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: Cisplatin; Drug: Placebo; Drug: Oxaliplatin; Drug: 5-Fluorouracil; Drug: Capecitabine; Drug: Tislelizumab

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 study was designed to compare the efficacy and safety of tislelizumab plus chemotherapy versus placebo plus chemotherapy as the first treatment (first-line) for adults diagnosed with 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 gastric cancer (GC) or gastroesophageal junction (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. Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1 within 7 days prior to randomization
4. Adequate organ function ≤ 7 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-programmed cell death protein-1 (PD-1), anti-programmed cell death protein ligand-1 (PD-L1), anti-programmed cell death protein ligand-2 (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 + Chemotherapy

Experimental group

Description:

Participants received 200 mg of tislelizumab intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Chemotherapy consisted of 1000 mg/m² capecitabine twice daily on Days 1-14 and 130 mg/m² oxaliplatin on Day 1, or 800 mg/m² 5-fluorouracil (5-FU) on Days 1-5 and 80 mg/m² cisplatin on Day 1 of each 21-day cycle. Thereafter, participants continued treatment with 200 mg tislelizumab, with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.

Treatment:

Drug: Tislelizumab

Drug: 5-Fluorouracil

Drug: Capecitabine

Drug: Oxaliplatin

Drug: Cisplatin

Placebo + Chemotherapy

Placebo Comparator group

Description:

Participants received placebo intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Chemotherapy consisted of 1000 mg/m² capecitabine twice daily on Days 1-14 and 130 mg/m² oxaliplatin on Day 1, or 800 mg/m² 5-FU on Days 1-5 and 80 mg/m² cisplatin on Day 1 of each 21-day cycle. Thereafter, participants continued treatment with placebo with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.

Treatment:

Drug: 5-Fluorouracil

Drug: Capecitabine

Drug: Oxaliplatin

Drug: Placebo

Drug: Cisplatin