Health Condition 1: C541- Malignant neoplasm of endometrium
Conditions
Interventions
Intervention1: Trastuzumab Deruxtecan: Route: Intravenous
Dose: IV infusion
Dosing
Regimen: Q3W (on day 1 of each
21-day cycle)
Duration: Maximum of 17 cycles
Control Intervention1: Combination of car
Sponsors
Daiichi Sankyo, Inc
IQVIA RDSIndia Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Sign and date the Tissue SCR ICF, prior to HER2 central testing. Sign and date the main SCR ICFs, prior to the start of any trial-specific qualification procedures not included in the Tissue SCR ICF. Consent to optional PGx prior to any PGx procedures. 2. Adults more than or equal to 18 years at the time the ICF is signed (Please follow local regulatory requirements if the legal age of consent for trial participation is more than 18 years old). 3. Has histologically confirmed diagnosis of epithelial endometrial carcinoma. All histologys are allowed except for sarcomas (carcinosarcomas are allowed). 4. Is newly diagnosed FIGO 2023 Stage IIC (including Stage IICmp53abn) or Stage III. 5. Has HER2-expression (IHC 3+/2+) per 2016 ASCO-CAP gastric cancer IHC scoring guidelines as confirmed by central laboratory testing. 6. Has adequate archived tumor tissue sample (sample from surgery is strongly recommended) available for assessment of HER2 status by central laboratory. 7. Has an MMR IHC local test result from an approved and/or validated test, according to the local regulations. 8. Is eligible for combination treatment with carboplatin and paclitaxel as adjuvant therapy per SoC and Investigator discretion. 9. Has undergone curative intent surgery that included hysterectomy and bilateral salpingooophorectomy. Pelvic lymph node sampling, para-aortic lymph node sampling, including sentinel lymph node, and lymph node dissection are optional but strongly encouraged. 10. Is disease-free with no evidence of loco-regional disease or distant metastasis postoperatively on imaging assessed by investigator and confirmed by BICR. 11. Trial intervention to start within 8 weeks of endometrial cancer surgery date. 12. Has not received any radiotherapy or systemic therapy, including immunotherapy, hormonal therapy, radiosensitizer chemotherapy or HIPEC, in any setting including the neoadjuvant setting for endometrial cancer. 13. Has LVEF more than or equal to 50% within 28 days before randomization. 14. ECOG performance status of 0 or 1 assessed no more than 14 days prior to randomization 15. Has adequate organ and bone marrow function as assessed by local laboratory within 14 days prior to randomization as defined below. Organ and bone marrow function criteria must also be met when laboratory tests are repeated within 72 hours of initiation of trial intervention as appropriate.
Exclusion criteria
Exclusion criteria: 1. Has uterine mesenchymal tumor such as an endometrial stromal sarcoma,leiomyosarcoma, or other types of pure sarcomas. Adenosarcomas are also not allowed. 2. Has recurrent or FIGO 2023 Stage IV 3. Has measurable residual tumor after surgery as determined by BICR assessment. 4. Is known to have a POLE mutation from an approved and/or validated local test, according to local regulations, if available 5. 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. 6. Has a QTcF prolongation to more than 480 msec based on average of the SCR triplicate12-lead ECG. 7. Any of the following within the past 6 months prior to enrollment: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event. 8. 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. 9. 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. 10. History of other active malignancy within 3 years prior to enrollment, with the exception of those with a negligible risk of metastasis or death (eg, 5-year OS rate more than 90%) and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, ductal carcinoma in situ). 11. History of hypersensitivity to the trial intervention or their excipients or any known contraindication (included in the approved local labels) to treatment with, including hypersensitivity to, the trial intervention. 12. History of severe hypersensitivity reactions to other monoclonal antibodies. 13. Has any evidence of severe or uncontrolled systemic diseases (including active bleeding diatheses or active infection, substance abuse) or other factors that in the investigator opinion , make it undesirable for the participant to participate in the trial or which would jeopardize compliance with the protocol. SCR for chronic conditions is not required. 14. Has an uncontrolled infection requiring systemic antibiotics, antivirals or antifungals. Participants with localized fungal infections of skin or nails are eligible. 15. Has active or uncontrolled HBV infection. Hepatitis B SCR testing is required. Participants are eligible if- Are HBsAg positive with chronic HBV infection (lasting 6 months or longer) and meet conditions below- HBV DNA viral load more than 2000 IU/mL Start or maintain antiviral treatment if clinically indicated as per the investigator. Have normal transaminase values 16. Has active or uncontrolled hepatitis C virus infection. Hepatitis C SCR testing is required. Participants are eligible if- Hi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy of T-DXd versus SoC as measured by DFS, as assessed by BICR or by histopathologic confirmation of disease recurrence per local assessment in the HER2 IHC 3+/2+ populationTimepoint: DFS is defined as time interval from the date of randomization to the first documented local regional recurrence, distant metastasis, or death due to any cause, whichever occurs first. DFS will be assessed radiographically by BICR or by histopathologic confirmation of disease recurrence per local assessment. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the efficacy of T-DXd versus SoC as measured by OS in the HER2 IHC 3+/2+ population Timepoint: OS is defined as the time interval from the date of randomization to the date of death due to any cause | — |
Countries
Argentina, Brazil, Canada, Chile, China, France, Germany, Greece, India, Israel, Italy, Japan, Poland, Portugal, Republic of Korea, Spain, Taiwan, Thailand, United States of America
Contacts
Public ContactShweta Pradhan
IQVIA RDS (India) Private Limited
Outcome results
None listed