Head and Neck Squamous Cell CarcinomaPhase 3NCT07435324
A Comparative Study of Efficacy and Safety of RPH-002 and Erbitux® in Unresectable Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma
A Phase 3 study testing RPH-002, Erbitux® and Cisplatin in people with Head and Neck Squamous Cell Carcinoma, run by R-Pharm at 34 sites in 2 countries.
Trial summary
The primary objective of the study is to evaluate the comparability of efficacy, safety, and immunogenicity of RPH-002 and Erbitux® when administered in combination with docetaxel and cisplatin as first-line therapy in patients with advanced head and neck squamous cell carcinoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- RPH-002, Erbitux® and Cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 34 sitesin 2 countries
- Study dates
- 8 Aug 2024to 25 Jun 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Main Period (Period 1)
- A voluntarily signed and dated Informed Consent form (ICF) of the patient
- Histologically confirmed squamous cell carcinoma of the head and neck
- Documented unresectable locoregional recurrence or distant metastases, or progression after prior chemoradiotherapy or combination therapy completed >3 months before screening, not amenable to local treatment (except cases with high risk of tumor lysis or bleeding), or newly diagnosed metastatic disease not previously treated with systemic therapy. Study treatment is first-line therapy
- At least one measurable lesion per RECIST 1.1
- Karnofsky performance status ≥70%
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- Screening laboratory values within the following limits (per local lab normal ranges):
- Hemoglobin ≥90 g/L
- Leukocytes ≥3.0 × 10^9/L
- Neutrophils ≥1.5 × 10^9/L
- Platelets ≥100 × 10^9/L
- Total bilirubin ≤2 × Upper Limit of Normal (ULN)
- Aspartate aminotransferase (AST) ≤3 × ULN
- Alanine aminotransferase (ALT) ≤3 × ULN
- Estimated glomerular filtration rate (eGFR) ≥60 mL/min
- Men and women of childbearing potential, and women within 2 years of menopause, must agree to use reliable contraception from informed consent through at least 6 months after study treatment; women of childbearing potential must have a negative urine pregnancy test. Women with no reproductive potential (≥2 years post-menopause or surgically sterile) are exempt
- Ability and willingness to comply with study protocol and procedures for the planned duration of participation
- Maintenance Therapy Period (Period 2)
- Registered objective response (stable disease or partial/complete response according to RECIST 1.1 criteria) to the therapy administered during the main study period
- Ability and willingness to provide written informed consent for participation in Period 2
- Karnofsky performance status ≥ 70%
- Laboratory values within the following limits (per local lab normal ranges):
- Hemoglobin ≥ 90 g/L
- Leukocytes ≥ 3.0 × 10^9/L
- Neutrophils ≥ 1.5 × 10^9/L
- Platelets ≥ 100 × 10^9/L
- Total bilirubin ≤ 2 × ULN (upper limit of normal)
- AST ≤ 3 × ULN
- ALT ≤ 3 × ULN
- eGFR ≥ 60 mL/min
- Men and women of childbearing potential, and women within 2 years of menopause, must agree to use reliable contraception from informed consent through at least 6 months after study treatment; women of childbearing potential must have a negative urine pregnancy test. Women with no reproductive potential (≥2 years post-menopause or surgically sterile) are exempt
Who cannot join
- Main Period (Period 1)
- Prior therapy with cetuximab or other monoclonal antibody-based biologics
- Chemotherapy, radiotherapy, or surgery for head and neck cancer within 3 months before screening
- Any other surgery (except biopsy, implantable venous port placement, or urgent non-cancer surgery) within 3 months before screening
- Nasopharyngeal carcinoma
- Other malignancy within the past 5 years or prior/concurrent squamous cell carcinoma (except cured in situ ductal carcinoma, cervical carcinoma in situ, basal cell or squamous cell skin cancer)
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- Expected survival < 3 months
- Women who are pregnant or breastfeeding, or unwilling to use effective contraception during the study and for at least 6 months after
- Significant cardiovascular disease per investigator, including uncontrolled hypertension (systolic ≥180 mmHg or diastolic ≥130 mmHg), coronary artery disease, myocardial infarction within 12 months, high-risk uncontrolled arrhythmias, or uncontrolled heart failure
- Active infection requiring systemic antibiotic therapy
- Ongoing systemic immunotherapy, hormone therapy, or other cancer treatments not specified in the protocol within 6 months prior to screening or during the study
- Known or suspected brain metastases, including parenchymal, leptomeningeal, or dural involvement associated with symptoms
- Positive screening for HBsAg, anti-HCV, anti-HIV1/2 antibodies, or syphilis within 3 months prior to screening
- Conditions preventing compliance with the study protocol per investigator
- Participation in another investigational drug study within 6 months prior to screening
- Unstable medical conditions, including uncontrolled diabetes, psychiatric disorders, or uncontrolled seizures, that could interfere with protocol adherence
- Known hypersensitivity to any component of study therapy or combination chemotherapy drugs
- Excessive alcohol use (>10 standard drinks/week) or history of alcoholism or substance abuse associated with symptoms. One standard drink = 250 mL beer, 125 mL wine, or 30 mL spirits
- Maintenance Therapy Period (Period 2)
- Absence of a confirmed objective response to the administered therapy during the main study period, defined as failure to achieve disease stabilization or a partial/complete response according to RECIST v1.1
- Women who are pregnant or breastfeeding, or unwilling to use effective contraception during the study and for at least 6 months after
- Significant cardiovascular disease per investigator, including uncontrolled hypertension (systolic ≥180 mmHg or diastolic ≥130 mmHg), coronary artery disease, myocardial infarction within 12 months, high-risk uncontrolled arrhythmias, or uncontrolled heart failure
- Active infection requiring systemic antibiotics
- Ongoing systemic immunotherapy, hormone therapy, or other cancer treatments not specified in the protocol for Period 2
- Known or suspected brain metastases, including parenchymal, leptomeningeal, or dural involvement associated with symptoms
- Conditions preventing compliance with study procedures per investigator
- Participation in another investigational drug study
- Unstable medical conditions, including uncontrolled diabetes, psychiatric disorders, or uncontrolled seizures, that could interfere with protocol adherence
- Excessive alcohol use (>10 standard drinks/week) or history of alcoholism or substance abuse associated with symptoms. One standard drink = 250 mL beer, 125 mL wine, or 30 mL spirits
Trial locations and contacts
34 sites in 2 countries.
34 sites in 2 countries
Russia33 sites
State Budgetary Healthcare Institution of Arkhangelsk Region "Arkhangelsk Clinical Oncological Dispensary"
Arkhangelsk, 163045
State Budgetary Healthcare Institution "Regional Oncological Dispensary"
Irkutsk, 664035
State Budgetary Healthcare Institution of Moscow "Moscow City Oncological Hospital No. 62, Department of Health of Moscow"
Istra, 143515
Regional Budgetary Healthcare Institution "Ivanovo Regional Oncological Dispensary"
Ivanovo, 153040
Budgetary Healthcare Institution of the Udmurt Republic "Sergey Grigoryevich Primushko Republican Clinical Oncological Dispensary" of the Ministry of Health of the Udmurt Republic
Izhevsk, 571207
State Budgetary Healthcare Institution of Kaluga Region "Kaluga Regional Clinical Oncology Dispensary"
Kaluga, 248007
State Autonomous Healthcare Institution "Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Tatarstan named after Professor M.Z. Sigal"
Kazan', 420029
State Budgetary Healthcare Institution "Kuzbass Clinical Oncology Dispensary named after M.S. Rappoport" (SBHI "KCOD")
Kemerovo, 650036
Kirov Regional State Clinical Budgetary Healthcare Institution "Center of Oncology and Medical Radiology"
Kirov, 610045
State Budgetary Healthcare Institution "Clinical Oncological Dispensary No. 1" of the Ministry of Health of Krasnodar Krai
Krasnodar, 350040
State Budgetary Healthcare Institution "Leningrad Regional Clinical Hospital"
Kuz'molovskiy, 191104
Federal State Budgetary Institution "N.N. Burdenko Main Military Clinical Hospital" of the Ministry of Defense of the Russian Federation
Moscow, 105094
State Budgetary Healthcare Institution of Moscow "A.S. Loginov Moscow Clinical Scientific and Practical Center" of the Moscow Department of Health
Moscow, 111123
Federal State Autonomous Educational Institution of Higher Education First Moscow State Medical University named after I.M. Sechenov of the Ministry of Health of the Russian Federation (Sechenov University)
Moscow, 119435
Branch of the Limited Liability Company "Hadassah Medical Ltd." (LLC Branch "Hadassah Medical")
Moscow, 121205
Federal State Autonomous Institution "National Medical Research Center 'Medical and Rehabilitation Center'" of the Ministry of Health of the Russian Federation
Moscow, 125367
State Budgetary Healthcare Institution of Moscow "City Clinical Hospital named after S.S. Yudin, Department of Health of Moscow"
Moscow, 129090
Joint-Stock Company "Medsi Group of Companies"
Moscow, 143442
State Autonomous Healthcare Institution of the Nizhny Novgorod Region "Research Institute of Clinical Oncology 'Nizhny Novgorod Regional Clinical Oncology Dispensary'"
Nizhny Novgorod, 603081
Limited Liability Company Medical and Sanitary Unit "Clinician-Pretor Clinic"
Novosibirsk, 630091
Federal State Budgetary Institution "National Medical Research Center of Radiology" of the Ministry of Health of the Russian Federation, Branch: A.F. Tsyba Medical Radiological Research Center
Obninsk, 249036
Federal State Budgetary Institution "National Medical Research Center of Radiology" of the Ministry of Health of the Russian Federation, Branch: P.A. Herzen Moscow Research Oncology Institute
Obninsk, 249036
Budgetary Healthcare Institution of Omsk Region "Clinical Oncological Dispensary"
Omsk, 644013
Private Medical Institution "Euromedservice"
Pushkin, 196603
State Budgetary Healthcare Institution of Stavropol Krai "Pyatigorsk Interdistrict Oncology Dispensary"
Pyatigorsk
Federal State Budgetary Institution "National Medical Research Center of Oncology" of the Ministry of Health of the Russian Federation
Rostov-on-Don, 344037
Private Healthcare Institution "RZD-Medicine Clinical Hospital" of Saint Petersburg
Saint Petersburg, 195271
Limited Liability Company "EuroCityClinic"
Saint Petersburg, 197022
Saint Petersburg State Budgetary Healthcare Institution "City Clinical Oncological Dispensary"
Saint Petersburg, 197022
Federal State Budgetary Educational Institution of Higher Education "Siberian State Medical University" of the Ministry of Health of the Russian Federation
Tomsk, 634028
State Autonomous Healthcare Institution "Republican Clinical Oncological Dispensary" of the Ministry of Health of the Republic of Bashkortostan
Ufa, 450054
State Budgetary Healthcare Institution of Yaroslavl Region "Regional Clinical Oncological Hospital"
Yaroslavl, 150054
State Autonomous Healthcare Institution of Sverdlovsk Region "Sverdlovsk Regional Oncology Dispensary"
Yekaterinburg, 620036
Uzbekistan1 site
Republican Specialized Scientific and Practical Medical Center of Oncology and Radiology, Tashkent Regional Branch
Tashkent, 100128
About this study
Official title: An International, Multicenter, Open-label, Randomized, Comparative Study of the Efficacy and Safety of RPH-002 and Erbitux® in Patients With Unresectable Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma
The primary objective of the study is to evaluate the comparability of efficacy, safety, and immunogenicity of RPH-002 and Erbitux® when administered in combination with docetaxel and cisplatin as first-line therapy in patients with advanced head and neck squamous cell carcinoma
Read the detailed description
This study is a international, multicenter, open-label, randomized, parallel-group Phase III study
The study will include the following periods:
- Screening Period 1 Includes Days -14 to -1 (prior to the first administration of the investigational product/comparator)
- Main Period (Period 1) The main study period includes Days 1-126 The Main Period begins with administration of cetuximab (RPH-002 or Erbitux®) and chemotherapy on Day 1 of Cycle 1. Chemotherapy continues for up to 6 cycles, each lasting 3 weeks (21 days). Chemotherapy agents are administered no earlier than 1 hour after completion of cetuximab infusion. Cetuximab is administered weekly for up to 18 doses In Period 1, tumor response is assessed every 6 weeks
- Screening Period 2 Includes Days -7 to 0 (prior to Visit 1 of the Maintenance Therapy Period) During Screening Period 2, the patient's general condition and laboratory and instrumental test results are evaluated to determine eligibility for continuation of therapy in the Maintenance Therapy Period
- Maintenance Therapy Period (Period 2) Includes Days 127-386 In the Maintenance Therapy Period, patients with a tumor response or stable disease at Week 18 of Period 1 are included in the study. Tumor response is assessed according to RECIST 1.1 criteria:
- Complete Response (CR) - disappearance of all target lesions, confirmed by CT scans for at least 4 weeks; the short axis of any lymph node previously considered pathological (target or non-target) must be <10 mm
- Partial Response (PR) - at least a 30% decrease in the sum of diameters of target lesions, maintained for at least 4 weeks compared with baseline (screening) measurements
- Progressive Disease (PD) - at least a 20% increase in the sum of diameters of target lesions compared with the smallest sum recorded during the study (with an absolute increase of at least 5 mm), or the appearance of one or more new lesions
- Stable Disease (SD) - neither sufficient shrinkage in the sum of diameters to qualify as partial response nor sufficient increase to qualify as progressive disease compared with the smallest sum recorded during the study During the Maintenance Therapy Period, patients receive monotherapy with cetuximab at 250 mg/m² once weekly. The maximum number of administrations of cetuximab during this period is 36 Therapy continues until the earliest of the following:
- up to 54 weeks from the start of study treatment
- disease progression (per RECIST 1.1 or clinical progression)
- unacceptable toxicity Radiologically confirmed progression according to RECIST 1.1 criteria is defined as an increase of at least 20% in the sum of diameters of target lesions compared with the smallest sum recorded during the study (with an absolute increase of at least 5 mm), or the appearance of one or more new lesions In Period 2, tumor response is assessed every 6 weeks
- Follow-up Period
The Follow-Up Period assesses the safety of study therapy in all patients who complete Period 1 and do not enter Period 2, as well as in patients who complete therapy in Period 2. The period lasts 28 ± 3 days after the last study drug administration (if therapy completes as planned at 54 weeks) or until death, loss to follow-up, or Day 365, whichever occurs first. A single follow-up visit is conducted 28 ± 3 days after the last study drug administration
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- Head and Neck Squamous Cell Carcinoma, RPH-002
- 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.
RPH-002Drug
Also called Arcetux®, L01002, cetuximab
RPH-002: solution for infusion, 100 mg/20 mL (5 mg/mL) per vial
RPH-002 is administered IV once weekly. The first dose is 400 mg/m², given as a 20 mg/m² IV test dose over 10 minutes followed by 380 mg/m² IV over the remainder of 120 minutes. Subsequent weekly doses are 250 mg/m² IV over 60 minutes
Thirty to sixty minutes prior to the infusion of RPH-002, premedication with diphenhydramine 50 mg (or other H1-receptor antagonist) administered orally or intravenously and a glucocorticosteroid (e.g., dexamethasone 8 mg) is required
Erbitux®Drug
Also called cetuximab
Erbitux®: solution for infusion, 5 mg/mL; vials of 10, 20, 50, and 100 mL containing 50, 100, 250, and 500 mg of the drug, respectively
Erbitux® is administered IV once weekly. The first dose is 400 mg/m², given as a 20 mg/m² IV test dose over 10 minutes followed by 380 mg/m² IV over the remainder of 120 minutes. Subsequent weekly doses are 250 mg/m² IV over 60 minutes
Thirty to sixty minutes prior to the infusion of Erbitux®, premedication with diphenhydramine 50 mg (or other H1-receptor antagonist) administered orally or intravenously and a glucocorticosteroid (e.g., dexamethasone 8 mg) is required
CisplatinDrug
Solution for injection (500 μg / 1 mg / 1 mL; 10 / 25 / 50 / 100 mg per vial)
Cisplatin is administered intravenously at 75 mg/m² once every 3 weeks. Hydration is required to promote diuresis and reduce cisplatin-related nephrotoxicity
DocetaxelDrug
Concentrate for solution for infusion (40 mg/mL; 0.5 mL / 2 mL per vial)
Docetaxel is administered intravenously at 75 mg/m² over 60 minutes once every 3 weeks, prior to the cisplatin infusion and concurrently with prehydration
| Study group | Role | What they receive |
|---|---|---|
| RPH-002 + docetaxel + cisplatin | Experimental | Patients receive RPH-002 in combination with docetaxel and cisplatin during the Main Period (up to 18 weeks, 6 cycles) and RPH-002 monotherapy during the Maintenance Period (up to 36 weeks), or until disease progression or unacceptable toxicity Receives: Drug: RPH-002; Drug: Cisplatin; Drug: Docetaxel |
| Erbitux® + docetaxel + cisplatin | Active comparator | Patients receive Erbitux® in combination with docetaxel and cisplatin during the Main Period (up to 18 weeks, 6 cycles) and Erbitux® monotherapy during the Maintenance Period (up to 8 weeks), or until disease progression or unacceptable toxicity
Patients who received therapy with Erbitux® during the Main Period will be switched to therapy with RPH-002 starting from Week 9 of the Maintenance Period Receives: Drug: Erbitux®; Drug: Cisplatin; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (%) (ORR)
Objective response rate (%) (ORR) for a period of up to 18 weeks of therapy inclusive
The objective response rate (ORR) is defined as the percentage of patients in each treatment group who achieve a complete or partial tumor response to therapy according to RECIST 1.1 criteria:
- Complete Response (CR) - disappearance of all target lesions, confirmed by CT scans for at least 4 weeks; the short axis of any lymph node previously considered pathological (target or non-target) must be <10 mm
- Partial Response (PR) - at least a 30% decrease in the sum of diameters of target lesions, maintained for at least 4 weeks compared with baseline (screening) measurements
Measured: At Visits 6 (Day 36), 12 (Day 78), and 18 (Day 120)
Secondary outcomes (10)
Disease Control Rate (%) (DCR; CR + PR + SD)
Disease Control Rate (DCR; CR + PR + SD), %, achieved within up to 18 weeks from the start of study treatment (inclusive)
The disease control rate is defined as the percentage of patients in a given treatment group who achieve a complete response, partial response, or stable disease during therapy, in accordance with RECIST 1.1 criteria:
- Complete Response (CR) - disappearance of all target lesions, confirmed by CT scans for at least 4 weeks; the short axis of any lymph node previously considered pathological (target or non-target) must be <10 mm
- Partial Response (PR) - at least a 30% decrease in the sum of diameters of target lesions, maintained for at least 4 weeks compared with baseline (screening) measurements
- Stable Disease (SD) - neither sufficient shrinkage in the sum of diameters to qualify as partial response nor sufficient increase to qualify as progressive disease compared with the smallest sum recorded during the study
Measured: At Visits 6 (Day 36), 12 (Day 78), and 18 (Day 120)
Proportion of patients (%) with adverse drug reactions (ADRs) of any severity
Proportion of patients (%) with adverse drug reactions (ADRs) of any severity
Measured: Up to Day 365
Proportion of patients (%) with adverse events (AEs) of any severity
Proportion of patients (%) with adverse events (AEs) of any severity
Measured: Up to Day 365
Proportion of patients (%) with AEs of severity grade ≥ 3
Proportion of patients (%) with AEs of severity grade ≥ 3 according to CTCAE 5.0
Measured: Up to Day 365
Proportion of patients (%) with ADRs of severity grade ≥ 3
Proportion of patients (%) with ADRs of severity grade ≥ 3 according to CTCAE 5.0
Measured: Up to Day 365
Proportion of patients (%) with serious adverse events (SAEs)
Proportion of patients (%) with serious adverse events (SAEs)
Measured: Up to Day 365
Proportion of patients (%) with serious adverse drug reactions (SADRs)
Proportion of patients (%) with serious adverse drug reactions (SADRs)
Measured: Up to Day 365
Proportion of patients (%) who required discontinuation of treatment due to development of ADRs/SADRs
Proportion of patients (%) who required discontinuation of treatment due to development of ADRs/SADRs
Measured: Up to Day 365
Proportion of patients (%) who developed anti-drug antibodies (ADA) to cetuximab
Proportion of patients (%) who developed anti-drug antibodies (ADA) to cetuximab
Measured: Pre-dose in Period 1 on Days 1, 15, 29, 57, and 85, and 28 ± 3 days post-last infusion; pre-dose in Period 2 on Days 6, 12, 18, 24, 30, and 36
Proportion of patients (%) who developed neutralizing antibodies (NAb) to cetuximab
Proportion of patients (%) who developed neutralizing antibodies (NAb) to cetuximab
Measured: Pre-dose in Period 1 on Days 1, 15, 29, 57, and 85, and 28 ± 3 days post-last infusion; pre-dose in Period 2 on Days 6, 12, 18, 24, 30, and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start8 Aug 2024
- Primary completion16 Sep 2025
- Study completion25 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies 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
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- R-Pharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mikhail Samsonov, Study director, R-Pharm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435324
- Sponsor's protocol ID
- CL01002356
- Status last verified
- Jul 2026
- First submitted
- 20 Feb 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International, Multicenter, Open-label, Randomized, Comparative Study of the Efficacy and Safety of RPH-002 and Erbitux® in Patients With Unresectable Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07435324
- Acronym / sponsor ID
- CL01002356
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- Head and Neck Squamous Cell Carcinoma, RPH-002
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- R-PharmIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2024 (actual)
- Primary completion
- 16 Sep 2025 (actual)
- Study completion
- 25 Jun 2026 (actual)
- First posted
- 27 Feb 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.
The primary objective of the study is to evaluate the comparability of efficacy, safety, and immunogenicity of RPH-002 and Erbitux® when administered in combination with docetaxel and cisplatin as first-line therapy in patients with advanced head and neck squamous cell carcinoma
Detailed description
This study is a international, multicenter, open-label, randomized, parallel-group Phase III study
The study will include the following periods:
- Screening Period 1 Includes Days -14 to -1 (prior to the first administration of the investigational product/comparator)
- Main Period (Period 1) The main study period includes Days 1-126 The Main Period begins with administration of cetuximab (RPH-002 or Erbitux®) and chemotherapy on Day 1 of Cycle 1. Chemotherapy continues for up to 6 cycles, each lasting 3 weeks (21 days). Chemotherapy agents are administered no earlier than 1 hour after completion of cetuximab infusion. Cetuximab is administered weekly for up to 18 doses In Period 1, tumor response is assessed every 6 weeks
- Screening Period 2 Includes Days -7 to 0 (prior to Visit 1 of the Maintenance Therapy Period) During Screening Period 2, the patient's general condition and laboratory and instrumental test results are evaluated to determine eligibility for continuation of therapy in the Maintenance Therapy Period
- Maintenance Therapy Period (Period 2) Includes Days 127-386 In the Maintenance Therapy Period, patients with a tumor response or stable disease at Week 18 of Period 1 are included in the study. Tumor response is assessed according to RECIST 1.1 criteria:
- Complete Response (CR) - disappearance of all target lesions, confirmed by CT scans for at least 4 weeks; the short axis of any lymph node previously considered pathological (target or non-target) must be <10 mm
- Partial Response (PR) - at least a 30% decrease in the sum of diameters of target lesions, maintained for at least 4 weeks compared with baseline (screening) measurements
- Progressive Disease (PD) - at least a 20% increase in the sum of diameters of target lesions compared with the smallest sum recorded during the study (with an absolute increase of at least 5 mm), or the appearance of one or more new lesions
- Stable Disease (SD) - neither sufficient shrinkage in the sum of diameters to qualify as partial response nor sufficient increase to qualify as progressive disease compared with the smallest sum recorded during the study During the Maintenance Therapy Period, patients receive monotherapy with cetuximab at 250 mg/m² once weekly. The maximum number of administrations of cetuximab during this period is 36 Therapy continues until the earliest of the following:
- up to 54 weeks from the start of study treatment
- disease progression (per RECIST 1.1 or clinical progression)
- unacceptable toxicity Radiologically confirmed progression according to RECIST 1.1 criteria is defined as an increase of at least 20% in the sum of diameters of target lesions compared with the smallest sum recorded during the study (with an absolute increase of at least 5 mm), or the appearance of one or more new lesions In Period 2, tumor response is assessed every 6 weeks
- Follow-up Period
The Follow-Up Period assesses the safety of study therapy in all patients who complete Period 1 and do not enter Period 2, as well as in patients who complete therapy in Period 2. The period lasts 28 ± 3 days after the last study drug administration (if therapy completes as planned at 54 weeks) or until death, loss to follow-up, or Day 365, whichever occurs first. A single follow-up visit is conducted 28 ± 3 days after the last study drug administration
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RPH-002 + docetaxel + cisplatin | Experimental | Drug: RPH-002, Drug: Cisplatin, Drug: DocetaxelPatients receive RPH-002 in combination with docetaxel and cisplatin during the Main Period (up to 18 weeks, 6 cycles) and RPH-002 monotherapy during the Maintenance Period (up to 36 weeks), or until disease progression or unacceptable toxicity |
| Erbitux® + docetaxel + cisplatin | Active comparator | Drug: Erbitux®, Drug: Cisplatin, Drug: DocetaxelPatients receive Erbitux® in combination with docetaxel and cisplatin during the Main Period (up to 18 weeks, 6 cycles) and Erbitux® monotherapy during the Maintenance Period (up to 8 weeks), or until disease progression or unacceptable toxicity Patients who received therapy with Erbitux® during the Main Period will be switched to therapy with RPH-002 starting from Week 9 of the Maintenance Period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Main Period (Period 1)
- A voluntarily signed and dated Informed Consent form (ICF) of the patient
- Histologically confirmed squamous cell carcinoma of the head and neck
- Documented unresectable locoregional recurrence or distant metastases, or progression after prior chemoradiotherapy or combination therapy completed >3 months before screening, not amenable to local treatment (except cases with high risk of tumor lysis or bleeding), or newly diagnosed metastatic disease not previously treated with systemic therapy. Study treatment is first-line therapy
- At least one measurable lesion per RECIST 1.1
Key exclusion criteria (29 listed)
- Main Period (Period 1)
- Prior therapy with cetuximab or other monoclonal antibody-based biologics
- Chemotherapy, radiotherapy, or surgery for head and neck cancer within 3 months before screening
- Any other surgery (except biopsy, implantable venous port placement, or urgent non-cancer surgery) within 3 months before screening
- Nasopharyngeal carcinoma
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 |
|---|---|---|
| RPH-002Also: Arcetux®, L01002, cetuximabRPH-002: solution for infusion, 100 mg/20 mL (5 mg/mL) per vial RPH-002 is administered IV once weekly. The first dose is 400 mg/m², given as a 20 mg/m² IV test dose over 10 minutes followed by 380 mg/m² IV over the remainder of 120 minutes. Subsequent weekly doses are 250 mg/m² IV over 60 minutes Thirty to sixty minutes prior to the infusion of RPH-002, premedication with diphenhydramine 50 mg (or other H1-receptor antagonist) administered orally or intravenously and a glucocorticosteroid (e.g., dexamethasone 8 mg) is required | Drug | RPH-002 + docetaxel + cisplatin |
| Erbitux®Also: cetuximabErbitux®: solution for infusion, 5 mg/mL; vials of 10, 20, 50, and 100 mL containing 50, 100, 250, and 500 mg of the drug, respectively Erbitux® is administered IV once weekly. The first dose is 400 mg/m², given as a 20 mg/m² IV test dose over 10 minutes followed by 380 mg/m² IV over the remainder of 120 minutes. Subsequent weekly doses are 250 mg/m² IV over 60 minutes Thirty to sixty minutes prior to the infusion of Erbitux®, premedication with diphenhydramine 50 mg (or other H1-receptor antagonist) administered orally or intravenously and a glucocorticosteroid (e.g., dexamethasone 8 mg) is required | Drug | Erbitux® + docetaxel + cisplatin |
| CisplatinSolution for injection (500 μg / 1 mg / 1 mL; 10 / 25 / 50 / 100 mg per vial) Cisplatin is administered intravenously at 75 mg/m² once every 3 weeks. Hydration is required to promote diuresis and reduce cisplatin-related nephrotoxicity | Drug | Erbitux® + docetaxel + cisplatin, RPH-002 + docetaxel + cisplatin |
| DocetaxelConcentrate for solution for infusion (40 mg/mL; 0.5 mL / 2 mL per vial) Docetaxel is administered intravenously at 75 mg/m² over 60 minutes once every 3 weeks, prior to the cisplatin infusion and concurrently with prehydration | Drug | Erbitux® + docetaxel + cisplatin, RPH-002 + docetaxel + cisplatin |
Primary outcome
Objective response rate (%) (ORR)
Time frame: At Visits 6 (Day 36), 12 (Day 78), and 18 (Day 120)
Objective response rate (%) (ORR) for a period of up to 18 weeks of therapy inclusive The objective response rate (ORR) is defined as the percentage of patients in each treatment group who achieve a complete or partial tumor response to therapy according to RECIST 1.1 criteria: * Complete Response (CR) - disappearance of all target lesions, confirmed by CT scans for at least 4 weeks; the short axis of any lymph node previously considered pathological (target or non-target) must be <10 mm * Partial Response (PR) - at least a 30% decrease in the sum of diameters of target lesions, maintained for at least 4 weeks compared with baseline (screening) measurements
10 secondary outcomes
Disease Control Rate (%) (DCR; CR + PR + SD)
Time frame: At Visits 6 (Day 36), 12 (Day 78), and 18 (Day 120)
Proportion of patients (%) with adverse drug reactions (ADRs) of any severity
Time frame: Up to Day 365
Proportion of patients (%) with adverse events (AEs) of any severity
Time frame: Up to Day 365
Proportion of patients (%) with AEs of severity grade ≥ 3
Time frame: Up to Day 365
Proportion of patients (%) with ADRs of severity grade ≥ 3
Time frame: Up to Day 365
Proportion of patients (%) with serious adverse events (SAEs)
Time frame: Up to Day 365
Proportion of patients (%) with serious adverse drug reactions (SADRs)
Time frame: Up to Day 365
Proportion of patients (%) who required discontinuation of treatment due to development of ADRs/SADRs
Time frame: Up to Day 365
Proportion of patients (%) who developed anti-drug antibodies (ADA) to cetuximab
Time frame: Pre-dose in Period 1 on Days 1, 15, 29, 57, and 85, and 28 ± 3 days post-last infusion; pre-dose in Period 2 on Days 6, 12, 18, 24, 30, and 36
Proportion of patients (%) who developed neutralizing antibodies (NAb) to cetuximab
Time frame: Pre-dose in Period 1 on Days 1, 15, 29, 57, and 85, and 28 ± 3 days post-last infusion; pre-dose in Period 2 on Days 6, 12, 18, 24, 30, and 36
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
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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. This study is not recruiting at the moment.
Mikhail Samsonov study director
R-Pharm
34 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RPH-002, Erbitux® and Cisplatin in people with Head and Neck Squamous Cell Carcinoma, run by R-Pharm at 34 sites in 2 countries.
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 31 inclusion and 29 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: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Russia, Uzbekistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (%) (ORR) (time frame: At Visits 6 (Day 36), 12 (Day 78), and 18 (Day 120)). 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 14 Jul 2026.