Ivonescimab Combined With Chemotherapy for the Treatment of Leptomeningeal Metastases Failed to EGFR-TKIs

Launched by JIANGSU PROVINCE NANJING BRAIN HOSPITAL · Jan 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the combination of a new treatment called Ivonescimab with chemotherapy for patients with a specific type of lung cancer known as non-small cell lung cancer (NSCLC) who have leptomeningeal metastases (a type of cancer spread in the brain and spinal cord) after their previous medications, called EGFR-TKIs, didn't work. The main goal is to find out how effective this combination is in helping patients stay free of disease progression in the brain, and researchers will also look at how safe the treatment is and how it affects patients' overall health and quality of life.

To participate in this trial, patients need to be between 18 and 75 years old, have confirmed EGFR mutations in their lung cancer, and have experienced a failure of initial EGFR-TKI treatments without a specific mutation known as T790M. Additionally, participants should have enough healthy organ function to tolerate the treatment. Patients will be monitored throughout the trial for any side effects and overall progress. This study is not yet recruiting, but it aims to provide valuable insights into new treatment options for those facing challenging cases of lung cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age range: 18-75y
• • EGFR mutation NSCLC
• • LM was diagnosed through head enhanced MRI or (and) CSF cytology
• • EGFR activation mutations were positive
• • Patients who have failed to first or second-generation EGFR-TKI treatment，without T790M mutation; or failed to third-generation EGFR-TKI treatment
• • Hematological, coagulation, renal and liver function is sufficient
• • Women of childbearing age must undergo a pregnancy test and the result must be negative
• Exclusion Criteria:
• • Patients with squamous cell carcinoma, large cell carcinoma, mixed cell lung cancer
• • The patient has other driver genes that can be treated with targeted drugs
• • Subjects who have previously received immunotherapy with a discontinuation time of less than 3 months
• • Received EGFR-TKI treatment within one week prior to the first administration
• • Received non-specific immunomodulatory therapy
• • Clinical manifestations of neurological failure
• • Non malignant neurological disorders
• • Radiotherapy for the chest and whole brain should be completed within 4 weeks before enrollment
• • Tumor surrounded important blood vessels or had obvious necrosis or cavities
• • Tumor has invaded important surrounding organs and blood vessels
• • History of severe bleeding tendency or coagulation dysfunction
• • The risk of developing esophagotracheal fistula or esophageal pleural fistula