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Clinical Trial Summary

A study of zolbetuximab (IMAB362) plus mFOLFOX6 versus placebo plus mFOLFOX6 in subjects with Claudin 18.2 positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Why is this study being done? SPOTLIGHT is a new clinical study for adult patients who have any of: - advanced unresectable gastric or GEJ cancer - metastatic gastric or GEJ cancer. These types of cancers have a unique set of proteins (called Claudin 18.2). We may be able to use a treatment that targets the proteins to kill the cancer cells. For patients with one of the types of cancer listed above, mFOLFOX6 (a combination of three chemotherapies known as Oxaliplatin, Leucovorin, and Fluorouracil) is a current treatment option. This study is testing an experimental medicine called zolbetuximab (IMAB362). Zolbetuximab attaches itself to Claudin 18.2 on the cancer cells causing cancer cell death. Patients will be assigned to one of two groups by chance and given either: - zolbetuximab with mFOLFOX6; or - a placebo with mFOLFOX6. A placebo is a treatment that looks like the experimental medicine, but contains no medicine. The goal of the study is to find out if zolbetuximab with mFOLFOX6 helps patients to live longer by stopping the cancer from getting worse.


Clinical Trial Description

The study consists of the following periods: screening; treatment; post-treatment follow up, safety follow up, long term and survival follow-up. After the marketing approval in Japan on 26 Mar 2024, this study continued as "post marketing clinical study" in Japan. In the rest of the countries which participated in this study, this study continued as clinical study. ;


Study Design


Related Conditions & MeSH terms

  • Adenocarcinoma
  • Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer
  • Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer
  • Metastatic Gastric Adenocarcinoma or Cancer
  • Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma

NCT number NCT03504397
Study type Interventional
Source Astellas Pharma Inc
Contact
Status Active, not recruiting
Phase Phase 3
Start date June 21, 2018
Completion date March 31, 2025

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03653507 - A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Phase 3
Available NCT06048081 - Early Access Program for Zolbetuximab