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Trial Summary

A study of zolbetuximab (IMAB362) plus mFOLFOX6 versus placebo plus mFOLFOX6 in subjects with Claudin 18.2 positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

Acronym:

SPOTLIGHT

ACTRN/NCT /ethics:

NCT03504397

Scientific title:

A Phase 3 Efficacy, Safety and Tolerability Study of Zolbetuximab (Experimental Drug) Plus mFOLFOX6 Chemotherapy Compared to Placebo Plus mFOLFOX6 as Treatment for Gastric and Gastroesophageal Junction (GEJ) Cancer

Sponsor / Cooperative group:

Astellas Pharma Global Development, Inc.

Trial & Patient Characteristics

Cancer TypeStomach & Oesophageal
Trial TypeTreatment
PhasePhase III
Age Range18 years and older
SexBoth
Tumour Stream Gastric and Gastroesophageal Junction (GEJ) Cancer
Cancer StageLocally Recurrent or Locally Advanced; Metastatic or Widespread
Anticipated Start Date2018-06-21
Anticipated End Daten/a

Participating Hospitals

HospitalThe Queen Elizabeth Hospital
Clinical Trial CoordinatorPamela Cooper
Emailpamela.cooper@sa.gov.au
Phone08 8222 6140
Principal InvestigatorProfessor Tim Price
Recruitment StatusRecruiting