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NCT06901531 · ClinicalTrials.gov registry record · Phase 3
A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer
A Phase 3 study of Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer and Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, sponsored by Astellas Pharma Global Development.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 500
- Enrollment target
- 20
- Study locations
NCT06901531: Recruiting Phase 3 study of Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer and Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, sponsored by Astellas Pharma Global Development.
NCT06901531 is a Phase 3 study of Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer and Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer that is actively recruiting participants, run by Astellas Pharma Global Development. The registered enrollment target is 500 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06901531, a Phase 3 study of Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer and Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, is actively recruiting participants, sponsored by Astellas Pharma Global Development.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 500 participants
- Enrollment target
- 20
- Study locations
Study Summary
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. Zolbetuximab with chemotherapy may be used to treat stomach and GEJ cancer when the cancer cells do not have a protein called HER2 (human epidermal growth factor receptor 2) on their surface (HER2-negative) but do have a protein called Claudin 18.2 (Claudin 18.2-positive). 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. Certain stomach and GEJ cancers may be treated with immunotherapy, which helps the body's immune system fight cancer. This study will give more information about how well zolbetuximab works when given with an immunotherapy medicine called pembrolizumab and chemotherapy. In this study, adults with stomach cancer or GEJ cancer will either be given zolbetuximab with pembrolizumab and chemotherapy or a placebo with pembrolizumab and chemotherapy. A placebo looks like zolbetuximab but doesn't have any medicine in it. The main aim of the study is to check how long people with stomach cancer and GEJ cancer live after treatment with zolbetuximab with pembrolizumab and chemotherapy compared to placebo with pembrolizumab and chemotherapy. Adults with locally advanced unresectable or metastatic stomach cancer or GEJ cancer can take part. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. A tumor sample (biopsy) of their cancer will have the Claudin 18.2 protein, PD-L1 protein, and be HER2-negative. They may have been previously treated with certain standard therapies. People cannot take part if they need to take medicines to suppress their immune system, have blockages or bleeding in their gut, have specific uncontrollable cancers such as sympt
Primary Outcome
OS is defined as the time from the date of randomization until the date of death from any cause.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Capecitabine
- DRUG Oxaliplatin
- DRUG zolbetuximab
- DRUG Folinic acid (leucovorin or local equivalent)
Study Locations (20)
Michigan
- University of Michigan Health System - Ann Arbor
- Barbara Ann Karmanos Cancer Center - Detroit
- Henry Ford Cancer Institute-Henry Ford Hospital - Detroit
Connecticut
- Hartford HealthCare - Hartford Hospital - Hartford
- Yale University School of Medicine - New Haven
Nebraska
- University of Nebraska Medical Center - Omaha
- Oncology Hematology West PC dba Nebraska Cancer Specialists - Omaha
New York
- NYU Langone Medical Center - New York
- Montefiore Medical Center - The Bronx
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
- Duke University Medical Center - Duke Cancer Centre - Durham
California
- TOI Clinical Research - Cerritos
Indiana
- Franciscan Health Oncology and Hematology Specialists - Indianapolis
Iowa
- Holden Comprehensive Cancer Center - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2025-05-22 |
| Est. Completion | 2028-09-30 |
| Phase | Phase 3 |
What NCT06901531 shows while recruiting
NCT06901531 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower).
The record links to 4 conditions, with Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT06901531 names 20 study sites across 14 states, led by Michigan, Connecticut, Nebraska.
Frequently Asked Questions
What is clinical trial NCT06901531 about?
NCT06901531 is a clinical study titled "A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer". 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. Zolbetuximab with chemotherapy may be used to treat stomach and GEJ cancer when the cancer cells do not have a protein ca...
What is the current status of trial NCT06901531?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 500 participants. The study started on 2025-05-22. Estimated completion is 2028-09-30.
What conditions does trial NCT06901531 study?
This clinical trial studies the following 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.
What interventions are being tested in trial NCT06901531?
The interventions under investigation include: Pembrolizumab (DRUG), Capecitabine (DRUG), Oxaliplatin (DRUG), zolbetuximab (DRUG), Folinic acid (leucovorin or local equivalent) (DRUG).
Who is sponsoring clinical trial NCT06901531?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06901531 being conducted?
This trial has 20 study locations across California, Connecticut, Indiana, Iowa, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06901531's enrollment target sits among peer trials
500 744th of 2000 higher than 1,227 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer.
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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 (GLOW).
ACTIVE NOT RECRUITING · Phase 3
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