Phase III Study Comparing LM-302 Plus Tislelizumab With Tislelizumab Plus Chemotherapy for First Treatment of Advanced CLDN18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma

What this Trial Is About

Researchers are studying the efficacy and safety of combining LM-302 injection with tislelizumab compared to tislelizumab plus chemotherapy for patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma that tests positive for CLDN18.2. This Phase III trial focuses on patients who have not been previously treated systemically for this cancer type and aims to understand if the new combination improves outcomes. Participants are randomly assigned to one of two study groups one receiving LM-302 injection with tislelizumab in 14-day treatment cycles, and the other receiving tislelizumab combined with oxaliplatin injection and capecitabine tablets in 21-day cycles. The trial is open-label, meaning both participants and researchers know which treatment is given. The study treatment period extends until disease progression or other discontinuation criteria are met. During the study, participants undergo regular assessments including imaging to measure progression-free survival, overall survival, tumor response rates, and adverse events over up to two years. Laboratory tests, tumor tissue analyses, and physical performance evaluations are conducted to monitor safety and treatment effects. Women of childbearing potential and men must use effective contraception during and after treatment. The entire study participation lasts until the primary outcome measure is reached or the study ends in May 2030.

Clinical Study on the Efficacy and Safety of LM-302 Injection Combined With Tislelizumab and Tislelizumab Combined Chemotherapy for the Treatment of Gastric or Gastroesophageal Junction Adenocarcinoma.