Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT04928846

PHASE3

A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Sponsor: AbbVie

View on ClinicalTrials.gov

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 if telisotuzumab vedotin works better than docetaxel and to assess how safe telisotuzumab vedotin is in adult participants with NSCLC who have previously been treated. Change in disease activity and adverse events will be assessed. Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC. Participants will be randomly assigned a treatment of telisotuzumab vedotin or docetaxel at an 1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin or IV infusion of docetaxel. Approximately 768 adult participants with c-Met overexpressing NSCLC will be enrolled in the study in approximately 330 sites worldwide. Participants will receive IV telisotuzumab vedotin every 2 weeks or docetaxel every 3 weeks until meeting study drug discontinuation criteria. At the conclusion of the study, participants who continue to demonstrate clinical benefit may be eligible to receive study treatment via an extension of the study, a rollover study, or through another mechanism. 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.

Official title: A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

768

Start Date

2022-03-25

Completion Date

2029-02

Last Updated

2026-10-29

Healthy Volunteers

Conditions

Non Small Cell Lung Cancer c-MET

Interventions

BIOLOGICAL

Telisotuzumab Vedotin

Intravenous (IV) Infusion

DRUG

Docetaxel

IV Infusion

Inclusion Criteria: * Projected life expectancy of at least 12 weeks. * Participants must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory using the VENTANA MET (SP44) RxDx assay. * Archival or fresh tumor material must be submitted for assessment of c-Met protein expression levels during the Pre-Screening period. Tumor material from the primary tumor site and/or metastatic sites are allowed. * If a participant was prescreened for Study M14-239 but did not enroll, tumor material previously submitted for Study M14-239 may be used for Study M18-868 Pre-Screening upon confirmation from AbbVie that sufficient evaluable tumor material is available (Except China). * A histologically or cytologically documented non-squamous cell NSCLC that is locally advanced or metastatic. * A known epidermal growth factor receptor (EGFR) activating mutation status. \-- Participants with EGFR activating mutations are not eligible * Actionable alterations in genes other than EGFR are eligible. * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. * An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1. * Have received no more than 1 line of prior systemic cytotoxic chemotherapy in the locally advanced or metastatic setting. * Have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC * Participants WITHOUT an actionable gene alteration: must have progressed on (or be considered ineligible for) platinum-based chemotherapy and immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy). * Participants WITH an actionable gene alteration for which immune checkpoint inhibitor therapy is not standard of care (e.g., anaplastic lymphoma kinase \[ALK\] translocation): must have progressed on (or be considered ineligible for) anti-cancer therapy targeting driver gene alterations and platinum-based chemotherapy. * Participants with gene alterations for which immune checkpoint inhibitor is standard of care must have also progressed on (or be considered ineligible for) immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy). * Must be considered appropriate for docetaxel therapy based on the assessment of the treating physician. * Participants with metastases to the central nervous system (CNS) are eligible only after adequate treatment (such as surgery, radiotherapy, or drug therapy) is provided and: * They are asymptomatic and off or on a stable or reducing dose of systemic steroids (on no more than 10 mg per day \[QD\] prednisone or equivalent) and/or anticonvulsants for at least 2 weeks prior to randomization. Exclusion Criteria: * Evidence of new, untreated CNS metastases or progressing CNS metastases after treatment. * Evidence of leptomeningeal disease. * Participants with adenosquamous or neuroendocrine histology, nor sarcomatoid features. * Epidermal growth factor receptor (EGFR) activating mutations. * Participants who have received prior c-Met-targeted antibodies, prior telisotuzumab vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of monomethylauristatin E.. * Participants who have received prior docetaxel therapy. * A history of other malignancies except: * Malignancy treated with curative intent and with no known active disease present for \>=2 years before the first dose of study drug and felt to be at low risk for recurrence by investigator. Additionally, participants must not be receiving any ongoing anti-cancer therapy, including maintenance therapy, prior to randomization.. * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. * Adequately treated carcinoma in situ without current evidence of disease. * A history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, evidence of active pneumonitis on screening chest computed tomography (CT) scan or prior pneumonectomy. A history of prior radiation pneumonitis in the radiation field (fibrosis) is not permitted. * Unresolved nor adverse event (AE) \>= Grade 2 from prior anticancer therapy, except for alopecia or anemia. Participants with hormone deficiencies caused by prior anticancer therapy who are asymptomatic and on a stable dose of replacement hormone are eligible for study. * Major surgery within 21 days prior to randomization. * Clinically significant condition(s) as listed in the protocol.

Locations (317)

University of Alabama at Birmingham - Main /ID# 247074

Birmingham, Alabama, United States

Ironwood Cancer & Res Ctr /ID# 262446

Chandler, Arizona, United States

Mayo Clinic Arizona /ID# 255858

Phoenix, Arizona, United States

Onvida Health Yuma Medical Center /ID# 253625

Yuma, Arizona, United States

City of Hope /ID# 243157

Duarte, California, United States

City Of Hope - Seacliff /ID# 263143

Huntington Beach, California, United States

City of Hope - Orange County Lennar Foundation Cancer Center /ID# 263144

Irvine, California, United States

City Of Hope - Antelope Valley /ID# 263138

Lancaster, California, United States

The Oncology Institute Of Hope & Innovation -East Los A /ID# 239774

Los Angeles, California, United States

Eisenhower Medical Center /ID# 233189

Rancho Mirage, California, United States

Premiere Oncology Foundation /ID# 253954

Santa Monica, California, United States

Mayo Clinic Hospital Jacksonville /ID# 254688

Jacksonville, Florida, United States

Ocala Oncology Florida Cancer Affiliates - Main /ID# 234228

Ocala, Florida, United States

BRCR Medical Center Inc /ID# 262344

Tamarac, Florida, United States

Memorial University Medical Center /ID# 264081

Savannah, Georgia, United States

Kaiser Permanente Moanalua Medical Center /ID# 238363

Honolulu, Hawaii, United States

Edward-Elmhurst Cancer Center /ID# 238552

Elmhurst, Illinois, United States

Springfield Clinic - First /ID# 262290

Springfield, Illinois, United States

Goshen Center for Cancer Care /ID# 257734

Goshen, Indiana, United States

Investigative Clinical Research of Indiana - Indianapolis /ID# 260468

Indianapolis, Indiana, United States

Baptist Health Lexington /ID# 252769

Lexington, Kentucky, United States

Dana-Farber Cancer Institute /ID# 247132

Boston, Massachusetts, United States

Trinity Health St. Joseph Mercy Ann Arbor /ID# 232190

Ypsilanti, Michigan, United States

Mayo Clinic Hospital Rochester /ID# 252052

Rochester, Minnesota, United States

Hattiesburg Clinic /ID# 248033

Hattiesburg, Mississippi, United States

St. Luke's Hospital - Chesterfield /ID# 251688

Chesterfield, Missouri, United States

St. Lukes Hosp. of Kansas City /ID# 259940

Kansas City, Missouri, United States

Alliance for Multispecialty Research (AMR) - Kansas City /ID# 247567

Kansas City, Missouri, United States

Hulston Cancer Center /ID# 232226

Springfield, Missouri, United States

Saint Louis University Cancer Center /ID# 260722

St Louis, Missouri, United States

Intermountain Health St Vincent Regional Hospital - Cancer Centers of Montana /ID# 253147

Billings, Montana, United States

Nebraska Hematology Oncology /ID# 257710

Lincoln, Nebraska, United States

Renown Medical Group - Oncology/Hematology /ID# 247942

Reno, Nevada, United States

Astera Cancer Care /ID# 257753

East Brunswick, New Jersey, United States

San Juan Oncology Associates /ID# 244387

Farmington, New Mexico, United States

Maimonides Medical Center /ID# 240783

Brooklyn, New York, United States

Northwell Health - Monter Cancer Center /ID# 247081

Lake Success, New York, United States

AdventHealth Hendersonville /ID# 265349

Hendersonville, North Carolina, United States

FirstHealth of the Carolinas- Speciality Center /ID# 241279

Pinehurst, North Carolina, United States

Genesis Cancer Care Center /ID# 239190

Zanesville, Ohio, United States

Cancer Care Associates Of York /ID# 266143

York, Pennsylvania, United States

Medical University of South Carolina /ID# 251383

Charleston, South Carolina, United States

St Francis Cancer Center /ID# 243596

Greenville, South Carolina, United States

Avera Cancer Institute - Aberdeen /ID# 257759

Aberdeen, South Dakota, United States

Avera Cancer Institute /ID# 239635

Sioux Falls, South Dakota, United States

Duplicate_Memphis VA Medical Center /ID# 263250

Memphis, Tennessee, United States

Dell Seton Medical Center /ID# 247016

Austin, Texas, United States

Community Cancer Trials of Utah - South Ogden /ID# 262829

Ogden, Utah, United States

Valley Medical Center /ID# 253950

Renton, Washington, United States

Medical Oncology Associates /ID# 247003

Spokane, Washington, United States

Cemic /Id# 231486

Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

Hospital Britanico de Buenos Aires /ID# 231495

Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

Centro Médico Austral /ID# 239860

Ciudad Autonoma Buenos Aires, Buenos Aires F.D., Argentina

Centro de Investigaciones Clinicas Clinica Viedma S.A. /ID# 232339

Viedma, Río Negro Province, Argentina

LC Investigacion /ID# 239880

Buenos Aires, Argentina

Instituto de Oncologia Angel H Roffo /ID# 231499

Buenos Aires, Argentina

Port Macquarie Base Hospital /ID# 273654

Port Macquarie, New South Wales, Australia

Westmead Hospital /ID# 274447

Westmead, New South Wales, Australia

Barwon Health /ID# 241920

Geelong, Victoria, Australia

Austin Health /ID# 247507

Heidelberg, Victoria, Australia

Medizinische Universitaet Wien /ID# 230615

Vienna, State of Vienna, Austria

Klinik Penzing /ID# 230700

Vienna, State of Vienna, Austria

Klinik Floridsdorf /ID# 230608

Vienna, State of Vienna, Austria

Medizinische Universitaet Innsbruck /ID# 240981

Innsbruck, Tyrol, Austria

Ordensklinikum Linz Elisabethinen /ID# 240967

Linz, Upper Austria, Austria

Klinikum Wels-Grieskirchen Gmbh /ID# 249000

Wels, Upper Austria, Austria

Landeskrankenhaus Feldkirch /ID# 250333

Feldkirch, Vorarlberg, Austria

Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 232467

Salzburg, Austria

Algemeen Ziekenhuis klina /ID# 239853

Brasschaat, Antwerpen, Belgium

Universitair Ziekenhuis Antwerpen /ID# 239971

Edegem, Antwerpen, Belgium

Grand Hopital de Charleroi - Les Viviers /ID# 234178

Charleroi, Hainaut, Belgium

Hospital La Louviere Site Jolimont - Helora /ID# 246771

La Louvière, Hainaut, Belgium

Jessa Ziekenhuis /ID# 246766

Hasselt, Limburg, Belgium

UZ Gent /ID# 273244

Ghent, Oost-Vlaanderen, Belgium

Vitaz /Id# 246773

Sint-Niklaas, Oost-Vlaanderen, Belgium

Institut Jules Bordet /ID# 246770

Anderlecht, Belgium

AZ Maria Middelares /ID# 246768

Ghent, Belgium

CHU de Liege /ID# 246772

Liège, Belgium

UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 246769

Namur, Belgium

Clinica Amo - Rio Vermelho /ID# 231604

Salvador, Estado de Bahia, Brazil

Hospital Da Crianca Santo Antonio /ID# 233249

Porto Alegre, Rio Grande do Sul, Brazil

Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 233247

Barretos, São Paulo, Brazil

OC Oncoclínicas SP /ID# 261828

São Paulo, São Paulo, Brazil

Instituto Nacional de Cancer (INCA) /ID# 231509

Rio de Janeiro, Brazil

Instituto Dor de Pesquisa e Ensino /ID# 233245

Rio de Janeiro, Brazil

Instituto de Ensino e Pesquisas Sao Lucas /ID# 247417

São Paulo, Brazil

Hospital Sirio Libanes - Sao Paulo /ID# 261827

São Paulo, Brazil

Casa de Saúde Santa Marcelina /ID# 231605

São Paulo, Brazil

Uni Hospital /ID# 273707

Panagyurishte, Pazardzhik, Bulgaria

University Multiprofile Hospital for Active Treatment Sofiamed /ID# 234108

Sofiya, Sofia, Bulgaria

Complex Oncology Center - Burgas /ID# 240532

Burgas, Bulgaria

Complex Cancer Center Plovdiv /ID# 234106

Plovdiv, Bulgaria

UMHAT Multiprofile Hospital for Active Treatment Sveta Marina /ID# 234112

Varna, Bulgaria

Cross Cancer Institute. /ID# 252065

Edmonton, Alberta, Canada

William Osler Health System - Brampton Civic Hospital /ID# 254420

Brampton, Ontario, Canada

CISSS de la Monteregie /ID# 239081

Greenfield Park, Quebec, Canada

CSSS Alphonse-Desjardins, CHAU de Levis /ID# 261158

Lévis, Quebec, Canada

Hopital Du Sacre-Coeur De Montreal /ID# 274584

Montreal, Quebec, Canada

Clinica Universidad Catolica del Maule /ID# 231294

Talca, Maule Region, Chile

Icegclinic /Id# 231212

La Florida, Santiago Metropolitan, Chile

And 217 more locations on ClinicalTrials.gov

Clinical Research Directory

A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (317)