Lung Cancer Clinical Trial
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)
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.
Must have MET amplification in tumor tissue as determined by the Sponsor-designated central laboratory MET FISH Assay or in plasma and/or tissue by a Sponsor-approved assay.
Must have histologically documented non-squamous adenocarcinoma non-small cell lung cancer (NSCLC) that is locally advanced or metastatic.
Must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Participant may have received prior adjuvant/neoadjuvant systemic chemotherapy and/or radiation and/or immunotherapy provided that the subject has not progressed on or within 6 months of completing the regimen and it was completed >= 6 months before subject's first dose of study drug.
Metastases to the central nervous system (CNS) are eligible only after definitive therapy is provided as noted in the protocol.
History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
Alterations in EGFR, ALK, ROS1, or BRAF that predict sensitivity to available targeted therapy. Participants with other alterations that are candidates for available targeted therapy.
Prior systemic therapy for locally advanced/metastatic NSCLC. Of note, limited treatment with no more than 1 cycle of chemotherapy is allowed prior to receiving the first dose of study drug provided there is no evidence of progression.
Have a history of other malignancies except those noted in the protocol.
Have 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.
Received prior c-Met-targeted antibodies.
Have NSCLC that is eligible for treatment with curative intent.
Have unresolved adverse events (AEs) >= Grade 2 from prior anticancer therapy, except for alopecia or anemia.
Have had major surgery within 21 days prior to the first dose of telisotuzumab vedotin.
Have clinically significant condition(s) as noted in the protocol.
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There are 26 Locations for this study
Los Alamitos California, 90720, United States
Clayton Victoria, 3168, Australia
Lille Hauts-de-France, 59037, France
Gauting , 82131, Germany
Ramat Gan Tel-Aviv, 52656, Israel
Jerusalem Yerushalayim, 91120, Israel
Haifa , 31096, Israel
Kfar Saba , 44281, Israel
Petakh Tikva , 49414, Israel
Monza Monza E Brianza, 20900, Italy
Candiolo Torino, 10060, Italy
Kashiwa-shi Chiba, 277-8, Japan
Fukuoka-shi Fukuoka, 811-1, Japan
Sapporo-shi Hokkaido, 060-8, Japan
Osaka-shi Osaka, 541-8, Japan
Sunto-gun Shizuoka, 411-8, Japan
Chuo-ku Tokyo, 104-0, Japan
Yangsan-si Gyeongsangnamdo, 50612, Korea, Republic of
Cheongju , 28644, Korea, Republic of
Daegu , 41931, Korea, Republic of
Seoul , 06351, Korea, Republic of
Kaohsiung City Kaohsiung, 833, Taiwan
Kaohsiung , 807, Taiwan
Tainan , 704, Taiwan
Taoyuan City , 333, Taiwan
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