Actively Recruiting
GT103 in Combination With Pembrolizumab for the Treatment of Advanced or Metastatic STK11 Mutant Non-Small Cell Lung Cancer
Led by Roswell Park Cancer Institute · Updated on 2026-05-05
28
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
GT103 in Combination With Pembrolizumab for the Treatment of Advanced or Metastatic STK11 Mutant Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at treatment start
- Confirmed diagnosis of STK11 mutant non-small cell lung cancer by DNA sequencing
- Disease progression on pembrolizumab-containing regimen and eligible to continue pembrolizumab
- Absolute neutrophil count at least 1.5 x 10^9/L
- Platelet count at least 100 x 10^9/L
- Hemoglobin level at least 9 g/dL
- Estimated glomerular filtration rate greater than 45 mL/min
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) no more than 3 times upper limit of normal (or up to 5 times if liver metastases present)
- Total bilirubin no more than 1.5 times upper limit of normal (up to 3 times for Gilbert's syndrome with normal direct bilirubin)
- Troponin-I within normal limits and B-type natriuretic peptide (BNP) less than 200 pg/mL
- Left ventricular ejection fraction at or above lower limit of normal
- Measurable disease per RECIST 1.1 criteria
- Agree to use effective contraception if of child-bearing potential
- Understand and sign informed consent
- Agree to provide blood samples and tumor biopsy tissue or have adequate archival tissue available
You will not qualify if you...
- Received anticancer chemotherapy within 4 weeks before first study drug dose
- Prior radiotherapy or gamma knife therapy within 2 weeks before treatment for non-brain metastasis without full recovery
- Active or untreated brain metastases; whole brain radiation or gamma knife less than 4 weeks prior
- Leptomeningeal disease involvement
- Tumors with oncogenic mutations in EGFR, ALK, ROS1, RET, MET, or NTRK genes
- History of autoimmune disorders except vitiligo or endocrine-related autoimmune conditions with appropriate hormone therapy
- Recent use of immunosuppressive drugs or systemic corticosteroids within 4 weeks before treatment, except certain exceptions
- Major surgery within 14 days before treatment or incomplete recovery from surgery side effects
- Known immunosuppressive diseases such as HIV or AIDS
- Active serious infections or uncontrolled medical conditions
- Known allergy to study drugs or analogs
- Recent major cardiac events, severe heart disease, uncontrolled hypertension, myocarditis, or ventricular arrhythmias
- Invasive cancer diagnosed within last 2 years except certain low-risk cancers
- Pregnant or breastfeeding women
- Any condition that interferes with study participation or safety as judged by the investigator
- Unwilling or unable to comply with study requirements
AI-Screening
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Trial Site Locations
Total: 1 location
1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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