Phase 3 Study of Cadonilimab and Chemotherapy vs. Chemotherapy with or without Nivolumab for First-Line Treatment of HER2-negative Advanced Gastric/GEJ Cancer

Sponsor: Akeso

Sponsor score: 0

ClinicalTrials ID:NCT07700979

This clinical trial is comparing the effectiveness of a new drug combination, cadonilimab with chemotherapy, against chemotherapy with or without nivolumab for treating patients with advanced gastric or gastroesophageal junction cancer that cannot be surgically removed.

Patient Parameters

Program Overview

The purpose of this study is to see if combining the drug cadonilimab with chemotherapy is more effective than chemotherapy alone or with nivolumab in treating patients with advanced gastric or gastroesophageal junction cancer that has not been treated before and cannot be surgically removed. The study will measure overall survival rates to determine which treatment is more beneficial.

Eligibility Criteria

Inclusion Criteria

  • Able to understand and agree to the study requirements and provide written consent.
  • Diagnosed with advanced gastric or gastroesophageal junction cancer that cannot be surgically removed or has spread.
  • No previous treatment for advanced gastric or gastroesophageal junction cancer, unless it was part of a treatment plan aimed at curing the cancer and at least 6 months have passed since the last treatment.
  • In good general health with a performance status score of 0 or 1.
  • At least 18 years old.
  • Have test results showing PD-L1 expression.
  • Have at least one tumor that can be measured by scans, even if it was previously treated with radiation.
  • Have good organ function based on recent lab tests.
  • Expected to live at least 3 more months.
  • Women who can become pregnant must have a negative pregnancy test and agree to use birth control during and after treatment for a specified time.
  • Men must agree to use birth control during and after treatment for a specified time.

Exclusion Criteria

  • Have a different type of cancer, such as squamous cell carcinoma or sarcoma.
  • Have HER2-positive cancer.
  • Have active cancer that has spread to the brain or spinal cord, unless previously treated and stable.
  • Have fluid buildup around the lungs, heart, or abdomen that needs frequent drainage.
  • Have significant bleeding issues recently.
  • Have a history of serious gastrointestinal problems within the last 6 months.
  • Have symptoms suggesting the cancer is worsening significantly.

Locations

FACILITYZIPCITYSTATE
Mayo Clinic85054PhoenixArizona
UCLA Health90095Los AngelesCalifornia
Rocky Mountain Cancer Centers80218DenverColorado
Yale School of Medicine06510New HavenConnecticut
Dana Farber Cancer Institute02215BostonMassachusetts
Henry Ford Health48202DetroitMichigan
Mount Sinai10029New YorkNew York
Memorial Sloan Kettering Cancer Center10065New YorkNew York
Oregon Health and Science University97239PortlandOregon
Sarah Cannon Research Institute (SCRI) - Oncology Partners37203NashvilleTennessee

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