Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

A study of Zolbetuximab (IMAB362) plus mFOLFOX6 versus placebo plus mFOLFOX6 in participants with Claudin 18.2 positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Why was this study being done? SPOTLIGHT was a new clinical study for adult participants who had any of advanced unresectable gastric or GEJ cancer - metastatic gastric or GEJ cancer. These types of cancers had 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 participants with one of the types of cancer listed above, mFOLFOX6 (a combination of three chemotherapies known as Oxaliplatin, Leucovorin, and Fluorouracil) was a current treatment option. This study was testing an experimental medicine called Zolbetuximab (IMAB362). Zolbetuximab attached itself to Claudin 18.2 on the cancer cells causing cancer cell death. Participants were assigned to one of two groups by chance and given either: Zolbetuximab with mFOLFOX6; or a placebo with mFOLFOX6. A placebo was a treatment that looks like the experimental medicine, but contained no medicine. The goal of the study was to find out if Zolbetuximab with mFOLFOX6 helped participants to live longer by stopping the cancer from getting worse.

Official Title

A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 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

Details

The study consisted 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.

Keywords

Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer, Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma, HER2, IMAB362, leucovorin, fluorouracil, Gastric cancer, claudiximab, zolbetuximab, oxaliplatin, adenocarcinoma, Gastro-Esophageal Junction cancer, HER2 Negative mFOLFOX6, Folic Acid, Levoleucovorin, folinic acid, mFOLFOX6 + Zolbetuximab

Eligibility

Locations

  • UCSF
    San Francisco California 94143 United States
  • University of California Davis
    Sacramento California 95817 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Astellas Pharma Global Development, Inc.
ID
NCT03504397
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 565 people participating
Last Updated