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)
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
2 other identifiers
interventional
698
31 countries
312
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 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 Teliso-V or Docetax at an 1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin or IV infusion of docetaxel. Approximately 698 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2022
Longer than P75 for phase_3
312 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2021
CompletedFirst Posted
Study publicly available on registry
June 16, 2021
CompletedStudy Start
First participant enrolled
March 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
April 14, 2026
April 1, 2026
5.9 years
June 14, 2021
April 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR)
PFS is defined as the time from randomization to the first occurrence of radiographic progression based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) per BICR or death from any cause.
Up to approximately 39 months
Overall Survival (OS)
OS is defined as the time from randomization to the event of death from any cause.
Up to approximately 39 months
Secondary Outcomes (5)
Objective Response Rate (ORR), per BICR.
Up to approximately 58.25 months
Duration of Response (DoR), per BICR
Up to approximately 58.25 months
PFS per Investigator Assessment
Up to approximately 58.25 months
Change from Baseline of Physical Functioning as measured by the Physical Functioning domain of the EORTC-QLQ-Core 30 (EORTC QLQ-C30).
Up to approximately 12 Weeks
Change from Baseline in Quality of Life as measured by the Global Health Status/Quality of Life Domain of the EORTC QLQ-C30.
Up to approximately 12 Weeks
Study Arms (2)
Telisotuzumab Vedotin
EXPERIMENTALParticipants will receive telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria.
Docetaxel
ACTIVE COMPARATORParticipants will receive docetaxel every 3 weeks until meeting study drug discontinuation criteria.
Interventions
Intravenous (IV) Infusion
Eligibility Criteria
You may qualify if:
- 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 actionable 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.
- Neoadjuvant and adjuvant systemic cytotoxic chemotherapy will count as a prior line for eligibility purposes if progression occurred within 6 months of the end of therapy.
- 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.
- +4 more criteria
You may not qualify if:
- 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, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. A history of prior radiation pneumonitis in the radiation field (fibrosis) is not permitted.
- Unresolved or neuroendocrine histology, nor sarcomatoid features 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (316)
University of Alabama at Birmingham - Main /ID# 247074
Birmingham, Alabama, 35233, United States
Ironwood Cancer & Res Ctr /ID# 262446
Chandler, Arizona, 85224-5665, United States
Mayo Clinic Arizona /ID# 255858
Phoenix, Arizona, 85054-4504, United States
Onvida Health Yuma Medical Center /ID# 253625
Yuma, Arizona, 85364, United States
City of Hope /ID# 243157
Duarte, California, 91010, United States
City Of Hope - Seacliff /ID# 263143
Huntington Beach, California, 92648, United States
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 263144
Irvine, California, 92618, United States
City Of Hope - Antelope Valley /ID# 263138
Lancaster, California, 93534, United States
The Oncology Institute Of Hope & Innovation -East Los A /ID# 239774
Los Angeles, California, 90033, United States
University of California, Los Angeles /ID# 253954
Los Angeles, California, 90095, United States
Eisenhower Medical Center /ID# 233189
Rancho Mirage, California, 92270-3221, United States
Mayo Clinic Hospital Jacksonville /ID# 254688
Jacksonville, Florida, 32224, United States
Ocala Oncology Florida Cancer Affiliates - Main /ID# 234228
Ocala, Florida, 34474-4445, United States
BRCR Medical Center Inc /ID# 262344
Tamarac, Florida, 33321-2919, United States
Memorial University Medical Center /ID# 264081
Savannah, Georgia, 31404, United States
Kaiser Permanente Moanalua Medical Center /ID# 238363
Honolulu, Hawaii, 96819-1469, United States
Edward-Elmhurst Cancer Center /ID# 238552
Elmhurst, Illinois, 60126, United States
Springfield Clinic - First /ID# 262290
Springfield, Illinois, 62702, United States
Goshen Center for Cancer Care /ID# 257734
Goshen, Indiana, 46526, United States
Investigative Clinical Research of Indiana - Indianapolis /ID# 260468
Indianapolis, Indiana, 46260, United States
Baptist Health Lexington /ID# 252769
Lexington, Kentucky, 40503, United States
Dana-Farber Cancer Institute /ID# 247132
Boston, Massachusetts, 02215, United States
Trinity Health St. Joseph Mercy Ann Arbor /ID# 232190
Ypsilanti, Michigan, 48197-1051, United States
Mayo Clinic - Rochester /ID# 252052
Rochester, Minnesota, 55905-0001, United States
Hattiesburg Clinic /ID# 248033
Hattiesburg, Mississippi, 39401, United States
St. Luke's Hospital - Chesterfield /ID# 251688
Chesterfield, Missouri, 63017, United States
St. Lukes Hosp. of Kansas City /ID# 259940
Kansas City, Missouri, 64111, United States
Alliance for Multispecialty Research (AMR) - Kansas City /ID# 247567
Kansas City, Missouri, 64114-4859, United States
Hulston Cancer Center /ID# 232226
Springfield, Missouri, 65807-5287, United States
Saint Louis University Cancer Center /ID# 260722
St Louis, Missouri, 63110-2539, United States
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 253147
Billings, Montana, 59102, United States
Nebraska Hematology Oncology /ID# 257710
Lincoln, Nebraska, 68506, United States
Renown Medical Group - Oncology/Hematology /ID# 247942
Reno, Nevada, 89502-1464, United States
Astera Cancer Care /ID# 257753
East Brunswick, New Jersey, 08816-4096, United States
San Juan Oncology Associates /ID# 244387
Farmington, New Mexico, 87401, United States
Maimonides Medical Center /ID# 240783
Brooklyn, New York, 11219, United States
Northwell Health - Monter Cancer Center /ID# 247081
Lake Success, New York, 11042, United States
AdventHealth Hendersonville /ID# 265349
Hendersonville, North Carolina, 28792, United States
FirstHealth of the Carolinas- Speciality Center /ID# 241279
Pinehurst, North Carolina, 28374, United States
Genesis Cancer Care Center /ID# 239190
Zanesville, Ohio, 43701-1406, United States
Cancer Care Associates Of York /ID# 266143
York, Pennsylvania, 17403, United States
Medical University of South Carolina /ID# 251383
Charleston, South Carolina, 29425, United States
St Francis Cancer Center /ID# 243596
Greenville, South Carolina, 29607-5253, United States
Avera Cancer Institute - Aberdeen /ID# 257759
Aberdeen, South Dakota, 57401, United States
Avera Cancer Institute /ID# 239635
Sioux Falls, South Dakota, 57105, United States
Duplicate_Memphis VA Medical Center /ID# 263250
Memphis, Tennessee, 38104, United States
Dell Seton Medical Center /ID# 247016
Austin, Texas, 78701, United States
Community Cancer Trials of Utah - South Ogden /ID# 262829
Ogden, Utah, 84405-7194, United States
Valley Medical Center /ID# 253950
Renton, Washington, 98055-5738, United States
Medical Oncology Associates /ID# 247003
Spokane, Washington, 99208, United States
Cemic /Id# 231486
Ciudad Autonoma Buenos Aires, Buenos Aires, 1431, Argentina
Hospital Britanico de Buenos Aires /ID# 231495
Ciudad Autonoma de Buenos Aire, Buenos Aires, 1280, Argentina
Centro Médico Austral /ID# 239860
Ciudad Autonoma Buenos Aires, Buenos Aires F.D., 1019, Argentina
Centro de Investigaciones Clinicas Clinica Viedma S.A. /ID# 232339
Viedma, Río Negro Province, 8500, Argentina
LC Investigacion /ID# 239880
Buenos Aires, 1125, Argentina
Instituto de Oncología Angel H. Roffo /ID# 231499
Buenos Aires, 1417, Argentina
Port Macquarie Base Hospital /ID# 273654
Port Macquarie, New South Wales, 2444, Australia
Westmead Hospital /ID# 274447
Westmead, New South Wales, 2145, Australia
Barwon Health /ID# 241920
Geelong, Victoria, 3220, Australia
Austin Health /ID# 247507
Heidelberg, Victoria, 3084, Australia
Medizinische Universitaet Wien /ID# 230615
Vienna, State of Vienna, 1090, Austria
Klinik Penzing /ID# 230700
Vienna, State of Vienna, 1140, Austria
Klinik Floridsdorf /ID# 230608
Vienna, State of Vienna, 1210, Austria
Medizinische Universitaet Innsbruck /ID# 240981
Innsbruck, Tyrol, 6020, Austria
Ordensklinikum Linz GmbH Elisabethinen /ID# 240967
Linz, Upper Austria, 4010, Austria
Klinikum Wels-Grieskirchen GmbH /ID# 249000
Wels, Upper Austria, 4600, Austria
Landeskrankenhaus Feldkirch /ID# 250333
Feldkirch, Vorarlberg, 6800, Austria
Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 232467
Salzburg, 5020, Austria
Algemeen Ziekenhuis klina /ID# 239853
Brasschaat, Antwerpen, 2930, Belgium
Universitair Ziekenhuis Antwerpen /ID# 239971
Edegem, Antwerpen, 2650, Belgium
Grand Hôpital de Charleroi - Les Viviers /ID# 234178
Charleroi, Hainaut, 6280, Belgium
Hospital La Louviere Site Jolimont - Helora /ID# 246771
La Louvière, Hainaut, 7100, Belgium
Jessa Ziekenhuis /ID# 246766
Hasselt, Limburg, 3500, Belgium
Vitaz /Id# 246773
Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium
Institut Jules Bordet /ID# 246770
Anderlecht, 1070, Belgium
AZ Maria Middelares /ID# 246768
Ghent, 9000, Belgium
CHU de Liege /ID# 246772
Liège, 4000, Belgium
UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 246769
Namur, 5000, Belgium
Clinica Amo - Rio Vermelho /ID# 231604
Salvador, Estado de Bahia, 41950-640, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre /ID# 233249
Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 233247
Barretos, São Paulo, 14784-400, Brazil
OC Oncoclínicas SP /ID# 261828
São Paulo, São Paulo, 05874-230, Brazil
Instituto Nacional de Cancer (INCA) /ID# 231509
Rio de Janeiro, 20231-050, Brazil
Instituto Dor de Pesquisa e Ensino /ID# 233245
Rio de Janeiro, 22281-100, Brazil
Instituto de Ensino e Pesquisas Sao Lucas /ID# 247417
São Paulo, 01236-030, Brazil
Hospital Sirio Libanes /ID# 261827
São Paulo, 01308-050, Brazil
Casa de Saúde Santa Marcelina /ID# 231605
São Paulo, 08270-070, Brazil
Mbal Uni Hospital /ID# 273707
Panagyurishte, Pazardzhik, 4500, Bulgaria
University Multiprofile Hospital for Active Treatment Sofiamed /ID# 234108
Sofiya, Sofia, 1797, Bulgaria
Complex Oncology Center - Burgas /ID# 240532
Burgas, 8000, Bulgaria
Complex Cancer Center Plovdiv /ID# 234106
Plovdiv, 4004, Bulgaria
UMHAT Multiprofile Hospital for Active Treatment Sveta Marina /ID# 234112
Varna, 9009, Bulgaria
Cross Cancer Institute. /ID# 252065
Edmonton, Alberta, T6G 1Z2, Canada
William Osler Health System - Brampton Civic Hospital /ID# 254420
Brampton, Ontario, L6R 3J7, Canada
CISSS de la Monteregie /ID# 239081
Greenfield Park, Quebec, J4V 2H1, Canada
CSSS Alphonse-Desjardins, CHAU de Levis /ID# 261158
Lévis, Quebec, G6V 3Z1, Canada
Hopital Du Sacre-Coeur De Montreal /ID# 274584
Montreal, Quebec, H4J 1C5, Canada
Clinica Universidad Catolica del Maule /ID# 231294
Talca, Maule Region, 3461341, Chile
Icegclinic /Id# 231212
La Florida, Santiago Metropolitan, 8241479, Chile
Sociedad Prosalud Montes y Orlandi /ID# 231154
Providencia, Santiago Metropolitan, 7500713, Chile
Fundacion Arturo Lopez Perez /ID# 231151
Providencia, Santiago Metropolitan, 7500921, Chile
Sociedad Oncovida /ID# 231152
Providencia, Santiago Metropolitan, 7510032, Chile
Hospital Clinico Universidad De Los Andes /ID# 260974
Santiago, 7501504, Chile
Anhui Medical University - Anhui Chest Hospital /ID# 231899
Hefei, Anhui, 230032, China
Beijing Cancer Hospital /ID# 231923
Beijing, Beijing Municipality, 100142, China
Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 233175
Beijing, Beijing Municipality, 100730, China
Beijing Chest Hospital, Capital Medical University /ID# 232202
Beijing, Beijing Municipality, 101149, China
The First Affiliated Hospital of Chongqing Medical University /ID# 251592
Chongqing, Chongqing Municipality, 400016, China
Fujian Provincial Cancer Hospital /ID# 243134
Fuzhou, Fujian, 350014, China
The First Affiliated Hospital of Xiamen University /ID# 242381
Xiamen, Fujian, 361003, China
The First Affiliated Hospital Of Guangzhou Medical University /ID# 238591
Guangzhou, Guangdong, 510163, China
Cancer Hospital of Shantou University Medical College /ID# 242182
Shantou, Guangdong, 515041, China
Affiliated Hospital of Guangdong Medical College /ID# 233317
Zhanjiang, Guangdong, 524004, China
Affiliated Cancer Hospital of Guangxi Medical University /ID# 231855
Nanning, Guangxi, 530021, China
People's Hospital of Guizhou Province /ID# 243614
Guiyang, Guizhou, 550002, China
Affiliated Hospital of Hebei University /ID# 239586
Baoding, Hebei, 071000, China
Harbin Medical University Cancer Hospital /Id# 231941
Harbin, Heilongjiang, 150081, China
The First affiliated Hospital of Nanyang Medical College /ID# 244652
Nanyang, Henan, 473007, China
People's Hospital of Henan Province /ID# 242187
Zhengzhou, Henan, 450003, China
Henan Cancer Hospital /ID# 239577
Zhengzhou, Henan, 450008, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 231904
Wuhan, Hubei, 430022, China
Tongji Hospital Tongji Medical College of HUST /ID# 239575
Wuhan, Hubei, 430030, China
Hubei Cancer Hospital /ID# 240045
Wuhan, Hubei, 430079, China
Hunan Cancer Hospital /ID# 231943
Changsha, Hunan, 410006, China
The Affiliated Hospital of Inner Mongolia Medical University /ID# 242179
Hohhot, Inner Mongolia, 010050, China
Nanjing Drum Tower Hospital /ID# 231791
Nanjing, Jiangsu, 210008, China
Nantong Tumor Hospital /ID# 232424
Nantong, Jiangsu, 226300, China
The First Affiliated Hospital of Nanchang University /ID# 231934
Nanchang, Jiangxi, 330006, China
The Second Affiliated Hospital of Nanchang University /ID# 231935
Nanchang, Jiangxi, 330008, China
Jilin Cancer Hospital /ID# 244702
Changchun, Jilin, 130012, China
The Second Affiliated Hospital of Dalian Medical University /ID# 239755
Dalian, Liaoning, 116023, China
First Affiliated Hospital of China Medical University /ID# 231924
Shenyang, Liaoning, 110001, China
The First Affiliated Hospital of Xi'an Jiaotong University /ID# 232023
Xi'an, Shaanxi, 710061, China
Shandong University - Jinan Central Hospital /ID# 231895
Jinan, Shandong, 250013, China
Shandong Cancer Hospital /ID# 251506
Jinan, Shandong, 251601, China
LinYi Cancer Hospital /ID# 239713
Linyi, Shandong, 276001, China
Shanghai Chest Hospital /ID# 231897
Shanghai, Shanghai Municipality, 200030, China
Shanxi Cancer Hospital /ID# 258674
Taiyuan, Shanxi, 030009, China
Sichuan Cancer Hospital /ID# 239707
Chengdu, Sichuan, 610041, China
West China Hospital, Sichuan University /ID# 233703
Chengdu, Sichuan, 610041, China
Tianjin Cancer Hospital /ID# 233176
Tianjin, Tianjin Municipality, 300000, China
Tianjin Medical University General Hospital /ID# 231839
Tianjin, Tianjin Municipality, 300052, China
The Affiliated Cancer Hospital of Xinjiang Medical University /ID# 240094
Ürümqi, Xinjiang, 830000, China
Yunnan Cancer Hospital /ID# 251388
Kunming, Yunnan, 650118, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 232032
Hangzhou, Zhejiang, 310003, China
Zhejiang Cancer hospital /ID# 242476
Hangzhou, Zhejiang, 310022, China
Taizhou Hospital of Zhejiang Province /ID# 232021
Linhai, Zhejiang, 317000, China
Ningbo No. 2 Hospital /ID# 242478
Ningbo, Zhejiang, 315010, China
Hospital Pablo Tobón Uribe /ID# 258128
Medellín, Antioquia, 050034, Colombia
Fundación Ctic - Centro De Tratamiento E Investigación Sobre Cáncer Luis Carlos /ID# 258131
Bogotá, Bogota D.C., 110131, Colombia
Sociedad de Oncologia y Hematologia del Cesar SAS /ID# 258130
Valledupar, Cesar Department, 200001, Colombia
Imat Oncomedica /ID# 258129
Montería, Departamento de Córdoba, 230018, Colombia
Masarykuv onkologicky ustav /ID# 232426
Brno, 656 53, Czechia
Nemocnice AGEL Novy Jicin, a.s. /ID# 232427
Nový Jičín, 741 01, Czechia
Roskilde Sygehus /ID# 241842
Roskilde, Region Sjælland, 4000, Denmark
Odense University Hospital /ID# 241663
Odense, Region Syddanmark, 5000, Denmark
APHM - Hopital Nord /ID# 251935
Marseille, Bouches-du-Rhone, 13015, France
CHU Lille - Hôpital Albert Calmette /ID# 251934
Lille, Hauts-de-France, 59037, France
Hopital Arnaud de Villeneuve /ID# 239404
Montpellier, Herault, 34295, France
Centre Hospitalier Universitaire de Bordeaux /ID# 244953
Pessac, Nouvelle-Aquitaine, 33604, France
Institut Curie /ID# 240141
Paris, Paris, 75248, France
Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 239409
Paris, Paris, 75679, France
Centre Hospitalier d'Avignon /ID# 275229
Avignon, Provence-Alpes-Côte d'Azur Region, 84000, France
Hospices Civils de Lyon (HCL) - Hopital Louis Pradel /ID# 251933
Bron, Rhone, 69500, France
Centre Leon Berard /ID# 267397
Lyon, Rhone, 69373, France
Centre Hosp Intercommunal de Creteil /ID# 251936
Créteil, Val-de-Marne, 94000, France
AP-HP - Hopital Tenon /ID# 239179
Paris, 75020, France
Institut Gustave Roussy /ID# 267415
Villejuif, Île-de-France Region, 94800, France
Thoraxklinik Heidelberg gGmbH /ID# 239656
Heidelberg, Baden-Wurttemberg, 69126, Germany
Universitatsklinikum Mannheim /ID# 238331
Mannheim, Baden-Wurttemberg, 68167, Germany
Asklepios Fachkliniken Muenchen-Gauting /ID# 272768
Gauting, Bavaria, 82131, Germany
Universitaetsklinikum Giessen /ID# 252973
Giessen, Hesse, 35392, Germany
Klinikum Kassel /ID# 240142
Kassel, Hesse, 34125, Germany
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 274719
Dresden, Saxony, 01307, Germany
Universitaetsklinikum Jena /ID# 239661
Jena, Thuringia, 07747, Germany
Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 234247
Berlin, 13353, Germany
Universitaetsklinikum Hamburg-Eppendorf /ID# 239658
Hamburg, 20246, Germany
Haemato-Onkologie Hamburg /ID# 241047
Hamburg, 20251, Germany
Henry Dunnant Hospital Center /ID# 267021
Athens, Attica, 11526, Greece
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 230824
Athens, Attica, 11527, Greece
Metropolitan Hospital /ID# 232158
Piraeus, Attica, 18547, Greece
Metropolitan Hospital /ID# 239170
Piraeus, Attica, 18547, Greece
Interbalkan Medical Center Of Thessaloniki /ID# 254407
Thessaloniki, 57001, Greece
ZIV Medical Center /ID# 238606
Safed, Northern District, 13100, Israel
The Edith Wolfson Medical Center /ID# 233781
Ashkelon, Southern District, 5822000, Israel
Soroka University Medical Center /ID# 252711
Beersheba, Southern District, 8410101, Israel
Tel Aviv Sourasky Medical Center /ID# 260519
Tel Aviv, Tel Aviv, 6423906, Israel
Humanitas Istituto Clinico Catanese /ID# 273050
Misterbianco, Catania, 95045, Italy
IRCCS Ospedale San Raffaele /ID# 254376
Milan, Milano, 20132, Italy
Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 252942
Naples, Napoli, 80138, Italy
Azienda Ospedaliera Complesso Ospedaliero San Giovanni-Addolorata /ID# 238618
Rome, Roma, 00184, Italy
I.R.C.C.S Istituto Tumori Giovanni Paolo II /ID# 238696
Bari, 70124, Italy
Azienda Socio Sanitaria Territoriale di Cremona /ID# 238698
Cremona, 26100, Italy
Azienda Ospedaliera Papardo /ID# 258038
Messina, 98158, Italy
Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 238473
Perugia, 06156, Italy
ASST Sette Laghi - Ospedale Di Circolo E Fondazione Macchi Varese /ID# 238536
Varese, 21100, Italy
NHO Nagoya Medical Center /ID# 246306
Nagoya, Aichi-ken, 460-0001, Japan
Nagoya University Hospital /ID# 239990
Nagoya, Aichi-ken, 466-8560, Japan
Hirosaki University Hospital /ID# 242377
Hirosaki-shi, Aomori, 036-8203, Japan
National Cancer Center Hospital East /ID# 233775
Kashiwa-shi, Chiba, 277-8577, Japan
National Hospital Organization Kyushu Medical Center /ID# 238533
Fukuoka, Fukuoka, 810-8563, Japan
Hospital Of The University Of Occupational And Environmental Health, Japan /ID# 241191
Kitakyushu-shi, Fukuoka, 807-8556, Japan
Kurume University Hospital /ID# 254900
Kurume-shi, Fukuoka, 830-0011, Japan
Fukushima Medical University Hospital /ID# 249691
Fukushima, Fukushima, 960-1295, Japan
Gunma Prefectural Cancer Center /ID# 233723
Ota-shi, Gunma, 373-8550, Japan
Chugoku Central Hospital /ID# 242970
Fukuyama, Hiroshima, 720-0001, Japan
Hiroshima University Hospital /ID# 241882
Hiroshima, Hiroshima, 734-8551, Japan
Hokkaido University Hospital /ID# 241289
Sapporo, Hokkaido, 060-8648, Japan
Kobe Minimally Invasive Cancer Center /ID# 254131
Kobe, Hyōgo, 650-0046, Japan
Takarazuka City Hospital /ID# 240786
Takarazuka-shi, Hyōgo, 665-0827, Japan
NHO Mito Medical Center /ID# 241709
Higashiibaraki-gun, Ibaraki, 311-3193, Japan
Ibaraki Prefectural Central Hospital /ID# 246145
Kasama-shi, Ibaraki, 309-1793, Japan
Iwate Medical University Hospital /ID# 239027
Shiwa-gun, Iwate, 028-3695, Japan
Kitasato University Hospital /ID# 239958
Sagamihara-shi, Kanagawa, 252-0375, Japan
Yokohama City University Medical Center /ID# 246554
Yokohama, Kanagawa, 232-0024, Japan
Kanagawa Cardiovascular and Respiratory Center /ID# 239052
Yokohama, Kanagawa, 236-0051, Japan
Kumamoto University Hospital /ID# 241039
Kumamoto, Kumamoto, 8608556, Japan
National Hospital Organization Mie Chuo Medical Center /ID# 246659
Tsu, Mie-ken, 514-1101, Japan
Miyagi Cancer Center /ID# 234198
Natori-shi, Miyagi, 981-1293, Japan
Sendai Kousei Hospital /ID# 253350
Sendai, Miyagi, 980-0873, Japan
University of Miyazaki Hospital /ID# 242161
Miyazaki, Miyazaki, 889-1692, Japan
Nagaoka Red Cross Hospital /ID# 240714
Nagaoka-shi, Niigata, 940-2085, Japan
Kurashiki Central Hospital /ID# 239344
Kurashiki-shi, Okayama-ken, 710-8602, Japan
Osaka Habikino Medical Center /ID# 239989
Habikino-shi, Osaka, 583-8588, Japan
Kansai Medical University Hospital /ID# 233476
Hirakata-shi, Osaka, 573-1191, Japan
Osaka Metropolitan University Hospital /ID# 238895
Osaka, Osaka, 545-8586, Japan
Kindai University Hospital /ID# 239085
Sakai-shi, Osaka, 590-0197, Japan
Fujieda Municipal General Hospital /ID# 255155
Fujieda-shi, Shizuoka, 426-8677, Japan
Tochigi Cancer Center /ID# 240020
Utsunomiya, Tochigi, 320-0834, Japan
Juntendo University Hospital /ID# 239932
Bunkyo-ku, Tokyo, 113-8431, Japan
National Cancer Center Hospital /ID# 251134
Chuo-ku, Tokyo, 104-0045, Japan
National Hospital Organization Tokyo Medical Center /ID# 246581
Meguro-ku, Tokyo, 152-8902, Japan
NTT Medical Center Tokyo /ID# 241067
Shinagawa-ku, Tokyo, 141-8625, Japan
Keio University Hospital /ID# 239506
Shinjuku-ku, Tokyo, 160-8582, Japan
Toyama University Hospital /ID# 241660
Toyama, Toyama, 930-0194, Japan
Wakayama Medical University Hospital /ID# 234004
Wakayama, Wakayama, 641-8510, Japan
Yamagata University Hospital /ID# 240815
Yamagata, Yamagata, 990-9585, Japan
Yamaguchi - Ube Medical Center /ID# 258779
Ube-shi, Yamaguchi, 755-0241, Japan
O.P.D. Hospital Civil de Guadalajara /ID# 238488
Guadalajara, Jalisco, 44280, Mexico
Centro de Investigacion Clínica Chapultepec SA de CV /ID# 231928
Morelia, Michoacán, 58260, Mexico
Clinical Research & Oncology Oaxaca /ID# 231883
Oaxaca City, 68020, Mexico
Ziekenhuis St. Jansdal /ID# 251932
Harderwijk, Gelderland, 3844 DG, Netherlands
Maastricht Universitair Medisch Centrum /ID# 233932
Maastricht, Limburg, 6229 HX, Netherlands
Isala /ID# 238846
Zwolle, Overijssel, 8025 AB, Netherlands
HagaZiekenhuis /ID# 243693
The Hague, South Holland, 2545 AA, Netherlands
Jeroen Bosch Ziekenhuis /ID# 234087
's-Hertogenbosch, 5223 GZ, Netherlands
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeyla /ID# 262489
Poznan, Greater Poland Voivodeship, 60-569, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 262095
Warsaw, Masovian Voivodeship, 02-781, Poland
MRUK-MED I Sp. z o.o. /ID# 239363
Rzeszów, Podkarpackie Voivodeship, 35-021, Poland
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie /ID# 239025
Olsztyn, Warmian-Masurian Voivodeship, 10-357, Poland
Instytut Centrum Zdrowia Matki Polki /ID# 239024
Lodz, Łódź Voivodeship, 93-338, Poland
Fundacao Champalimaud /ID# 241925
Lisbon, Lisbon District, 1400-038, Portugal
Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 241572
Porto, 4099-001, Portugal
Hospital CUF Porto /ID# 241570
Porto, 4100-180, Portugal
IPO Porto FG, EPE /ID# 241569
Porto, 4200-072, Portugal
Unidade Local de Saude Sao Joao, EPE /ID# 241930
Porto, 4200-319, Portugal
Spitalul Pelican /ID# 254066
Oradea, Bihor County, 410469, Romania
Cardiomed Srl /Id# 255320
Cluj-Napoca, Cluj, 400015, Romania
Sc Oncolab Srl /Id# 239105
Craiova, Dolj, 200385, Romania
Institutul Regional de Oncologie /ID# 254065
Iași, Iaşi, 700483, Romania
SC RTC Radiology Therapeutic Center SRL /ID# 240744
Otopeni, Ilfov, 075100, Romania
Oncocenter - Oncologie Clinica Srl /Id# 239103
Timișoara, Timiș County, 300166, Romania
Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL /ID# 240826
Brasov, 500283, Romania
S.C. Sigmedical Services SRL /ID# 239108
Suceava, 720214, Romania
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 230084
Banská Bystrica, Banská Bystrica Region, 975 17, Slovakia
Wits Clinical Research /ID# 230841
Johannesburg, Gauteng, 1864, South Africa
Sandton Oncology Medical Group PTY Ltd /ID# 230843
Johannesburg, Gauteng, 2196, South Africa
Steve Biko Academic Hospital /ID# 230883
Pretoria, Gauteng, 0001, South Africa
National Cancer Center /ID# 260663
Goyang-si, Gyeonggido, 10408, South Korea
CHA Bundang Medical Center /ID# 233318
Seongnam, Gyeonggido, 13496, South Korea
The Catholic University Of Korea St. Vincent's Hospital /ID# 256942
Suwon, Gyeonggido, 16247, South Korea
Ajou University Hospital /ID# 233319
Suwon, Gyeonggido, 16499, South Korea
Gyeongsang National University Hospital /ID# 234244
Jinju, Gyeongsangnam-do, 52727, South Korea
Pusan National University Yangsan Hospital /ID# 257836
Yangsan, Gyeongsangnam-do, 50612, South Korea
Chungbuk National University Hospital /ID# 257891
Cheongju-si, North Chungcheong, 28644, South Korea
Kangbuk Samsung Hospital /ID# 233711
Seoul, Seoul Teugbyeolsi, 03181, South Korea
Samsung Medical Center /ID# 256941
Seoul, Seoul Teugbyeolsi, 06351, South Korea
SMG-SNU Boramae Medical Center /ID# 233710
Seoul, Seoul Teugbyeolsi, 07061, South Korea
CHU Insular-Materno Infantil /ID# 255094
Las Palmas de Gran Canaria, Las Palmas, 35016, Spain
Hospital Universitario Fundacion Alcorcon /ID# 255100
Alcorcón, Madrid, 28922, Spain
Hospital Universitario de Fuenlabrada /ID# 255093
Fuenlabrada, Madrid, 28942, Spain
Hospital Nuestra Senora de Sonsoles /ID# 255102
Ávila, 05004, Spain
UOMi Cancer Center - Clinica Tres Torres /ID# 240584
Barcelona, 08017, Spain
Hospital Universitario Dexeus - Grupo Quironsalud /ID# 255105
Barcelona, 08028, Spain
Hospital Universitario de Jaen /ID# 240588
Jaén, 23007, Spain
Hospital Universitario 12 de Octubre /ID# 240176
Madrid, 28041, Spain
Hospital Clinico Universitario de Valencia /ID# 240378
Valencia, 46010, Spain
Karolinska University Hospital Solna /ID# 229853
Solna, Stockholm County, 171 64, Sweden
Sahlgrenska Universitetssjukhuset /ID# 229943
Gothenburg, Västra Götaland County, 413 46, Sweden
E-DA Cancer Hospital /ID# 239718
Kaohsiung City, Kaohsiung, 82445, Taiwan
National Taiwan University Hospital /ID# 238378
Taipei City, Taipei, 100, Taiwan
Changhua Christian Hospital /ID# 238394
Changhua City, Changhua County, 50006, Taiwan
National Taiwan University Hospital - Hsinchu branch /ID# 238393
Hsinchu, 30059, Taiwan
Hualien Tzu Chi Hospital /ID# 238398
Hualien City, 97002, Taiwan
Chung Shan Medical University Hospital /ID# 238444
Taichung, 402, Taiwan
Mackay Memorial Hospital /ID# 238392
Taipei, 104, Taiwan
Taipei Medical University Hospital /ID# 238380
Taipei, 11031, Taiwan
Memorial Ankara Hastanesi /ID# 234212
Çankaya, Ankara, 06520, Turkey (Türkiye)
Izmir Ekonomi Universitesi Ozel Medicalpoint Hastanesi /ID# 234209
Cordaleo, İzmir, 35575, Turkey (Türkiye)
Adana Sehir Egitim ve Arastirma Hastanesi /ID# 255638
Adana, 01060, Turkey (Türkiye)
Adana Acıbadem Hospital /ID# 234208
Adana, 01130, Turkey (Türkiye)
Medical Park Seyhan Hastanesi /ID# 255637
Adana, 01140, Turkey (Türkiye)
Gazi Universitesi /ID# 265425
Ankara, 06560, Turkey (Türkiye)
Ankara City Hospital /ID# 234210
Ankara, 06800, Turkey (Türkiye)
Inonu Universitesi Turgut Ozal /ID# 234038
Battalgazi/malatya, 44280, Turkey (Türkiye)
Uludag University Medical Faculty /ID# 234205
Bursa, 16059, Turkey (Türkiye)
Dicle Universitesi Tip /ID# 234036
Diyarbakır, 21200, Turkey (Türkiye)
Bagcilar Medipol Mega Universite Hastanesi /ID# 234211
Istanbul, 34214, Turkey (Türkiye)
Ege University Medical Faculty /ID# 234039
Izmir, 35040, Turkey (Türkiye)
Dr. Suat Seren Gogus Has /ID# 262291
Izmir, 35110, Turkey (Türkiye)
Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 254342
London, Greater London, E1 2ES, United Kingdom
University College London Hospital /ID# 249407
London, Greater London, NW1 2BU, United Kingdom
Nottingham City Hospital /ID# 254707
Nottingham, Nottinghamshire, NG5 1PB, United Kingdom
University Hospitals Birmingham NHS Foundation Trust /ID# 258141
Birmingham, B15 2TH, United Kingdom
The Royal Marsden NHS Foundation Trust /ID# 246974
London, SW3 6JJ, United Kingdom
The Christie Hospital /ID# 243422
Manchester, M20 4BX, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
June 14, 2021
First Posted
June 16, 2021
Study Start
March 25, 2022
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
March 1, 2028
Last Updated
April 14, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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/
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.