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.
A Randomized, Open-Label, Multicenter Phase III Study of Tecotabart Vedotin Plus Tislelizumab Versus Tislelizumab Plus Chemotherapy as First-Line Treatment in Patients With CLDN18.2-Positive, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
1 other identifier
interventional
752
1 country
106
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2026
Typical duration for phase_3
106 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2026
CompletedFirst Posted
Study publicly available on registry
February 4, 2026
CompletedStudy Start
First participant enrolled
April 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2030
June 25, 2026
May 1, 2026
2.5 years
January 25, 2026
June 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
1.5 years
Secondary Outcomes (6)
Overall Survival (OS)
During the study period (Baseline up to two years)
Progression-free survival (PFS) assessed by Investigator
During the study period (Baseline up to two years)
Objective Response Rate (ORR)
During the study period (Baseline up to two years)
Disease Control Rate (DCR)
During the study period (Baseline up to two years)
Objective response rates (ORR)
During the study period (Baseline up to two years)
- +1 more secondary outcomes
Study Arms (2)
LM-302 Injection+Tislelizumab
EXPERIMENTALLM-302 Injection combined with Tislelizumab, 14days as a treatment cycle.
Tislelizumab + oxaliplatin Injection +Capecitabine Tablets
ACTIVE COMPARATORTislelizumab combined with oxaliplatin and capecitabine tablets, 21days as a treatment cycle.
Interventions
The LM-302 injection is an ADC drug targeting CLDN18.2.
Tislelizumab is a humanized monoclonal antibody targeting programmed cell death receptor-1 (PD-1).
Oxaliplatin injection is a platinum-based antitumor drug.
Capecitabine tablets belong to the fluorouracil-class prodrugs.
Eligibility Criteria
You may qualify if:
- 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.
- For locally advanced unresectable or metastatic adenocarcinoma of the stomach or gastroesophageal junction that has not previously received any systemic treatment:
- 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.
- The calculation of a 6-month interval is defined as recurrence within the same date range after 6 months. For example, if the end date of the last treatment is January 1, the 6-month period from that date refers to January 1 to July 1 (including July 1). Alternatively, if the end date of the last treatment is August 31, the 6-month period from that date refers to August 31 to February 28 (or February 29 in leap years).
- Archived specimens or fresh tumor tissue specimens from ≤3 years ago must be provided for CLDN18.2 and PD-L1 testing (PD-L1 results are not a condition for enrollment). When multiple samples are present, the most recent accessible and qualified sample must be provided. After confirmation by the central laboratory, tumor tissue with positive CLDN18.2 expression is defined as ≥25% tumor cell membrane staining intensity 2+ \& 3+. For patients who have previously received radical neoadjuvant chemotherapy or adjuvant chemotherapy (radiotherapy) based on platinum-containing combination chemotherapy regimens, newly obtained tissue from recurrent or metastatic lesions must be provided for CLDN18.2 and PD-L1 testing.
- A negative report on the expression detection of human epidermal growth factor receptor-2 (HER2) in tumor tissue must be provided. The definition of HER2 negative expression is ImmunoHistoChemistry (IHC) score 0/1+, IHC score 2+, and fluorescence in situ hybridization (FISH) negative.
- According to the RECIST 1.1 evaluation criteria, there must be at least one measurable lesion.
- Expected survival duration ≥ 3 months.
- According to the Eastern Cooperative Oncology Group (ECOG) standards, the physical performance status score is 0 or 1.
- Good organ function: a. Bone marrow reserve: Platelets (PLT) ≥ 100×10\^9/L, absolute neutrophil count (ANC) ≥ 1.5×10\^9/L, Hemoglobin (Hb) ≥ 90 g/L (no blood transfusion or supportive treatment such as colony-stimulating factors within 14 days prior to hematology parameter examination during the screening period); b. Coagulation function: International normalized ratio (INR) ≤ 1.5, Activated partial thromboplastin time (APTT) ≤ 1.5×upper limit of normal (ULN); c. Liver function: Total bilirubin ≤ 1.5×ULN, Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase (ALP) ≤ 2.5×ULN (if there is liver metastasis, then ALT and AST ≤ 5×ULN) and Albumin (ALB) ≥ 30 g/L; d. Renal function: Creatinine clearance rate ≥ 50 mL/min (calculated according to the Cockcroft-Gault formula); e. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%; QT interval (QTcF) ≤ 470 ms for females and ≤ 450 ms for males.
- Women of childbearing age must have a negative blood pregnancy test within 7 days before administration; any fertile male and female subjects must agree to use highly effective contraception throughout the study medication period and for 7 months after the last dose of the study. Males must agree to refrain from donating sperm during the study period and for 7 months after the last dose of the study. Females must agree to refrain from breastfeeding during the study period.
You may not qualify if:
- 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.
- Patients with symptomatic spinal cord compression, or those who are expected to develop symptoms of spinal cord compression if left untreated; or for patients with previously diagnosed and treated spinal cord compression, there is no evidence indicating that the disease was clinically stable for ≥4 weeks before the first study drug administration; except for patients with asymptomatic spinal cord compression indicated by imaging, who are assessed as stable by a specialist and do not require treatment for spinal cord compression at this time.
- Accompanied by severe peritoneal metastasis, the main manifestations are: clinically significant intestinal obstruction; barium enema indicating small intestinal stenosis.
- History of gastrointestinal perforation or gastrointestinal fistula within the previous 6 months. If the perforation or fistula has been treated through resection or repair surgery, and the condition is assessed by the investigator as having been cured or controlled, participation in the study is permissible.
- Poorly controlled tumor-related pain:
- For patients requiring analgesic treatment, a stable dosage of treatment must be established before participating in the study.
- Symptomatic lesions suitable for palliative radiotherapy (such as bone metastasis or metastasis causing nerve damage) should be treated before enrollment.
- Before enrollment, if appropriate, consideration should be given to local treatment for asymptomatic metastatic lesions that may lead to functional deficits or intractable pain due to further growth (e.g., epidural metastasis not currently associated with spinal cord compression).
- Patients with a body weight of less than 35kg or a body weight loss of more than 10% within 2 months prior to signing the informed consent form.
- History of malignancy other than Gastric Cancer (GC)/GastroEsophageal Junction adenocarcinoma (GEJ) adenocarcinoma within 2 years prior to randomization, with the following exceptions: basal cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, squamous cell carcinoma of the skin, etc., which have been completely cured and treated.
- History of autoimmune diseases, including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. The following conditions are excluded: • Subjects with autoimmune-related hypothyroidism who are receiving stable-dose thyroid hormone replacement therapy.
- Subjects with type 1 diabetes who are well-controlled under a stable insulin treatment regimen.
- +31 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (106)
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230000, China
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230000, China
Anhui Provincial Hospital (The First Affiliated Hospital of China University of Science and Technology)
Hefei, Anhui, 230000, China
The Second Hospital Of Anhui Medical University
Hefei, Anhui, 230601, China
The First Affiliated Hospital Of Wannan Medical College
Wuhu, Anhui, 241001, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Beijing Lu He Hospital ,Capital Medical University
Beijing, Beijing Municipality, 101149, China
Beijing Gaobo Hospital Co., Ltd.
Beijing, Beijing Municipality, 102200, China
Beijing Tsinghua changgung Hospital
Beijing, Beijing Municipality, 102218, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010, China
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, 404000, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350000, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350000, China
Fujian Provincial Hospital
Fuzhou, Fujian, 350000, China
The First Affiliated Hospital Of Xiamen University
Xiamen, Fujian, 361003, China
Gansu Provincial Hospital
Lanzhou, Gansu, 730000, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000, China
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, 730050, China
Gansu Wuwei Tumour Hospital
Wuwei, Gansu, 730000, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510030, China
Guangdong provincial people's hospital
Guangzhou, Guangdong, 510080, China
The Sixth Affiliated Hospital,Sun Yat-sen University
Guangzhou, Guangdong, 510655, China
Meizhou People's Hospital
Meizhou, Guangdong, 514000, China
Shantou University Medical College Affiliated Tumor Hospital
Shantou, Guangdong, 515000, China
Guigang City People's Hospital
Guigang, Guangxi, 537100, China
Guangxi Medical University Afiliated Tomor Hospital
Nanning, Guangxi, 530000, China
The People's Hospital of Guizhou Province
Guiyang, Guizhou, 550002, China
The Second Affiliated Hospital Of Zunyi Medical University
Zunyi, Guizhou, 550002, China
Hainan general hospital
Haikou, Hainan, 570311, China
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570311, China
Affiliated Hospital of Chengde Medical University
Chengde, Hebei, 067000, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050035, China
Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, 150081, China
Jiamusi Tuberculosis Hospital (Jiamusi Cancer Hospital)
Jiamusi, Heilongjiang, 154002, China
Anyang Cancer Hospital
Anyang, Henan, 455000, China
Luoyang Central Hospital
Luoyang, Henan, 471000, China
The First Affiliated Hospital Of Henan University of Science and Technology
Luoyang, Henan, 471000, China
Nanyang Second General Hospital
Nanyang, Henan, 473000, China
The First affiliated Hospital of Nanyang Medical College
Nanyang, Henan, 474450, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000, China
Henan Provincial Cancer Hospital
Zhengzhou, Henan, 450003, China
Jingzhou First People's Hospital
Jingzhou, Hubei, 430000, China
Tongji Hospital Tongji Medical College Of Hust
Wuhan, Hubei, 430030, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 433000, China
Hunan Cancer Hospital
Changsha, Hunan, 410000, China
Hunan Cancer Hospital
Changsha, Hunan, 410000, China
Chifeng Municipal Hospital
Chifeng, Inner Mongolia, 24000, China
Peking University Cancer Hospital Inner Mongolia Hospita
Hohhot, Inner Mongolia, 010000, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 010000, China
The First People's Hospital Of Changzhou
Changzhou, Jiangsu, 213000, China
Jiangsu Provincial Cancer Hospital
Nanjing, Jiangsu, 210009, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210009, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
Nantong Tumor Hospital
Nantong, Jiangsu, 226300, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
The Fourth Affiliated Hospital Of Soochow University (SuZhou Du Shu Lake Hospital)
Suzhou, Jiangsu, 215124, China
Xuzhou central hospital
Xuzhou, Jiangsu, 221000, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221004, China
Affiliated Hospital of Yangzhou Univrtsity
Yangzhou, Jiangsu, 225000, China
Subei People's Hospital of Jiangsu province
Yangzhou, Jiangsu, 225001, China
Nanchang University First Affiliated Hospital
Nanchang, Jiangxi, 330006, China
The Second Affiliated Hospital Of Nangchang University
Nanchang, Jiangxi, 330006, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029, China
China-Japan Union Hospital of Jilin University
Changchun, Jilin, 130000, China
Jilin Cancer Hospital
Changchun, Jilin, 130000, China
The first hospital of Jilin University
Changchun, Jilin, 130000, China
Affiliated Zhongshan Hospital Of Dalian University
Dalian, Liaoning, 116001, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110001, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110801, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110801, China
QinghaiI University Affiliated Hospital
Xining, Qinghai, 810000, China
Baoji Central Hospital
Baoji, Shaanxi, 721008, China
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 710000, China
Xijing Hospital
Xi'an, Shaanxi, 710032, China
The Second Affiliated Hospital of PLA Air Force Military Medical University
Xi'an, Shaanxi, 710038, China
The First Affiliated Hospital Of Xi 'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute, Shandong Cancer Hospital)
Jinan, Shandong, 250000, China
Jinan Central Hospital (City level)
Jinan, Shandong, 250000, China
Affiliated Hospital Of Ji Ning Medical University
Jining, Shandong, 272029, China
Linyi People's Hospital
Linyi, Shandong, 276000, China
Linyi Cancer Hospital
Linyi, Shandong, 276034, China
Qingdao Municipal Hospital (Group)
Qingdao, Shandong, 266100, China
Weifang Yidu Central Hospital
Weifang, Shandong, 262500, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200001, China
ZhongShan Hospital
Shanghai, Shanghai Municipality, 200030, China
Shanghai GoBroad Cancer Hospital China Pharmaceutical University
Shanghai, Shanghai Municipality, 200131, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 201321, China
Chang zhi People's Hospital
Changzhi, Shanxi, 046000, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030000, China
First Hospital Of Shan Xi Medical University
Taiyuan, Shanxi, 30001, China
Yuncheng Central Hospital
Yuncheng, Shanxi, 044000, China
Sichuan Academy of Medical Science&Sichuan Provincial People' Hospital
Chengdu, Sichuan, 610000, China
Sichuan Provincial Cancer Hospital
Chengdu, Sichuan, 610041, China
West China Hospital,Sichuan University
Chengdu, Sichuan, 610041, China
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, 637000, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300300, China
Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000, China
Yunnan Cancer Hospital
Kunming, Yunnan, 650000, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016, China
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310017, China
Lishui Central Hospitall
Lishui, Zhejiang, 323000, China
Wenzhou Medical University Affiliated First Hospital
Wenzhou, Zhejiang, 325000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2026
First Posted
February 4, 2026
Study Start
April 15, 2026
Primary Completion (Estimated)
October 1, 2028
Study Completion (Estimated)
May 1, 2030
Last Updated
June 25, 2026
Record last verified: 2026-05