OncoMatch/Clinical Trials/NCT05234307
PBF-1129 and Nivolumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer
Is NCT05234307 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Nivolumab and Adenosine A2B Receptor Antagonist PBF-1129 for metastatic lung non-small cell carcinoma.
Treatment: Adenosine A2B Receptor Antagonist PBF-1129 · Nivolumab — This phase I trial studies the side effects and best dose of PBF-1129 in combination with nivolumab in treating patients with non-small cell lung cancer that has come back (recurrent) or spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as PBF-1129 and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Allowed: ALK actionable mutation
Allowed: EGFR actionable mutation
Disease stage
Required: Stage IV, IVA, IVB (AJCC v8)
Metastatic disease required
Confirmed recurrent or metastatic non-small cell carcinoma of the lung of any histology without curative options; Measurable disease based on RECIST 1.1
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: chemotherapy
Patients must have received standard of care chemotherapy
Must have received: immunotherapy
Patients must have received standard of care...immunotherapy
Must have received: anti-PD-1 therapy
Prior PD-1 and/or PD-L1 directed therapies are required
Must have received: anti-PD-L1 therapy
Prior PD-1 and/or PD-L1 directed therapies are required
Cannot have received: targeted therapy
Exception: Patients with known actionable mutations with FDA-approved treatment options must have received all approved and standard of care treatment options (ie osimertinib for EGFR, alectinib for ALK, etc)
Patients may have received no more than 3 prior lines of therapy in the metastatic setting (excluding targeted therapies)
Lab requirements
Blood counts
Absolute neutrophil count (ANC) >= 1,500 /mcL; Platelets >= 100,000 / mcL
Kidney function
Serum creatinine OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or creatinine clearance [CrCl]) <= 1.5 X ULN OR >= 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN
Liver function
Serum total bilirubin <= 1.5 X ULN OR direct bilirubin <= ULN for subjects with total bilirubin levels > 1.5 ULN; AST and ALT <= 3 X ULN OR <= 5 X ULN for subjects with liver metastases; Albumin >= 2.5 mg/dL
Cardiac function
Mean resting corrected QT interval (QTcF) > 470 msec (Fridericia's Criteria); Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block)
Absolute neutrophil count (ANC) >= 1,500 /mcL; Platelets >= 100,000 / mcL; Serum creatinine OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or creatinine clearance [CrCl]) <= 1.5 X ULN OR >= 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN; Serum total bilirubin <= 1.5 X ULN OR direct bilirubin <= ULN for subjects with total bilirubin levels > 1.5 ULN; AST and ALT <= 3 X ULN OR <= 5 X ULN for subjects with liver metastases; Albumin >= 2.5 mg/dL; Mean resting corrected QT interval (QTcF) > 470 msec (Fridericia's Criteria); Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Ohio State University Comprehensive Cancer Center · Columbus, Ohio
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