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)

NCT05513703 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: M22-1372022-500608-23-00
• Study Type: interventional
• Target: 9
• Locations: 9 countries
• Sites: 29

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

Keywords

c-Met NSCLC; Telisotuzumab Vedotin; ABBV-399; Cancer; Non Small Cell Lung Cancer; NSCLC; MET Amplified NSCLC

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) as Assessed by an Independent Central Review (ICR)

  ORR was defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 as assessed by ICR.

  Up to approximately 1.5 years

Secondary Outcomes (8)

• Duration of Response (DoR)

  Up to approximately 1.5 years

• Disease Control Rate (DCR)

  Up to approximately 1.5 years

• Progression Free Survival (PFS) Per ICR

  Up to approximately 1.5 years

• Overall Survival (OS)

  Up to approximately 1.5 years

• Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)

  Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 28, 30, 32

Study Arms (1)

Telisotuzumab Vedotin

EXPERIMENTAL

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

Biological: Telisotuzumab Vedotin

Interventions

Telisotuzumab Vedotin BIOLOGICAL

Intravenous (IV) Infusion

Also known as: ABBV-399

Telisotuzumab Vedotin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (29)

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

Los Alamitos, California, 90720-3309, United States

Location

Valley Medical Center /ID# 251880

Renton, Washington, 98055-5738, United States

Location

Monash Health - Monash Medical Centre /ID# 247679

Clayton, Victoria, 3168, Australia

Location

CHU Lille - Hôpital Albert Calmette /ID# 246263

Lille, Hauts-de-France, 59037, France

Location

Hospices Civils de Lyon (HCL) - Hopital Louis Pradel /ID# 246267

Bron, Rhone, 69500, France

Location

Centre Jean Perrin /ID# 246268

Clermont-Ferrand, 63011, France

Location

Asklepios Fachkliniken Muenchen-Gauting /ID# 248082

Gauting, 82131, Germany

Location

Meir Medical Center /ID# 243208

Kfar Saba, Central District, 4428164, Israel

Location

Rambam Health Care Campus /ID# 246781

Haifa, H_efa, 3109601, Israel

Location

Hadassah Medical Center-Hebrew University /ID# 243298

Jerusalem, Jerusalem, 91120, Israel

Location

The Chaim Sheba Medical Center /ID# 243207

Ramat Gan, Tel Aviv, 5265601, Israel

Location

Rabin Medical Center /ID# 248631

Petah Tikva, 4941492, Israel

Location

Duplicate_Fondazione IRCCS San Gerardo dei Tintori /ID# 247584

Monza, Monza E Brianza, 20900, Italy

Location

Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 248329

Candiolo, Torino, 10060, Italy

Location

IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 247585

Rome, 00144, Italy

Location

National Cancer Center Hospital East /ID# 250317

Kashiwa-shi, Chiba, 277-8577, Japan

Location

Duplicate_National Hospital Organization Kyushu Cancer Center /ID# 250714

Fukuoka, Fukuoka, 811-1395, Japan

Location

Hokkaido University Hospital /ID# 250316

Sapporo, Hokkaido, 060-8648, Japan

Location

Osaka International Cancer Institute /ID# 251507

Osaka, Osaka, 541-8567, Japan

Location

Shizuoka Cancer Center /ID# 251752

Sunto-gun, Shizuoka, 411-8777, Japan

Location

National Cancer Center Hospital /ID# 250319

Chuo-ku, Tokyo, 104-0045, Japan

Location

Keimyung University Dongsan Hospital /ID# 247371

Daegu, Gyeongsangbuk-do, 42601, South Korea

Location

Pusan National University Yangsan Hospital /ID# 248489

Yangsan, Gyeongsangnam-do, 50612, South Korea

Location

Chungbuk National University Hospital /ID# 248405

Cheongju-si, North Chungcheong, 28644, South Korea

Location

Samsung Medical Center /ID# 248407

Seoul, Seoul Teugbyeolsi, 06351, South Korea

Location

Kaohsiung Chang Gung Memorial Hospital /ID# 248143

Kaohsiung City, Kaohsiung, 833, Taiwan

Location

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

Kaohsiung City, 807, Taiwan

Location

National Cheng Kung University Hospital /ID# 248142

Tainan, 704, Taiwan

Location

Linkou Chang Gung Memorial Hospital /ID# 248145

Taoyuan, 333, Taiwan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasms

Interventions

telisotuzumab vedotin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 24, 2022
• Study Start: November 21, 2022
• Primary Completion: October 28, 2024
• Study Completion: October 28, 2024
• Last Updated: October 24, 2025
• Results First Posted: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

FR (3); IL (5); US (2); IT (3); JP (6); AU (1); KR (4); TW (4); DE (1)