Phase
Condition
N/ATreatment
sigvotatug vedotin
docetaxel
SGN-B6A
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically or cytologically confirmed diagnosis of locally advanced,unresectable (Stage IIIB, IIIC), or metastatic Stage IV (M1a, M1b, or M1c) NSCLCAmerican Joint Committee on Cancer (AJCC) Staging Manual, Version 8.0, and the Unionfor International Cancer Control (UICC) Staging System (Eighth edition).
Participants must have NSCLC with nonsquamous histology
Tumors with squamous, or predominantly squamous histology are excluded.
Tumors with small cell elements are excluded.
Participants who have NSCLC with known actionable genomic alteration (AGAs) arepermitted
Participants must have received the following prior therapies and progressed duringor relapsed after receiving their most recent prior therapy:
Participants with no known AGAs must fulfill 1 of the following conditions:
Received a platinum-based combination therapy for the treatment ofmetastatic or recurrent disease and a PD-(L)1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy), unlesscontraindicated.
Experienced disease progression within 6 months of the last dose ofplatinum-based chemotherapy in the adjuvant or neoadjuvant setting andreceived a PD-(L)1 monoclonal antibody at any time during the course oftreatment.
Participants with known AGAs must fulfill the following conditions:
Must have received at least 1 relevant AGA targeted therapy and in theopinion of the investigator, additional AGA targeted therapy is not in thebest interest of the participant.
Received a platinum-based combination therapy for the treatment ofmetastatic or recurrent disease, or experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the adjuvantor neoadjuvant setting
May have received up to 1 PD-(L)1 monoclonal antibody (concurrently orsequentially with platinum-based chemotherapy).
Measurable disease based on RECIST v1.1
Participants must have an Eastern Cooperative Oncology Group (ECOG) performancestatus of 0 or 1, with adequate baseline hematologic, hepatic, and renal functionand measurable disease according to RECIST v1.1
Exclusion
Exclusion Criteria:
Life expectancy of less than (<) 3 months
Known allergies/hypersensitivity/intolerance to or contraindication of taxanes,docetaxel, or any excipient contained in the drug formulation of sigvotatug vedotin
History of another malignancy within 3 years before Cycle 1 Day 1, or any evidenceof residual disease from a previously diagnosed malignancy. Exceptions aremalignancies with a negligible risk of metastasis or death
Participants with any of the following respiratory conditions:
Evidence of noninfectious interstitial lung disease (ILD) or pneumonitis that:
Was previous diagnosed and required systemic steroids, or
Is currently diagnosed and managed, or
Is suspected on radiologic imaging at screening
Known diffusing capacity of the lung for carbon monoxide (DLCO) < 50%
Any Grade greater than or equal to (≥) 3 pulmonary disease unrelated tounderlying malignancy
Pre-existing peripheral neuropathy Grade greater than or equal to (≥) 2
Uncontrolled diabetes mellitus
Prior therapy:
Prior treatment with antimicrotubule agents (taxanes, vinca alkaloids, orMMAEs) in the locally advanced, unresectable/refractory, or metastatic setting
Prior antimicrotubule agent exposure in curative settings (including adjuvant,neoadjuvant, or chemoradiotherapy) is permissible.
Received more than 1 prior line of cytotoxic chemotherapy in the locallyadvanced, unresectable/refractory, or metastatic setting
Prior cytotoxic chemotherapy in curative settings is permissible
At least 14 days must have elapsed from the last dose of radiotherapy untilCycle 1 Day 1.
Prior radiation therapy to the lung parenchyma that is >30 Gray (Gy) within 6months of Cycle 1 Day 1.
Any systemic anticancer therapy (standard or experimental) within 21 days priorto Cycle 1 Day 1.
Active central nervous system (CNS) lesions, including leptomeningeal metastasis,are excluded. Participants with definitively treated brain metastases are eligiblein they meet the following criteria:
Have been clinically stable for at least 4 weeks prior to treatment initiationand baseline scans show no evidence of new or enlarged metastasis
On a stable dose of less than or equal to (≤) 10mg/day of prednisone orequivalent for a least 2 weeks (if requiring steroid treatment)
Treatment with corticosteroids greater than (>) 1 month prior to Screeningvisit
No evidence of clinical and radiographic disease progression in the CNS for ≥ 21 days after definitive radiotherapy and/or surgery
Study Design
Connect with a study center
Instituto de Oncologia de Rosario
Rosario, Other S2000KZE
ArgentinaActive - Recruiting
Sanatorio Parque
Rosario, Other S2000DSV
ArgentinaActive - Recruiting
Calvary Mater Newcastle
Waratah, Other 2298
AustraliaActive - Recruiting
AKH - Medizinische Universitat Wien
Vienna, Other 1090
AustriaActive - Recruiting
Algemeen Ziekenhuis Klina
Brasschaat, Other 2930
BelgiumActive - Recruiting
Universitair Ziekenhuis Antwerpen
Edegem, Other 2650
BelgiumActive - Recruiting
University Hospital Ghent
Ghent, Other 9000
BelgiumActive - Recruiting
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, Other 3500
BelgiumActive - Recruiting
CHU de Liege
Liege, Other 4000
BelgiumActive - Recruiting
Tom Baker Cancer Centre
Calgary, Alberta T2N4N2
CanadaActive - Recruiting
University of Alberta / Cross Cancer Institute
Edmonton, Alberta T6G 1Z2
CanadaActive - Recruiting
William Osler Health Sciences
East Brampton, Ontario L6R 3J7
CanadaActive - Recruiting
Ottawa Hospital Cancer Centre
Ottawa, Ontario K1H 8L6
CanadaActive - Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario M4N 3M5
CanadaActive - Recruiting
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec H2X 0C2
CanadaActive - Recruiting
McGill University Department of Oncology / McGill University Health Centre
Montreal, Quebec H4A 3J1
CanadaActive - Recruiting
BIOCENTER Centro Clinico de Investigacion
Concepción, Other 4070268
ChileActive - Recruiting
Fakultni Nemocnice Olomouc (Fnol) - Onkologicka Klinika
Olomouc, Other 779 00
CzechiaActive - Recruiting
Vseobecna fakultni nemocnice v Praze
Prague, Other 128 08
CzechiaActive - Recruiting
Centre Hospitalier de Cholet
Cholet, Other 49300
FranceActive - Recruiting
Centre Hospitalier Intercommunal Creteil - CHI Creteil
Creteil, Other 94000
FranceActive - Recruiting
CHRU de Lille
Lille, Other 59037
FranceActive - Recruiting
Hopital Nord Marseille
Marseille, Other 13015
FranceActive - Recruiting
Centre de Cancerologie du Grand Montpellier
Montpellier, Other 34070
FranceActive - Recruiting
Hopital Bichat-Claude Bernard - APHP
Paris, Other 75018
FranceActive - Recruiting
Hopital Cochin
Paris, Other 75014
FranceActive - Recruiting
CHU Bordeaux Hopital Haut-Leveque
Pessac, Other 33604
FranceActive - Recruiting
Hospital Center De Cornouaille
Quimper Cedex, Other 29 107
FranceActive - Recruiting
Centre Hospitalier Universitaire de Rennes, Hopital Pontchaillou
Rennes, Other 35000
FranceActive - Recruiting
Institut de cancerologie Strasbourg Europe
Strasbourg, Other 67200
FranceActive - Recruiting
Chits Sainte Musse
Toulon, Other 83 000
FranceActive - Recruiting
CHU Toulouse - hopital Larrey
Toulouse, Other 31059
FranceActive - Recruiting
Institut Gustave Roussy
Villejuif Cedex, Other 94805
FranceActive - Recruiting
University Hospital of Besancon
Besancon Cedex, 25030
FranceActive - Recruiting
Johanniter Krankenhaus Bonn
Bonn, Other 53113
GermanyActive - Recruiting
Klinikum Esslingen GmbH
Esslingen, Other 73730
GermanyActive - Recruiting
Asklepios Klinik Gauting GmbH
Gauting, Other 82131
GermanyActive - Recruiting
LungenClinic Grosshansdorf
Grosshansdorf, Other 22927
GermanyActive - Recruiting
Krankenhaus Martha-Maria Halle-Dölau GmbH
Halle, Other 06120
GermanyActive - Recruiting
Universitatsklinikum Heidelberg
Heidelberg, Other 69126
GermanyActive - Recruiting
Klinikum Kassel GmbH
Kassel, Other 34125
GermanyActive - Recruiting
Alexandra General Hospital of Athens
Athens, Other 11528
GreeceActive - Recruiting
Metropolitan General Hospital
Athens, Other 18547
GreeceActive - Recruiting
University Hospital of Patras
Patras, Other 26504
GreeceActive - Recruiting
National Koranyi Institute of Pulmonology
Budapest, Other 1121
HungaryActive - Recruiting
Farkasgyepui Tudogyogyintezet
Farkasgyepu, Other 8582
HungaryActive - Recruiting
Shaare Zedek Medical Center
Jerusalem, Other 9103102
IsraelActive - Recruiting
Kaplan Medical Center
Rehovot, Other 7661041
IsraelActive - Recruiting
Centro di Riferimento Oncologico di Aviano
Aviano (Pordenone), Other 33081
ItalyActive - Recruiting
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, Other 25123
ItalyActive - Recruiting
Azienda Ospedaliera di Rilievo Nazionale Sant'Anna e San Sebastiano
Caserta, Other 81100
ItalyActive - Recruiting
A.O.U Policlinico G. Rodolico S. Marco
Catania, Other 95123
ItalyActive - Recruiting
Azienda Ospedaliera Universitaria San Martino
Genova, Other 16132
ItalyActive - Recruiting
IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori- IRST S.r.l
Meldola, Other 47014
ItalyActive - Recruiting
Ospedale San Raffaele
Milano, Other 20132
ItalyActive - Recruiting
Fondazione IRCCS San Gerardo dei Tintori
Monza, Other 20900
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria di Parma
Parma, Other 43126
ItalyActive - Recruiting
Istituto Nazionale Tumori 'Regina Elena'
Roma, Other 00144
ItalyActive - Recruiting
Policlinico Universitario Agostino Gemelli
Roma, Other 00168
ItalyActive - Recruiting
A.O.U. - Ospedali Riuniti di Ancona
Torrette, Other 60126
ItalyActive - Recruiting
National Cancer Center Hospital
Chuo-ku, Other 104-0045
JapanActive - Recruiting
The Cancer Institute Hospital of JFCR
Koto-ku, Other 135-8550
JapanActive - Recruiting
Aichi Cancer Center
Nagoya-shi, Other 464-8681
JapanActive - Recruiting
Cryptex Investigacion Clinica S.C.
Distrito Federal, Other 6100
MexicoActive - Recruiting
Maastricht UMC
Maastricht, Other 6229 HX
NetherlandsActive - Recruiting
Erasmus Medisch Centrum Daniel Den Hoed
Rotterdam, Other 3015GD
NetherlandsActive - Recruiting
Vestre Viken Health Trust
Drammen, Other 3004
NorwayActive - Recruiting
Oslo University Hospital
Oslo, Other 0450
NorwayActive - Recruiting
St. Olavs Hospital
Trondheim, Other 7030
NorwayActive - Recruiting
Medical University of Gdansk
Gdansk, Other 80-214
PolandActive - Recruiting
Instytut MSF Sp zoo
Lodz, Other 90-302
PolandActive - Recruiting
Institute of Genetics and Immunology GENIM LCC
Lublin, Other 20-609
PolandActive - Recruiting
Med Polonia Sp. z o. o.
Poznan, Other 60-693
PolandActive - Recruiting
Spitalul de Oncologie Monza SRL
Bucuresti, Other 13823
RomaniaActive - Recruiting
Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj-Napoca
Cluj-Napoca, Other 400015
RomaniaActive - Recruiting
Medisprof Cancer Center
Cluj-Napoca, Other 400641
RomaniaActive - Recruiting
Ovidius Clinical Hospital S.R.L
Constanta, Other 905900
RomaniaActive - Recruiting
Centrul de Oncologie Sf Nectarie
Craiova, Other 200542
RomaniaActive - Recruiting
Oncocenter-Oncologie Clinica SRL
Timisoara, Other 300166
RomaniaActive - Recruiting
Complejo Hospitalario Universitario La Coruna
A Coruna, Other 15009
SpainActive - Recruiting
Hospital Universitari Germans Trias i Pujol
Badalona, Other 08916
SpainActive - Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, Other 08035
SpainActive - Recruiting
Hospital General Universitario Gregorio Maranon
Madrid, Other 28007
SpainActive - Recruiting
Hospital Universitario 12 de Octubre
Madrid, Other 28041
SpainActive - Recruiting
Hospital Quiron Salud Malaga
Malaga, Other 29004
SpainActive - Recruiting
Hospital Universitario Son Espases
Palma de Mallorca, Other 07120
SpainActive - Recruiting
Fundación Instituto Valenciano de Oncología (FIVO)
Valencia, Other 46009
SpainActive - Recruiting
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Other 46026
SpainActive - Recruiting
Hospital Clinico Universitario Lozano Blesa de Zaragoza
Zaragoza, Other 50009
SpainActive - Recruiting
Universitatsspital Basel
Basel, Other 4031
SwitzerlandActive - Recruiting
Inselspital
Bern, Other 3010
SwitzerlandActive - Recruiting
Kantonsspital Graubunden
Chur, Other 7000
SwitzerlandActive - Recruiting
Stiftung Kantonsspital Graubunden
Chur, Other 7000
SwitzerlandActive - Recruiting
University Hospital Lausanne CHUV
Lausanne, Other 1011
SwitzerlandActive - Recruiting
Universitatsspital Zurich
Zurich, Other CH-8091
SwitzerlandActive - Recruiting
Changhua Christian Hospital
Changhua, Other 50006
TaiwanActive - Recruiting
National Taiwan University Hospital Yunlin Branch
Douliou City, Other 640
TaiwanActive - Recruiting
Kaohsiung Medical University Hospital
Kaohsiung, Other 807
TaiwanActive - Recruiting
Taipei Veterans General Hospital
Taipei City, Other 11217
TaiwanActive - Recruiting
Barts Health NHS Trust Saint Bartholomews Hospital
London, Other EC1A 7BE
United KingdomActive - Recruiting
Sarah Cannon Research Institute UK
London, Other W1G 6AD
United KingdomActive - Recruiting
Alaska Oncology and Hematology
Anchorage, Alaska 99508
United StatesActive - Recruiting
Arizona Oncology Associates
Prescott, Arizona 86301
United StatesActive - Recruiting
Comprehensive Blood and Cancer Center TRIO
Bakersfield, California 93309
United StatesActive - Recruiting
Providence Medical Foundation
Fullerton, California 92835
United StatesActive - Recruiting
Cancer and Blood Specialty Clinic
Los Alamitos, California 92720
United StatesActive - Recruiting
St. Joseph Hospital Orange
Orange, California 92868
United StatesActive - Recruiting
University of California, San Francisco | HDFCCC - Hematopoietic Malignancies
San Francisco, California 94158
United StatesActive - Recruiting
Sansum Clinic
Santa Barbara, California 93105
United StatesActive - Recruiting
Rocky Mountain Cancer Centers - Aurora
Lone Tree, Colorado 80124
United StatesActive - Recruiting
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida 33176
United StatesActive - Recruiting
Cancer Care Centers of Brevard, Inc.
Palm Bay, Florida 32901
United StatesActive - Recruiting
Illinois Cancer Care
Niles, Illinois 60714
United StatesActive - Recruiting
Cancer Center of Kansas
Wichita, Kansas 67214
United StatesActive - Recruiting
Maryland Oncology Hematology, P.A.
Annapolis, Maryland 21401
United StatesActive - Recruiting
Southcoast Health
Fall River, Massachusetts 02720
United StatesActive - Recruiting
Beth Israel Deaconess Medical Center
Milton, Massachusetts 02215
United StatesActive - Recruiting
Allina Health Cancer Institute
Minneapolis, Minnesota 55407
United StatesActive - Recruiting
Minnesota Oncology Hematology P.A.
Minneapolis, Minnesota 55404
United StatesActive - Recruiting
Hattiesburg Clinic Hematology/Oncology
Hattiesburg, Mississippi 39401
United StatesActive - Recruiting
Saint Luke's Cancer Institute LLC
Kansas City, Missouri 64111
United StatesCompleted
University of Nebraska Medical Center
Omaha, Nebraska 68198
United StatesActive - Recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89169
United StatesActive - Recruiting
Summit Medical Group
Florham Park, New Jersey 07932
United StatesActive - Recruiting
New Mexico Cancer Center
Albuquerque, New Mexico 87131
United StatesActive - Recruiting
NYU Langone Hospital
Mineola, New York 11501
United StatesActive - Recruiting
NYU Langone Hospital
New York, New York 10016
United StatesActive - Recruiting
Oncology Hematology Care
Cincinnati, Ohio 45242
United StatesActive - Recruiting
Cleveland Clinic Fairview Hospital
Cleveland, Ohio 44111
United StatesActive - Recruiting
Cleveland Clinic, The
Cleveland, Ohio 44195
United StatesActive - Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesActive - Recruiting
Cleveland Clinic Hillcrest Hospital
Mayfield Heights, Ohio 44124
United StatesActive - Recruiting
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon 97401
United StatesActive - Recruiting
Oregon Health and Science University
Portland, Oregon 97239
United StatesActive - Recruiting
Northwest Cancer Centers, P.C.
Tigard, Oregon 97223
United StatesActive - Recruiting
Alliance Cancer Specialists, PC
Horsham, Pennsylvania 19044
United StatesActive - Recruiting
Texas Oncology
Austin, Texas 78745
United StatesActive - Recruiting
Texas Oncology
Odessa, Texas 79761
United StatesActive - Recruiting
UT Health East Texas Hope Cancer Center
Tyler, Texas 75701
United StatesActive - Recruiting
Texas Oncology
Webster, Texas 77598
United StatesActive - Recruiting
Oncology and Hematology Associates of Southwest Virginia
Blacksburg, Virginia 24060
United StatesActive - Recruiting
Vista Oncology Inc PS
Olympia, Washington 98506
United StatesActive - Recruiting
Northwest Cancer Centers, P.C.
Vancouver, Washington 98684
United StatesSite Not Available
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