A Study of Sigvotatug Vedotin Versus Docetaxel in Previously Treated Non-small Cell Lung Cancer (Be6A Lung-01).

Last updated: February 19, 2025
Sponsor: Seagen Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

sigvotatug vedotin

docetaxel

SGN-B6A

Clinical Study ID

NCT06012435
SGNB6A-002
Be6A Lung-01
C5751002
2023-503827-25-01
  • Ages > 18
  • All Genders

Study Summary

This clinical trial is studying nonsquamous non-small cell lung cancer (NSCLC). Participants in this study must have cancer that has spread through their body or can't be removed with surgery. Participants in this study must have been treated with no more than a platinum-based chemotherapy and an anti-PD-(L)1 drug. Participants with tumors that have certain treatable genomic alterations must have had at least 1 drug for that genomic alteration, in addition to platinum-based chemotherapy.

This clinical trial uses an experimental drug called sigvotatug vedotin, which is a type of antibody drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. This clinical trial also uses a drug called docetaxel. Docetaxel is an anticancer drug that has been approved to treat non-small cell lung cancer. It is usually given to patients who previously received another anticancer treatment. In this study, one group of participants will get sigvotatug vedotin on Days 1 and 15 during each 28-day-cycle. A second group of participants will get docetaxel on Day 1 during each 21-day cycle.

This study is being done to see if sigvotatug vedotin works better than docetaxel to treat participants with NSCLC. This study will also test what side effects happen when participants take these drugs. A side effect is anything a drug does to the body besides treating the disease.

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

Total Participants: 560
Treatment Group(s): 3
Primary Treatment: sigvotatug vedotin
Phase: 3
Study Start date:
February 21, 2024
Estimated Completion Date:
July 31, 2028

Connect with a study center

  • Instituto de Oncologia de Rosario

    Rosario, Other S2000KZE
    Argentina

    Active - Recruiting

  • Sanatorio Parque

    Rosario, Other S2000DSV
    Argentina

    Active - Recruiting

  • Calvary Mater Newcastle

    Waratah, Other 2298
    Australia

    Active - Recruiting

  • AKH - Medizinische Universitat Wien

    Vienna, Other 1090
    Austria

    Active - Recruiting

  • Algemeen Ziekenhuis Klina

    Brasschaat, Other 2930
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Antwerpen

    Edegem, Other 2650
    Belgium

    Active - Recruiting

  • University Hospital Ghent

    Ghent, Other 9000
    Belgium

    Active - Recruiting

  • Jessa Ziekenhuis - Campus Virga Jesse

    Hasselt, Other 3500
    Belgium

    Active - Recruiting

  • CHU de Liege

    Liege, Other 4000
    Belgium

    Active - Recruiting

  • Tom Baker Cancer Centre

    Calgary, Alberta T2N4N2
    Canada

    Active - Recruiting

  • University of Alberta / Cross Cancer Institute

    Edmonton, Alberta T6G 1Z2
    Canada

    Active - Recruiting

  • William Osler Health Sciences

    East Brampton, Ontario L6R 3J7
    Canada

    Active - Recruiting

  • Ottawa Hospital Cancer Centre

    Ottawa, Ontario K1H 8L6
    Canada

    Active - Recruiting

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario M4N 3M5
    Canada

    Active - Recruiting

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec H2X 0C2
    Canada

    Active - Recruiting

  • McGill University Department of Oncology / McGill University Health Centre

    Montreal, Quebec H4A 3J1
    Canada

    Active - Recruiting

  • BIOCENTER Centro Clinico de Investigacion

    Concepción, Other 4070268
    Chile

    Active - Recruiting

  • Fakultni Nemocnice Olomouc (Fnol) - Onkologicka Klinika

    Olomouc, Other 779 00
    Czechia

    Active - Recruiting

  • Vseobecna fakultni nemocnice v Praze

    Prague, Other 128 08
    Czechia

    Active - Recruiting

  • Centre Hospitalier de Cholet

    Cholet, Other 49300
    France

    Active - Recruiting

  • Centre Hospitalier Intercommunal Creteil - CHI Creteil

    Creteil, Other 94000
    France

    Active - Recruiting

  • CHRU de Lille

    Lille, Other 59037
    France

    Active - Recruiting

  • Hopital Nord Marseille

    Marseille, Other 13015
    France

    Active - Recruiting

  • Centre de Cancerologie du Grand Montpellier

    Montpellier, Other 34070
    France

    Active - Recruiting

  • Hopital Bichat-Claude Bernard - APHP

    Paris, Other 75018
    France

    Active - Recruiting

  • Hopital Cochin

    Paris, Other 75014
    France

    Active - Recruiting

  • CHU Bordeaux Hopital Haut-Leveque

    Pessac, Other 33604
    France

    Active - Recruiting

  • Hospital Center De Cornouaille

    Quimper Cedex, Other 29 107
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Rennes, Hopital Pontchaillou

    Rennes, Other 35000
    France

    Active - Recruiting

  • Institut de cancerologie Strasbourg Europe

    Strasbourg, Other 67200
    France

    Active - Recruiting

  • Chits Sainte Musse

    Toulon, Other 83 000
    France

    Active - Recruiting

  • CHU Toulouse - hopital Larrey

    Toulouse, Other 31059
    France

    Active - Recruiting

  • Institut Gustave Roussy

    Villejuif Cedex, Other 94805
    France

    Active - Recruiting

  • University Hospital of Besancon

    Besancon Cedex, 25030
    France

    Active - Recruiting

  • Johanniter Krankenhaus Bonn

    Bonn, Other 53113
    Germany

    Active - Recruiting

  • Klinikum Esslingen GmbH

    Esslingen, Other 73730
    Germany

    Active - Recruiting

  • Asklepios Klinik Gauting GmbH

    Gauting, Other 82131
    Germany

    Active - Recruiting

  • LungenClinic Grosshansdorf

    Grosshansdorf, Other 22927
    Germany

    Active - Recruiting

  • Krankenhaus Martha-Maria Halle-Dölau GmbH

    Halle, Other 06120
    Germany

    Active - Recruiting

  • Universitatsklinikum Heidelberg

    Heidelberg, Other 69126
    Germany

    Active - Recruiting

  • Klinikum Kassel GmbH

    Kassel, Other 34125
    Germany

    Active - Recruiting

  • Alexandra General Hospital of Athens

    Athens, Other 11528
    Greece

    Active - Recruiting

  • Metropolitan General Hospital

    Athens, Other 18547
    Greece

    Active - Recruiting

  • University Hospital of Patras

    Patras, Other 26504
    Greece

    Active - Recruiting

  • National Koranyi Institute of Pulmonology

    Budapest, Other 1121
    Hungary

    Active - Recruiting

  • Farkasgyepui Tudogyogyintezet

    Farkasgyepu, Other 8582
    Hungary

    Active - Recruiting

  • Shaare Zedek Medical Center

    Jerusalem, Other 9103102
    Israel

    Active - Recruiting

  • Kaplan Medical Center

    Rehovot, Other 7661041
    Israel

    Active - Recruiting

  • Centro di Riferimento Oncologico di Aviano

    Aviano (Pordenone), Other 33081
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Spedali Civili di Brescia

    Brescia, Other 25123
    Italy

    Active - Recruiting

  • Azienda Ospedaliera di Rilievo Nazionale Sant'Anna e San Sebastiano

    Caserta, Other 81100
    Italy

    Active - Recruiting

  • A.O.U Policlinico G. Rodolico S. Marco

    Catania, Other 95123
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria San Martino

    Genova, Other 16132
    Italy

    Active - Recruiting

  • IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori- IRST S.r.l

    Meldola, Other 47014
    Italy

    Active - Recruiting

  • Ospedale San Raffaele

    Milano, Other 20132
    Italy

    Active - Recruiting

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, Other 20900
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria di Parma

    Parma, Other 43126
    Italy

    Active - Recruiting

  • Istituto Nazionale Tumori 'Regina Elena'

    Roma, Other 00144
    Italy

    Active - Recruiting

  • Policlinico Universitario Agostino Gemelli

    Roma, Other 00168
    Italy

    Active - Recruiting

  • A.O.U. - Ospedali Riuniti di Ancona

    Torrette, Other 60126
    Italy

    Active - Recruiting

  • National Cancer Center Hospital

    Chuo-ku, Other 104-0045
    Japan

    Active - Recruiting

  • The Cancer Institute Hospital of JFCR

    Koto-ku, Other 135-8550
    Japan

    Active - Recruiting

  • Aichi Cancer Center

    Nagoya-shi, Other 464-8681
    Japan

    Active - Recruiting

  • Cryptex Investigacion Clinica S.C.

    Distrito Federal, Other 6100
    Mexico

    Active - Recruiting

  • Maastricht UMC

    Maastricht, Other 6229 HX
    Netherlands

    Active - Recruiting

  • Erasmus Medisch Centrum Daniel Den Hoed

    Rotterdam, Other 3015GD
    Netherlands

    Active - Recruiting

  • Vestre Viken Health Trust

    Drammen, Other 3004
    Norway

    Active - Recruiting

  • Oslo University Hospital

    Oslo, Other 0450
    Norway

    Active - Recruiting

  • St. Olavs Hospital

    Trondheim, Other 7030
    Norway

    Active - Recruiting

  • Medical University of Gdansk

    Gdansk, Other 80-214
    Poland

    Active - Recruiting

  • Instytut MSF Sp zoo

    Lodz, Other 90-302
    Poland

    Active - Recruiting

  • Institute of Genetics and Immunology GENIM LCC

    Lublin, Other 20-609
    Poland

    Active - Recruiting

  • Med Polonia Sp. z o. o.

    Poznan, Other 60-693
    Poland

    Active - Recruiting

  • Spitalul de Oncologie Monza SRL

    Bucuresti, Other 13823
    Romania

    Active - Recruiting

  • Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj-Napoca

    Cluj-Napoca, Other 400015
    Romania

    Active - Recruiting

  • Medisprof Cancer Center

    Cluj-Napoca, Other 400641
    Romania

    Active - Recruiting

  • Ovidius Clinical Hospital S.R.L

    Constanta, Other 905900
    Romania

    Active - Recruiting

  • Centrul de Oncologie Sf Nectarie

    Craiova, Other 200542
    Romania

    Active - Recruiting

  • Oncocenter-Oncologie Clinica SRL

    Timisoara, Other 300166
    Romania

    Active - Recruiting

  • Complejo Hospitalario Universitario La Coruna

    A Coruna, Other 15009
    Spain

    Active - Recruiting

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Other 08916
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, Other 08035
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Maranon

    Madrid, Other 28007
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, Other 28041
    Spain

    Active - Recruiting

  • Hospital Quiron Salud Malaga

    Malaga, Other 29004
    Spain

    Active - Recruiting

  • Hospital Universitario Son Espases

    Palma de Mallorca, Other 07120
    Spain

    Active - Recruiting

  • Fundación Instituto Valenciano de Oncología (FIVO)

    Valencia, Other 46009
    Spain

    Active - Recruiting

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, Other 46026
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario Lozano Blesa de Zaragoza

    Zaragoza, Other 50009
    Spain

    Active - Recruiting

  • Universitatsspital Basel

    Basel, Other 4031
    Switzerland

    Active - Recruiting

  • Inselspital

    Bern, Other 3010
    Switzerland

    Active - Recruiting

  • Kantonsspital Graubunden

    Chur, Other 7000
    Switzerland

    Active - Recruiting

  • Stiftung Kantonsspital Graubunden

    Chur, Other 7000
    Switzerland

    Active - Recruiting

  • University Hospital Lausanne CHUV

    Lausanne, Other 1011
    Switzerland

    Active - Recruiting

  • Universitatsspital Zurich

    Zurich, Other CH-8091
    Switzerland

    Active - Recruiting

  • Changhua Christian Hospital

    Changhua, Other 50006
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital Yunlin Branch

    Douliou City, Other 640
    Taiwan

    Active - Recruiting

  • Kaohsiung Medical University Hospital

    Kaohsiung, Other 807
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital

    Taipei City, Other 11217
    Taiwan

    Active - Recruiting

  • Barts Health NHS Trust Saint Bartholomews Hospital

    London, Other EC1A 7BE
    United Kingdom

    Active - Recruiting

  • Sarah Cannon Research Institute UK

    London, Other W1G 6AD
    United Kingdom

    Active - Recruiting

  • Alaska Oncology and Hematology

    Anchorage, Alaska 99508
    United States

    Active - Recruiting

  • Arizona Oncology Associates

    Prescott, Arizona 86301
    United States

    Active - Recruiting

  • Comprehensive Blood and Cancer Center TRIO

    Bakersfield, California 93309
    United States

    Active - Recruiting

  • Providence Medical Foundation

    Fullerton, California 92835
    United States

    Active - Recruiting

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California 92720
    United States

    Active - Recruiting

  • St. Joseph Hospital Orange

    Orange, California 92868
    United States

    Active - Recruiting

  • University of California, San Francisco | HDFCCC - Hematopoietic Malignancies

    San Francisco, California 94158
    United States

    Active - Recruiting

  • Sansum Clinic

    Santa Barbara, California 93105
    United States

    Active - Recruiting

  • Rocky Mountain Cancer Centers - Aurora

    Lone Tree, Colorado 80124
    United States

    Active - Recruiting

  • Miami Cancer Institute at Baptist Health, Inc.

    Miami, Florida 33176
    United States

    Active - Recruiting

  • Cancer Care Centers of Brevard, Inc.

    Palm Bay, Florida 32901
    United States

    Active - Recruiting

  • Illinois Cancer Care

    Niles, Illinois 60714
    United States

    Active - Recruiting

  • Cancer Center of Kansas

    Wichita, Kansas 67214
    United States

    Active - Recruiting

  • Maryland Oncology Hematology, P.A.

    Annapolis, Maryland 21401
    United States

    Active - Recruiting

  • Southcoast Health

    Fall River, Massachusetts 02720
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Center

    Milton, Massachusetts 02215
    United States

    Active - Recruiting

  • Allina Health Cancer Institute

    Minneapolis, Minnesota 55407
    United States

    Active - Recruiting

  • Minnesota Oncology Hematology P.A.

    Minneapolis, Minnesota 55404
    United States

    Active - Recruiting

  • Hattiesburg Clinic Hematology/Oncology

    Hattiesburg, Mississippi 39401
    United States

    Active - Recruiting

  • Saint Luke's Cancer Institute LLC

    Kansas City, Missouri 64111
    United States

    Completed

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Active - Recruiting

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada 89169
    United States

    Active - Recruiting

  • Summit Medical Group

    Florham Park, New Jersey 07932
    United States

    Active - Recruiting

  • New Mexico Cancer Center

    Albuquerque, New Mexico 87131
    United States

    Active - Recruiting

  • NYU Langone Hospital

    Mineola, New York 11501
    United States

    Active - Recruiting

  • NYU Langone Hospital

    New York, New York 10016
    United States

    Active - Recruiting

  • Oncology Hematology Care

    Cincinnati, Ohio 45242
    United States

    Active - Recruiting

  • Cleveland Clinic Fairview Hospital

    Cleveland, Ohio 44111
    United States

    Active - Recruiting

  • Cleveland Clinic, The

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Cleveland Clinic Hillcrest Hospital

    Mayfield Heights, Ohio 44124
    United States

    Active - Recruiting

  • Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon 97401
    United States

    Active - Recruiting

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Northwest Cancer Centers, P.C.

    Tigard, Oregon 97223
    United States

    Active - Recruiting

  • Alliance Cancer Specialists, PC

    Horsham, Pennsylvania 19044
    United States

    Active - Recruiting

  • Texas Oncology

    Austin, Texas 78745
    United States

    Active - Recruiting

  • Texas Oncology

    Odessa, Texas 79761
    United States

    Active - Recruiting

  • UT Health East Texas Hope Cancer Center

    Tyler, Texas 75701
    United States

    Active - Recruiting

  • Texas Oncology

    Webster, Texas 77598
    United States

    Active - Recruiting

  • Oncology and Hematology Associates of Southwest Virginia

    Blacksburg, Virginia 24060
    United States

    Active - Recruiting

  • Vista Oncology Inc PS

    Olympia, Washington 98506
    United States

    Active - Recruiting

  • Northwest Cancer Centers, P.C.

    Vancouver, Washington 98684
    United States

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