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

  • STATUS
    Recruiting
  • End date
    Aug 25, 2022
  • participants needed
    980
  • sponsor
    BeiGene
Updated on 25 January 2021

Summary

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.

Details
Condition Gastric or Gastroesophageal Junction Adenocarcinoma
Treatment Capecitabine, cisplatin, Placebo, Oxaliplatin, 5-FU, tislelizumab, Tislelizumab (BGB-A317) combined with oxaliplatin and capecitabine or Tislelizumab (BGB-A317) combined with Cisplatin and 5-FU, Placebo combined with oxaliplatin and capecitabine or Placebo combined with Cisplatin and 5-FU
Clinical Study IdentifierNCT03777657
SponsorBeiGene
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

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

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
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