Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma

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About the study

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 advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Key Inclusion Criteria:


  1. Locally advanced unresectable or metastatic gastric cancer (GC) or gastroesophageal junction (GEJ) carcinoma and have histologically confirmed adenocarcinoma
  2. 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.
  3. Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1 within 7 days prior to randomization
  4. Adequate organ function ≤ 7 days prior to randomization

EXCLUSION CRITERIA

Key Exclusion Criteria:


  1. Has squamous cell or undifferentiated or other histological type GC
  2. Active leptomeningeal disease or uncontrolled brain metastasis
  3. Diagnosed with gastric or GEJ adenocarcinoma with positive HER2
  4. 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.


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Study Locations

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How to Apply


Contact the study center to learn if this study is a good match for you.

Study Details


Contition
Gastric, or Gastroesophageal Junction Adenocarcinoma
Age (in years)
18+
Phase
PHASE3
Participants Needed
997
Est. Completion Date
Aug 27, 2024
Treatment Type
INTERVENTIONAL

Sponsor
BeiGene
ClinicalTrials.gov NCT Identifier
NCT03777657
Study Number
BGB-A317-305

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