Non Small Cell Lung CancerPhase 3NCT04928846
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 study testing Telisotuzumab Vedotin and Docetaxel in people with Non Small Cell Lung Cancer and c-MET, run by AbbVie at 317 sites in 32 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, c-MET
- What is being tested?
- Telisotuzumab Vedotin and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 768 participants
- Where
- 317 sitesin 32 countries
- Study dates
- 25 Mar 2022to Feb 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- -- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
317 sites in 32 countries. Contact the study team or a site near you to ask about taking part.
317 sites in 32 countries
United States50 sites, 9 recruiting
- Completed
Avera Cancer Institute - Aberdeen /ID# 257759
Aberdeen, South Dakota, 57401
- Active, not recruiting
Dell Seton Medical Center /ID# 247016
Austin, Texas, 78701
- Active, not recruiting
Intermountain Health St Vincent Regional Hospital - Cancer Centers of Montana /ID# 253147
Billings, Montana, 59102
- Completed
University of Alabama at Birmingham - Main /ID# 247074
Birmingham, Alabama, 35233
- Completed
Dana-Farber Cancer Institute /ID# 247132
Boston, Massachusetts, 02215
- Active, not recruiting
Maimonides Medical Center /ID# 240783
Brooklyn, New York, 11219
- Active, not recruiting
Ironwood Cancer & Res Ctr /ID# 262446
Chandler, Arizona, 85224-5665
- Completed
Medical University of South Carolina /ID# 251383
Charleston, South Carolina, 29425
- Completed
St. Luke's Hospital - Chesterfield /ID# 251688
Chesterfield, Missouri, 63017
- Recruiting
City of Hope /ID# 243157
Duarte, California, 91010
- Completed
Astera Cancer Care /ID# 257753
East Brunswick, New Jersey, 08816-4096
- Active, not recruiting
Edward-Elmhurst Cancer Center /ID# 238552
Elmhurst, Illinois, 60126
- Completed
San Juan Oncology Associates /ID# 244387
Farmington, New Mexico, 87401
- Completed
Goshen Center for Cancer Care /ID# 257734
Goshen, Indiana, 46526
- Completed
St Francis Cancer Center /ID# 243596
Greenville, South Carolina, 29607-5253
- Recruiting
Hattiesburg Clinic /ID# 248033
Hattiesburg, Mississippi, 39401
- Completed
AdventHealth Hendersonville /ID# 265349
Hendersonville, North Carolina, 28792
- Recruiting
Kaiser Permanente Moanalua Medical Center /ID# 238363
Honolulu, Hawaii, 96819-1469
- Recruiting
City Of Hope - Seacliff /ID# 263143
Huntington Beach, California, 92648
- Completed
Investigative Clinical Research of Indiana - Indianapolis /ID# 260468
Indianapolis, Indiana, 46260
- Recruiting
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 263144
Irvine, California, 92618
- Completed
Mayo Clinic Hospital Jacksonville /ID# 254688
Jacksonville, Florida, 32224
- Recruiting
St. Lukes Hosp. of Kansas City /ID# 259940
Kansas City, Missouri, 64111
- Completed
Alliance for Multispecialty Research (AMR) - Kansas City /ID# 247567
Kansas City, Missouri, 64114-4859
- Completed
Northwell Health - Monter Cancer Center /ID# 247081
Lake Success, New York, 11042
- Recruiting
City Of Hope - Antelope Valley /ID# 263138
Lancaster, California, 93534
- Completed
Baptist Health Lexington /ID# 252769
Lexington, Kentucky, 40503
- Completed
Nebraska Hematology Oncology /ID# 257710
Lincoln, Nebraska, 68506
- Completed
The Oncology Institute Of Hope & Innovation -East Los A /ID# 239774
Los Angeles, California, 90033
- Completed
Duplicate_Memphis VA Medical Center /ID# 263250
Memphis, Tennessee, 38104
- Completed
Ocala Oncology Florida Cancer Affiliates - Main /ID# 234228
Ocala, Florida, 34474-4445
- Completed
Community Cancer Trials of Utah - South Ogden /ID# 262829
Ogden, Utah, 84405-7194
- Active, not recruiting
Mayo Clinic Arizona /ID# 255858
Phoenix, Arizona, 85054-4504
- Completed
FirstHealth of the Carolinas- Speciality Center /ID# 241279
Pinehurst, North Carolina, 28374
- Completed
Eisenhower Medical Center /ID# 233189
Rancho Mirage, California, 92270-3221
- Completed
Renown Medical Group - Oncology/Hematology /ID# 247942
Reno, Nevada, 89502-1464
- Recruiting
Valley Medical Center /ID# 253950
Renton, Washington, 98055-5738
- Active, not recruiting
Mayo Clinic - Rochester /ID# 252052
Rochester, Minnesota, 55905-0001
- Completed
Premiere Oncology Foundation /ID# 253954
Santa Monica, California, 90404
- Completed
Memorial University Medical Center /ID# 264081
Savannah, Georgia, 31404
- Completed
Avera Cancer Institute /ID# 239635
Sioux Falls, South Dakota, 57105
- Completed
Medical Oncology Associates /ID# 247003
Spokane, Washington, 99208
- Active, not recruiting
Springfield Clinic - First /ID# 262290
Springfield, Illinois, 62702
- Recruiting
Hulston Cancer Center /ID# 232226
Springfield, Missouri, 65807-5287
- Completed
Saint Louis University Cancer Center /ID# 260722
St Louis, Missouri, 63110-2539
- Completed
BRCR Medical Center Inc /ID# 262344
Tamarac, Florida, 33321-2919
- Completed
Cancer Care Associates Of York /ID# 266143
York, Pennsylvania, 17403
- Completed
Trinity Health St. Joseph Mercy Ann Arbor /ID# 232190
Ypsilanti, Michigan, 48197-1051
- Completed
Onvida Health Yuma Medical Center /ID# 253625
Yuma, Arizona, 85364
- Active, not recruiting
Genesis Cancer Care Center /ID# 239190
Zanesville, Ohio, 43701-1406
China45 sites, 44 recruiting
- Recruiting
Affiliated Hospital of Hebei University /ID# 239586
Baoding, Hebei, 071000
- Recruiting
Beijing Cancer Hospital /ID# 231923
Beijing, Beijing Municipality, 100142
- Recruiting
Peking Union Medical College Hospital East - Dongdan Campus /ID# 233175
Beijing, Beijing Municipality, 100730
- Recruiting
Beijing Chest Hospital, Capital Medical University /ID# 232202
Beijing, Beijing Municipality, 101149
- Recruiting
Jilin Cancer Hospital /ID# 244702
Changchun, Jilin, 130012
- Recruiting
Hunan Cancer Hospital /ID# 231943
Changsha, Hunan, 410006
- Recruiting
Sichuan Cancer Hospital /ID# 239707
Chengdu, Sichuan, 610041
- Recruiting
West China Hospital, Sichuan University /ID# 233703
Chengdu, Sichuan, 610041
- Recruiting
The First Affiliated Hospital of Chongqing Medical University /ID# 251592
Chongqing, Chongqing Municipality, 400016
- Recruiting
The Second Affiliated Hospital of Dalian Medical University /ID# 239755
Dalian, Liaoning, 116023
- Recruiting
Fujian Provincial Cancer Hospital /ID# 243134
Fuzhou, Fujian, 350014
- Recruiting
The First Affiliated Hospital Of Guangzhou Medical University - Yanjiang W Road /ID# 238591
Guangzhou, Guangdong, 510120
- Recruiting
People's Hospital of Guizhou Province /ID# 243614
Guiyang, Guizhou, 550002
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 232032
Hangzhou, Zhejiang, 310003
- Recruiting
Zhejiang Cancer hospital /ID# 242476
Hangzhou, Zhejiang, 310022
- Recruiting
Harbin Medical University Cancer Hospital /Id# 231941
Harbin, Heilongjiang, 150081
- Recruiting
Anhui Medical University - Anhui Chest Hospital /ID# 231899
Hefei, Anhui, 230032
- Completed
The Affiliated Hospital of Inner Mongolia Medical University /ID# 242179
Hohhot, Inner Mongolia, 010050
- Recruiting
Jinan Central Hospital /ID# 231895
Jinan, Shandong, 250013
- Recruiting
Shandong Cancer Hospital /ID# 251506
Jinan, Shandong, 251601
- Recruiting
Yunnan Cancer Hospital /ID# 251388
Kunming, Yunnan, 650118
- Recruiting
Taizhou Hospital of Zhejiang Province /ID# 232021
Linhai, Zhejiang, 317000
- Recruiting
LinYi Cancer Hospital /ID# 239713
Linyi, Shandong, 276001
- Recruiting
The First Affiliated Hospital of Nanchang University /ID# 231934
Nanchang, Jiangxi, 330006
- Recruiting
The Second Affiliated Hospital of Nanchang University /ID# 231935
Nanchang, Jiangxi, 330008
- Recruiting
Nanjing Drum Tower Hospital /ID# 231791
Nanjing, Jiangsu, 210008
- Recruiting
Affiliated Cancer Hospital of Guangxi Medical University /ID# 231855
Nanning, Guangxi, 530021
- Recruiting
Nantong Tumor Hospital /ID# 232424
Nantong, Jiangsu, 226300
- Recruiting
The First affiliated Hospital of Nanyang Medical College /ID# 244652
Nanyang, Henan, 473007
- Recruiting
Ningbo No. 2 Hospital /ID# 242478
Ningbo, Zhejiang, 315010
- Recruiting
Shanghai Chest Hospital /ID# 231897
Shanghai, Shanghai Municipality, 200030
- Recruiting
Cancer Hospital of Shantou University Medical College /ID# 242182
Shantou, Guangdong, 515041
- Recruiting
First Affiliated Hospital of China Medical University /ID# 231924
Shenyang, Liaoning, 110001
- Recruiting
Shanxi Cancer Hospital /ID# 258674
Taiyuan, Shanxi, 030009
- Recruiting
Tianjin Cancer Hospital /ID# 233176
Tianjin, Tianjin Municipality, 300000
- Recruiting
Tianjin Medical University General Hospital /ID# 231839
Tianjin, Tianjin Municipality, 300052
- Recruiting
The Affiliated Cancer Hospital of Xinjiang Medical University /ID# 240094
Ürümqi, Xinjiang, 830000
- Recruiting
Tongji Hospital Tongji Medical College of HUST /ID# 239575
Wuhan, Hubei, 430030
- Recruiting
Union Hospital Tongji Medical College /ID# 231904
Wuhan, Hubei, 430048
- Recruiting
Hubei Cancer Hospital /ID# 240045
Wuhan, Hubei, 430079
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University /ID# 232023
Xi'an, Shaanxi, 710061
- Recruiting
The First Affiliated Hospital of Xiamen University /ID# 242381
Xiamen, Fujian, 361003
- Recruiting
Affiliated Hospital of Guangdong Medical College /ID# 233317
Zhanjiang, Guangdong, 524004
- Recruiting
People's Hospital of Henan Province /ID# 242187
Zhengzhou, Henan, 450003
- Recruiting
Henan Cancer Hospital /ID# 239577
Zhengzhou, Henan, 450008
Japan42 sites, 41 recruiting
- Recruiting
Juntendo University Hospital /ID# 239932
Bunkyo-ku, Tokyo, 113-8431
- Recruiting
National Cancer Center Hospital /ID# 251134
Chuo-ku, Tokyo, 104-0045
- Recruiting
Fujieda Municipal General Hospital /ID# 255155
Fujieda-shi, Shizuoka, 426-8677
- Recruiting
National Hospital Organization Kyushu Medical Center /ID# 238533
Fukuoka, Fukuoka, 810-8563
- Recruiting
Fukushima Medical University Hospital /ID# 249691
Fukushima, 960-1295
- Recruiting
Chugoku Central Hospital /ID# 242970
Fukuyama, Hiroshima, 720-0001
- Recruiting
Osaka Habikino Medical Center /ID# 239989
Habikino-shi, Osaka, 583-8588
- Recruiting
NHO Mito Medical Center /ID# 241709
Higashiibaraki-gun, Ibaraki, 311-3193
- Recruiting
Kansai Medical University Hospital /ID# 233476
Hirakata-shi, Osaka, 573-1191
- Recruiting
Hirosaki University Hospital /ID# 242377
Hirosaki-shi, Aomori, 036-8203
- Recruiting
Hiroshima University Hospital /ID# 241882
Hiroshima, Hiroshima, 734-8551
- Recruiting
Ibaraki Prefectural Central Hospital /ID# 246145
Kasama-shi, Ibaraki, 309-1793
- Recruiting
National Cancer Center Hospital East /ID# 233775
Kashiwa-shi, Chiba, 277-8577
- Recruiting
Hospital Of The University Of Occupational And Environmental Health, Japan /ID# 241191
Kitakyushu-shi, Fukuoka, 807-8556
- Recruiting
Kobe Minimally Invasive Cancer Center /ID# 254131
Kobe, Hyōgo, 650-0046
- Recruiting
Kumamoto University Hospital /ID# 241039
Kumamoto, Kumamoto, 8608556
- Recruiting
Kurashiki Central Hospital /ID# 239344
Kurashiki-shi, Okayama-ken, 710-8602
- Recruiting
Kurume University Hospital /ID# 254900
Kurume-shi, Fukuoka, 830-0011
- Recruiting
National Hospital Organization Tokyo Medical Center /ID# 246581
Meguro-ku, Tokyo, 152-8902
Site Coordinator, +81-3-3411-0111
- Recruiting
University of Miyazaki Hospital /ID# 242161
Miyazaki, Miyazaki, 889-1692
- Recruiting
Nagaoka Red Cross Hospital /ID# 240714
Nagaoka-shi, Niigata, 940-2085
- Recruiting
NHO Nagoya Medical Center /ID# 246306
Nagoya, Aichi-ken, 460-0001
- Recruiting
Nagoya University Hospital /ID# 239990
Nagoya, Aichi-ken, 466-8560
- Recruiting
Miyagi Cancer Center /ID# 234198
Natori-shi, Miyagi, 981-1293
- Recruiting
Osaka Metropolitan University Hospital /ID# 238895
Osaka, Osaka, 545-8586
- Recruiting
Gunma Prefectural Cancer Center /ID# 233723
Ota-shi, Gunma, 373-8550
- Recruiting
Kitasato University Hospital /ID# 239958
Sagamihara-shi, Kanagawa, 252-0375
- Recruiting
Kindai University Hospital /ID# 239085
Sakai-shi, Osaka, 590-0197
- Recruiting
Hokkaido University Hospital /ID# 241289
Sapporo, Hokkaido, 060-8648
- Recruiting
Sendai Kousei Hospital /ID# 253350
Sendai, Miyagi, 980-0873
- Recruiting
NTT Medical Center Tokyo /ID# 241067
Shinagawa-ku, Tokyo, 141-8625
- Recruiting
Keio University Hospital /ID# 239506
Shinjuku-ku, Tokyo, 160-8582
- Recruiting
Iwate Medical University Hospital /ID# 239027
Shiwa-gun, Iwate, 028-3695
- Recruiting
Takarazuka City Hospital /ID# 240786
Takarazuka-shi, Hyōgo, 665-0827
- Recruiting
Toyama University Hospital /ID# 241660
Toyama, Toyama, 930-0194
- Recruiting
National Hospital Organization Mie Chuo Medical Center /ID# 246659
Tsu, Mie-ken, 514-1101
- Recruiting
Yamaguchi - Ube Medical Center /ID# 258779
Ube-shi, Yamaguchi, 755-0241
- Recruiting
Tochigi Cancer Center /ID# 240020
Utsunomiya, Tochigi, 320-0834
- Recruiting
Wakayama Medical University Hospital /ID# 234004
Wakayama, Wakayama, 641-8510
- Completed
Yamagata University Hospital /ID# 240815
Yamagata, Yamagata, 990-9585
- Recruiting
Yokohama City University Medical Center /ID# 246554
Yokohama, Kanagawa, 232-0024
- Recruiting
Kanagawa Cardiovascular and Respiratory Center /ID# 239052
Yokohama, Kanagawa, 236-0051
Turkey (Türkiye)13 sites, 12 recruiting
- Recruiting
Adana Sehir Egitim ve Arastirma Hastanesi /ID# 255638
Adana, 01060
- Completed
Adana Acıbadem Hospital /ID# 234208
Adana, 01130
- Recruiting
Medical Park Seyhan Hastanesi /ID# 255637
Adana, 01140
- Recruiting
Gazi Universitesi /ID# 265425
Ankara, 06560
- Recruiting
Ankara City Hospital /ID# 234210
Ankara, 06800
- Recruiting
Inonu Universitesi Turgut Ozal /ID# 234038
Battalgazi/malatya, 44280
- Recruiting
Uludag University Medical Faculty /ID# 234205
Bursa, 16059
- Recruiting
Memorial Ankara Hastanesi /ID# 234212
Çankaya, Ankara, 06520
- Recruiting
Izmir Ekonomi Universitesi Ozel Medicalpoint Hastanesi /ID# 234209
Cordaleo, İzmir, 35575
- Recruiting
Dicle Universitesi Tip /ID# 234036
Diyarbakır, 21200
- Recruiting
Bagcilar Medipol Mega Universite Hastanesi /ID# 234211
Istanbul, 34214
- Recruiting
Ege University Medical Faculty /ID# 234039
Izmir, 35040
- Recruiting
Dr. Suat Seren Gogus Has /ID# 262291
Izmir, 35110
France12 sites, 12 recruiting
- Recruiting
Centre Hospitalier d'Avignon /ID# 275229
Avignon, Provence-Alpes-Côte d'Azur Region, 84000
- Recruiting
Hospices Civils de Lyon - Hopital Louis Pradel /ID# 251933
Bron, Rhone, 69500
- Recruiting
Centre Hosp Intercommunal de Creteil /ID# 251936
Créteil, Val-de-Marne, 94000
- Recruiting
Centre Hospitalier Regional Universitaire de Lille - Hopital Albert Calmette /ID# 251934
Lille, Hauts-de-France, 59037
- Recruiting
Centre Leon Berard /ID# 267397
Lyon, Rhone, 69373
- Recruiting
APHM - Hopital Nord /ID# 251935
Marseille, Bouches-du-Rhone, 13015
- Recruiting
Hopital Arnaud de Villeneuve /ID# 239404
Montpellier, Herault, 34295
- Recruiting
Institut Curie /ID# 240141
Paris, Paris, 75248
- Recruiting
Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 239409
Paris, Paris, 75679
- Recruiting
AP-HP - Hopital Tenon /ID# 239179
Paris, 75020
- Recruiting
Centre Hospitalier Universitaire de Bordeaux /ID# 244953
Pessac, New Aquitaine, 33604
- Recruiting
Institut Gustave Roussy /ID# 267415
Villejuif, Île-de-France Region, 94800
Belgium11 sites, 11 recruiting
- Recruiting
Institut Jules Bordet /ID# 246770
Anderlecht, 1070
- Recruiting
Algemeen Ziekenhuis klina /ID# 239853
Brasschaat, Antwerpen, 2930
- Recruiting
Grand Hopital de Charleroi - Les Viviers /ID# 234178
Charleroi, Hainaut, 6280
- Recruiting
Universitair Ziekenhuis Antwerpen /ID# 239971
Edegem, Antwerpen, 2650
- Recruiting
UZ Gent /ID# 273244
Ghent, Oost-Vlaanderen, 9000
- Recruiting
AZ Maria Middelares /ID# 246768
Ghent, 9000
- Recruiting
Jessa Ziekenhuis /ID# 246766
Hasselt, Limburg, 3500
- Recruiting
Hospital La Louviere Site Jolimont - Helora /ID# 246771
La Louvière, Hainaut, 7100
- Recruiting
CHU de Liege /ID# 246772
Liège, 4000
- Recruiting
UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 246769
Namur, 5000
- Recruiting
Vitaz /Id# 246773
Sint-Niklaas, Oost-Vlaanderen, 9100
Germany10 sites, 10 recruiting
- Recruiting
Zentralklinik Bad Berka /ID# 239661
Bad Berka, Thuringia, 99437
- Recruiting
Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 234247
Berlin, 13353
- Recruiting
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 274719
Dresden, Saxony, 01307
- Recruiting
Asklepios Fachkliniken Muenchen-Gauting /ID# 272768
Gauting, Bavaria, 82131
- Recruiting
Universitaetsklinikum Giessen /ID# 252973
Giessen, Hesse, 35392
- Recruiting
Universitaetsklinikum Hamburg-Eppendorf /ID# 239658
Hamburg, 20246
- Recruiting
Haemato-Onkologie Hamburg /ID# 241047
Hamburg, 20251
- Recruiting
Thoraxklinik Heidelberg gGmbH /ID# 239656
Heidelberg, Baden-Wurttemberg, 69126
- Recruiting
Klinikum Kassel /ID# 240142
Kassel, Hesse, 34125
- Recruiting
Universitatsklinikum Mannheim /ID# 238331
Mannheim, Baden-Wurttemberg, 68167
South Korea10 sites, 10 recruiting
- Recruiting
Chungbuk National University Hospital /ID# 257891
Cheongju-si, North Chungcheong, 28644
Site Coordinator, 043-261-3703
- Recruiting
National Cancer Center /ID# 260663
Goyang-si, Gyeonggido, 10408
- Recruiting
Gyeongsang National University Hospital /ID# 234244
Jinju, Gyeongsangnam-do, 52727
- Recruiting
CHA Bundang Medical Center /ID# 233318
Seongnam, Gyeonggido, 13496
- Recruiting
Kangbuk Samsung Hospital /ID# 233711
Seoul, Seoul Teugbyeolsi, 03181
- Recruiting
Samsung Medical Center /ID# 256941
Seoul, Seoul Teugbyeolsi, 06351
- Recruiting
SMG-SNU Boramae Medical Center /ID# 233710
Seoul, Seoul Teugbyeolsi, 07061
- Recruiting
The Catholic University Of Korea St. Vincent's Hospital /ID# 256942
Suwon, Gyeonggido, 16247
- Recruiting
Ajou University Hospital - Suwon-si /ID# 233319
Suwon, Gyeonggido, 16499
- Recruiting
Pusan National University Yangsan Hospital /ID# 257836
Yangsan, Gyeongsangnam-do, 50612
Brazil9 sites, 9 recruiting
- Recruiting
Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 233247
Barretos, São Paulo, 14784-400
- Recruiting
Hospital Da Crianca Santo Antonio /ID# 233249
Porto Alegre, Rio Grande do Sul, 90020-090
- Recruiting
Instituto Nacional de Cancer (INCA) /ID# 231509
Rio de Janeiro, 20231-050
- Recruiting
Instituto Dor de Pesquisa e Ensino /ID# 233245
Rio de Janeiro, 22281-100
- Recruiting
Clinica Amo - Rio Vermelho /ID# 231604
Salvador, Estado de Bahia, 41950-640
- Recruiting
OC Oncoclínicas SP /ID# 261828
São Paulo, São Paulo, 05874-230
- Recruiting
Instituto de Ensino e Pesquisas Sao Lucas /ID# 247417
São Paulo, 01236-030
- Recruiting
Hospital Sirio Libanes - Sao Paulo /ID# 261827
São Paulo, 01308-050
- Recruiting
Casa de Saúde Santa Marcelina /ID# 231605
São Paulo, 08270-070
Italy9 sites, 8 recruiting
- Recruiting
I.R.C.C.S Istituto Tumori Giovanni Paolo II /ID# 238696
Bari, 70124
- Recruiting
Azienda Socio Sanitaria Territoriale di Cremona /ID# 238698
Cremona, 26100
- Completed
Azienda Ospedaliera Papardo /ID# 258038
Messina, 98158
- Recruiting
IRCCS Ospedale San Raffaele /ID# 254376
Milan, Milano, 20132
- Recruiting
Humanitas Istituto Clinico Catanese /ID# 273050
Misterbianco, Catania, 95045
- Recruiting
Azienda Ospedaliera Universitaria Luigi Vanvitelli - Miraglia /ID# 252942
Naples, Napoli, 80138
- Recruiting
Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 238473
Perugia, 06156
- Recruiting
Azienda Ospedaliera Complesso Ospedaliero San Giovanni-Addolorata /ID# 238618
Rome, Roma, 00184
- Recruiting
ASST Sette Laghi - Ospedale Di Circolo E Fondazione Macchi Varese /ID# 238536
Varese, 21100
Spain9 sites, 9 recruiting
- Recruiting
Hospital Universitario Fundacion Alcorcon /ID# 255100
Alcorcón, Madrid, 28922
- Recruiting
Hospital Nuestra Senora de Sonsoles /ID# 255102
Ávila, 05004
- Recruiting
UOMi Cancer Center - Clinica Tres Torres /ID# 240584
Barcelona, 08017
- Recruiting
Hospital Universitario Dexeus - Grupo Quironsalud /ID# 255105
Barcelona, 08028
- Recruiting
Hospital Universitario de Fuenlabrada /ID# 255093
Fuenlabrada, Madrid, 28942
- Recruiting
Hospital Universitario de Jaen /ID# 240588
Jaén, 23007
- Recruiting
CHU Insular-Materno Infantil /ID# 255094
Las Palmas de Gran Canaria, Las Palmas, 35016
- Recruiting
Hospital Universitario 12 de Octubre /ID# 240176
Madrid, 28041
- Recruiting
Hospital Clinico Universitario de Valencia /ID# 240378
Valencia, 46010
Austria8 sites, 8 recruiting
- Recruiting
Landeskrankenhaus Feldkirch /ID# 250333
Feldkirch, Vorarlberg, 6800
- Recruiting
Medizinische Universitaet Innsbruck /ID# 240981
Innsbruck, Tyrol, 6020
Site Coordinator, 004351290030
- Recruiting
Ordensklinikum Linz Elisabethinen /ID# 240967
Linz, Upper Austria, 4010
- Recruiting
Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 232467
Salzburg, 5020
- Recruiting
Medizinische Universitaet Wien /ID# 230615
Vienna, State of Vienna, 1090
- Recruiting
Klinik Penzing /ID# 230700
Vienna, State of Vienna, 1140
- Recruiting
Klinik Floridsdorf /ID# 230608
Vienna, State of Vienna, 1210
- Recruiting
Klinikum Wels-Grieskirchen Gmbh /ID# 249000
Wels, Upper Austria, 4600
Romania8 sites, 8 recruiting
- Recruiting
Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL /ID# 240826
Brasov, 500283
- Recruiting
Cardiomed Srl /Id# 255320
Cluj-Napoca, Cluj, 400015
- Recruiting
Sc Oncolab Srl /Id# 239105
Craiova, Dolj, 200385
- Recruiting
Institutul Regional de Oncologie /ID# 254065
Iași, 700483
- Recruiting
Spitalul Pelican /ID# 254066
Oradea, Bihor County, 410469
- Recruiting
SC RTC Radiology Therapeutic Center SRL /ID# 240744
Otopeni, Ilfov, 075100
- Recruiting
S.C. Sigmedical Services SRL /ID# 239108
Suceava, 720214
- Recruiting
Oncocenter - Oncologie Clinica Srl /Id# 239103
Timișoara, Timiș County, 300166
Taiwan8 sites, 8 recruiting
- Recruiting
Changhua Christian Hospital /ID# 238394
Changhua City, Changhua County, 50006
- Recruiting
National Taiwan University Hospital - Hsinchu branch /ID# 238393
Hsinchu, 30059
- Recruiting
Hualien Tzu Chi Hospital /ID# 238398
Hualien City, 97002
- Recruiting
E-DA Cancer Hospital /ID# 239718
Kaohsiung City, Kaohsiung, 82445
- Recruiting
Chung Shan Medical University Hospital /ID# 238444
Taichung, 402
- Recruiting
National Taiwan University Hospital /ID# 238378
Taipei, 100
- Recruiting
Mackay Memorial Hospital /ID# 238392
Taipei, 104
- Recruiting
Taipei Medical University Hospital /ID# 238380
Taipei, 11031
Argentina6 sites, 6 recruiting
- Recruiting
LC Investigacion /ID# 239880
Buenos Aires, 1125
- Recruiting
Instituto de Oncologia Angel H Roffo /ID# 231499
Buenos Aires, 1417
Site Coordinator, 5491141689984
- Recruiting
Cemic /Id# 231486
Ciudad Autonoma Buenos Aires, Buenos Aires, 1431
- Recruiting
Centro Médico Austral /ID# 239860
Ciudad Autonoma Buenos Aires, Buenos Aires F.D., 1019
- Recruiting
Hospital Britanico de Buenos Aires /ID# 231495
Ciudad Autonoma de Buenos Aire, Buenos Aires, 1280
- Recruiting
Centro de Investigaciones Clinicas Clinica Viedma S.A. /ID# 232339
Viedma, Río Negro Province, 8500
Chile6 sites, 5 recruiting
- Recruiting
Icegclinic /Id# 231212
La Florida, Santiago Metropolitan, 8241479
- Recruiting
Sociedad Prosalud Montes y Orlandi /ID# 231154
Providencia, Santiago Metropolitan, 7500713
- Recruiting
Fundacion Arturo Lopez Perez /ID# 231151
Providencia, Santiago Metropolitan, 7500921
- Completed
Sociedad Oncovida /ID# 231152
Providencia, Santiago Metropolitan, 7510032
- Recruiting
Hospital Clinico Universidad De Los Andes /ID# 260974
Santiago, 7501504
- Recruiting
Clinica Universidad Catolica del Maule /ID# 231294
Talca, Maule Region, 3461341
United Kingdom6 sites, 6 recruiting
- Recruiting
Heartlands Hospital - University Hospitals Birmingham /ID# 258141
Birmingham, West Midlands, B9 5SS
- Recruiting
St Bartholomews Hospital - Barts Health /ID# 254342
London, Greater London, EC1A 7BE
- Recruiting
UCLH NHS FT - University College Hospital /ID# 249407
London, Greater London, NW1 2BU
- Recruiting
The Royal Marsden NHS Foundation Trust /ID# 246974
London, SW3 6JJ
- Recruiting
The Christie Hospital /ID# 243422
Manchester, M20 4BX
- Recruiting
Nottingham City Hospital /ID# 254707
Nottingham, Nottinghamshire, NG5 1PB
Bulgaria5 sites, 4 recruiting
- Completed
Complex Oncology Center - Burgas /ID# 240532
Burgas, 8000
- Recruiting
Uni Hospital /ID# 273707
Panagyurishte, Pazardzhik, 4500
- Recruiting
Complex Cancer Center Plovdiv /ID# 234106
Plovdiv, 4004
- Recruiting
University Multiprofile Hospital for Active Treatment Sofiamed /ID# 234108
Sofiya, Sofia, 1797
- Recruiting
UMHAT Multiprofile Hospital for Active Treatment Sveta Marina /ID# 234112
Varna, 9009
Canada5 sites, 5 recruiting
- Recruiting
William Osler Health System - Brampton Civic Hospital /ID# 254420
Brampton, Ontario, L6R 3J7
- Recruiting
Cross Cancer Institute. /ID# 252065
Edmonton, Alberta, T6G 1Z2
- Recruiting
CISSS de la Monteregie /ID# 239081
Greenfield Park, Quebec, J4V 2H1
- Recruiting
CSSS Alphonse-Desjardins, CHAU de Levis /ID# 261158
Lévis, Quebec, G6V 3Z1
- Recruiting
Hopital Du Sacre-Coeur De Montreal /ID# 274584
Montreal, Quebec, H4J 1C5
Greece5 sites, 4 recruiting
- Recruiting
Henry Dunnant Hospital Center /ID# 267021
Athens, Attica, 11526
- Recruiting
Thoracic General Hospital of Athens I Sotiria /ID# 230824
Athens, Attica, 11527
- Recruiting
Metropolitan Hospital /ID# 232158
Piraeus, Attica, 18547
- Recruiting
Metropolitan Hospital /ID# 239170
Piraeus, Attica, 18547
- Completed
Interbalkan Medical Center Of Thessaloniki /ID# 254407
Thessaloniki, 57001
Netherlands5 sites, 5 recruiting
- Recruiting
Jeroen Bosch Ziekenhuis /ID# 234087
's-Hertogenbosch, 5223 GZ
- Recruiting
Ziekenhuis St. Jansdal /ID# 251932
Harderwijk, Gelderland, 3844 DG
- Recruiting
Maastricht Universitair Medisch Centrum /ID# 233932
Maastricht, Limburg, 6229 HX
- Recruiting
HagaZiekenhuis /ID# 243693
The Hague, South Holland, 2545 AA
- Recruiting
Isala /ID# 238846
Zwolle, Overijssel, 8025 AB
Poland5 sites, 5 recruiting
- Recruiting
Instytut Centrum Zdrowia Matki Polki /ID# 239024
Lodz, Łódź Voivodeship, 93-338
- Recruiting
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie /ID# 239025
Olsztyn, Warmian-Masurian Voivodeship, 10-357
- Recruiting
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeyla /ID# 262489
Poznan, Greater Poland Voivodeship, 60-569
- Recruiting
MRUK-MED I Sp. z o.o. /ID# 239363
Rzeszów, Podkarpackie Voivodeship, 35-021
- Recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 262095
Warsaw, Masovian Voivodeship, 02-781
Portugal5 sites, 5 recruiting
- Recruiting
Fundacao Champalimaud /ID# 241925
Lisbon, Lisbon District, 1400-038
- Recruiting
Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 241572
Porto, 4099-001
- Recruiting
Hospital CUF Porto /ID# 241570
Porto, 4100-180
- Recruiting
IPO Porto FG, EPE /ID# 241569
Porto, 4200-072
- Recruiting
Unidade Local de Saude Sao Joao /ID# 241930
Porto, 4200-319
Australia4 sites, 4 recruiting
- Recruiting
Barwon Health /ID# 241920
Geelong, Victoria, 3220
- Recruiting
Austin Health /ID# 247507
Heidelberg, Victoria, 3084
- Recruiting
Port Macquarie Base Hospital /ID# 273654
Port Macquarie, New South Wales, 2444
- Recruiting
Westmead Hospital /ID# 274447
Westmead, New South Wales, 2145
Colombia4 sites, 4 recruiting
- Recruiting
Fundacion Ctic - Centro De Tratamiento E Investigacion Sobre Cancer Luis Carlos /ID# 258131
Bogotá, Bogota D.C., 110131
- Recruiting
Hospital Pablo Tobon Uribe /ID# 258128
Medellín, Antioquia, 050034
- Recruiting
Imat Oncomedica /ID# 258129
Montería, Departamento de Córdoba, 230018
- Recruiting
Sociedad de Oncologia y Hematologia del Cesar SAS /ID# 258130
Valledupar, Cesar Department, 200001
Israel4 sites, 3 recruiting
- Recruiting
Soroka University Medical Center /ID# 252711
Beersheba, Southern District, 8410101
- Completed
The Edith Wolfson Medical Center /ID# 233781
Holon, Southern District, 5822000
- Recruiting
ZIV Medical Center /ID# 238606
Safed, Northern District, 13100
- Recruiting
Tel Aviv Sourasky Medical Center /ID# 260519
Tel Aviv, Tel Aviv, 6423906
Mexico3 sites, 2 recruiting
- Recruiting
O.P.D. Hospital Civil de Guadalajara /ID# 238488
Guadalajara, Jalisco, 44280
- Completed
Centro de Investigacion Clínica Chapultepec SA de CV /ID# 231928
Morelia, Michoacán, 58260
- Recruiting
Clinical Research & Oncology Oaxaca /ID# 231883
Oaxaca City, 68020
South Africa3 sites, 1 recruiting
- Completed
Wits Clinical Research /ID# 230841
Johannesburg, Gauteng, 1864
- Completed
Sandton Oncology Medical Group PTY Ltd /ID# 230843
Johannesburg, Gauteng, 2196
- Recruiting
Steve Biko Academic Hospital /ID# 230883
Pretoria, Gauteng, 0001
Czechia2 sites, 1 recruiting
- Recruiting
Masarykuv onkologicky ustav /ID# 232426
Brno, 656 53
- Completed
Nemocnice AGEL Novy Jicin, a.s. /ID# 232427
Nový Jičín, 741 01
Denmark2 sites, 2 recruiting
- Recruiting
Zealand University Hospital /ID# 241842
Køge, Region Sjælland, 4600
- Recruiting
Odense University Hospital /ID# 241663
Odense, Region Syddanmark, 5000
Sweden2 sites, 2 recruiting
- Recruiting
Sahlgrenska Universitetssjukhuset /ID# 229943
Gothenburg, Västra Götaland County, 413 46
- Recruiting
Karolinska University Hospital Solna /ID# 229853
Solna, Stockholm County, 171 64
Slovakia1 site
- Completed
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 230084
Banská Bystrica, Banská Bystrica Region, 975 17
About this study
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
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.
Read more
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.
- Conditions
- Non Small Cell Lung Cancer, c-MET
- Being tested
- Telisotuzumab Vedotin, Docetaxel
- Keywords
- c-Met Overexpressing Non-Small Cell Lung Cancer, c-Met NSCLC, Telisotuzumab Vedotin, ABBV-399, Docetaxel, Cancer, Non Small Cell Lung Cancer, NSCLC, TeliMET NSCLC-01, Teliso-V, c-Met protein overexpression
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telisotuzumab VedotinBiological
Also called ABBV-399
Intravenous (IV) Infusion
DocetaxelDrug
IV Infusion
| Study group | Role | What they receive |
|---|---|---|
| Telisotuzumab Vedotin | Experimental | Participants will receive telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria. Receives: Biological: Telisotuzumab Vedotin |
| Docetaxel | Active comparator | Participants will receive docetaxel every 3 weeks until meeting study drug discontinuation criteria. Receives: Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 39 months
Overall Survival (OS)
OS is defined as the time from randomization to the event of death from any cause.
Measured: Up to approximately 39 months
Secondary outcomes (5)
Objective Response Rate (ORR), per BICR.
ORR is defined as the proportion of participants with a complete response (CR) or partial response (PR) based on RECIST v1.1
Measured: Up to approximately 58.25 months
Duration of Response (DoR), per BICR
DoR is defined for responders as the time from response (CR or PR) to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause.
Measured: Up to approximately 58.25 months
PFS per Investigator Assessment
PFS is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 per investigator or death from any cause. Participants with no PFS event will be censored at the last evaluable radiographic assessment per investigator. Participants with no event and no evaluable post-baseline assessment will be censored at randomization.
Measured: 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).
The EORTC QLQ-C30 assesses health-related quality of life in cancer patients participating in clinical trials. The EORTC QLQ-C30 comprises 5 functional scales (physical, role, emotional, social, cognitive), 8 single-item symptom scales (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, and dyspnea), as well as subscales assessing global health/quality of life and financial impact. Raw scores are transformed to a scale of 0 to 100, with higher scores representing better functioning/quality of life and greater symptom burden.
Measured: 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.
The EORTC QLQ-C30 assesses health-related quality of life in cancer patients participating in clinical trials. The EORTC QLQ-C30 comprises 5 functional scales (physical, role, emotional, social, cognitive), 8 single-item symptom scales (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, and dyspnea), as well as subscales assessing global health/quality of life and financial impact. Raw scores are transformed to a scale of 0 to 100, with higher scores representing better functioning/quality of life and greater symptom burden.
Measured: Up to approximately 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start25 Mar 2022
- Primary completionDec 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 768 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928846
- Sponsor's protocol ID
- M18-868
- Other IDs
- 2023-505749-14-00, 2023
- Status last verified
- Oct 2026
- First submitted
- 14 Jun 2021
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
- Expanded access
- Available