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

Sponsor
Ji Dongmei
Study ID
NCT07509099
Phase
PHASE3
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Squamous Cell Carcinoma of Head and Neck

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • cetuximab+PD-1 mAb(Pembrolizumab/Finotonlimab)+chemotherapy — DRUG
    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.
  • PD-1 mAb (Pembrolizumab/Finotonlimab) + chemothearpy — DRUG
    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.

Study Details

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.

Key Dates

Start date
Apr 1, 2026
Status verified
Mar 2026
Primary completion
Sep 30, 2030
Completion
Sep 30, 2030

Study Design

Enrollment
316 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Group
    cetuximab + PD-1 mAb + chemotherapy
  • Active Comparator: Control Group
    PD-1 mAb + chemotherapy

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Expected 51 months following the First Subject First Visit (FSFV) ]

Central Contacts

Related Studies