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Stomach
General Information
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
Protocol Number:
NCT03504397
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.
Offered at:
Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A department of Inova Fairfax Hospital
Eligibility Information
Participant has histologically confirmed diagnosis of Gastric or GEJ adenocarcinoma
Participant has radiologically confirmed locally advanced unresectable or metastatic disease within 28 days prior to the first dose of study treatment
For participants with only 1 measurable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy
Participant has a HER2-Negative tumor as determined by local or central testing on a gastric or GEJ tumor specimen
Additional inclusions in protocol
Ineligibility Information
Participant has received prior systemic chemotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. However, subject may have received either neo-adjuvant or adjuvant chemotherapy as long as it was completed at least 6 months prior to the first dose of study treatment
Participant has received systemic immunosuppressive therapy, including systemic corticosteroids within 14 days prior to first dose of study treatment. Subjects using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone) or a single dose of systemic corticosteroids are allowed.
Participant has known dihydropyrimidine dehydrogenase (DPD) deficiency (NOTE: screening for DPD deficiency should be conducted per local requirements.)
Participant has gastric outlet syndrome or persistent/recurrent vomiting
Participant has an active autoimmune disease that has required systemic treatment within the past 2 years
Participant has significant cardiovascular disease
Additional exclusions in protocol
Contact Information
Contact Name:
Lindsey Tishman
Contact Phone:
571-472-0633
Contact Email:
lindsey.tishman@inova.org