OncoMatch/Clinical Trials/NCT05260671
Penpulimab in Combination With Cetuximab as First-line Treatment in R/M SCCHN
Is NCT05260671 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Penpulimab combined with cetuximab for head and neck neoplasms.
Treatment: Penpulimab combined with cetuximab — This trial is a multicenter, prospective, single-arm exploratory clinical study to evaluate the efficacy and safety of Penpulimab injection combined with cetuximab in the first-line treatment of recurrent/metastatic squamous cell carcinoma of the head and neck.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Tumor Agnostic
Biomarker criteria
Required: PD-L1 (CD274) expression CPS ≥ 1 (CPS ≥ 1)
The tumor expresses PD-L1, with a comprehensive positive score CPS ≥ 1
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic chemotherapy
Exception: chemotherapy for locally advanced disease as a part of multimodal treatment (induction chemotherapy, radiotherapy with concurrent chemotherapy, and adjuvant chemotherapy)
Received systemic chemotherapy, but excluding chemotherapy for locally advanced disease as a part of multimodal treatment
Cannot have received: anti-PD-1 therapy
Previous immunotherapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies or any other antibody or drug specifically targeting T cell costimulation or immune checkpoint pathways
Cannot have received: anti-PD-L1 therapy
Previous immunotherapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies or any other antibody or drug specifically targeting T cell costimulation or immune checkpoint pathways
Cannot have received: anti-PD-L2 therapy
Previous immunotherapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies or any other antibody or drug specifically targeting T cell costimulation or immune checkpoint pathways
Cannot have received: anti-CD137 therapy
Previous immunotherapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies or any other antibody or drug specifically targeting T cell costimulation or immune checkpoint pathways
Cannot have received: anti-CTLA-4 therapy
Previous immunotherapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies or any other antibody or drug specifically targeting T cell costimulation or immune checkpoint pathways
Cannot have received: EGFR inhibitor (cetuximab, nimotuzumab, gefitinib, afatinib)
Previous use of anti-EGFR drugs such as cetuximab, nimotuzumab, gefitinib, and afatinib
Lab requirements
Blood counts
HB ≥ 90 g/L; ANC ≥ 1.5 × 10^9/L; PLT ≥ 75 × 10^9/L
Kidney function
Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50ml/min (Cockcroft-Gault formula)
Liver function
BIL ≤ 1.5 × ULN (≤ 3 × ULN for patients with Gilbert's syndrome); ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastasis)
Cardiac function
left ventricular ejection fraction (LVEF) ≥ 50% assessed by cardiac Doppler ultrasound
Normal function of major organs, meeting the following criteria: blood routine examination criteria must be met: (no blood transfusion within 14 days before screening) 1) HB ≥ 90 g/L; 2) ANC ≥ 1.5 × 10^9/L; 3) PLT ≥ 75 × 10^9/L; biochemistry: (without transfusion or blood product within 14 days before screening) 1) BIL ≤ 1.5 × ULN (≤ 3 × ULN for patients with Gilbert's syndrome); 2) ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastasis); 3) Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50ml/min (Cockcroft-Gault formula); 4) Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5 × ULN; left ventricular ejection fraction (LVEF) ≥ 50% assessed by cardiac Doppler ultrasound
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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 qualify