Recruiting
Phase 3

T-DXd

Sponsor:

Daiichi Sankyo

Code:

NCT07022483

Conditions

Endometrial Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Trastuzumab Deruxtecan

Chemotherapy

Study Details

Brief 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.

Conditions

Endometrial Cancer

Study ID

NCT07022483

Start date

Sep 30, 2025

Status verified date

Jul, 2026

Completion date

Mar 23, 2032

Anticipated

Primary completion date

Mar 23, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

710 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: T-DXd

Participants will receive T-DXd 5.4 mg/kg intravenously (IV) once every 3 weeks (Q3W) with or without \[optional\] radiotherapy

active comparator: Arm B: Standard of Care Chemotherapy

Participants will receive carboplatin AUC 5 or 6 and paclitaxel 175 mg/m2 Q3W, or AUC 5 or 6 and paclitaxel 175 mg/m2 Q3W with or without \[optional\] radiotherapy or chemoradiotherapy (EBRT plus cisplatin \[as radiosensitizer\] 50 mg/m2

Interventions

Trastuzumab Deruxtecan

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

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.

Primary outcome measure

  • Disease-Free Survival as Assessed by Blinded Independent Central Review or by Histopathologic Confirmation of Disease Recurrence per Local Assessment [ Time Frame: From randomization to the first documented local regional recurrence, distant metastasis, or death due to any cause, whichever occurs first, up to approximately 51 months ]

Central Contacts and Locations

Central contacts

Contact for Trial Information

908-992-6400CTRinfo_us@daiichisankyo.com

Locations

Broward Health Medical Center

Recruiting

Fort Lauderdale, Florida, United States, 33316

Miami Cancer Institute

Recruiting

Miami, Florida, United States, 33176

Mount Sinai Medical Center

Recruiting

Miami Beach, Florida, United States, 33140

Parkview Research Center

Recruiting

Fort Wayne, Indiana, United States, 46845

Trials365 LLC

Recruiting

Shreveport, Louisiana, United States, 71103

FirstHealth of the Carolinas, Inc.

Recruiting

Pinehurst, North Carolina, United States, 28374

University of Cincinnati Physicians Group, LLC

Recruiting

Cincinnati, Ohio, United States, 45206

Avera Medical Group Gynecologic Oncology Sioux Falls

Recruiting

Sioux Falls, South Dakota, United States, 57105

Texas Oncology, P.A. - Tyler

Recruiting

Sioux Falls, South Dakota, United States, 57105

Texas Oncology San Antonio Medical Center

Recruiting

San Antonio, Texas, United States, 78240

More Information

Sponsor

Daiichi Sankyo

Last update posted

Jul 28, 2026

Last verified

Jul, 2026

Keywords

  • endometrial cancer
  • cancer
  • T-DXd
  • HER2

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Daiichi Sankyo on 2026-07-28.