Phase 2 Study of T-DXd in the Neoadjuvant Treatment for Patients With HER2 Positive Gastric and GEJ Adenocarcinoma

Gastric Adenocarcinoma Clinical Trial

Official title: Phase 2 Study of Trastuzumab Deruxtecan (T-DXd) in the Neoadjuvant Treatment for Patients With HER2 Positive Gastric and Gastroesophageal Junction Adenocarcinoma

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This study is an open-label, single-arm, multicenter, phase 2 clinical trial. Eligible patients are with previously untreated gastric and gastroesophageal junction adenocarcinoma as defined by cT2-4 and/or cN+ without evidence of metastatic disease. Study treatment in this study is neoadjuvant treatment with the investigational drug, T-DXd alone, followed by surgery. T-DXd will be administered at a dose of 6.4 mg/kg (decimal) by intravenous infusion every 21 days (3 weeks) for 3 cycles as the neoadjuvant treatment followed by surgery.

The analyses will be performed on the following 2 cohorts:

• Gastric cancer or gastroesophageal junction cancer with HER2 overexpression (IHC3+, or IHC2+ and ISH positive [FISH or DISH]) (Primary cohort)

• Gastric or gastroesophageal junction cancer patients with HER2 low expression (IHC1+, or IHC2+ and ISH-negative [FISH or DISH]) and HER2-ECD > 11.6 ng/mL (Exploratory cohort) ;

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Neoplasms
• Gastric Adenocarcinoma
• Gastroesophageal Junction Adenocarcinoma

• NCT number: NCT05034887
• Study type: Interventional
• Source: National Cancer Center Hospital East
• Contact: Kohei Shitara, MD
• Phone: +81-4-7133-1111
• Email: T-DXd_NAC_core@east.ncc.go.jp
• Status: Recruiting
• Phase: Phase 2
• Start date: January 31, 2022
• Completion date: March 31, 2025