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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

Completed
Phase 3

Conditions

Gastric, or Gastroesophageal Junction Adenocarcinoma

Treatments

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

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:

  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.

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

Trial contacts and locations

140

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Data sourced from clinicaltrials.gov

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