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Brief Title: A Study to Assess Disease Activity of Intravenously (IV) Infused Telisotuzumab Vedotin in Adult Participants With Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Official Title: Phase 2, Open-Label Study in Subjects With Previously Untreated MET Amplified Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Study ID: NCT05513703
Brief Summary: 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 how telisotuzumab vedotin affects the disease state in adult participants with previously untreated participants with MET amplified non-squamous NSCLC. Change in disease activity will be assessed. Telisotuzumab vedotin is an investigational drug being developed for the treatment of MET amplified non-squamous NSCLC. Participants receive intravenously (IV) infused of telisotuzumab vedotin. Approximately 70 adult participants with previously untreated MET amplified locally advanced/metastatic non-squamous NSCLC will be enrolled in the study in approximately 110 sites worldwide. Participants will receive IV telisotuzumab vedotin every 2 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Cancer and Blood Speciality Clinic - Los Alamitos /ID# 251671, Los Alamitos, California, United States
Valley Medical Center /ID# 251880, Renton, Washington, United States
Monash Medical Centre /ID# 247679, Clayton, Victoria, Australia
CHU Lille - Hôpital Albert Calmette /ID# 246263, Lille, Hauts-de-France, France
HCL - Hopital Louis Pradel /ID# 246267, Bron, Rhone, France
Centre Jean Perrin /ID# 246268, Clermont Ferrand, , France
Asklepios Fachkliniken Muenchen-Gauting /ID# 248082, Gauting, , Germany
Rambam Health Care Campus /ID# 246781, Haifa, H_efa, Israel
Rabin Medical Center /ID# 248631, Haifa, H_efa, Israel
Meir Medical Center /ID# 243208, Kfar Saba, HaMerkaz, Israel
The Chaim Sheba Medical Center /ID# 243207, Ramat Gan, Tel-Aviv, Israel
Hadassah Medical Center-Hebrew University /ID# 243298, Jerusalem, Yerushalayim, Israel
Fondazione IRCCS San Gerardo dei Tintori /ID# 247584, Monza, Monza E Brianza, Italy
Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 248329, Candiolo, Torino, Italy
IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 247585, Rome, , Italy
National Cancer Center Hospital East /ID# 250317, Kashiwa-shi, Chiba, Japan
National Hospital Organization Kyushu Cancer Center /ID# 250714, Fukuoka-shi, Fukuoka, Japan
Hokkaido University Hospital /ID# 250316, Sapporo-shi, Hokkaido, Japan
Osaka International Cancer Institute /ID# 251507, Osaka-shi, Osaka, Japan
Shizuoka Cancer Center /ID# 251752, Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital /ID# 250319, Chuo-ku, Tokyo, Japan
Pusan National University Yangsan Hospital /ID# 248489, Yangsan-si, Gyeongsangnamdo, Korea, Republic of
Chungbuk National Univ Hosp /ID# 248405, Cheongju, , Korea, Republic of
Keimyung University Dongsan Medical Center /ID# 247371, Daegu, , Korea, Republic of
Samsung Medical Center /ID# 248407, Seoul, , Korea, Republic of
Kaohsiung Chang Gung Memorial Hospital /ID# 248143, Kaohsiung City, Kaohsiung, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 248144, Kaohsiung, , Taiwan
National Cheng Kung University Hospital /ID# 248142, Tainan, , Taiwan
Linkou Chang Gung Memorial Hospital /ID# 248145, Taoyuan City, , Taiwan
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR