NCT07509099

Cetuximab Combined With Pembrolizumab or Finotonlimab and Chemotherapy in R/M HNSCC

Cetuximab Combined With Pembrolizumab or Finotonlimab and Chemotherapy in R/M HNSCC: an Open-label, Randomized, Prospective, Multicenter Phase III Trial

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 316 (estimated)
• Sponsor: Ji Dongmei · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, randomized, prospective, multicenter phase III trial to evaluate the efficacy and safety of the combination therapy of cetuximab with either pembrolizumab or finotonlimab, alongside chemotherapy, as a first-line treatment, compared with pembrolizumab or finotonlimab with chemotherapy for R/M HNSCC.

Detailed description

Patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who are not candidates for curative-intent therapies have a poor prognosis. Currently, the standard treatment involves a combination of cetuximab with chemotherapy or a PD-1 inhibitor-based regimen. This study is an open-label, randomized, prospective, multicenter phase III trial requiring a total of 316 R/M HNSCC patients. Participants will be randomized into either the experimental group or the control group. The stratification factors include the choice of PD-1 inhibitor (pembrolizumab versus finotonlimab) and the primary tumor site (oral cavity, hypopharynx, or others). Patients in the experimental group will receive cetuximab along with either pembrolizumab or finotonlimab, nab-paclitaxel, and cisplatin. Those in the control group will receive either pembrolizumab or finotonlimab, nab-paclitaxel, and cisplatin.

Conditions

• Squamous Cell Carcinoma of Head and Neck

Interventions

Type	Name	Description
DRUG	cetuximab+PD-1 mAb(Pembrolizumab/Finotonlimab)+chemotherapy	Cetuximab: 400 mg/m2 initial dose followed by 250 mg/m2 (weekly), iv, until disease progression, intolerable toxicity, or the subject voluntarily requests to discontinue the trial treatment. Pembrolizumab or Finotonlimab：200mg, iv, administered on Day 1, Q3W, until disease progression, intolerable toxicity, or the subject voluntarily requests to discontinue the trial treatment. Nab-paclitaxel: 260 mg/m², iv over 30 minutes, administered on Day 1, Q3W, for a maximum of 6 cycles. Cisplatin: 75 mg/m², iv (hydration), administered on Day 1, repeated Q3W (if cisplatin-related non-hematological toxicity occurs, treatment may switch to carboplatin area under the curve(AUC)=5; if cisplatin intolerant patients, carboplatin(AUC=5) could be used), for a maximum of 6 cycles.
DRUG	PD-1 mAb (Pembrolizumab/Finotonlimab) + chemothearpy	Pembrolizumab or Finotonlimab：200mg, iv, administered on Day 1, Q3W, until disease progression, intolerable toxicity, or the subject voluntarily requests to discontinue the trial treatment. Nab-paclitaxel: 260 mg/m², iv over 30 minutes, administered on Day 1, Q3W, for a maximum of 6 cycles. Cisplatin: 75 mg/m², iv (hydration), administered on Day 1, repeated Q3W (if cisplatin-related non-hematological toxicity occurs, treatment may switch to carboplatin area under the curve(AUC)=5; if cisplatin intolerant patients, carboplatin(AUC=5) could be used), for a maximum of 6 cycles.

Timeline

• Start date: 2026-04-01
• Primary completion: 2030-09-30
• Completion: 2030-09-30
• First posted: 2026-04-03
• Last updated: 2026-04-03

Locations

1 site across 1 country: China