For Healthcare Professionals

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 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.
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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

  1. Locally advanced unresectable or metastatic GC or 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. ECOG PS ≤ 1 within 7 days prior to randomization
  4. Adequate organ function as indicated by the following laboratory values ≤ days prior to randomization 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-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.
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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.
Phone iconCall +1-877-828-5568Email iconEmail Study Center

Study’s details


Contition

Gastric, or Gastroesophageal Junction Adenocarcinoma

Age

18+

Phase

Phase 3

Participants needed

997

Est. Completion Date

Feb 2024

Treatment type

Interventional


Sponsor

BeiGene

ClinicalTrials.gov identifier

NCT03777657

Study number

BGB-A317-305

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