OncoMatch/Clinical Trials/NCT05260671
Penpulimab in Combination With Cetuximab as First-line Treatment in R/M SCCHN
Is NCT05260671 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Targeted therapy
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)
Demographics
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.
Frequently asked questions
Is NCT05260671 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require CD274?
Yes, CD274 expression CPS ≥ 1 is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 80 years or younger.
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