Protocol Number:
NCT03504397

Study Name:
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 (SPOTLIGHT)

Age Group:
Adult

Background Information:
This global, multi-center, double-blind, 1:1 randomized, phase 3 study will evaluate efficacy of zolbetuximab plus mFOLFOX6 versus placebo plus mFOLFOX6 as first-line treatment in subjects with CLDN18.2-positive, HER2-negative locally advanced unresectable or metastatic gastric and GEJ adenocarcinoma.

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