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

Trial Status: Closed
Start Date: September, 2018
Expected Enrolment: 507
Type of Trial: Interventional
Protocol IDs: NCT03653507, 8951-CL-0302, 2018-000519-26, CTR20190261
Trial Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)
Trial Phase: Phase 3
Medical Conditions: 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
Drugs:
  • oxaliplatin
  • capecitabine
  • placebo
  • zolbetuximab
Lead Sponsor: Astellas Pharma Global Development, Inc.
Sponsors/Study Groups: None specified
Type of Treatment: None specified
Principal Investigator(s): Medical Director, Astellas Pharma Global Development
Date posted on clinicaltrials.gov: August 24, 2018
Last updated: March 19, 2022
This trial was imported from ClinicalTrials.gov

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