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RECRUITING

NCT07022483

PHASE3

Study of Trastuzumab Deruxtecan Versus Standard of Care Chemotherapy for HER2-Expressing (IHC 3+/2+) Endometrial Cancer

Sponsor: Daiichi Sankyo

View on ClinicalTrials.gov

Summary

This study is designed to assess efficacy and safety of T-DXd adjuvant therapy, with or without radiotherapy, post-surgery in anticancer treatment naïve (including neoadjuvant therapy) endometrial cancer with various HER2 expression levels.

Official title: A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan Versus Standard of Care Chemotherapy With or Without Radiotherapy as Adjuvant Treatment for HER2-Expressing (IHC 3+/2+) Endometrial Cancer (DESTINY-Endometrial02/ GOG-3122/ ENGOT-en30/GINECO)

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

710

Start Date

2025-09-30

Completion Date

2032-03-23

Last Updated

2026-05-28

Healthy Volunteers

Conditions

Endometrial Cancer

Interventions

DRUG

Trastuzumab Deruxtecan

T-DXd will be administered at a dose of 5.4 mg/kg IV Q3W.

DRUG

Chemotherapy

Carboplatin AUC 5 or 6 and paclitaxel will be administered at a dose of 175 mg/m2 Q3W, or carboplatin AUC 5 or 6 and paclitaxel 175 mg/m2 Q3W followed by chemoradiotherapy.

Key Inclusion Criteria * Adults ≥18 years at the time the ICF is signed (Please follow local regulatory requirements if the legal age of consent for trial participation is \>18 years old) * Has histologically confirmed diagnosis of epithelial endometrial carcinoma. All histology's are allowed except for sarcomas (carcinosarcomas are allowed). * Is newly diagnosed FIGO 2023 Stage IIC (including Stage IICmp53abn) or Stage III Note: FIGO 2023 Stage IIC includes disease with aggressive histological types (aggressive histological types are composed of high-grade EECs (grade 3), serous, clear cell, undifferentiated, mixed, mesonephric-like, gastrointestinal mucinous type carcinomas, and carcinosarcomas) with any myometrial involvement. FIGO 2023 Stage III includes disease with local and/or regional spread of the tumor of any histological subtype. * Has HER2-expression (IHC 3+/2+) per 2016 ASCO-CAP gastric cancer IHC scoring guidelines as confirmed by central laboratory testing. * Has adequate archived tumor tissue sample (sample from surgery is strongly recommended) available for assessment of HER2 status by central laboratory. Key Exclusion Criteria * Has uterine mesenchymal tumor such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas. Adenosarcomas are also not allowed. * Has recurrent or FIGO 2023 Stage IV * Has measurable residual tumor after surgery as determined by BICR assessment. * Is known to have a POLE mutation from an approved and/or validated local test, according to local regulations, if available * Has a medical history of MI within 6 months before randomization/enrollment, symptomatic CHF (NYHA Class II to IV). Participants with troponin levels above ULN at SCR (as defined by the manufacturer), and without any MI related symptoms should have a cardiologic consultation during SCR Period to rule out MI. * Has a QTcF prolongation to \> 480 msec based on average of the SCR triplicate12-lead ECG. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the trial enrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion, etc.) and any autoimmune, connective tissue, or inflammatory disorder with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or prior pneumonectomy. * Has a history of (noninfectious) ILD/pneumonitis that required corticosteroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at SCR.

Locations (61)

Broward Health Medical Center

Fort Lauderdale, Florida, United States

Miami Cancer Institute

Miami, Florida, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

Trials365 LLC

Shreveport, Louisiana, United States

FirstHealth of the Carolinas, Inc.

Pinehurst, North Carolina, United States

University of Cincinnati Physicians Group, LLC

Cincinnati, Ohio, United States

Avera Medical Group Gynecologic Oncology Sioux Falls

Sioux Falls, South Dakota, United States

Texas Oncology San Antonio Medical Center

San Antonio, Texas, United States

Hospital Italiano de Buenos Aires

Ciudad Autonoma Buenos Aires, Argentina

Sanatorio Allende Cerro

Córdoba, Argentina

Centro de Investigaciones Medicas Mar del Plata

Mar del Plata, Argentina

Beijing Cancer Hospital

Beijing, China

The First Hospital of Jilin University

Changchun, China

West China Second University Hospital, Sichuan University

Chengdu, China

Obstetrics and Gynecology Hospital Affiliated to Zhejiang University School of Medicine

Hangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

Cancer Hospital of Shandong First Medical University

Jinan, China

Linyi Cancer Hospital

Linyi, China

Jiangxi Maternal and Child Health Hospital

Nanchang, China

Guangxi Medical University Affiliated Tumor Hospital

Nanning, China

Shanghai First Maternity and Infant HospitalShanghai First Maternity and Infant Hospital

Shanghai, China

Shanghai Tenth People's Hospital

Shanghai, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

Wuhan, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, China

Yantai Yuhuangding Hospital

Yantai, China

Centre Francois Baclesse

Caen, France

Institut Claudius Regaud

Toulouse, France

Klinikum Lippe-Detmold

Detmold, Germany

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

Bologna, Italy

Azienda Ospedaliera Universitaria Careggi

Florence, Italy

IEO Istituto Europeo di Oncologia

Milan, Italy

Ospedale Mauriziano Umberto I

Torino, Italy

Hyogo Cancer Center

Akashi-shi, Japan

NHO Kyushu Cancer Center

Fukuoka, Japan

Fukushima Medical University Hospital

Fukushima, Japan

Saitama Medical University International Medical Center

Hidaka-shi, Japan

Cancer Institute Hospital of JFCR

Kōtoku, Japan

Kurume University Hospital

Kurume-shi, Japan

Niigata Cancer Center Hospital

Niigata, Japan

Okayama University Hospital

Okayama, Japan

Gunma Prefectural Cancer Center

Ota-shi, Japan

NHO Hokkaido Cancer Center

Sapporo, Japan

Tohoku University Hospital

Sendai, Japan

Keio University Hospital

Shinjuku-ku, Japan

Mie University Hospital

Tsu, Japan

Yamagata University Hospital

Yamagata, Japan

Hospital da Luz

Lisbon, Portugal

Keimyung University Dongsan Hospital

Daegu, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Complejo Hospitalario Universitario A Coruña

A Coruña, Spain

Hospital Universitario Virgen de la Arrixaca

El Palmar, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitari Son Espases

Palma de Mallorca, Spain

Taichung Veterans General Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital