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RecruitingNCT07509099Updated Oct 2, 2026

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

A Phase 3 interventional study of cetuximab+PD-1 mAb(Pembrolizumab/Finotonlimab)+chemotherapy and PD-1 mAb (Pembrolizumab/Finotonlimab) + chemothearpy in Squamous Cell Carcinoma of Head and Neck, sponsored by Ji Dongmei. Recruiting at 2 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by Ji Dongmei · Phase 3, Interventional, and Treatment

Updated Oct 2, 2026Now RecruitingSite recruiting status changed+2 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
316
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Squamous Cell Carcinoma of Head and Neck
03

In context

Squamous Cell Carcinoma of Head and Neck

1,680 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 539 are open to participants now.

This study's planned enrollment of 316 is above the median of 49 across 1,432 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.

Browse Squamous Cell Carcinoma of Head and Neck studies →

Lead sponsor

Ji Dongmei is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age 18-70 years;
  2. ECOG Performance Status 0 or 1;
  3. Histologically confirmed diagnosis of head and neck squamous cell carcinoma;
  4. Subjects with distant metastasis or local recurrence not suitable for curative treatment; local recurrence patients must have previously received radiotherapy (postoperative or radical);
  5. No prior systemic chemotherapy; subjects who have ceased chemotherapy for locally advanced disease as part of multidisciplinary treatment for more than 6 months may be enrolled;
  6. At least one measurable lesion available for evaluation by enhanced CT or MRI according to RECIST 1.1;
  7. Adequate organ function:
  8. Estimated survival greater than 3 months;
  9. Voluntary signing of informed consent form, with good compliance expected, and ability to follow up as required by the protocol.

Exclusion criteria

Exclusion Criteria:

  1. Nasopharyngeal carcinoma；
  2. Known allergic reaction against any of the components of the trial treatment;
  3. a. Previous treatment with immune checkpoint inhibitors (ICIs) (Prior receipt of ICIs is allowed if they were given as part of curative-intent neoadjuvant therapy, with more than 6 months between the last dose and disease recurrence, or as adjuvant ICI monotherapy that achieved disease control for over 6 months); b. Previous treatment with cetuximab (Prior receipt of cetuximab is allowed if they were given as part of curative-intent therapy, with more than 6 months between the last dose and disease recurrence); c．Previous treatment with chemotherapy (Prior receipt of chemotherapy is allowed if they were given as part of curative-intent neoadjuvant and adjuvant therapy, with more than 6 months between the last dose and disease recurrence) The end date of the therapies mentioned above is the date of the last administration.
  4. Clinically significant heart disease, including severe heart failure: NYHA heart failure class III\~IV, ischemic heart disease (e.g., myocardial infarction or angina), acute myocardial infarction or congestive heart failure or QTc interval greater than 500 ms within the last 6 months;
  5. Undergoing or expected to undergo secondary or higher surgeries within three weeks prior to the first dose;
  6. Autoimmune diseases requiring treatment or a history of syndromes requiring systemic use of corticosteroids or immunosuppressants, such as pituitary inflammation, pneumonia, colitis, hepatitis, nephritis, hyperthyroidism, hypothyroidism, etc.;
  7. Other serious uncontrolled concomitant diseases affecting protocol compliance or result interfere, including uncontrolled diabetes or pulmonary diseases (interstitial pneumonia, obstructive lung disease, and symptomatic bronchospasm history);
  8. Known active central nervous system metastasis and/or leptomeningeal disease; Note: Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging (using the identical imaging modality for each assessment, either MRI or CT scan) for at least 4 weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
  9. Hepatitis B (HBV) (HBsAg positive and HBV-DNA≥ 103 IU/ml), hepatitis C (HCV) infection (HCV antibody positive and detectable HCV-RNA); and other acquired or congenital immunodeficiency diseases, including but not limited to HIV infection;
  10. Pregnant or breastfeeding women, or women planning to conceive during treatment and within 6 months after the last dose of study medication. Fertile women and sexually active men unwilling to use highly effective contraception during the study and for 6 months afterward.
  11. Severe active infections;
  12. Severe neurological or psychiatric history, including dementia or epilepsy;
  13. Drug abuse, medical, psychological, or social conditions that may interfere with the subject's participation in the trial or the assessment of results;
  14. Other reasons deemed unsuitable for enrollment by the investigator.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
316 participants (estimated)

Study arms

  • Experimental
    Experimental Group

    cetuximab + PD-1 mAb + chemotherapy

    Drug: cetuximab+PD-1 mAb(Pembrolizumab/Finotonlimab)+chemotherapy

  • Active comparator
    Control Group

    PD-1 mAb + chemotherapy

    Drug: PD-1 mAb (Pembrolizumab/Finotonlimab) + chemothearpy

Interventions

  • Drugcetuximab+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.

  • DrugPD-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.

06

What researchers measure

Primary outcomes

  1. Progression Free Survival (PFS)

    PFS assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Time frame: Expected 51 months following the First Subject First Visit (FSFV)

Secondary outcomes

  1. Objective Response Rate (ORR)

    Disease Control Rate (DCR), Duration of Response (DoR), Time to Response (TTR), Overall Survival (OS)

    Time frame: Expected 51 months following the First Subject First Visit (FSFV)

  2. Disease Control Rate (DCR)

    The disease control rate (DCR) is defined as the proportion of subjects in the full analysis set (FAS) whose best overall response is either complete response (CR), partial response (PR), or stable disease (SD) based on investigator assessment using RECIST v1.1. Subjects with SD must have maintained SD for at least 6 weeks from the first dose to be counted as disease control.

    Time frame: Expected 51 months following the First Subject First Visit (FSFV)

  3. Duration of Response (DoR)

    The time from the first documented evidence of objective response (CR or PR) to the first documented disease progression or death from any cause, whichever occurred first.

    Time frame: Expected 51 months following the First Subject First Visit (FSFV)

  4. Time to Response (TTR)

    The time from the date of randomization to the date of the first documented objective response (complete response \[CR\] or partial response \[PR\]) in patients who ultimately achieve a response.

    Time frame: Expected 51 months following the First Subject First Visit (FSFV)

  5. Overall Survival (OS)

    The time from randomization to death from any cause.

    Time frame: Expected 51 months following the First Subject First Visit (FSFV)

  6. Safety Endpoints

    Incidence and severity of adverse events (AEs) and serious adverse events (SAE), including abnormalities in vital signs, electrocardiograms, and laboratory tests.

    Time frame: Expected 51 months following the First Subject First Visit (FSFV)

07

Study locations

1 of 2 sites recruiting
  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai Municipality 200032, China
    Recruiting
  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai Municipality, China
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Oct 2, 2026
Sites
1 site added. Fudan University Shanghai Cancer Center is now Recruiting
Show site
  • Fudan University Shanghai Cancer Center · Shanghai, China
Oct 2, 2026
Start date
Sep 30, 2026→Sep 15, 2026 (actual)
Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    Not yet recruiting→Recruiting
    1 site added. Fudan University Shanghai Cancer Center is now Recruiting
    Show site
    • Fudan University Shanghai Cancer Center · Shanghai, China
    Start date Sep 30, 2026→Sep 15, 2026 (now actual)
    + 1 other change: contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07509099
Lead sponsor
Ji Dongmei
Responsible party
Ji Dongmei (Doctor, Fudan University) — Sponsor-investigator
First posted
Apr 3, 2026
Start date
Sep 15, 2026
Primary completion
Sep 30, 2031 (estimated)
Completion
Sep 30, 2031 (estimated)
Last update
Oct 2, 2026

Study contacts

Dongmei Ji, Doctor
Contact
jidm2025@163.com
+86 021 64175590 88900
Youzhou Sang, Doctor
Contact
youzhousang@163.com
+86 021 64175590 88900

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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