BENITIONSClinical Trial Intelligence

A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer.

第3相 実施中(募集終了) NCT03504397

対象疾患Locally Advanced Unresectable Gastroesophageal Junction Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer, Metastatic Gastroesophageal Junction Adenocarcinoma
第3相
スポンサーAstellas Pharma Global Development, Inc.
ステータス実施中(募集終了)
参加者数565 名
介入(薬剤)zolbetuximab, oxaliplatin, folinic acid, fluorouracil
開始日2018年6月21日
完了日2022年9月9日
結果公開日2025年2月26日

概要

Zolbetuximab is being studied in people with cancer in and around the stomach or where the food pipe (esophagus) joins the stomach, called gastroesophageal junction (GEJ) cancer. Most people with this type of cancer have a protein called Claudin 18.2 in their tumor. Zolbetuximab is thought to work by attaching to the Claudin 18.2 protein in their tumor, which switches on the body's immune system to attack the tumor. There is an unmet medical need to treat people with advanced stomach cancer or GEJ cancer. This study will give more information about how well zolbetuximab works when given with chemotherapy in adults with advanced stomach cancer or GEJ cancer. In this study, adults with advanced stomach cancer or GEJ cancer will either be given zolbetuximab with chemotherapy or a placebo with chemotherapy. A placebo looks like zolbetuximab but doesn't have any medicine in it. Zolbetuximab with chemotherapy has already been approved to treat gastric cancer and GEJ cancer in some countries. This study is being done in countries where zolbetuximab has not yet been approved for use. If zolbetuximab becomes approved for use in those countries taking part in this study, the study doctor wil

Progression Free Survival (PFS)

From date of randomization until the date of first documented radiological progression or date of death from any cause, whichever occurred first (up to 62 months and 18 days) · Months

mFOLFOX6 + Zolbetuximab11.04 Months
mFOLFOX6+ Placebo8.94 Months
p-value0.0024
Hazard Ratio (HR)0.734 (95% CI 0.591–0.910)

BENITIONS で見る ClinicalTrials.gov の原文を見る

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