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)

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Must have MET amplification in tumor tissue as determined by the Sponsor-designated central laboratory or in plasma and/or tissue by a Sponsor-approved assay.
Must have histologically documented non-squamous cell 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 if it was completed >= 6 months before participant'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.

Exclusion Criteria:

Have adenosquamous histology.
Alterations in EGFR, ALK, ROS1, or BRAF that predict sensitivity to targeted therapy. Participants with other alterations that are candidates for available targeted therapy.
Prior systemic therapy for locally advanced/metastatic NSCLC.
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 clinically significant 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.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

70

Study ID:

NCT05513703

Recruitment Status:

Recruiting

Sponsor:

AbbVie

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There are 63 Locations for this study

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Valley Medical Center /ID# 251880
Renton Washington, 98055, United States
Monash Medical Centre /ID# 247679
Clayton Victoria, 3168, Australia
Beijing Cancer Hospital /ID# 247881
Beijing Beijing, 10014, China
Chongqing University Three Gorges Hospital /ID# 247772
Wanzhou Chongqing, 40419, China More Info
Site Coordinator
Contact
023-58103238
The First Affiliated Hospital of Guangzhou Medical University /ID# 247828
Guangzhou Guangdong, 51016, China
Harbin Medical University Cancer Hospital /ID# 248982
Harbin Heilongjiang, 15008, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 247882
Wuhan Hubei, 43002, China
Renmin Hospital of Wuhan University /ID# 249019
Wuhan Hubei, 43006, China
Shandong Cancer Hospital /ID# 247823
Jinan Shandong, 25160, China
West China Hospital, Sichuan University /ID# 247783
Chengdu Sichuan, 61004, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 249068
Hangzhou Zhejiang, 31000, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 247840
Hangzhou Zhejiang, 31002, China
Zhejiang Cancer hospital /ID# 248958
Hangzhou Zhejiang, 31002, China
Sichuan Cancer Hospital /ID# 247909
Chengdu , 61004, China
Shanghai Chest Hospital /ID# 247826
Shanghai , 20003, China
Zhongshan Hospital Fudan University /ID# 247771
Shanghai , 20003, China More Info
Site Coordinator
Contact
86 02164041990
Tongji Hospital Tongji Medical College of HUST /ID# 249018
Wuhan , 43003, China
CHU Lille - Hôpital Albert Calmette /ID# 246263
Lille Hauts-de-France, 59037, France
HCL - Hôpital Louis Pradel /ID# 246267
Bron , 69500, France
Centre Jean Perrin /ID# 246268
Clermont Ferrand , 63011, France
Universitaetsklinikum Giessen /ID# 250462
Gießen Hessen, 35392, Germany
Asklepios Fachkliniken Muenchen-Gauting /ID# 248082
Gauting , 82131, Germany
Pius-Hospital Oldenburg /ID# 249107
Oldenburg , 26121, Germany
The Chaim Sheba Medical Center /ID# 243207
Ramat Gan Tel-Aviv, 52656, Israel
Hadassah Medical Center-Hebrew University /ID# 243298
Jerusalem Yerushalayim, 91120, Israel
Rambam Health Care Campus /ID# 246781
Haifa , 31096, Israel
Meir Medical Center /ID# 243208
Kfar Saba , 44281, Israel
Rabin Medical Center /ID# 248631
Petakh Tikva , 49414, Israel
Ospedale San Raffaele IRCCS /ID# 247588
Milan Milano, 20132, Italy
ASST Monza/Ospedale San Gerardo /ID# 247584
Monza Monza E Brianza, 20900, Italy
Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 248329
Candiolo Torino, 10060, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 249156
Ancona , 60126, Italy
IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 247585
Rome , 00144, Italy
National Cancer Center Hospital East /ID# 250317
Kashiwa-shi Chiba, 277-8, Japan
National Hospital Organization Kyushu Cancer Center /ID# 250714
Fukuoka-shi Fukuoka, 811-1, Japan
Hokkaido University Hospital /ID# 250316
Sapporo-shi Hokkaido, 060-8, Japan
Osaka International Cancer Institute /ID# 251507
Osaka-shi Osaka, 541-8, Japan
Shizuoka Cancer Center /ID# 251752
Sunto-gun Shizuoka, 411-8, Japan
National Cancer Center Hospital /ID# 250319
Chuo-ku Tokyo, 104-0, Japan
Pusan National University Yangsan Hospital /ID# 248489
Yangsan-si Gyeongsangnamdo, 50612, Korea, Republic of
Yonsei University Health System Severance Hospital /ID# 248404
Seoul Seoul Teugbyeolsi, 03722, Korea, Republic of
Chungbuk National Univ Hosp /ID# 248405
Cheongju , 28644, Korea, Republic of
Keimyung University Dongsan Medical Center /ID# 247371
Daegu , 41931, Korea, Republic of
Samsung Medical Center /ID# 248407
Seoul , 06351, Korea, Republic of
Spitalul Municipal Ploiesti /ID# 248609
Ploiesti Prahova, 10033, Romania
Spitalul Clinic Coltea /ID# 248608
Bucharest , 03017, Romania
Institutul Oncologic Prof Dr I Chiricuta /ID# 248610
Cluj Napoca , 40001, Romania
S.C. Radiotherapy Center Cluj SRL /ID# 248639
Cluj , 40728, Romania
CHU Insular-Materno Infantil /ID# 248121
Las Palmas de Gran Canaria Las Palmas, 35016, Spain
Hospital Universitario Fundacion Alcorcon /ID# 248116
Alcorcon Madrid, 28922, Spain
Hospital Universitario Dexeus - Grupo Quironsalud /ID# 248125
Barcelona , 08028, Spain
Institut Catala d'Oncologia -Hospital Duran i Reynals /ID# 248117
Barcelona , 08907, Spain
Hospital Clinico Universitario Lozano Blesa /ID# 248126
Zaragoza , 50009, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 248144
Kaohsiung , 807, Taiwan
Kaohsiung Chang Gung Memorial Hospital /ID# 248143
Kaohsiung , 833, Taiwan
National Cheng Kung University Hospital /ID# 248142
Tainan , 704, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 248145
Taoyuan City , 333, Taiwan
Adana Sehir Egitim ve Arastirma Hastanesi /ID# 246089
Adana , 01060, Turkey
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 246090
Ankara , 06200, Turkey
Gazi University Medical Faculty /ID# 246086
Ankara , 06560, Turkey
Akdeniz Universitesi Tip Fakul /ID# 246092
Antalya , 07059, Turkey
Trakya University Medical Facu /ID# 246083
Edirne, Istanbul , 22030, Turkey
Prof. Dr. Suleyman Yalcin Sehir Hastanesi /ID# 246084
Istanbul , 34722, Turkey
Dr. Suat Seren Gogus Has /ID# 246088
Izmir , 35110, Turkey
Leicester Royal Infirmary /ID# 246827
Leicester England, LE1 5, United Kingdom
University Hospitals Birmingham NHS Foundation Trust /ID# 246826
Birmingham , B15 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

70

Study ID:

NCT05513703

Recruitment Status:

Recruiting

Sponsor:


AbbVie

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