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JOURNAL ONKOLOGIE – STUDIE

Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer

Rekrutierend

NCT-Nummer:
NCT03539536

Studienbeginn:
Oktober 2018

Letztes Update:
20.04.2021

Wirkstoff:
Telisotuzumab vedotin

Indikation (Clinical Trials):
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
AbbVie

Collaborator:
-

Studienleiter

AbbVie Inc.
Study Director
AbbVie

Kontakt

Studienlocations
(3 von 177)

KH Martha-Maria Halle Dolau /ID# 205442
06120 Halle (Saale)
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps
Vivantes Klinikum Neukolln /ID# 205928
12351 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Asklepios Fachkliniken M. Gaut /ID# 207789
82131 Gauting
(Bayern)
GermanyRekrutierend» Google-Maps
Evangelisches Krankenhaus Hamm /ID# 208043
59063 Hamm
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Klinikum Kassel /ID# 205443
34125 Kassel
(Hessen)
GermanyRekrutierend» Google-Maps
Pius Hospital Oldenburg /ID# 211615
26121 Oldenburg
(Niedersachsen)
GermanyRekrutierend» Google-Maps
University of South Alabama /ID# 212939
36604-3302 Mobile
United StatesRekrutierend» Google-Maps
Mayo Clinic Arizona /ID# 218550
85054-4504 Phoenix
United StatesRekrutierend» Google-Maps
Highlands Oncology Group /ID# 215600
72762 Springdale
United StatesRekrutierend» Google-Maps
University of California, Los Angeles /ID# 203219
90095 Los Angeles
United StatesRekrutierend» Google-Maps
Sutter Medical Center Sacramen /ID# 203299
95816 Sacramento
United StatesRekrutierend» Google-Maps
Icri /Id# 227835
90603 Whittier
United StatesNoch nicht rekrutierend» Google-Maps
Univ of Colorado Cancer Center /ID# 203212
80045 Aurora
United StatesRekrutierend» Google-Maps
Rocky Mountain Cancer Centers, LLP- Sky Ridge /ID# 215789
80124 Lone Tree
United StatesRekrutierend» Google-Maps
Mayo Clinic - Jacksonville /ID# 218488
32224 Jacksonville
United StatesRekrutierend» Google-Maps
University of Miami, Miller School of Medicine /ID# 221247
33136 Miami
United StatesNoch nicht rekrutierend» Google-Maps
AdventHealth Cancer Institute - Orlando /ID# 215649
32804 Orlando
United StatesNoch nicht rekrutierend» Google-Maps
Straub Clinic and Hospital /ID# 217905
96813-3097 Honolulu
United StatesRekrutierend» Google-Maps
Northwestern University Feinberg School of Medicine /ID# 203239
60611-2927 Chicago
United StatesRekrutierend» Google-Maps
The University of Chicago Medical Center /ID# 203216
60637-1443 Chicago
United StatesAbgeschlossen» Google-Maps
NorthShore University HealthSystem - Evanston Hospital /ID# 215583
60201 Evanston
United StatesRekrutierend» Google-Maps
Ingalls Memorial Hosp /ID# 203228
60426 Harvey
United StatesRekrutierend» Google-Maps
Joliet Oncology-Hematology Associates, LTD /ID# 203238
60435 Joliet
United StatesAbgeschlossen» Google-Maps
Goshen Center for Cancer Care /ID# 215584
46526 Goshen
United StatesRekrutierend» Google-Maps
Univ Kansas Med Ctr /ID# 216804
66160 Kansas City
United StatesRekrutierend» Google-Maps
Cancer Center of Kansas /ID# 203235
67214 Wichita
United StatesRekrutierend» Google-Maps
Baptist Health /ID# 203283
40503-1463 Lexington
United StatesRekrutierend» Google-Maps
Norton Cancer Institute /ID# 203284
40207 Louisville
United StatesRekrutierend» Google-Maps
Central Maine Medical Center /ID# 216583
04240 Lewiston
United StatesRekrutierend» Google-Maps
Massachusetts General Hospital /ID# 203215
02114 Boston
United StatesRekrutierend» Google-Maps
Beth Israel Deaconess Medical Center /ID# 208124
02215-5400 Boston
United StatesRekrutierend» Google-Maps
Dana-Farber Cancer Institute /ID# 203248
02215 Boston
United StatesRekrutierend» Google-Maps
Henry Ford Hospital - West Bloomfield /ID# 203220
48322 West Bloomfield
United StatesRekrutierend» Google-Maps
Mayo Clinic /ID# 215603
55905-0001 Rochester
United StatesNoch nicht rekrutierend» Google-Maps
Hattiesburg Clinic /ID# 227691
39401 Hattiesburg
United StatesNoch nicht rekrutierend» Google-Maps
Washington University-School of Medicine /ID# 203217
63110 Saint Louis
United StatesRekrutierend» Google-Maps
St. Vincent Frontier Cancer Center /ID# 203292
59102 Billings
United StatesRekrutierend» Google-Maps
Dartmouth-Hitchcock Medical Center /ID# 203350
03756 Lebanon
United StatesRekrutierend» Google-Maps
Astera Cancer Care /ID# 228868
08816 East Brunswick
United StatesNoch nicht rekrutierend» Google-Maps
Atlantic Health System /ID# 203404
07960-6136 Morristown
United StatesRekrutierend» Google-Maps
Overlook Medical Center /ID# 211160
07901-3533 Summit
United StatesRekrutierend» Google-Maps
University of New Mexico /ID# 208339
87102-4517 Albuquerque
United StatesRekrutierend» Google-Maps
Univ Hosp Cleveland /ID# 215648
44106 Cleveland
United StatesRekrutierend» Google-Maps
Providence Cancer Center Oncology and Hematology Care - Westside Portland /ID# 203301
97225 Portland
United StatesRekrutierend» Google-Maps
Penn State University and Milton S. Hershey Medical Center /ID# 221844
17033-2360 Hershey
United StatesNoch nicht rekrutierend» Google-Maps
Allegheny General Hospital /ID# 215585
15212 Pittsburgh
United StatesRekrutierend» Google-Maps
Veterans Healthcare System /ID# 215602
15240 Pittsburgh
United StatesNoch nicht rekrutierend» Google-Maps
Thompson Cancer Survival Ctr /ID# 228874
37916 Knoxville
United StatesNoch nicht rekrutierend» Google-Maps
Vanderbilt University Med Ctr /ID# 203281
37232-6307 Nashville
United StatesRekrutierend» Google-Maps
Houston Methodist Hospital - Scurlock Tower /ID# 213268
77030 Houston
United StatesRekrutierend» Google-Maps
Baylor Scott & White Medical Center- Temple /ID# 216578
76508-0001 Temple
United StatesRekrutierend» Google-Maps
Virginia Cancer Specialists /ID# 203224
22031 Fairfax
United StatesRekrutierend» Google-Maps
University of Washington /ID# 206056
98109-1024 Seattle
United StatesRekrutierend» Google-Maps
Medical College of Wisconsin /ID# 210062
53226-3522 Milwaukee
United StatesRekrutierend» Google-Maps
The Kinghorn Cancer Centre /ID# 207666
2010 Darlinghurst
AustraliaRekrutierend» Google-Maps
Newcastle Private Hospital /ID# 206600
2305 Lambton Heights
AustraliaRekrutierend» Google-Maps
The Tweed Hospital /ID# 206601
2485 Tweed Heads
AustraliaRekrutierend» Google-Maps
St. John of God Subiaco Hosp /ID# 226943
6008 Subiaco
AustraliaNoch nicht rekrutierend» Google-Maps
Cross Cancer Institute /ID# 204540
T6G 1Z2 Edmonton
CanadaRekrutierend» Google-Maps
The Ottawa Hospital /ID# 205579
K1H 8L6 Ottawa
CanadaRekrutierend» Google-Maps
Princess Margaret Cancer Centre /ID# 204423
M5G 2M9 Toronto
CanadaRekrutierend» Google-Maps
CISSS de la Monteregie /ID# 211356
J4V 2H1 Greenfield Park
CanadaRekrutierend» Google-Maps
Anhui Provincial Hospital /ID# 212096
230001 Hefei
ChinaRekrutierend» Google-Maps
Fujian Provincial Cancer Hospital /ID# 210808
350014 Fuzhou
ChinaRekrutierend» Google-Maps
Henan Cancer Hospital /ID# 210961
450008 Zhengzhou
ChinaRekrutierend» Google-Maps
Affiliated Hospital of Jiangnan University /ID# 227252
214062 Wuxi
ChinaNoch nicht rekrutierend» Google-Maps
Jilin Cancer Hosptial /ID# 210563
130000 Changchun
ChinaRekrutierend» Google-Maps
Fudan University Shanghai Cancer Center /Id# 210084
200032 Shanghai
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital, Zhejiang University /ID# 211154
310003 Hangzhou
ChinaRekrutierend» Google-Maps
Zhejiang Cancer Hospital /ID# 210085
310022 Hangzhou
ChinaRekrutierend» Google-Maps
Beijing Cancer Hospital /ID# 210133
100142 Beijing
ChinaRekrutierend» Google-Maps
West China Hospital, Sichuan University /ID# 210022
610041 Chengdu
ChinaRekrutierend» Google-Maps
Shanghai Chest Hospital /ID# 210930
200030 Shanghai
ChinaRekrutierend» Google-Maps
Nemocnice Horovice, NH Hospita /ID# 228953
268 31 Horovice
CzechiaNoch nicht rekrutierend» Google-Maps
Vseobecna Fakultni Nemocnice /ID# 229797
128 08 Prague
CzechiaNoch nicht rekrutierend» Google-Maps
CHU Hopital Nord /ID# 209854
13915 Marseille
FranceRekrutierend» Google-Maps
Institut Bergonie /ID# 216207
33000 Bordeaux
FranceRekrutierend» Google-Maps
Institut Curie /ID# 207046
75248 Paris CEDEX 05
FranceRekrutierend» Google-Maps
Centre Leon Berard /ID# 205107
69373 Lyon CEDEX 08
FranceRekrutierend» Google-Maps
Centre Hosp Intercommunal de Creteil /ID# 227108
94000 Creteil
FranceNoch nicht rekrutierend» Google-Maps
Institut Gustave Roussy /ID# 205149
94805 Villejuif Cedex
FranceRekrutierend» Google-Maps
Hopital Louis Pradel /ID# 216209
69500 Bron
FranceRekrutierend» Google-Maps
CHRU de Lille - Hopital Albert Calmette /ID# 205105
59037 Lille
FranceRekrutierend» Google-Maps
Nouvel Hopital Civil (NHC) /ID# 208080
67091 Strasbourg
FranceRekrutierend» Google-Maps
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 205528
11527 Athens
GreeceNoch nicht rekrutierend» Google-Maps
Metropolitan Hospital /ID# 205529
18547 Athens
GreeceRekrutierend» Google-Maps
University General Hospital of Heraklion PA.G.N.I /ID# 205530
71110 Heraklion
GreeceRekrutierend» Google-Maps
Bioclinic Thessaloniki /ID# 227261
54622 Thessaloniki
GreeceNoch nicht rekrutierend» Google-Maps
Euromedica General Clinic /ID# 227264
54645 Thessaloniki
GreeceNoch nicht rekrutierend» Google-Maps
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 204878
3529 Miskolc
HungaryRekrutierend» Google-Maps
Torokbalinti Tudogyogyintezet /ID# 204883
2045 Budapest
HungaryRekrutierend» Google-Maps
Semmelweis Egyetem /ID# 204434
1085 Budapest
HungaryRekrutierend» Google-Maps
Veszprem Megyei Tudogyogyintez /ID# 213950
8582 Farkasgyepu
HungaryRekrutierend» Google-Maps
Matrahaza Gyogyintezet /ID# 204432
3233 Kékesteto
HungaryRekrutierend» Google-Maps
St. James's Hospital /ID# 205104
D08 E9P6 Dublin 8
IrelandRekrutierend» Google-Maps
Cork University Hospital /ID# 205103
T12 E8YV Cork
IrelandRekrutierend» Google-Maps
St Vincent's University Hosp /ID# 205102
D04 T6F4 Dublin
IrelandRekrutierend» Google-Maps
University Hospital Limerick /ID# 229873
V94F858 Limerick
IrelandNoch nicht rekrutierend» Google-Maps
Soroka Medical Center /ID# 204898
84101 Be'er Sheva
IsraelRekrutierend» Google-Maps
Rabin Medical Center /ID# 215322
4941492 Petakh Tikva
IsraelRekrutierend» Google-Maps
Rambam Health Care Campus /ID# 204866
3109601 Haifa
IsraelRekrutierend» Google-Maps
Meir Medical Center /ID# 204255
4428164 Kfar Saba
IsraelRekrutierend» Google-Maps
Sheba Medical Center /ID# 204254
5239424 Ramat Gan
IsraelRekrutierend» Google-Maps
IRST IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori /ID# 205601
47014 Meldola
ItalyRekrutierend» Google-Maps
Policlinico Universitario Campus Bio-Medico /ID# 215918
00128 Rome
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera San Camillo Forlanini /ID# 205163
00152 Rome
ItalyRekrutierend» Google-Maps
AO San Giuseppe Moscati /ID# 204707
83100 Avellino
ItalyRekrutierend» Google-Maps
A.O.U. San Luigi Gonzaga /ID# 204706
10043 Orbassano
ItalyRekrutierend» Google-Maps
Azienda Ospedaliero Uni Parma /ID# 204983
43100 Parma
ItalyRekrutierend» Google-Maps
Aichi Cancer Center Hospital /ID# 207790
464-8681 Nagoya-shi
JapanNoch nicht rekrutierend» Google-Maps
National Hospital Organization Kyushu Cancer Center /ID# 206061
811-1395 Fukuoka-shi
JapanRekrutierend» Google-Maps
Sendai Kousei Hospital /ID# 216460
980-0873 Sendai-shi
JapanRekrutierend» Google-Maps
Niigata Cancer Center Hospital /ID# 216462
951-8566 Niigata-shi
JapanRekrutierend» Google-Maps
Okayama University Hospital /ID# 227851
700-8558 Okayama-shi
JapanNoch nicht rekrutierend» Google-Maps
Osaka International Cancer Institute /ID# 210735
541-8567 Osaka-shi
JapanRekrutierend» Google-Maps
Kinki-Chuo Chest Medical Center /ID# 216461
591-8555 Sakai-shi
JapanRekrutierend» Google-Maps
Shizuoka Cancer Center /ID# 205065
411-8777 Sunto-gun
JapanRekrutierend» Google-Maps
National Cancer Center Hospital /ID# 205066
104-0045 Chuo-ku
JapanRekrutierend» Google-Maps
The Cancer Institute Hospital Of JFCR /ID# 216463
135-8550 Koto-ku
JapanRekrutierend» Google-Maps
Yamaguchi - Ube Medical Center /ID# 227778
755-0241 Ube-shi
JapanNoch nicht rekrutierend» Google-Maps
Hiroshima Citizens Hospital /ID# 218087
730-8518 Hiroshima
JapanRekrutierend» Google-Maps
Matsusaka Municipal Hospital /ID# 230219
515-8544 Matsusaka-shi MIE
JapanNoch nicht rekrutierend» Google-Maps
Kanagawa Cancer Center /ID# 205068
241-0815 Yokohama
JapanRekrutierend» Google-Maps
National Cancer Center /ID# 204241
10408 Goyang
Korea, Republic ofRekrutierend» Google-Maps
Seoul National Univ Bundang ho /ID# 204237
13620 Seongnam
Korea, Republic ofRekrutierend» Google-Maps
Samsung Medical Center /ID# 227083
06351 Seoul
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Chungbuk National Univ Hosp /ID# 205680
28644 Cheongju
Korea, Republic ofAbgeschlossen» Google-Maps
Chonnam National University Hwasun Hospital /ID# 206951
58128 Jeonnam
Korea, Republic ofRekrutierend» Google-Maps
Asan Medical Center /ID# 204236
05505 Seoul
Korea, Republic ofAbgeschlossen» Google-Maps
Antoni van Leeuwenhoek /ID# 216657
1066 CX Amsterdam
NetherlandsRekrutierend» Google-Maps
Meander Medisch Centrum /ID# 217756
3813 TZ Amersfoort
NetherlandsRekrutierend» Google-Maps
Ziekenhuis St. Jansdal /ID# 216658
3844 DG Harderwijk
NetherlandsRekrutierend» Google-Maps
VA Caribbean Healthcare System /ID# 206336
00921-3201 San Juan
Puerto RicoAbgeschlossen» Google-Maps
Puerto Rico Hematology Oncolog /ID# 206337
00959 San Juan
Puerto RicoAbgeschlossen» Google-Maps
S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 227623
200347 Craiova
RomaniaNoch nicht rekrutierend» Google-Maps
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti /ID# 227216
022328 Bucharest
RomaniaNoch nicht rekrutierend» Google-Maps
Coltea Clinical Hospital /ID# 227241
030171 Bucharest
RomaniaNoch nicht rekrutierend» Google-Maps
S.C. Gral Medical Srl /Id# 227215
031422 Bucharest
RomaniaNoch nicht rekrutierend» Google-Maps
Institutul Oncologic /ID# 206320
400015 Cluj Napoca
RomaniaRekrutierend» Google-Maps
Spitalul Municipal Ploiesti /ID# 229097
100337 Ploiesti
RomaniaNoch nicht rekrutierend» Google-Maps
Avicenna medical center /ID# 212397
630099 Novosibirsk
Russian FederationRekrutierend» Google-Maps
Tatarstan Cancer Center /ID# 206463
420029 Kazan
Russian FederationRekrutierend» Google-Maps
Volgograd Regional Clinical Oncology Dispensary /ID# 206520
400138 Volgograd
Russian FederationAbgeschlossen» Google-Maps
Arkhangelsk clinical oncology /ID# 216418
163045 Arkhangelsk
Russian FederationRekrutierend» Google-Maps
LLC Evimed /ID# 216473
454048 Chelyabinsk
Russian FederationRekrutierend» Google-Maps
Univercity Headache Clynic,LTD /ID# 212080
109028 Moscow
Russian FederationRekrutierend» Google-Maps
VitaMed LLC /ID# 228957
121309 Moscow
Russian FederationNoch nicht rekrutierend» Google-Maps
PMI Euromedservice /ID# 206390
196603 Pushkin
Russian FederationRekrutierend» Google-Maps
LLC Novaya Clinica /ID# 216262
357502 Pyatigorsk
Russian FederationRekrutierend» Google-Maps
OOO Centre of Palliative Medicine De Vita /ID# 212900
197343 Saint Petersburg
Russian FederationRekrutierend» Google-Maps
St.Petersburg City Cancer Center /ID# 206405
198218 Sankt-Peterburg
Russian FederationRekrutierend» Google-Maps
Hospital Clínico Universitario de Santiago-CHUS /ID# 204367
15706 Santiago de Compostela
SpainRekrutierend» Google-Maps
Instituto Catalan de Oncologia (ICO) Badalona /ID# 216106
08916 Badalona
SpainRekrutierend» Google-Maps
Hospital Regional de Malaga /ID# 216081
29010 Málaga
SpainRekrutierend» Google-Maps
Hospital Universitario Vall d'Hebron /ID# 206997
08035 Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitario Ramon y Cajal /ID# 203922
28034 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario HM Sanchinarro /ID# 203913
28050 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario Virgen del Rocio /ID# 216058
41013 Sevilla
SpainRekrutierend» Google-Maps
Hospital Universitario y Politecnico La Fe /ID# 203862
46026 Valencia
SpainRekrutierend» Google-Maps
National Cheng Kung University Hospital /ID# 205307
70403 Tainan City
TaiwanRekrutierend» Google-Maps
National Taiwan University Hospital /ID# 205100
100 Taipei City
TaiwanRekrutierend» Google-Maps
Dalin Tzu Chi General Hospital /ID# 205309
622 Dalin Township
TaiwanRekrutierend» Google-Maps
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 205831
80708 Kaohsiung
TaiwanRekrutierend» Google-Maps
Taipei Med Univ Shuang Ho Hosp /ID# 215356
23561 New Taipei City
TaiwanRekrutierend» Google-Maps
Taichung Veterans General Hosp /ID# 205308
40705 Taichung City
TaiwanRekrutierend» Google-Maps
Linkou Chang Gung Memorial Ho /ID# 205424
33305 Taoyuan City
TaiwanRekrutierend» Google-Maps
Adana Sehir Egitim ve Arastirma Hastanesi /ID# 206000
01060 Adana
TurkeyRekrutierend» Google-Maps
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 205243
06200 Ankara
TurkeyRekrutierend» Google-Maps
Akdeniz Universitesi Tip Fakul /ID# 205238
07059 Antalya
TurkeyRekrutierend» Google-Maps
Trakya University Medical Facu /ID# 205242
22030 Edirne, Istanbul
TurkeyRekrutierend» Google-Maps
Prof. Dr. Suleyman Yalcın Sehir Hastanesi /ID# 215082
34722 Istanbul
TurkeyRekrutierend» Google-Maps
Dr. Suat Seren Gogus Has /ID# 215083
35110 Izmir
TurkeyRekrutierend» Google-Maps
Heart of England NHS Foundation Trust /ID# 206209
B9 5SS Birmingham
United KingdomRekrutierend» Google-Maps
Oxford Univ Hosp NHS Trust /ID# 205890
OX3 7LE Oxford
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

This study is designed to identify the target Non-Small Cell Lung Cancer (NSCLC)

population(s) that over express c-Met (c-Met+) best suited for telisotuzumab vedotin therapy

in the second line or third line setting (Stage 1) and then to expand the group(s) to further

evaluate efficacy in the selected population(s) (Stage 2).

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Histologically confirmed non-squamous cell non-small cell lung cancer (NSCLC) with

known epidermal growth factor receptor (EGFR) status (wild type or mutant; with site

documented status). Of note, participants with other actionable mutations are eligible

as long as EGFR status is known and all other eligibility criteria are met.

- Has locally advanced or metastatic NSCLC.

- Has c-Met+ NSCLC as assessed by an AbbVie designated immunohistochemistry (IHC)

laboratory. Participant must submit archival or fresh tumor material for assessment of

c-Met levels during the pre-screening period. If archival tissue is c-Met negative,

participant can submit fresh biopsy material for reassessment of c-Met expression.

- Have received no more than 2 lines of prior systemic therapy (including no more than 1

line of systemic cytotoxic chemotherapy) in the locally advanced or metastatic

setting.

- Multiple lines of tyrosine kinase inhibitors (TKIs) targeting the same gene

alteration count as 1 line of therapy for the purposes of this eligibility

criterion.

- Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.

Exclusion Criteria:

- Have received prior c-Met-targeted antibody-based therapies.

- Has adenosquamous histology.

- Participants with metastases to the central nervous system (CNS) are eligible only

after definitive therapy (such as surgery or radiotherapy).

- Has a clinically significant condition(s) described in the protocol.

- Has unresolved clinically significant adverse events >= grade 2 from prior anticancer

therapy, except for alopecia or anemia.

- Had major surgery within 21 days prior to the first dose of telisotuzumab vedotin.

- Has received live vaccine within 30 days of the first dose of telisotuzumab vedotin.

- History of interstitial lung disease or pneumonitis that required treatment with

systemic steroids, or any evidence of active interstitial lung disease or pneumonitis.

- Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.

- Participants do not have any evidence of pulmonary fibrosis on screening imaging

assessment or any history of pneumonitis or interstitial lung disease within 3 months

of the planned first dose of the study drug.

- Participants must not have received radiation therapy to the lung <6 months prior to

the first dose of telisotuzumab vedotin.

Studien-Rationale

Primary outcome:

1. Overall Response Rate (ORR) (Time Frame - Up to approximately 3 years):
ORR is defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.



Secondary outcome:

1. Duration of Response (DoR) (Time Frame - Up to approximately 3 years):
DoR is defined as the time from the participant's initial response (CR or PR) to the first occurrence of radiographic progression determined by an independent central review or death from any cause for the responders.

2. Disease Control Rate (DCR) (Time Frame - Up to approximately 3 years):
DCR is defined as the percentage of participants with best overall response of confirmed CR, confirmed PR, or stable disease (SD) for at least 12 weeks following enrollment, based on RECIST, version 1.1.

3. Progression-Free Survival (PFS) (Time Frame - Up to approximately 3 years):
PFS is defined as the time from the participant's first dose of study drug until the first occurrence of radiographic progression determined by an independent central review or death from any cause.

4. Overall Survival (OS) (Time Frame - Up to approximately 3 years):
OS is defined as the time from the participant's first dose of study drug until death from any cause.

Geprüfte Regime

  • Telisotuzumab vedotin (ABBV-399):
    Intravenous (IV) infusion

Quelle: ClinicalTrials.gov


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