Squamous Cell Carcinoma of Head and NeckPhase 3NCT07509099
Cetuximab Combined With Pembrolizumab or Finotonlimab and Chemotherapy in R/M HNSCC
A Phase 3 study testing cetuximab+PD-1 mAb(Pembrolizumab/Finotonlimab)+chemotherapy and PD-1 mAb (Pembrolizumab/Finotonlimab) + chemothearpy in people with Squamous Cell Carcinoma of Head and Neck, run by Ji Dongmei at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- cetuximab+PD-1 mAb(Pembrolizumab/Finotonlimab)+chemotherapy and PD-1 mAb (Pembrolizumab/Finotonlimab) + chemothearpy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 2 sitesChina
- Study dates
- 15 Sep 2026to 30 Sep 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.;
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Dongmei Ji, Docter, +86 021 64175590 88900, jidongmei2000@hotmail.com
Youzhou Sang, Doctor, youzhousang@163.com
- Not yet recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Dongmei Ji Doctor, +86 13564183928, jidm2025@163.com
About this study
Official title: Cetuximab Combined With Pembrolizumab or Finotonlimab and Chemotherapy in R/M HNSCC: an Open-label, Randomized, Prospective, Multicenter Phase III Trial
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.
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Being tested
- cetuximab+PD-1 mAb(Pembrolizumab/Finotonlimab)+chemotherapy, PD-1 mAb (Pembrolizumab/Finotonlimab) + chemothearpy
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cetuximab+PD-1 mAb(Pembrolizumab/Finotonlimab)+chemotherapyDrug
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) + chemothearpyDrug
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 group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | cetuximab + PD-1 mAb + chemotherapy Receives: Drug: cetuximab+PD-1 mAb(Pembrolizumab/Finotonlimab)+chemotherapy |
| Control Group | Active comparator | PD-1 mAb + chemotherapy Receives: Drug: PD-1 mAb (Pembrolizumab/Finotonlimab) + chemothearpy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
PFS assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: Expected 51 months following the First Subject First Visit (FSFV)
Secondary outcomes (6)
Objective Response Rate (ORR)
Disease Control Rate (DCR), Duration of Response (DoR), Time to Response (TTR), Overall Survival (OS)
Measured: Expected 51 months following the First Subject First Visit (FSFV)
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.
Measured: Expected 51 months following the First Subject First Visit (FSFV)
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.
Measured: Expected 51 months following the First Subject First Visit (FSFV)
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.
Measured: Expected 51 months following the First Subject First Visit (FSFV)
Overall Survival (OS)
The time from randomization to death from any cause.
Measured: Expected 51 months following the First Subject First Visit (FSFV)
Safety Endpoints
Incidence and severity of adverse events (AEs) and serious adverse events (SAE), including abnormalities in vital signs, electrocardiograms, and laboratory tests.
Measured: Expected 51 months following the First Subject First Visit (FSFV)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start15 Sep 2026
- Primary completion30 Sep 2031 (estimated)
- Study completion30 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of Head and NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 316 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ji Dongmei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ji Dongmei, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509099
- Sponsor's protocol ID
- FUSCC-HN-003
- Status last verified
- Sep 2026
- First submitted
- 24 Mar 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cetuximab Combined With Pembrolizumab or Finotonlimab and Chemotherapy in R/M HNSCC: an Open-label, Randomized, Prospective, Multicenter Phase III Trial
- ClinicalTrials.gov ID
- NCT07509099
- Acronym / sponsor ID
- FUSCC-HN-003
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- Ji DongmeiUniversity, hospital or other
- Study start
- 15 Sep 2026 (actual)
- Primary completion
- 30 Sep 2031 (estimated)
- Study completion
- 30 Sep 2031 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: cetuximab+PD-1 mAb(Pembrolizumab/Finotonlimab)+chemotherapycetuximab + PD-1 mAb + chemotherapy |
| Control Group | Active comparator | Drug: PD-1 mAb (Pembrolizumab/Finotonlimab) + chemothearpyPD-1 mAb + chemotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cetuximab+PD-1 mAb(Pembrolizumab/Finotonlimab)+chemotherapyCetuximab: 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 | Experimental Group |
| PD-1 mAb (Pembrolizumab/Finotonlimab) + chemothearpyPembrolizumab 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 | Control Group |
Primary outcome
Progression Free Survival (PFS)
Time frame: Expected 51 months following the First Subject First Visit (FSFV)
PFS assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
6 secondary outcomes
Objective Response Rate (ORR)
Time frame: Expected 51 months following the First Subject First Visit (FSFV)
Disease Control Rate (DCR)
Time frame: Expected 51 months following the First Subject First Visit (FSFV)
Duration of Response (DoR)
Time frame: Expected 51 months following the First Subject First Visit (FSFV)
Time to Response (TTR)
Time frame: Expected 51 months following the First Subject First Visit (FSFV)
Overall Survival (OS)
Time frame: Expected 51 months following the First Subject First Visit (FSFV)
Safety Endpoints
Time frame: Expected 51 months following the First Subject First Visit (FSFV)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cetuximab+PD-1 mAb(Pembrolizumab/Finotonlimab)+chemotherapy and PD-1 mAb (Pembrolizumab/Finotonlimab) + chemothearpy in people with Squamous Cell Carcinoma of Head and Neck, run by Ji Dongmei at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dongmei Ji, Doctor (+86 021 64175590 88900, jidm2025@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: Expected 51 months following the First Subject First Visit (FSFV)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.