Phase 2 Study of Trastuzumab Deruxtecan in the Neoadjuvant Treatment, or Trastuzumab Deruxtecan P… (NCT05034887) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Phase 2 Study of Trastuzumab Deruxtecan in the Neoadjuvant Treatment, or Trastuzumab Deruxtecan Plus Capecitabine Plus Durvalumab(MEDI4736) in the Preoperative and Postoperative Adjuvant Treatment for Patients With HER2 Positive Gastric and Gastroesophageal Junction Adenocarcinoma
Japan64 participantsStarted 2022-01-31
Plain-language summary
This study is an open-label, single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of neoadjuvant chemotherapy with T-DXd monotherapy in patients with HER2-positive gastric cancer.
In the combination cohort, the efficacy and safety of neoadjuvant chemotherapy combined with T-DXd, capecitabine, and durvalumab are evaluated.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction.
. Has HER2 overexpression (IHC3+, or IHC2+ and ISH positive \[FISH or DISH\]). (HER2 Low expression: IHC1+, or IHC2+ and ISH-negative \[FISH or DISH\] with HER2-ECD \> 11.6 ng/mL in the exploratory cohort).
. Have previously untreated gastric and gastroesophageal junction adenocarcinoma and cT2-4 and/or cN+M0.according to the UICC TNM classification (8th edition),
. Age ≥ 20 years as the day of informed consent.
. Has an ECOG performance status (PS) of 0 or 1.
. Has a left ventricular ejection fraction (LVEF) ≥ 50% by either echocardiogram (ECHO) or multigated collecting acquisition (MUGA) scan within 28 days before enrollment (acceptable on the same day of the week).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Major pathological response [MPR] rate: by central assessment
. Has a corrected QT interval (QTc) ≦ 470 ms in females, or QTc ≦ 450 ms in males based on a 12-lead ECG screening within 28 days before enrollment (allowed on the same day of the week). \[Fridericia's correction is recommended\]
. Satisfies all of the following requirements within 14 days before enrollment (allowed on the same day of the week).
Exclusion criteria
. Has a medical history of myocardial infarction or congestive heart failure (New York Heart Association Classes II-IV) within 6 months before enrollment, corresponding to the value diagnosed as myocardial infarction as defined by the \*validated test within 28 days before enrollment (allowed on the same day), unstable angina, or any serious arrhythmia requiring treatment.
. Active other cancers \[Synchronous other cancers and metachronous other cancers within 3 years prior to enrollment, but carcinoma in situ or other lesions corresponding to mucosal carcinoma that are considered curable with local treatment will not be included in active other cancers.\]
. Has serious (hospitalized) complications (intestinal palsy, intestinal obstruction, pulmonary fibrosis, diabetes mellitus that is difficult to control, heart failure, myocardial infarction, unstable angina, renal failure, liver failure, psychiatric disorders, cerebrovascular disorders, etc.).
. Has history of gastrointestinal perforation and/or gastrointestinal fistula within 6 months before enrollment.
. Has any of the following infections:
. HIV infection
. Lung diseases defined as:
. Has history of concomitant autoimmune disease or chronic or recurrent autoimmune disease.