Nanning | Guangxi |
China | Nantong Tumor Hospital /ID# 232424 | Nantong | Jiangsu |
China | The First affiliated Hospital of Nanyang Medical College /ID# 244652 | Nanyang | Henan |
China | Ningbo No. 2 Hospital /ID# 242478 | Ningbo | |
China | Shanghai Chest Hospital /ID# 231897 | Shanghai | Shanghai |
China | Cancer Hospital of Shantou University Medical College /ID# 242182 | Shantou | Guangdong |
China | The First Hospital of China Medical University /ID# 231924 | Shenyang | Liaoning |
China | Shanxi Cancer Hospital /ID# 258674 | Taiyuan | Shanxi |
China | Tianjin Cancer Hospital /ID# 233176 | Tianjin | Tianjin |
China | Tianjin Medical University General Hospital /ID# 231839 | Tianjin | |
China | The Affiliated Cancer Hospital of Xinjiang Medical University /ID# 240094 | Urumqi | Xinjiang |
China | Hubei Cancer Hospital /ID# 240045 | Wuhan | Hubei |
China | Tongji Hospital Tongji Medical College of HUST /ID# 239575 | Wuhan | Hubei |
China | Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 231904 | Wuhan | Hubei |
China | The First Affiliated Hospital of Xiamen University /ID# 242381 | Xiamen | Fujian |
China | The First Affiliated Hospital of Xi'an Jiaotong University /ID# 232023 | Xian | Shaanxi |
China | Affiliated Hospital of Guangdong Medical College /ID# 233317 | Zhanjiang | Guangdong |
China | Henan Cancer Hospital /ID# 239577 | Zhengzhou | Henan |
China | People's Hospital of Henan Province /ID# 242187 | Zhengzhou | Henan |
Czechia | Masarykuv onkologicky ustav /ID# 232426 | Brno | |
Czechia | Nemocnice AGEL Novy Jicin, a.s. /ID# 232427 | Novy Jicin | |
Denmark | Odense University Hospital /ID# 241663 | Odense | Syddanmark |
Denmark | Roskilde Sygehus /ID# 241842 | Roskilde | Sjælland |
France | Hospices Civils de Lyon (HCL) - Hopital Louis Pradel /ID# 251933 | Bron | Rhone |
France | Centre Hosp Intercommunal de Creteil /ID# 251936 | Creteil | Val-de-Marne |
France | CHU Lille - Hôpital Albert Calmette /ID# 251934 | Lille | Hauts-de-France |
France | APHM - Hopital Nord /ID# 251935 | Marseille | Bouches-du-Rhone |
France | Hopital Arnaud de Villeneuve /ID# 239404 | Montpellier Cedex 5 | |
France | AP-HP - Hopital Tenon /ID# 239179 | Paris | |
France | Institut Curie /ID# 240141 | Paris CEDEX 05 | Paris |
France | Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 239409 | Paris CEDEX 14 | Paris |
France | Centre Hospitalier Universitaire de Bordeaux /ID# 244953 | Pessac CEDEX | Gironde |
Germany | Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 234247 | Berlin | |
Germany | Universitaetsklinikum Giessen /ID# 252973 | Gießen | Hessen |
Germany | Haemato-Onkologie Hamburg /ID# 241047 | Hamburg | |
Germany | Universitaetsklinikum Hamburg-Eppendorf /ID# 239658 | Hamburg | |
Germany | Thoraxklinik Heidelberg gGmbH /ID# 239656 | Heidelberg | |
Germany | Universitaetsklinikum Jena /ID# 239661 | Jena | Thueringen |
Germany | Klinikum Kassel /ID# 240142 | Kassel | Hessen |
Germany | Universitatsklinikum Mannheim /ID# 238331 | Mannheim | Baden-Wuerttemberg |
Greece | General Hospital of Chest Diseases of Athens SOTIRIA /ID# 230824 | Athens | Attiki |
Greece | Metropolitan Hospital /ID# 232158 | Piraeus | Attiki |
Greece | Metropolitan Hospital /ID# 239170 | Piraeus | Attiki |
Greece | Euromedica General Clinic /ID# 254407 | Thessaloniki | |
Israel | The Edith Wolfson Medical Center /ID# 233781 | Ashkelon | HaDarom |
Israel | Soroka University Medical Center /ID# 252711 | Be'er Sheva | HaDarom |
Israel | ZIV Medical Center /ID# 238606 | Safed | HaTsafon |
Israel | Tel Aviv Sourasky Medical Center /ID# 260519 | Tel Aviv | Tel-Aviv |
Italy | I.R.C.C.S Istituto Tumori Giovanni Paolo II /ID# 238696 | Bari | |
Italy | Azienda Socio Sanitaria Territoriale di Cremona /ID# 238698 | Cremona | |
Italy | Azienda Ospedaliera Papardo /ID# 258038 | Messina | |
Italy | AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 252942 | Napoli | |
Italy | Azienda Ospedaliera di Perugia /ID# 238473 | Perugia | Umbria |
Italy | Azienda Ospedaliera San Giovanni Addolorata /ID# 238618 | Rome | Roma |
Italy | ASST Sette Laghi /ID# 238536 | Varese | |
Japan | Juntendo University Hospital /ID# 239932 | Bunkyo-ku | Tokyo |
Japan | National Cancer Center Hospital /ID# 251134 | Chuo-ku | Tokyo |
Japan | Fujieda Municipal General Hospital /ID# 255155 | Fujieda-shi | |
Japan | National Hospital Organization Kyushu Medical Center /ID# 238533 | Fukuoka shi | Fukuoka |
Japan | Fukushima Medical University Hospital /ID# 249691 | Fukushima-shi | Fukushima |
Japan | Chugoku Central Hospital /ID# 242970 | Fukuyama | Hiroshima |
Japan | Osaka Habikino Medical Center /ID# 239989 | Habikino-shi | Osaka |
Japan | National Hospital Organization Mito Medical Center /ID# 241709 | Higashi Ibaraki-gun | Ibaraki |
Japan | Kansai Medical University Hospital /ID# 233476 | Hirakata-shi | Osaka |
Japan | Hirosaki University Hospital /ID# 242377 | Hirosaki-shi | Aomori |
Japan | Hiroshima University Hospital /ID# 241882 | Hiroshima-shi | Hiroshima |
Japan | Ibaraki Prefectural Central Hospital /ID# 246145 | Kasama-shi | Ibaraki |
Japan | National Cancer Center Hospital East /ID# 233775 | Kashiwa-shi | Chiba |
Japan | Hospital of the University of Occupational and Environmental Health, Japan /ID# 241191 | Kitakyushu-shi | Fukuoka |
Japan | Kobe Minimally Invasive Cancer Center /ID# 254131 | Kobe-shi | Hyogo |
Japan | Kumamoto University Hospital /ID# 241039 | Kumamoto shi | Kumamoto |
Japan | Kurashiki Central Hospital /ID# 239344 | Kurashiki-shi | Okayama |
Japan | Kurume University Hospital /ID# 254900 | Kurume-shi | Fukuoka |
Japan | National Hospital Organization Tokyo Medical Center /ID# 246581 | Meguro-ku | Tokyo |
Japan | University of Miyazaki Hospital /ID# 242161 | Miyazaki-shi | Miyazaki |
Japan | Nagaoka Red Cross Hospital /ID# 240714 | Nagaoka-shi | Niigata |
Japan | Nagoya University Hospital /ID# 239990 | Nagoya-shi | Aichi |
Japan | NHO Nagoya Medical Center /ID# 246306 | Nagoya-shi | Aichi |
Japan | Miyagi Cancer Center /ID# 234198 | Natori-shi | Miyagi |
Japan | Osaka Metropolitan University Hospital /ID# 238895 | Osaka-shi | Osaka |
Japan | Kindai University Hospital /ID# 239085 | Osakasayama-shi | Osaka |
Japan | Gunma Prefectural Cancer Center /ID# 233723 | Ota-shi | Gunma |
Japan | Kitasato University Hospital /ID# 239958 | Sagamihara-shi | Kanagawa |
Japan | Hokkaido University Hospital /ID# 241289 | Sapporo-shi | Hokkaido |
Japan | Sendai Kousei Hospital /ID# 253350 | Sendai-shi | Miyagi |
Japan | NTT Medical Center Tokyo /ID# 241067 | Shinagawa-ku | Tokyo |
Japan | Keio University Hospital /ID# 239506 | Shinjuku-ku | Tokyo |
Japan | Iwate Medical University Hospital /ID# 239027 | Shiwa-gun | Iwate |
Japan | Takarazuka City Hospital /ID# 240786 | Takarazuka-shi | Hyogo |
Japan | Toyama University Hospital /ID# 241660 | Toyama-shi | Toyama |
Japan | National Hospital Organization Mie Chuo Medical Center /ID# 246659 | Tsu-shi | Mie |
Japan | Yamaguchi - Ube Medical Center /ID# 258779 | Ube-shi | Yamaguchi |
Japan | Tochigi Cancer Center /ID# 240020 | Utsunomiya-shi | Tochigi |
Japan | Wakayama Medical University Hospital /ID# 234004 | Wakayama-shi | Wakayama |
Japan | Yamagata University Hospital /ID# 240815 | Yamagata-shi | Yamagata |
Japan | Yokohama City University Medical Center /ID# 246554 | Yokohama shi | Kanagawa |
Japan | Kanagawa Cardiovascular and Respiratory Center /ID# 239052 | Yokohama-shi | Kanagawa |
Korea, Republic of | Chungbuk National University Hospital /ID# 257891 | Cheongju | Chungcheongbugdo |
Korea, Republic of | National Cancer Center /ID# 260663 | Goyang-si | Gyeonggido |
Korea, Republic of | Gyeongsang National University Hospital /ID# 234244 | Jinju | Gyeongsangnamdo |
Korea, Republic of | CHA Bundang Medical Center /ID# 233318 | Seongnam | Gyeonggido |
Korea, Republic of | Kangbuk Samsung Hospital /ID# 233711 | Seoul | Seoul Teugbyeolsi |
Korea, Republic of | Samsung Medical Center /ID# 256941 | Seoul | |
Korea, Republic of | SMG-SNU Boramae Medical Center /ID# 233710 | Seoul | |
Korea, Republic of | The Catholic University Of Korea St. Vincent's Hospital /ID# 256942 | Suwon | Gyeonggido |
Korea, Republic of | Ajou University Hospital /ID# 233319 | Suwon-si | Gyeonggido |
Korea, Republic of | Pusan National University Yangsan Hospital /ID# 257836 | Yangsan-si | Gyeongsangnamdo |
Mexico | O.P.D. Hospital Civil de Guadalajara /ID# 238488 | Guadalajara | Jalisco |
Mexico | Centro de Investigacion Clínica Chapultepec SA de CV /ID# 231928 | Morelia | Michoacan |
Mexico | Clinical Research & Oncology Oaxaca /ID# 231883 | Oaxaca | |
Netherlands | HagaZiekenhuis /ID# 243693 | Den Haag | |
Netherlands | Ziekenhuis St. Jansdal /ID# 251932 | Harderwijk | |
Netherlands | Maastricht Universitair Medisch Centrum /ID# 233932 | Maastricht | |
Netherlands | Isala /ID# 238846 | Zwolle | |
Poland | Instytut Centrum Zdrowia Matki Polki /ID# 239024 | Lodz | Lodzkie |
Poland | Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie /ID# 239025 | Olsztyn | Warminsko-mazurskie |
Poland | MRUK-MED I Sp. z o.o. /ID# 239363 | Rzeszow | Podkarpackie |
Portugal | Fundacao Champalimaud /ID# 241925 | Lisbon | Lisboa |
Portugal | Centro Hospitalar Universitario de Sao Joao, EPE /ID# 241930 | Porto | |
Portugal | Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 241572 | Porto | |
Portugal | Hospital CUF Porto /ID# 241570 | Porto | |
Portugal | IPO Porto FG, EPE /ID# 241569 | Porto | |
Romania | Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL /ID# 240826 | Brasov | |
Romania | Cardiomed Srl /Id# 255320 | Cluj-Napoca | Cluj |
Romania | Sc Oncolab Srl /Id# 239105 | Craiova | |
Romania | Institutul Regional de Oncologie /ID# 254065 | Jassi | Iasi |
Romania | Spitalul Pelican /ID# 254066 | Oradea | Bihor |
Romania | SC RTC Radiology Therapeutic Center SRL /ID# 240744 | Otopeni | Ilfov |
Romania | S.C. Sigmedical Services SRL /ID# 239108 | Suceava | |
Romania | Oncocenter - Oncologie Clinica Srl /Id# 239103 | Timisoara | Timis |
Slovakia | Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 230084 | Banska Bystrica | |
South Africa | Sandton Oncology Medical Group PTY Ltd /ID# 230843 | Johannesburg | Gauteng |
South Africa | Wits Clinical Research /ID# 230841 | Johannesburg | Gauteng |
South Africa | Dept Medical Oncology, University of Pretoria and Steve Biko Academic Hospital /ID# 230883 | Pretoria | Gauteng |
Spain | Hospital Universitario Fundacion Alcorcon /ID# 255100 | Alcorcon | Madrid |
Spain | Hospital Nuestra Senora de Sonsoles /ID# 255102 | Avila | |
Spain | Hospital Universitario Dexeus - Grupo Quironsalud /ID# 255105 | Barcelona | |
Spain | UOMi Cancer Center - Clinica Tres Torres /ID# 240584 | Barcelona | |
Spain | Hospital Universitario de Fuenlabrada /ID# 255093 | Fuenlabrada | Madrid |
Spain | Hospital Universitario de Jaen /ID# 240588 | Jaen | |
Spain | CHU Insular-Materno Infantil /ID# 255094 | Las Palmas de Gran Canaria | Las Palmas |
Spain | Hospital Universitario 12 de Octubre /ID# 240176 | Madrid | |
Spain | Hospital Clinico Universitario de Valencia /ID# 240378 | Valencia | |
Sweden | Sahlgrenska Universitetssjukhuset /ID# 229943 | Göteborg | Vastra Gotalands Lan |
Sweden | Karolinska University Hospital Solna /ID# 229853 | Solna | Stockholms Lan |
Taiwan | Changhua Christian Hospital /ID# 238394 | Changhua City, Changhua County | |
Taiwan | National Taiwan University Hospital - Hsinchu branch /ID# 238393 | Hsinchu City | |
Taiwan | Hualien Tzu Chi Hospital /ID# 238398 | Hualien City | |
Taiwan | E-DA Cancer Hospital /ID# 239718 | Kaohsiung City | |
Taiwan | Chung Shan Medical University Hospital /ID# 238444 | Taichung | |
Taiwan | Mackay Memorial Hospital /ID# 238392 | Taipei City | Taipei |
Taiwan | National Taiwan University Hospital /ID# 238378 | Taipei City | Taipei |
Taiwan | Taipei Medical University Hospital /ID# 238380 | Taipei City | |
Turkey | Adana Acibadem Hospital /ID# 234208 | Adana | |
Turkey | Medical Park Seyhan Hastanesi /ID# 255637 | Adana | |
Turkey | Ankara City Hospital /ID# 234210 | Ankara | |
Turkey | Inonu Universitesi Turgut Ozal /ID# 234038 | Battalgazi/malatya | |
Turkey | Uludag University Medical Faculty /ID# 234205 | Bursa | |
Turkey | Memorial Ankara Hastanesi /ID# 234212 | Çankaya | Ankara |
Turkey | Dicle Universitesi Tip /ID# 234036 | Diyarbakir | |
Turkey | Bagcilar Medipol Mega Universite Hastanesi /ID# 234211 | Istanbul | |
Turkey | Ege University Medical Faculty /ID# 234039 | Izmir | |
Turkey | Izmir Ekonomi Universitesi Ozel Medicalpoint Hastanesi /ID# 234209 | Karsiyaka | Izmir |
United Kingdom | Barts Health NHS Trust /ID# 254342 | London | London, City Of |
United Kingdom | The Royal Marsden NHS Foundation Trust /ID# 246974 | London | |
United Kingdom | University College London Hospitals NHS Foundation Trust /ID# 249407 | London | |
United Kingdom | The Christie Hospital /ID# 243422 | Manchester | |
United Kingdom | Nottingham City Hospital /ID# 254707 | Nottingham | Nottinghamshire |
United States | Avera Cancer Institute - Aberdeen /ID# 257759 | Aberdeen | South Dakota |
United States | Intermountain Health - St Vincent Regional Hospital - Cancer Centers of Montana /ID# 253147 | Billings | Montana |
United States | Dana-Farber Cancer Institute /ID# 247132 | Boston | Massachusetts |
United States | Maimonides Medical Center /ID# 240783 | Brooklyn | New York |
United States | Ironwood Cancer & Res Ctr /ID# 262446 | Chandler | Arizona |
United States | Medical University of South Carolina /ID# 251383 | Charleston | South Carolina |
United States | St. Luke's Hospital - Chesterfield /ID# 251688 | Chesterfield | Missouri |
United States | City of Hope /ID# 243157 | Duarte | California |
United States | Astera Cancer Care /ID# 257753 | East Brunswick | New Jersey |
United States | Edward-Elmhurst Cancer Center /ID# 238552 | Elmhurst | Illinois |
United States | San Juan Oncology Associates /ID# 244387 | Farmington | New Mexico |
United States | Goshen Center for Cancer Care /ID# 257734 | Goshen | Indiana |
United States | Hattiesburg Clinic /ID# 248033 | Hattiesburg | Mississippi |
United States | Kaiser Permanente Moanalua Medical Center /ID# 238363 | Honolulu | Hawaii |
United States | City of Hope - Huntington Beach /ID# 263143 | Huntington Beach | California |
United States | Investigative Clinical Research of Indiana - Indianapolis /ID# 260468 | Indianapolis | Indiana |
United States | City of Hope Orange County Lennar Foundation Cancer Center /ID# 263144 | Irvine | California |
United States | Mayo Clinic /ID# 254688 | Jacksonville | Florida |
United States | Alliance for Multispecialty Research (AMR) - Kansas City /ID# 247567 | Kansas City | Missouri |
United States | St. Luke's Hosp. of Kansas City /ID# 259940 | Kansas City | Missouri |
United States | City of Hope - Antelope Valley /ID# 263138 | Lancaster | California |
United States | Baptist Health Lexington /ID# 252769 | Lexington | Kentucky |
United States | The Oncology Institute of Hope and Innovation - DTLA /ID# 239774 | Los Angeles | California |
United States | University of California, Los Angeles /ID# 253954 | Los Angeles | California |
United States | Ocala Oncology Florida Cancer Affiliates - Main /ID# 234228 | Ocala | Florida |
United States | Community Cancer Trials of Utah - South Ogden /ID# 262829 | Ogden | Utah |
United States | Mayo Clinic Arizona /ID# 255858 | Phoenix | Arizona |
United States | FirstHealth of the Carolinas- Speciality Center /ID# 241279 | Pinehurst | North Carolina |
United States | Eisenhower Medical Center /ID# 233189 | Rancho Mirage | California |
United States | Renown Medical Group - Oncology/Hematology /ID# 247942 | Reno | Nevada |
United States | Valley Medical Center /ID# 253950 | Renton | Washington |
United States | Mayo Clinic - Rochester /ID# 252052 | Rochester | Minnesota |
United States | Avera Cancer Institute /ID# 239635 | Sioux Falls | South Dakota |
United States | Medical Oncology Associates /ID# 247003 | Spokane | Washington |
United States | Hulston Cancer Center /ID# 232226 | Springfield | Missouri |
United States | Springfield Clinic /ID# 262290 | Springfield | Illinois |
United States | Trinity Health St. Joseph Mercy Ann Arbor /ID# 232190 | Ypsilanti | Michigan |
United States | Yuma Regional Medical Center /ID# 253625 | Yuma | Arizona |
United States | Genesis Cancer Care Center /ID# 239190 | Zanesville | Ohio |
Lead Sponsor | Collaborator |
---|---|
AbbVie |
United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czechia, Denmark, France, Germany, Greece, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Taiwan, Turkey, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-Free Survival (PFS) per Independent Central Review (ICR) | PFS is defined as the time from randomization to the first occurrence of radiographic progression based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) per ICR or death from any cause. | Up to approximately 39 months | |
Primary | Overall Survival (OS) | OS is defined as the time from randomization to the event of death from any cause. | Up to approximately 39 months | |
Secondary | Objective Response Rate (ORR), per ICR. | ORR is defined as the proportion of participants with a complete response (CR) or partial response (PR) based on RECIST v1.1 | Up to approximately 58.25 months | |
Secondary | Duration of Response (DoR), per ICR | DoR is defined for responders as the time from response (CR or PR) to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause. | Up to approximately 58.25 months | |
Secondary | PFS per Investigator Assessment | PFS is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 per investigator or death from any cause. Participants with no PFS event will be censored at the last evaluable radiographic assessment per investigator. Participants with no event and no evaluable post-baseline assessment will be censored at randomization. | Up to approximately 58.25 months | |
Secondary | Time to Deterioration in Cough, Pain or Dyspnea as measured by the Cough, Pain and Dyspnea items of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) | The EORTC QLQ-LC13 is the lung cancer specific module of the core EORTC QLQ-C30. The QLQ-LC13 includes 13 questions that include both multi-item and single-item scales of lung cancer-associated symptoms (e.g., pain, coughing, hemoptysis, and dyspnea) and side-effects from chemo- and radiotherapy (e.g., hair loss, neuropathy, sore mouth and dysphagia). All scale and item scores are linearly transformed to a 0 to 100 scale, with higher scores representing increasing symptom levels or impacts. | Up to approximately 58.25 months | |
Secondary | Time to Deterioration of Physical Functioning as measured by the Physical Functioning domain of the EORTC-QLQ-Core 30 (EORTC QLQ-C30). | The EORTC QLQ-C30 assesses health-related quality of life in cancer patients participating in clinical trials. The EORTC QLQ-C30 comprises 5 functional scales (physical, role, emotional, social, cognitive), 8 single-item symptom scales (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, and dyspnea), as well as subscales assessing global health/quality of life and financial impact. Raw scores are transformed to a scale of 0 to 100, with higher scores representing better functioning/quality of life and greater symptom burden. | Up to approximately 58.25 months | |
Secondary | Change from Baseline in Quality of Life as measured by the Global Health Status/Quality of Life Domain of the EORTC QLQ-C30. | The EORTC QLQ-C30 assesses health-related quality of life in cancer patients participating in clinical trials. The EORTC QLQ-C30 comprises 5 functional scales (physical, role, emotional, social, cognitive), 8 single-item symptom scales (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, and dyspnea), as well as subscales assessing global health/quality of life and financial impact. Raw scores are transformed to a scale of 0 to 100, with higher scores representing better functioning/quality of life and greater symptom burden. | Up to approximately 58.25 months |
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