Treatment of Claudin18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma with LM-302
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.
This study tests if a new treatment called LM-302 can help people with advanced stomach cancer that has a specific marker called Claudin 18.2, after they've already tried other therapies.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 375 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | LaNova Medicines Limited Industry-sponsored |
| Locations | 2 sites (Beijing, Beijing and 1 other locations) |
| Trial ID | NCT06351020 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of LM-302 compared to the treatment of physician's choice in patients with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma that is positive for Claudin 18.2. Participants must have progressed after receiving at least two lines of systemic therapy. The study aims to determine whether LM-302 can provide better outcomes for these patients. The trial will involve measuring the response of the cancer to the treatment using established criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with confirmed Claudin 18.2-positive gastric or gastroesophageal junction adenocarcinoma who have progressed after at least two lines of systemic therapy.
Not a fit: Patients with HER2-positive tumors or those who have had other malignancies within the last five years may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced gastric cancer who have limited treatment choices.
How similar studies have performed: Other studies targeting Claudin 18.2-positive cancers have shown promise, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 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 * Urine protein qualitative result ≥ 3+, or urine protein qualitative result is 2+and 24-hour urine protein quantification\>1g * Individuals with a history of severe cardiovascular and cerebrovascular diseases * 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 * Current peripheral sensory or motor neuropathy ≥ grade 2 * Uncontrollable third space effusion in clinical practice * Received or planned to undergo major surgery or intervention during the study period within the first 28 days of randomization * The researcher determined that there are other situations that are not suitable for participation in this study
Where this trial is running
Beijing, Beijing and 1 other locations
- Peking Union Medical College Hospital — Beijing, Beijing, China (Recruiting)
- Shanghai East Hospital — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Chunmei Bai — Peking Union Medical College Hospital
- Study coordinator: Wei Wang
- Email: Weiwang@lanovamed.com
- Phone: 021-68889618
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.