A Study of SGN-B6A Versus Docetaxel in Previously Treated Non-small Cell Lung Cancer
- Conditions
- Interventions
- Registration Number
- NCT06012435
- Lead Sponsor
- Seagen Inc.
- Brief 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 ...
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
-
Histologically or cytologically confirmed diagnosis of locally advanced, unresectable (Stage IIIB, IIIC), or metastatic Stage IV (M1a, M1b, or M1c) NSCLC
-
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) are permitted
-
Participants must have received the following prior therapies and progressed during or 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 of metastatic or recurrent disease and a PD-(L)1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy), unless contraindicated.
- Experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the adjuvant or neoadjuvant setting and received a PD-(L)1 monoclonal antibody at any time during the course of treatment.
-
Participants with known AGAs must fulfill the following conditions:
- Must have received at least 1 relevant AGA targeted therapy and in the opinion of the investigator, additional AGA targeted therapy is not in the best interest of the participant.
- Received a platinum-based combination therapy for the treatment of metastatic or recurrent disease, or experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the adjuvant or neoadjuvant setting
- May have received up to 1 PD-(L)1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy).
-
-
Measurable disease based on RECIST v1.1
-
Eastern cooperative Oncology Group (ECOG) performance status score of 0 or 1
-
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 evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies 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 to underlying 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, or MMAEs) in the locally advanced, unresectable, or metastatic setting
- Received more than 1 prior line of cytotoxic chemotherapy in the locally advanced, unresectable, or metastatic setting
- At least 14 days must have elapsed from the last dose of radiotherapy until Cycle 1 Day 1.
- Prior radiation therapy to the lung parenchyma that is >30 Gray (Gy) within 6 months of Cycle 1 Day 1.
- Any systemic anticancer therapy (standard or experimental) within 21 days prior to Cycle 1 Day 1.
-
Active central nervous system (CNS) lesions, including leptomeningeal metastasis, are excluded. Participants with definitively treated brain metastases are eligible in they meet the following criteria:
- Have been clinically stable for at least 4 weeks prior to treatment initiation and baseline scans show no evidence of new or enlarged metastasis
- On a stable dose of less than or equal to (≤) 10mg/day of prednisone or equivalent for a least 2 weeks (if requiring steroid treatment)
- Treatment with corticosteroids greater than (>) 1 month prior to Screening visit
- No evidence of clinical and radiographic disease progression in the CNS for ≥ 21 days after definitive radiotherapy and/or surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Arm docetaxel Docetaxel monotherapy Experimental Arm sigvotatug vedotin sigvotatug vedotin monotherapy
- Primary Outcome Measures
Name Time Method Overall Survival (OS) Approximately 5 years The time from date of randomization to date of death due to any cause.
Confirmed Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) as assessed by Blinded Independent Central Review (BICR) Approximately 5 years The proportion of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1.
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS) per RECIST v1.1 by BICR Approximately 5 years The time from date of randomization to the first documented disease progression per RECIST v1.1 or to death due to any cause.
Confirmed ORR per RECIST v1.1 by investigator assessment Approximately 5 years The proportion of participants with confirmed CR or PR according to RECIST v1.1.
PFS per RECIST v1.1 by investigator assessment Approximately 5 years The time from date of randomization to the first documented disease progression per RECIST v1.1 or to death due to any cause.
Duration of Response (DOR) per RECIST v1.1 by BICR Approximately 5 years The time from the first documented objective response (CR or PR that is subsequently confirmed) to the first documented disease progression per RECIST v1.1 or to death due to any cause.
DOR per RECIST v1.1 by investigator assessment Approximately 5 years The time from the first documented objective response (CR or PR that is subsequently confirmed) to the first documented disease progression per RECIST v1.1 or to death due to any cause.
Number of participants with adverse events (AEs) Through 30 days after the last study intervention; Approximately 5 years An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Mean score in the global health status/QoL combined score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Approximately 5 years The EORTC QLQ-C30 was developed as a quantitative measure of health-related quality of life (HRQoL). Scores range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomat...
Change from baseline in global health status/QoL combined score on the EORTC QLQ-C30 Approximately 5 years The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL. Scores range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Mean score in physical functioning scores on the EORTC QLQ-C30 Approximately 5 years The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL. Scores range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Change from baseline score in physical functioning scores on the EORTC QLQ-C30 Approximately 5 years The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL. Scores range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Mean score in role functioning scores on the EORTC QLQ-C30 Approximately 5 years The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL. Scores range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Change from baseline score in role functioning scores on the EORTC QLQ-C30 Approximately 5 years The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL. Scores range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Mean scores in the dyspnea, cough, and chest pain scores on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Approximately 5 years The EORTC QLQ-LC13 is a lung-cancer specific module that serves as an additional 13 item questionnaire to the general EORTC cancer questionnaire. It incorporates 1 multi-item scale to assess dyspnea, and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. Scores range from 0 to 100. A hig...
Change from baseline in the dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13 Approximately 5 years The EORTC QLQ-LC13 is a lung-cancer specific module that serves as an additional 13 item questionnaire to the general EORTC cancer questionnaire. It incorporates 1 multi-item scale to assess dyspnea, and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. Scores range from 0 to 100. A hig...
Time to Deterioration (TTD) in the global health status/QoL combined score on the EORTC QLQ-C30 Approximately 5 years TTD is defined as the time from date of randomization to first onset of PRO deterioration with or without subsequent confirmation. The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL. Scores range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL rep...
TTD in physical functioning scores on the EORTC QLQ-C30 Approximately 5 years TTD is defined as the time from date of randomization to first onset of PRO deterioration with or without subsequent confirmation. The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL. Scores range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL rep...
TTD in role functioning scores on the EORTC QLQ-C30 Approximately 5 years TTD is defined as the time from date of randomization to first onset of PRO deterioration with or without subsequent confirmation. The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL. Scores range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL rep...
TTD in the dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13 Approximately 5 years TTD is defined as the time from date of randomization to first onset of PRO deterioration with or without subsequent confirmation. The EORTC QLQ-LC13 is a lung-cancer specific module that serves as an additional 13 item questionnaire to the general EORTC cancer questionnaire. It incorporates 1 multi-item scale to assess dyspnea, and a series of single items ...
Trial Locations
- Locations (138)
Inselspital
🇨🇭Bern, Other, Switzerland
Hospital Center De Cornouaille
🇫🇷Quimper Cedex, Other, France
Centre Hospitalier Universitaire de Rennes, Hopital Pontchaillou
🇫🇷Rennes, Other, France
Alaska Oncology and Hematology
🇺🇸Anchorage, Alaska, United States
Arizona Oncology Associates
🇺🇸Prescott, Arizona, United States
Comprehensive Blood and Cancer Center TRIO
🇺🇸Bakersfield, California, United States
Providence Medical Foundation
🇺🇸Fullerton, California, United States
Cancer and Blood Specialty Clinic
🇺🇸Los Alamitos, California, United States
St. Joseph Hospital Orange
🇺🇸Orange, California, United States
University of California, San Francisco | HDFCCC - Hematopoietic Malignancies
🇺🇸San Francisco, California, United States
Sansum Clinic
🇺🇸Santa Barbara, California, United States
Rocky Mountain Cancer Centers - Aurora
🇺🇸Lone Tree, Colorado, United States
Miami Cancer Institute at Baptist Health, Inc.
🇺🇸Miami, Florida, United States
Cancer Care Centers of Brevard, Inc.
🇺🇸Palm Bay, Florida, United States
Illinois Cancer Care
🇺🇸Niles, Illinois, United States
Cancer Center of Kansas
🇺🇸Wichita, Kansas, United States
Maryland Oncology Hematology, P.A.
🇺🇸Annapolis, Maryland, United States
Southcoast Health
🇺🇸Fall River, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Milton, Massachusetts, United States
Minnesota Oncology Hematology P.A.
🇺🇸Minneapolis, Minnesota, United States
Allina Health Cancer Institute
🇺🇸Minneapolis, Minnesota, United States
Hattiesburg Clinic Hematology/Oncology
🇺🇸Hattiesburg, Mississippi, United States
Saint Luke's Cancer Institute LLC
🇺🇸Kansas City, Missouri, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
Summit Medical Group
🇺🇸Florham Park, New Jersey, United States
New Mexico Cancer Center
🇺🇸Albuquerque, New Mexico, United States
NYU Langone Hospital
🇺🇸New York, New York, United States
Oncology Hematology Care
🇺🇸Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Fairview Hospital
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic, The
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Hillcrest Hospital
🇺🇸Mayfield Heights, Ohio, United States
Willamette Valley Cancer Institute and Research Center
🇺🇸Eugene, Oregon, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Northwest Cancer Centers, P.C.
🇺🇸Tigard, Oregon, United States
Alliance Cancer Specialists, PC
🇺🇸Horsham, Pennsylvania, United States
Texas Oncology
🇺🇸Webster, Texas, United States
UT Health East Texas Hope Cancer Center
🇺🇸Tyler, Texas, United States
Oncology and Hematology Associates of Southwest Virginia
🇺🇸Blacksburg, Virginia, United States
Vista Oncology Inc PS
🇺🇸Olympia, Washington, United States
Sanatorio Parque
🇦🇷Rosario, Other, Argentina
Instituto de Oncologia de Rosario
🇦🇷Rosario, Other, Argentina
Calvary Mater Newcastle
🇦🇺Waratah, Other, Australia
AKH - Medizinische Universitat Wien
🇦🇹Vienna, Other, Austria
Algemeen Ziekenhuis Klina
🇧🇪Brasschaat, Other, Belgium
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Other, Belgium
University Hospital Ghent
🇧🇪Ghent, Other, Belgium
Jessa Ziekenhuis - Campus Virga Jesse
🇧🇪Hasselt, Other, Belgium
CHU de Liege
🇧🇪Liege, Other, Belgium
Tom Baker Cancer Centre
🇨🇦Calgary, Alberta, Canada
University of Alberta / Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
William Osler Health Sciences
🇨🇦East Brampton, Ontario, Canada
Ottawa Hospital Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal
🇨🇦Montreal, Quebec, Canada
McGill University Department of Oncology / McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
BIOCENTER Centro Clinico de Investigacion
🇨🇱Concepción, Other, Chile
Fakultni Nemocnice Olomouc (Fnol) - Onkologicka Klinika
🇨🇿Olomouc, Other, Czechia
Vseobecna fakultni nemocnice v Praze
🇨🇿Prague, Other, Czechia
Centre Hospitalier de Cholet
🇫🇷Cholet, Other, France
Centre Hospitalier Intercommunal Creteil - CHI Creteil
🇫🇷Creteil, Other, France
CHRU de Lille
🇫🇷Lille, Other, France
Hopital Nord Marseille
🇫🇷Marseille, Other, France
Centre de Cancerologie du Grand Montpellier
🇫🇷Montpellier, Other, France
Hopital Cochin
🇫🇷Paris, Other, France
Hopital Bichat-Claude Bernard - APHP
🇫🇷Paris, Other, France
CHU Bordeaux Hopital Haut-Leveque
🇫🇷Pessac, Other, France
Institut de cancerologie Strasbourg Europe
🇫🇷Strasbourg, Other, France
Chits Sainte Musse
🇫🇷Toulon, Other, France
CHU Toulouse - hopital Larrey
🇫🇷Toulouse, Other, France
Institut Gustave Roussy
🇫🇷Villejuif Cedex, Other, France
University Hospital of Besancon
🇫🇷Besancon Cedex, France
Johanniter Krankenhaus Bonn
🇩🇪Bonn, Other, Germany
Klinikum Esslingen GmbH
🇩🇪Esslingen, Other, Germany
Asklepios Klinik Gauting GmbH
🇩🇪Gauting, Other, Germany
LungenClinic Grosshansdorf
🇩🇪Grosshansdorf, Other, Germany
Krankenhaus Martha-Maria Halle-Dölau GmbH
🇩🇪Halle, Other, Germany
Universitatsklinikum Heidelberg
🇩🇪Heidelberg, Other, Germany
Klinikum Kassel GmbH
🇩🇪Kassel, Other, Germany
Alexandra General Hospital of Athens
🇬🇷Athens, Other, Greece
Metropolitan General Hospital
🇬🇷Athens, Other, Greece
University Hospital of Patras
🇬🇷Patras, Other, Greece
National Koranyi Institute of Pulmonology
🇭🇺Budapest, Other, Hungary
Farkasgyepui Tudogyogyintezet
🇭🇺Farkasgyepu, Other, Hungary
Shaare Zedek Medical Center
🇮🇱Jerusalem, Other, Israel
Kaplan Medical Center
🇮🇱Rehovot, Other, Israel
Centro di Riferimento Oncologico di Aviano
🇮🇹Aviano (Pordenone), Other, Italy
Azienda Ospedaliera Spedali Civili di Brescia
🇮🇹Brescia, Other, Italy
Azienda Ospedaliera di Rilievo Nazionale Sant'Anna e San Sebastiano
🇮🇹Caserta, Other, Italy
A.O.U Policlinico G. Rodolico S. Marco
🇮🇹Catania, Other, Italy
Azienda Ospedaliera Universitaria San Martino
🇮🇹Genova, Other, Italy
IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori- IRST S.r.l
🇮🇹Meldola, Other, Italy
Ospedale San Raffaele
🇮🇹Milano, Other, Italy
Fondazione IRCCS San Gerardo dei Tintori
🇮🇹Monza, Other, Italy
Azienda Ospedaliero Universitaria di Parma
🇮🇹Parma, Other, Italy
Istituto Nazionale Tumori 'Regina Elena'
🇮🇹Roma, Other, Italy
Policlinico Universitario Agostino Gemelli
🇮🇹Roma, Other, Italy
A.O.U. - Ospedali Riuniti di Ancona
🇮🇹Torrette, Other, Italy
National Cancer Center Hospital
🇯🇵Chuo-ku, Other, Japan
The Cancer Institute Hospital of JFCR
🇯🇵Koto-ku, Other, Japan
Aichi Cancer Center
🇯🇵Nagoya-shi, Other, Japan
Cryptex Investigacion Clinica S.C.
🇲🇽Distrito Federal, Other, Mexico
Maastricht UMC
🇳🇱Maastricht, Other, Netherlands
Erasmus Medisch Centrum Daniel Den Hoed
🇳🇱Rotterdam, Other, Netherlands
Vestre Viken Health Trust
🇳🇴Drammen, Other, Norway
Oslo University Hospital
🇳🇴Oslo, Other, Norway
St. Olavs Hospital
🇳🇴Trondheim, Other, Norway
Medical University of Gdansk
🇵🇱Gdansk, Other, Poland
Instytut MSF Sp zoo
🇵🇱Lodz, Other, Poland
Institute of Genetics and Immunology GENIM LCC
🇵🇱Lublin, Other, Poland
Med Polonia Sp. z o. o.
🇵🇱Poznan, Other, Poland
Spitalul de Oncologie Monza SRL
🇷🇴Bucuresti, Other, Romania
Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj-Napoca
🇷🇴Cluj-Napoca, Other, Romania
Medisprof Cancer Center
🇷🇴Cluj-Napoca, Other, Romania
Ovidius Clinical Hospital S.R.L
🇷🇴Constanta, Other, Romania
Centrul de Oncologie Sf Nectarie
🇷🇴Craiova, Other, Romania
Oncocenter-Oncologie Clinica SRL
🇷🇴Timisoara, Other, Romania
Complejo Hospitalario Universitario La Coruna
🇪🇸A Coruna, Other, Spain
Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona, Other, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Other, Spain
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Other, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Other, Spain
Hospital Quiron Salud Malaga
🇪🇸Malaga, Other, Spain
Hospital Universitario Son Espases
🇪🇸Palma de Mallorca, Other, Spain
Fundación Instituto Valenciano de Oncología (FIVO)
🇪🇸Valencia, Other, Spain
Hospital Universitari i Politecnic La Fe de Valencia
🇪🇸Valencia, Other, Spain
Hospital Clinico Universitario Lozano Blesa de Zaragoza
🇪🇸Zaragoza, Other, Spain
Universitatsspital Basel
🇨🇭Basel, Other, Switzerland
Stiftung Kantonsspital Graubunden
🇨🇭Chur, Other, Switzerland
University Hospital Lausanne CHUV
🇨🇭Lausanne, Other, Switzerland
Universitatsspital Zurich
🇨🇭Zurich, Other, Switzerland
Changhua Christian Hospital
🇨🇳Changhua, Other, Taiwan
National Taiwan University Hospital Yunlin Branch
🇨🇳Douliou City, Other, Taiwan
Kaohsiung Medical University Hospital
🇨🇳Kaohsiung, Other, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei City, Other, Taiwan
Barts Health NHS Trust Saint Bartholomews Hospital
🇬🇧London, Other, United Kingdom
Sarah Cannon Research Institute UK
🇬🇧London, Other, United Kingdom