This study primarily evaluates the efficacy and safety of the LM-302 plus tislelizumab regimen versus tislelizumab plus chemotherapy in the treatment of previously untreated locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma patients with CLDN18.2 positivity.
Willing and able to comply with the study's visit schedule, treatment plan, laboratory tests, and other research procedures.
Age ≥ 18 years.
Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction.
Patients who have previously received radical neoadjuvant chemotherapy or adjuvant chemotherapy (radiotherapy) based on a platinum-based combination chemotherapy regimen and have not developed distant metastasis or local recurrence within 6 months after completion of treatment can be included.
Other pathological types confirmed by histopathology, such as squamous cell carcinoma, sarcoma, or undifferentiated carcinoma.
There are gastric cancer lesions confirmed by imaging that are accompanied by cavities or necrosis, and are closely related to major blood vessels, and are assessed by the researchers as posing a high risk of major bleeding.
Patients with known central nervous system (CNS) metastases. Patients with non-meningeal, midbrain, pontine, or spinal cord metastases who are judged by the investigator to have stable brain metastases can be enrolled. Stable brain metastases are defined as patients whose brain metastases have undergone treatment and the condition of the metastases has stabilized (brain imaging examination at least 28 days before randomization shows stable lesions, no neurological symptoms, and no immediate need for local or systemic treatment within 14 days before randomization), with no evidence of new or previously existing brain metastases enlarging.
Clinically uncontrollable third-space effusion, such as moderate or greater volume, requiring long-term catheterization, previous history of intestinal obstruction or paralysis, compartmented ascites, undergoing or planning to undergo local treatment (including drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy) within 14 days prior to screening, or significant increase within 2 weeks after local treatment, meeting any of the above criteria or deemed unsuitable for enrollment by the investigator.
Parallel
LM-302 Injection
DrugThe LM-302 injection is an ADC drug targeting CLDN18.2.
Tislelizumab
DrugTislelizumab is a humanized monoclonal antibody targeting programmed cell death receptor-1 (PD-1).
Oxaliplatin Injection
DrugOxaliplatin injection is a platinum-based antitumor drug.
Capecitabine Tablets
DrugCapecitabine tablets belong to the fluorouracil-class prodrugs.
Progression-free survival (PFS)
To compare the progression-free survival (PFS) of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who were previously untreated and had a PD-L1-positive status (CPS≥1) and high CLDN18.2 expression (≥75% 2+\&3+) with the LM-302 plus tislelizumab regimen versus the tislelizumab plus chemotherapy regimen in the LM-302 plus tislelizumab group and in all randomized populations. The PFS was assessed using blind independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST1.1) criteria.
Overall Survival (OS)
The preriod from the first use of the drug to death from all causes. For subjects who are still alive at the last follow-up, the OS will be counted as data censored based on the last follow-up. For subjects who are lost follow-up, the OS will be counted as data cesored based on the last confirmed survival time before being lost to follow-up.
Progression-free survival (PFS) assessed by Investigator
The period from the first use of the drug to disease progression or death (whichever occurs first).
Objective Response Rate (ORR)
The period from firstly-recorded objective tumor response (CR or PR) to firstly-recorded objective tumor progression or death due to any cause (whichever occurs first).
Disease Control Rate (DCR)
Proportion of subjects whose tumors shrink or remain stable for a certain period, including complete remission (CR), partial remission (PR) and stable disease (SD).
Click on the lead sponsor to view all of their trials.
