Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma
About the study
This is a randomized (1:1), double-blind, placebo-controlled, Phase 3 study designed to compare the efficacy and safety of tislelizumab or placebo plus chemotherapy as first-line (1L) therapy for locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Key Inclusion Criteria:
- Locally advanced unresectable or metastatic GC or 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.
- ECOG PS ≤ 1 within 7 days prior to randomization
- Adequate organ function as indicated by the following laboratory values ≤ days prior to randomization
EXCLUSION CRITERIA
Key Exclusion Criteria:
- 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-PD-1, anti-PD-L1, anti-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.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Gastric, or Gastroesophageal Junction Adenocarcinoma
Age (in years)
18+
Phase
Phase 3
Participants needed
997
Est. Completion Date
Dec 31, 2024
Treatment type
Interventional
Sponsor
BeiGene
ClinicalTrials.gov identifier
NCT03777657
Study number
BGB-A317-305
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?