RecruitingPhase 2NCT07017829

GT103 in Combination With Pembrolizumab for the Treatment of Advanced or Metastatic STK11 Mutant Non-Small Cell Lung Cancer

A Phase II Trial of GT103 in Combination With Pembrolizumab in STK11 Mutant Non-Small Cell Lung Cancer (NSCLC)

Sponsor

Roswell Park Cancer Institute

Enrollment

28 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Metastatic Lung Non-Small Cell Carcinoma Stage III Lung Cancer AJCC v8 Stage IV Lung Cancer AJCC v8 Advanced Lung Non-Small Cell Carcinoma

Summary

This phase II trial tests how well GT103 in combination with pembrolizumab works in treating patients with STK11 mutant non-small cell lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). GT103 is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. GT103 targets the tumor cell-protein complement factor H found on some cancer cells and may provide specific anti-tumor activity that may help block the formation of growths that may become cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving GT103 in combination with pembrolizumab may kill more cancer cells and improve outcomes in patients with advanced or metastatic STK11 mutant non-small cell lung cancer.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing GT103, a new drug, in combination with the immunotherapy pembrolizumab in patients with non-small cell lung cancer (NSCLC) that carries a specific genetic mutation called STK11, which is known to make tumors resistant to standard immunotherapy alone. **You may be eligible if...** - You are 18 or older with confirmed STK11-mutant non-small cell lung cancer - Your cancer has progressed while on a pembrolizumab-containing regimen - Your treating physician considers you eligible to continue pembrolizumab after progression - You have measurable disease on scans - You are in good general health (ECOG 0 or 1) - Your blood counts, kidney, liver, and heart function are within acceptable ranges **You may NOT be eligible if...** - You do not have a confirmed STK11 mutation - You have not previously received pembrolizumab - You have significant autoimmune disease or are on immunosuppressive therapy - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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