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

NCT07509099 | Recruiting Phase 3

• 1 other identifier: FUSCC-HN-003
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Squamous Cell Carcinoma of Head and Neck

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

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

  Expected 51 months following the First Subject First Visit (FSFV)

Secondary Outcomes (6)

• Objective Response Rate (ORR)

  Expected 51 months following the First Subject First Visit (FSFV)

• Disease Control Rate (DCR)

  Expected 51 months following the First Subject First Visit (FSFV)

• Duration of Response (DoR)

  Expected 51 months following the First Subject First Visit (FSFV)

• Time to Response (TTR)

  Expected 51 months following the First Subject First Visit (FSFV)

• Overall Survival (OS)

  Expected 51 months following the First Subject First Visit (FSFV)

Study Arms (2)

Experimental Group

EXPERIMENTAL

cetuximab + PD-1 mAb + chemotherapy

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

Control Group

ACTIVE COMPARATOR

PD-1 mAb + chemotherapy

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

Interventions

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.

Control Group

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.

Experimental Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years;
• ECOG Performance Status 0 or 1;
• Histologically confirmed diagnosis of head and neck squamous cell carcinoma;
• Subjects with distant metastasis or local recurrence not suitable for curative treatment; local recurrence patients must have previously received radiotherapy (postoperative or radical);
• 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;
• At least one measurable lesion available for evaluation by enhanced CT or MRI according to RECIST 1.1;
• Adequate organ function:
• Estimated survival greater than 3 months;
• Voluntary signing of informed consent form, with good compliance expected, and ability to follow up as required by the protocol.

You may not qualify if:

• Nasopharyngeal carcinoma；
• Known allergic reaction against any of the components of the trial treatment;
• 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.
• 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;
• Undergoing or expected to undergo secondary or higher surgeries within three weeks prior to the first dose;
• 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.;
• 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);
• 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.
• 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;
• 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.
• Severe active infections;
• Severe neurological or psychiatric history, including dementia or epilepsy;
• Drug abuse, medical, psychological, or social conditions that may interfere with the subject's participation in the trial or the assessment of results;
• Other reasons deemed unsuitable for enrollment by the investigator.

Sponsors & Collaborators

• Ji Dongmei: lead

Study Sites (2)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Central Study Contacts

Dongmei Ji, Doctor

CONTACT

+86 021 64175590 88900; jidm2025@163.com

Youzhou Sang, Doctor

CONTACT

+86 021 64175590 88900; youzhousang@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: April 3, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): September 30, 2031
• Study Completion (Estimated): September 30, 2031
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)