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Clinical trial

A Phase 3, Global, Multi-center, Double-blind, Randomized Study of ASP2138 Plus Chemotherapy (CAPOX or mFOLFOX6) With Pembrolizumab vs Placebo Plus Chemotherapy With or Without Pembrolizumab in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma in Participants Whose Tumors Are HER2-negative and Claudin (CLDN) 18.2-positive

NCT07673887 is registered in ClinicalTrials.gov with Astellas Pharma Global Development, Inc. as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase 3, Global, Multi-center, Double-blind, Randomized Study of ASP2138 Plus Chemotherapy (CAPOX or mFOLFOX6) With Pembrolizumab vs Placebo Plus Chemotherapy With or Without Pembrolizumab in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma in Participants Whose Tumors Are HER2-negative and Claudin (CLDN) 18.2-positive
Lead sponsor
Astellas Pharma Global Development, Inc.
Phase
Phase 3
Overall status
Recruiting
Start date
June 30, 2026
Completion date
February 28, 2031
Enrollment
570 (estimated)
Sites
3

Conditions

As the registry lists them; a condition with its own page is linked.

gastric adenocarcinoma, gastroesophageal junction (gej) adenocarcinoma