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

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

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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