A Study of SGN-B6A Versus Docetaxel in Previously Treated Non-small Cell Lung Cancer
Launched by SEAGEN, A WHOLLY OWNED SUBSIDIARY OF PFIZER · Aug 21, 2023
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, called Be6A Lung-01, is looking at how well a new experimental drug named sigvotatug vedotin works compared to a standard treatment called docetaxel for patients with advanced non-small cell lung cancer (NSCLC). This study is for adults whose lung cancer has either spread to other parts of the body or cannot be surgically removed. To participate, patients must have previously received certain treatments, including a type of chemotherapy and an immunotherapy drug. The trial aims to find out if sigvotatug vedotin is more effective and to monitor any side effects that may occur from either treatment.
Eligible participants are adults aged 65 to 74 with a specific type of NSCLC that is not squamous. They should have measurable cancer and a good performance status, meaning they can carry out daily activities without significant issues. Throughout the trial, participants will receive either the experimental drug or docetaxel, with the treatments given on specific schedules. This study is actively recruiting participants, so if you or someone you know fits the criteria and is interested, it may be a good opportunity to consider.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Histologically or cytologically confirmed diagnosis of locally advanced, unresectable (Stage IIIB, IIIC), or metastatic Stage IV (M1a, M1b, or M1c) NSCLC American Joint Committee on Cancer (AJCC) Staging Manual, Version 8.0, and the Union for 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) 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
- • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with adequate baseline hematologic, hepatic, and renal function and measurable disease according to RECIST v1.1
- 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 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/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 locally advanced, 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 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
About Seagen, A Wholly Owned Subsidiary Of Pfizer
Seagen, a wholly owned subsidiary of Pfizer, is a leading biotechnology company dedicated to developing innovative cancer therapies. With a strong focus on targeted therapies and antibody-drug conjugates, Seagen leverages its advanced scientific expertise and robust research capabilities to address the unmet needs of patients with various forms of cancer. The company's commitment to precision medicine and collaboration with healthcare professionals underpins its mission to improve treatment outcomes and enhance the quality of life for cancer patients worldwide. Through rigorous clinical trials and a patient-centric approach, Seagen aims to bring transformative therapies to market, advancing the field of oncology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Madrid, , Spain
Madrid, , Spain
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Brampton, Ontario, Canada
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Omaha, Nebraska, United States
Cleveland, Ohio, United States
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Tacoma, Washington, United States
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Dallas, Texas, United States
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Madrid, , Spain
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Melbourne, Victoria, Australia
Zurich, , Switzerland
Woolloongabba, Queensland, Australia
Wichita, Kansas, United States
Vancouver, Washington, United States
Graz, , Austria
Chuo Ku, Tokyo, Japan
Glasgow, , United Kingdom
Trondheim, , Norway
Kassel, , Germany
Waratah, New South Wales, Australia
Cincinnati, Ohio, United States
Portland, Oregon, United States
Austin, Texas, United States
Kurume, Fukuoka, Japan
Paris, , France
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Albury, New South Wales, Australia
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Las Vegas, Nevada, United States
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Edegem, , Belgium
Niigata Shi, Niigata, Japan
Sunto Gun, Shizuoka, Japan
Kaohsiung, , Taiwan
Basel, , Switzerland
Frankston, , Australia
Athens, , Greece
Guangzhou, Guangdong, China
Barcelona, , Spain
Luebeck, , Germany
Bern, , Switzerland
Lille, , France
Muenster, , Germany
Hangzhou, Zhejiang, China
Waco, Texas, United States
Bunkyo Ku, Tokyo, Japan
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Osakasayama, Osaka, Japan
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Milano, , Italy
Nanjing, Jiangsu, China
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Chur, , Switzerland
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Budapest, , Hungary
Jerusalem, , Israel
Liege, , Belgium
Koto Ku, Tokyo, Japan
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Bunkyo Ku, Tokyo, Japan
Esslingen, , Germany
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Cholet, , France
Foshan, Guangdong, China
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Nanchang, Jiangxi, China
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Jinan, Shandong, China
Kfar Saba, , Israel
Ghent, , Belgium
Luoyang, Henan, China
Brasschaat, , Belgium
Zhengzhou, Henan, China
Beijing, , China
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Taizhou, Zhejiang, China
Leeds, , United Kingdom
Tigard, Oregon, United States
Edmonton, Alberta, Canada
Rennes Cedex 9, , France
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Kanazawa Shi, Ishikawa, Japan
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Maastricht, , Netherlands
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Toulouse, , France
Kaohsiung, , Taiwan
Rosario, , Argentina
Besancon, , France
Petah Tikva, , Israel
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Kobe Shi, , Japan
Birmingham, Alabama, United States
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Yokohama, Kanagawa, Japan
Groningen, , Netherlands
Kashiwa Shi, Chiba, Japan
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Budapest, , Hungary
Silver Spring, Maryland, United States
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Graz, , Austria
Besancon Cedex, , France
Zaragoza, , Spain
Changhua, , Taiwan
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Bonn, , Germany
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Olympia, Washington, United States
Alabaster, Alabama, United States
Murdoch, Western Australia, Australia
Lakewood, Colorado, United States
Columbia, Maryland, United States
Hefei, Anhui, China
Cleveland, Ohio, United States
Edegem, Other, Belgium
Madrid, Other, Spain
Heidelberg, , Germany
Chongqing, Chongqing, China
Strasbourg, , France
Fall River, Massachusetts, United States
Drammen, , Norway
Miami, Florida, United States
Lausanne, , Switzerland
Takatsuki Shi, Osaka, Japan
Los Alamitos, California, United States
Madrid, Other, Spain
Greenfield Park, Quebec, Canada
Changchun, Jilin, China
Santo Andre, Sao Paulo, Brazil
Marseille, , France
Tyler, Texas, United States
Albuquerque, New Mexico, United States
Badalona, Other, Spain
Eugene, Oregon, United States
Rockville, Maryland, United States
Nagoya Shi, Aichi, Japan
Brescia, Other, Italy
Valencia, Other, Spain
Meldola, Other, Italy
Orange, California, United States
Wytheville, Virginia, United States
Olympia, Washington, United States
Patras, , Greece
Fullerton, California, United States
Cordoba, , Argentina
Liege, Other, Belgium
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Roma, Other, Italy
Torrette, Other, Italy
Chuo Ku, Other, Japan
Nagoya Shi, Other, Japan
Osaka, Other, Japan
Rotterdam, Other, Netherlands
Lausanne, Other, Switzerland
London, Other, United Kingdom
Lone Tree, Colorado, United States
Villejuif Cedex, Other, France
Montreal, Quebec, Canada
Ijui, , Brazil
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Fullerton, California, United States
Valencia, , Spain
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Taiyuan, Shanxi, China
Ciudad De Mexico, , Mexico
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Rosario, , Argentina
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Milano, Other, Italy
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Anchorage, Alaska, United States
Suwon Si, , Korea, Republic Of
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Annapolis, Maryland, United States
Matsuyama Shi, Ehime, Japan
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Olomouc, , Czechia
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Graz, , Austria
Graz, , Austria
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Concepción, , Chile
Jiangmen City, Guangdong, China
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Chengdu, Sichuan, China
Ostrava, , Czechia
Praha 2, , Czechia
Toulon, Var, France
Creteil, , France
Montpellier, , France
Paris, , France
Pessac, , France
Villejuif, , France
Frankfurt, , Germany
Halle, , Germany
Luebeck, , Germany
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Budapest, , Hungary
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Monza, Mb, Italy
Monza, Mb, Italy
Brescia, , Italy
Roma, Rome, Italy
Roma, Rome, Italy
Catania, Sicily, Italy
Catania, , Italy
Roma, , Italy
Rome, , Italy
Kobe Shi, Hyōgo, Japan
Ota Shi, Tokyo, Japan
Ciudad De México. México., México, Mexico
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Rotterdam, , Netherlands
Oslo, , Norway
Oslo, , Norway
Trondheim, , Norway
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Lodz, , Poland
Lublin, , Poland
Poznan, , Poland
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Craiova, , Romania
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Alicante, , Spain
Badalona, , Spain
Castello De La Plana, , Spain
Malaga, , Spain
Chur, Graubünden (De), Switzerland
Chur, Other, Switzerland
Changhua, , Taiwan
London, Others, United Kingdom
London, , United Kingdom
London, , United Kingdom
Sutton, , United Kingdom
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Brandywine, Maryland, United States
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Largo, Maryland, United States
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Jaú, , Brazil
Salvador, , Brazil
Tian Jin, Tian Jin, China
Olomouc, , Czechia
Paris, , France
Munster, , Germany
Genova, , Italy
Parma, , Italy
Suwon Si, Other, Korea, Republic Of
Suwon Si, Other, Korea, Republic Of
Jeonju Si, , Korea, Republic Of
Madrid, , Spain
Chur, Graubünden (De), Switzerland
London, , United Kingdom
Vina Del Mar, , Chile
Brescia, Province Of Brescia, Italy
Chur, , Switzerland
Patients applied
Trial Officials
Pfizer CT.gov Call Center
Study Director
Pfizer
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported