Status:
COMPLETED
Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma
Lead Sponsor:
BeiGene
Conditions:
Gastric, or Gastroesophageal Junction Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study was designed to compare the efficacy and safety of tislelizumab plus chemotherapy versus placebo plus chemotherapy as the first treatment (first-line) for adults diagnosed with locally adva...
Eligibility Criteria
Inclusion
- Key
- Locally advanced unresectable or metastatic gastric cancer (GC) or gastroesophageal junction (GEJ) carcinoma and have histologically confirmed adenocarcinoma
- No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer. NOTE: Participants may have received prior neoadjuvant or adjuvant therapy as long as it was completed and have no recurrence or disease progression for at least 6 months.
- Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1 within 7 days prior to randomization
- Adequate organ function ≤ 7 days prior to randomization
- Key
Exclusion
- Has squamous cell or undifferentiated or other histological type GC
- Active leptomeningeal disease or uncontrolled brain metastasis
- Diagnosed with gastric or GEJ adenocarcinoma with positive HER2
- Prior therapy with an anti-programmed cell death protein-1 (PD-1), anti-programmed cell death protein ligand-1 (PD-L1), anti-programmed cell death protein ligand-2 (PD-L2), or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
December 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 27 2024
Estimated Enrollment :
997 Patients enrolled
Trial Details
Trial ID
NCT03777657
Start Date
December 13 2018
End Date
August 27 2024
Last Update
February 14 2025
Active Locations (149)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California Davis Health System
Sacramento, California, United States, 95817
2
Southeastern Regional Medical Center
Newnan, Georgia, United States, 30265
3
Ohio State University Hospital
Columbus, Ohio, United States, 43210
4
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111