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)

Trial Title: 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

Condition: Non Small Cell Lung Cancer

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung

Conditions: Keywords:
c-Met NSCLC
Telisotuzumab Vedotin
ABBV-399
Cancer
Non Small Cell Lung Cancer
NSCLC
MET Amplified NSCLC

Study type: Interventional

Study phase: Phase 2

Overall status: Active, not recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: Telisotuzumab Vedotin
Description: Intravenous (IV) Infusion
Arm group label: Telisotuzumab Vedotin

Other name: ABBV-399

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

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

Address:
City: Los Alamitos
Zip: 90720-3309
Country: United States

Facility:
Name: Valley Medical Center /ID# 251880

Address:
City: Renton
Zip: 98055-5738
Country: United States

Facility:
Name: Monash Medical Centre /ID# 247679

Address:
City: Clayton
Zip: 3168
Country: Australia

Facility:
Name: CHU Lille - Hôpital Albert Calmette /ID# 246263

Address:
City: Lille
Zip: 59037
Country: France

Facility:
Name: HCL - Hopital Louis Pradel /ID# 246267

Address:
City: Bron
Zip: 69500
Country: France

Facility:
Name: Centre Jean Perrin /ID# 246268

Address:
City: Clermont Ferrand
Zip: 63011
Country: France

Facility:
Name: Asklepios Fachkliniken Muenchen-Gauting /ID# 248082

Address:
City: Gauting
Zip: 82131
Country: Germany

Facility:
Name: Rambam Health Care Campus /ID# 246781

Address:
City: Haifa
Zip: 3109601
Country: Israel

Facility:
Name: Rabin Medical Center /ID# 248631

Address:
City: Haifa
Zip: 4941492
Country: Israel

Facility:
Name: Meir Medical Center /ID# 243208

Address:
City: Kfar Saba
Zip: 4428164
Country: Israel

Facility:
Name: The Chaim Sheba Medical Center /ID# 243207

Address:
City: Ramat Gan
Zip: 5265601
Country: Israel

Facility:
Name: Hadassah Medical Center-Hebrew University /ID# 243298

Address:
City: Jerusalem
Zip: 91120
Country: Israel

Facility:
Name: Fondazione IRCCS San Gerardo dei Tintori /ID# 247584

Address:
City: Monza
Zip: 20900
Country: Italy

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

Address:
City: Candiolo
Zip: 10060
Country: Italy

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

Address:
City: Rome
Zip: 00144
Country: Italy

Facility:
Name: National Cancer Center Hospital East /ID# 250317

Address:
City: Kashiwa-shi
Zip: 277-8577
Country: Japan

Facility:
Name: National Hospital Organization Kyushu Cancer Center /ID# 250714

Address:
City: Fukuoka-shi
Zip: 811-1395
Country: Japan

Facility:
Name: Hokkaido University Hospital /ID# 250316

Address:
City: Sapporo-shi
Zip: 060-8648
Country: Japan

Facility:
Name: Osaka International Cancer Institute /ID# 251507

Address:
City: Osaka-shi
Zip: 541-8567
Country: Japan

Facility:
Name: Shizuoka Cancer Center /ID# 251752

Address:
City: Sunto-gun
Zip: 411-8777
Country: Japan

Facility:
Name: National Cancer Center Hospital /ID# 250319

Address:
City: Chuo-ku
Zip: 104-0045
Country: Japan

Facility:
Name: Pusan National University Yangsan Hospital /ID# 248489

Address:
City: Yangsan-si
Zip: 50612
Country: Korea, Republic of

Facility:
Name: Chungbuk National Univ Hosp /ID# 248405

Address:
City: Cheongju
Zip: 28644
Country: Korea, Republic of

Facility:
Name: Keimyung University Dongsan Medical Center /ID# 247371

Address:
City: Daegu
Zip: 41931
Country: Korea, Republic of

Facility:
Name: Samsung Medical Center /ID# 248407

Address:
City: Seoul
Zip: 06351
Country: Korea, Republic of

Facility:
Name: Kaohsiung Chang Gung Memorial Hospital /ID# 248143

Address:
City: Kaohsiung City
Zip: 833
Country: Taiwan

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

Address:
City: Kaohsiung
Zip: 807
Country: Taiwan

Facility:
Name: National Cheng Kung University Hospital /ID# 248142

Address:
City: Tainan
Zip: 704
Country: Taiwan

Facility:
Name: Linkou Chang Gung Memorial Hospital /ID# 248145

Address:
City: Taoyuan City
Zip: 333
Country: Taiwan

Start date: November 21, 2022

Completion date: March 31, 2026

Lead sponsor:
Agency: AbbVie
Agency class: Industry

Source: AbbVie

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05513703
https://www.abbvieclinicaltrials.com/study/?id=M22-137