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.
Age ≥ 18 years.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 at the time of study treatment initiation.
Have pathologically confirmed diagnosis of STK11 mutant NSCLC. STK11 mutation will be based on subject's local clinically accredited laboratory testing (Clinical Laboratory Improvement Amendments [CLIA]-certified) using deoxyribonucleic acid (DNA) sequencing test.
Must have progressed on a pembrolizumab containing regimen and eligible for continuing pembrolizumab post-progression as determined by treating physician. Other anti-PD-1 or anti-PD-L1 checkpoint inhibitors may also be used in place of pembrolizumab
Receipt of anticancer chemotherapy within 4 weeks before the first administration of study drug.
Prior radiotherapy or gamma knife within 2 weeks of study treatment for non-brain metastasis. Subjects must have recovered from all radiation related toxicities.
Active/untreated brain metastasis. Whole brain radiation or gamma knife radiosurgery performed less than 4 weeks prior to first administration of study drug. Previously treated brain metastasis allowed as long as not requiring steroids and stable on imaging at least 4 weeks after completing radiation therapy.
Leptomeningeal involvement regardless of treatment status.
Single group
Anti-CFH Monoclonal Antibody GT103
Biological/VaccineGiven IV
Biopsy Procedure
Procedure/SurgeryUndergo tumor biopsy
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Computed Tomography
Procedure/SurgeryUndergo CT
Echocardiography Test
Procedure/SurgeryUndergo ECHO
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Pembrolizumab
Biological/VaccineGiven IV
Progression-free survival
Will be summarized using standard Kaplan-Meier methods, where estimates will be obtained with 90% confidence intervals.
Objective response rate
Will be defined by the Response Evaluation Criteria in Solid Tumors version 1.1. Will be estimated using 90% credible regions obtained by Jeffrey's prior method.
Overall survival
Will be assessed using standard Kaplan-Meier methods, where estimates will be obtained with 90% confidence intervals.
Duration of response
Will be summarized using standard Kaplan-Meier methods, where estimates will be obtained with 90% confidence intervals.
Disease control rate
Will be defined as the proportion of patients with a best overall response of confirmed complete response, confirmed partial response, or stable disease ≥ 12 weeks. The best response status will be summarized using frequencies and relative frequencies.
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