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 (May 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
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: ALK wild-type
Required: EGFR wild-type
Required: MET wild-type
Required: NTRK1 wild-type
Required: NTRK2 wild-type
Required: NTRK3 wild-type
Required: RET wild-type
Required: ROS1 wild-type
Required: STK11 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.
Cannot have received: chemotherapy
Exception: within 4 weeks before the first administration of study drug
Receipt of anticancer chemotherapy within 4 weeks before the first administration of study drug.
Cannot have received: radiotherapy
Exception: within 2 weeks of study treatment for non-brain metastasis
Prior radiotherapy or gamma knife within 2 weeks of study treatment for non-brain metastasis.
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 (Cockroft and Gault formula)
Liver function
ALT and AST ≤ 3 x ULN (≤ 5 x ULN if liver metastases present); total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN with Gilbert's syndrome and direct bilirubin within normal range)
Cardiac function
Troponin-I ≤ ULN; BNP < 200 pg/mL; LVEF ≥ lower limit of normal (institutional limit)
ANC ≥ 1.5 x 10^9/L. Platelets ≥ 100 x 10^9/L. Hemoglobin ≥ 9 g/dL. Estimated GFR > 45mL/min. ALT and AST ≤ 3 x ULN (≤ 5 x ULN if liver metastases present). Total bilirubin ≤ 1.5 x ULN. For patients with well documented Gilbert's syndrome, total bilirubin ≤ 3 x ULN with direct bilirubin within normal range. Troponin-I ≤ ULN and BNP < 200 pg/mL. LVEF ≥ lower limit of normal (LLN) (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
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