CompletedPhase 3

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

United States997 participantsStarted 2018-12-13

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Locally advanced unresectable or metastatic gastric cancer (GC) or gastroesophageal junction (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.
✓. Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1 within 7 days prior to randomization
✓. Adequate organ function ≤ 7 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-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

What they're measuring

Overall Survival in PD-L1 Positive Participants

Timeframe: From randomization up to the primary analysis data cut-off date of 8 October 2021; Median (range) time on follow-up was 11.8 (0.1 - 33.4) months.

Overall Survival in the Intent-to-Treat (ITT) Analysis Set

Timeframe: From randomization up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months.

Trial details

NCT IDNCT03777657

SponsorBeiGene

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-02-28

Results submitted2025-01-24

View on ClinicalTrials.gov More Gastric, or Gastroesophageal Junction Adenocarcinoma trials