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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BeiGene

Status and phase

Active, not recruiting
Phase 3

Conditions

Gastric, or Gastroesophageal Junction Adenocarcinoma

Treatments

Drug: Oxaliplatin
Drug: Cisplatin
Drug: Capecitabine
Drug: Tislelizumab
Drug: 5-FU
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03777657
JapicCTI-194799 (Registry Identifier)
2018-000312-24 (EudraCT Number)
BGB-A317-305
CTR20181841 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

997 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

997 participants in 2 patient groups, including a placebo group

Tislelizumab (BGB-A317) + chemotherapy
Experimental group
Description:
Tislelizumab and chemotherapy. Oxaliplatin + capecitabine or cisplatin + 5-Fluorouracil regimens are used as the backbone chemotherapy.
Treatment:
Drug: 5-FU
Drug: Tislelizumab
Drug: Capecitabine
Drug: Oxaliplatin
Drug: Cisplatin
Placebo + chemotherapy
Placebo Comparator group
Description:
Placebo and chemotherapy. Oxaliplatin + capecitabine or cisplatin + 5-FU regimens are used as the backbone chemotherapy.
Treatment:
Drug: Placebo
Drug: 5-FU
Drug: Capecitabine
Drug: Oxaliplatin
Drug: Cisplatin

Trial contacts and locations

151

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Data sourced from clinicaltrials.gov

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