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)

NCT ID: NCT05513703

Last Updated: 2025-10-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-21
• Study Completion Date: 2024-10-28

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.

Conditions

Non Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Telisotuzumab Vedotin

Participants will receive telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria.

Group Type: EXPERIMENTAL

Telisotuzumab Vedotin

Intervention Type: BIOLOGICAL

Intravenous (IV) Infusion

Interventions

Telisotuzumab Vedotin

Intravenous (IV) Infusion

Intervention Type: BIOLOGICAL

Other Intervention Names

ABBV-399

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

Cancer and Blood Speciality Clinic - Los Alamitos /ID# 251671

Los Alamitos, California, United States

Valley Medical Center /ID# 251880

Renton, Washington, United States

Monash Health - Monash Medical Centre /ID# 247679

Clayton, Victoria, Australia

CHU Lille - Hôpital Albert Calmette /ID# 246263

Lille, Hauts-de-France, France

Hospices Civils de Lyon (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

Meir Medical Center /ID# 243208

Kfar Saba, Central District, Israel

Rambam Health Care Campus /ID# 246781

Haifa, H_efa, Israel

Hadassah Medical Center-Hebrew University /ID# 243298

Jerusalem, Jerusalem, Israel

The Chaim Sheba Medical Center /ID# 243207

Ramat Gan, Tel Aviv, Israel

Rabin Medical Center /ID# 248631

Petah Tikva, , Israel

Duplicate_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

Duplicate_National Hospital Organization Kyushu Cancer Center /ID# 250714

Fukuoka, Fukuoka, Japan

Hokkaido University Hospital /ID# 250316

Sapporo, Hokkaido, Japan

Osaka International Cancer Institute /ID# 251507

Osaka, Osaka, Japan

Shizuoka Cancer Center /ID# 251752

Sunto-gun, Shizuoka, Japan

National Cancer Center Hospital /ID# 250319

Chuo-ku, Tokyo, Japan

Keimyung University Dongsan Hospital /ID# 247371

Daegu, Gyeongsangbuk-do, South Korea

Pusan National University Yangsan Hospital /ID# 248489

Yangsan, Gyeongsangnam-do, South Korea

Chungbuk National University Hospital /ID# 248405

Cheongju-si, North Chungcheong, South Korea

Samsung Medical Center /ID# 248407

Seoul, Seoul Teugbyeolsi, South Korea

Kaohsiung Chang Gung Memorial Hospital /ID# 248143

Kaohsiung City, Kaohsiung, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 248144

Kaohsiung City, , Taiwan

National Cheng Kung University Hospital /ID# 248142

Tainan City, , Taiwan

Linkou Chang Gung Memorial Hospital /ID# 248145

Taoyuan, , Taiwan

Countries

United States; Australia; France; Germany; Israel; Italy; Japan; South Korea; Taiwan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.abbvieclinicaltrials.com/study/?id=M22-137

Related Info

Other Identifiers

2022-500608-23-00

Identifier Type: OTHER

Identifier Source: secondary_id

M22-137

Identifier Type: -

Identifier Source: org_study_id