OncoMatch/Clinical Trials/NCT07017829
GT103 in Combination With Pembrolizumab for the Treatment of Advanced or Metastatic STK11 Mutant Non-Small Cell Lung Cancer
Is NCT07017829 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including Anti-CFH Monoclonal Antibody GT103 and Pembrolizumab for advanced lung non-small cell carcinoma.
Treatment: Anti-CFH Monoclonal Antibody GT103 · Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: STK11 mutation
Excluded: ALK oncogenic mutation
Excluded: EGFR oncogenic mutation
Excluded: MET oncogenic mutation
Excluded: NTRK1 oncogenic mutation
Excluded: NTRK2 oncogenic mutation
Excluded: NTRK3 oncogenic mutation
Excluded: RET oncogenic mutation
Excluded: ROS1 oncogenic mutation
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1 therapy (pembrolizumab)
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
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^9/L; platelets ≥ 100 x 10^9/L; hemoglobin ≥ 9 g/dL
Kidney function
Estimated GFR > 45 mL/min
Liver function
ALT and AST ≤ 3 x ULN (≤ 5 x ULN if liver metastases); total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN with Gilbert's syndrome and direct bilirubin normal)
Cardiac function
LVEF ≥ lower limit of normal (institutional limit)
Adequate bone marrow and organ function as defined by the following lab values: ANC ≥ 1.5 x 10^9/L; platelets ≥ 100 x 10^9/L; hemoglobin ≥ 9 g/dL; GFR > 45 mL/min; ALT and AST ≤ 3 x ULN (≤ 5 x ULN if liver metastases); total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN with Gilbert's syndrome and direct bilirubin normal); LVEF ≥ lower limit of normal (institutional limit)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Roswell Park Cancer Institute · Buffalo, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07017829 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received anti-PD-1 therapy.
Does this trial require STK11?
Yes, STK11 mutation is a required biomarker for enrollment.
Are patients with ALK alterations eligible?
No. ALK oncogenic mutation is an exclusion criterion.
Are patients with EGFR alterations eligible?
No. EGFR oncogenic mutation is an exclusion criterion.
What disease stage is eligible?
Stage III or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages