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NCT06351020Active, not recruitingPhase 3

LM-302 for the Treatment of Subjects With Claudin18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma.

A Phase III, Open-Label, Multi Center, Randomized Study of LM-302 Versus Treatment of Physician's Choice (TPC) in Patients With CLDN18.2-Positive, Locally Advanced or Metastatic Gastric(GC) and Gastroesophageal Junction(GEJ) Adenocarcinoma.

Source: ClinicalTrials.gov · Last updated 6 Feb 2026

Brief summary (registry, in English)

This study will assess the efficacy and safety of LM-302 Versus Treatment of Physician's Choice (TPC) in Subjects With locally advanced or metastatic, Claudin (CLDN) 18.2-positive, Gastric or Gastroesophageal Junction Adenocarcinoma who have progressed on or after 2 lines of systemic therapy

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
387 (actual)
First submitted
15 Mar 2024
Start date
24 Jun 2024
Primary completion date
10 Nov 2026
Lead sponsor
LaNova Medicines Zhejiang Co., Ltd.
NCT number
NCT06351020

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 387
  • From 24 Jun 2024 to the primary completion date, 10 Nov 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Individuals with a history of previous immunodeficiency, including those with other acquired or congenital immunodeficiency diseases, or those with a history of organ transplantation, allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation
  • Individuals who are unable to control or have serious illnesses, including but not limited to active infections requiring systemic antibiotic treatment within 2 weeks prior to initial medication, interstitial pneumonia/lung disease requiring intervention during screening, and tumor related pain requiring local treatment during screening
  • Received or planned to undergo major surgery or intervention during the study period within the first 28 days of randomization

Other illness

  • Within the first 5 years of randomization, there is a history of malignant tumors other than GC/GEJ adenocarcinoma, except for skin basal cell carcinoma, cervical carcinoma in situ, breast carcinoma in situ, and skin squamous cell carcinoma that have been cured and cured after treatment
  • Individuals with a history of severe cardiovascular and cerebrovascular diseases

Other

  • Urine protein qualitative result ≥ 3+, or urine protein qualitative result is 2+and 24-hour urine protein quantification\>1g
  • Current peripheral sensory or motor neuropathy ≥ grade 2
  • Uncontrollable third space effusion in clinical practice
  • The researcher determined that there are other situations that are not suitable for participation in this study

Who the study is looking for

  • Age 18-80 years old, male and female
  • Has histopathologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the gastric/gastroesophageal junction (G/GEJ AC).
  • Has received and progressed on at least 2 lines of systemic therapy. A prior (neo)adjuvant systemic therapy that ended within 6 months prior to disease relapse is defined as the first line therapy.
  • Centrally confirmed CLDN18.2-positive
  • HER2 negative
  • At least one measurable lesion according to the solid tumor response Evaluation Criteria (RECIST 1.1)
  • ECOG: 0-1
  • Expected survival ≥12 weeks;
  • Good blood reserve and liver, kidney and coagulation function
  • Willing to provide informed consent for study participation.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Peking Union Medical College Hospital
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
Shanghai East Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.