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Clinical Trials List

Protocol NumberDS8201-854
NCT Number(ClinicalTrials.gov Identfier)NCT07022483
Active

2025-11-01 - 2033-12-31

Phase III

Not yet recruiting5

ICD-10C54.1

Malignant neoplasm of endometrium

ICD-10C54.2

Malignant neoplasm of myometrium

ICD-10C54.3

Malignant neoplasm of fundus uteri

ICD-10C54.9

Malignant neoplasm of corpus uteri, unspecified

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9182.0

Malignant neoplasm of corpus uteri, except isthmus

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)

  • Trial Applicant

     Daiichi Sankyo Taiwan Ltd. 

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/08/13

Investigators and Locations

Principal Investigator 張志隆 Division of Obstetrics & Gynecology
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator - - Division of Obstetrics & Gynecology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chien-Hsing Lu Division of Obstetrics & Gynecology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Peng-Hui Wang Division of Obstetrics & Gynecology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Yu-Fang Huang
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Endometrial Cancer

Objectives

這是一項全球、多中心、開放標示的第 3 期試驗，旨在評估 T-DXd 相較於 SoC 化療，併用或不併用放射治療作為表現 HER2（免疫組織化學染色法 [IHC] 3+/2+）的子宮內膜癌參與者之輔助性治療的療效和安全性。參與者將以 1:1 的比例隨機分配至接受 T-DXd 或 SoC 化療作為輔助性治療。主要目的為由盲性中央獨立評估委員會 (BICR)評估無疾病存活期 (DFS)，或是藉由當地評估進行組織病理學確認疾病復發情形。

Test Drug

凍晶注射劑
靜脈輸注液
靜脈輸注液
靜脈輸注液
靜脈輸注液

Active Ingredient

trastuzumab deruxtecan
CARBOPLATIN
PACLITAXEL
Docetaxel
CISPLATIN

Dosage Form

243
246
246
246
246

Dosage

100 mg/vial
150, 600 mg/vial
100, 300 mg/vial
80 mg/vial
50 mg/vial

Endpoints

無疾病存活期或由盲性中央獨立評估委員會 評估或根據當地評估組織病理學確認疾病復發情形。

Inclution Criteria

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.

Exclusion Criteria

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.

The Estimated Number of Participants

  • Taiwan

    30 participants

  • Global

    710 participants

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