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  • SPOTLIGHT

    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

    Summary of trial and patient characteristics

    Cancer Type Stomach & Oesophageal
    Trial Type Treatment
    Phase Phase III Tumour Stream Gastro-oesophageal
    Age Range 18 years and older Cancer Stage Metastatic or Widespread
    Sex Both Anticipated Start Date 2018-06-21
    Molecular Target Anticipated End Date
    Cancer Type Stomach & Oesophageal
    Trial Type Treatment
    Phase Phase III
    Age Range 18 years and older
    Sex Both
    Molecular Target
    Tumour Stream Gastro-oesophageal
    Cancer Stage Metastatic or Widespread
    Anticipated Start Date 2018-06-21
    Anticipated End Date

    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. Why is this study being done? SPOTLIGHT is a new clinical study for adult patients who have any of: - advanced unresectable gastric or GEJ cancer - metastatic gastric or GEJ cancer These types of cancers have a unique set of proteins (called Claudin 18.2). We may be able to use a treatment that targets the proteins to kill the cancer cells. For patients with one of the types of cancer listed above, mFOLFOX6 (a combination of three chemotherapies known as Oxaliplatin, Leucovorin, and Fluorouracil) is a current treatment option. This study is testing an experimental medicine called zolbetuximab (IMAB362). Zolbetuximab attaches itself to Claudin 18.2 on the cancer cells causing cancer cell death. Patients will be assigned to one of two groups by chance and given either: - zolbetuximab with mFOLFOX6; or - a placebo with mFOLFOX6 A placebo is a treatment that looks like the experimental medicine, but contains no medicine. The goal of the study is to find out if zolbetuximab with mFOLFOX6 helps patients to live longer by stopping the cancer from getting worse.

    Lay Summary

    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.

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    The Queen Elizabeth Hospital Sue Yeend Sue.Yeend@sa.gov.au 08 8222 6148 Professor Tim Price Recruiting