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 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.

Exclusion Criteria:

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.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

9

Study ID:

NCT05513703

Recruitment Status:

Active, not recruiting

Sponsor:

AbbVie

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There are 29 Locations for this study

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Cancer and Blood Speciality Clinic - Los Alamitos /ID# 251671
Los Alamitos California, 90720, United States
Valley Medical Center /ID# 251880
Renton Washington, 98055, United States
Monash Medical Centre /ID# 247679
Clayton Victoria, 3168, Australia
CHU Lille - Hôpital Albert Calmette /ID# 246263
Lille Hauts-de-France, 59037, France
HCL - Hopital Louis Pradel /ID# 246267
Bron Rhone, 69500, France
Centre Jean Perrin /ID# 246268
Clermont Ferrand , 63011, France
Asklepios Fachkliniken Muenchen-Gauting /ID# 248082
Gauting , 82131, Germany
Rambam Health Care Campus /ID# 246781
Haifa H_efa, 31096, Israel
Rabin Medical Center /ID# 248631
Haifa H_efa, 49414, Israel
Meir Medical Center /ID# 243208
Kfar Saba HaMerkaz, 44281, Israel
The Chaim Sheba Medical Center /ID# 243207
Ramat Gan Tel-Aviv, 52656, Israel
Hadassah Medical Center-Hebrew University /ID# 243298
Jerusalem Yerushalayim, 91120, Israel
Fondazione IRCCS San Gerardo dei Tintori /ID# 247584
Monza Monza E Brianza, 20900, Italy
Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 248329
Candiolo Torino, 10060, 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
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
Kaohsiung Chang Gung Memorial Hospital /ID# 248143
Kaohsiung City Kaohsiung, 833, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 248144
Kaohsiung , 807, Taiwan
National Cheng Kung University Hospital /ID# 248142
Tainan , 704, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 248145
Taoyuan City , 333, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

9

Study ID:

NCT05513703

Recruitment Status:

Active, not recruiting

Sponsor:


AbbVie

How clear is this clinincal trial information?

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