Radioactive Iodine-refractory, Differentiated Thyroid Cancer With NRAS MutationPhase 2NCT06970353
Phase II Trial of Tunlametinib in NRAS-Mutant Advanced Thyroid Cancer
A Phase 2 study testing Tunlametinib and Tunlametinib+PD-1 mAb in people with Radioactive Iodine-refractory, Differentiated Thyroid Cancer With NRAS Mutation and Advanced PDTC or ATC With NRAS Mutation, run by Fudan University at 1 site in China.
Trial summary
This phase II trial evaluates Tunlametinib (MEK inhibitor) ± PD-1 in NRAS-mutant advanced thyroid cancer. Key Objectives: Assess efficacy (ORR by RECIST v1.1) Evaluate safety profiles Study Design: Single-arm, single-center 4 cohorts based on: Histology (differentiated vs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radioactive Iodine-refractory, Differentiated Thyroid Cancer With NRAS Mutation, Advanced PDTC or ATC With NRAS Mutation
- What is being tested?
- Tunlametinib and Tunlametinib+PD-1 mAb
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 27 May 2025to 30 Dec 2031
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients voluntarily join this study and sign an informed consent form;
- Age: ≥ 18 years old, male or female not limited;
- For locally advanced or recurrent/metastatic thyroid cancer diagnosed by histology and unable to undergo curative surgery, one of the following requirements must be met:
- Iodine refractory thyroid cancer;
- Differentiated thyroid cancer not suitable for iodine therapy;
- High grade, poorly differentiated or poorly differentiated thyroid cancer;
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- Undifferentiated thyroid carcinoma;
- Have undergone NGS testing (at our hospital or an external hospital), and be able to find that the test report or medical history has recorded a positive result for NRAS mutation in the gene test.
- ECOG score 0-2 points; According to RECIST v1.1 evaluation, there is at least one assessable lesion;
- 7. Expected survival>12 weeks; 8. The main organ function and bone marrow function are normal.
- Blood routine: Hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); Absolute neutrophil count ≥ 1.5 × 109/L; platelet count ≥ 100 × 109/L;
- Liver function: Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) are ≤ 2.5 times the upper limit of normal (ULN). If there is liver metastasis, ALT and AST are ≤ 5 times ULN, and ALP is ≤ 6 times ULN; Total bilirubin ≤ 1.5 × ULN; Albumin ≥ 30 g/L;
- Renal function: serum creatinine ≤ 1.5 × ULN or creatinine clearance rate calculated by Cockroft Gault formula>60 mL/min;
- Cardiac function: Echocardiography shows a left ventricular ejection fraction (LVEF) of ≥ 55%; ECG QTcF ≤ 480ms; Creatine kinase (CK) ≤ 1 × ULN, troponin/hypersensitive troponin ≤ 1 × ULN;
- Coagulation function: International normalized ratio of prothrombin time (INR) ≤ 1.5 × ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; 9. Women of childbearing age must undergo a pregnancy test (serum or urine) with a negative result within 14 days before enrollment, and voluntarily use appropriate contraception methods during the observation period and within 3 months after the last administration of the study drug; For males, surgical sterilization or consent to use appropriate contraception methods during the observation period and within 3 months after the last administration of the study drug should be used.
Who cannot join
- Within 4 weeks before the first medication, major surgery (excluding biopsy and outpatient minor surgery, such as placement of vascular access) or severe trauma occurred;
- There are clinical symptoms of third interstitial fluid accumulation that cannot be controlled by drainage or other methods (such as a large amount of pleural fluid or ascites);
- Cardiovascular and cerebrovascular diseases with impaired heart function or significant clinical significance, including but not limited to any of the following:
- Within 6 months prior to the start of treatment, acute coronary syndrome occurred, including acute myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, and stent implantation;
- Symptomatic congestive heart failure (NYHA classification ≥ II); Evidence of clinically significant arrhythmia and/or conduction abnormalities within 6 months prior to the start of treatment or at present;
- Poor control of hypertension (systolic blood pressure ≥ 140 and/or diastolic blood pressure ≥ 90 mmHg under medication control); Abnormal cardiac valve morphology (≥ grade 2) recorded by echocardiography, Note: Patients with grade 1 abnormal valve morphology (such as mild regurgitation/stenosis) are allowed to be enrolled, but patients with moderate valve thickening are prohibited from being enrolled;
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- History of congenital long QT syndrome; Or those who take drugs known to prolong the QT interval and cannot guarantee discontinuation during the study period;
- Previous or screening retinal diseases, such as retinal vein occlusion (RVO), retinal artery occlusion, retinal vasculitis, diabetes retinopathy, hypertensive retinopathy, retinal telangiectasia (Costs disease), retinal pigment epithelial detachment (RPED), etc; Risk factors for RVO during screening (such as uncontrolled glaucoma or high intraocular pressure, history of high viscosity or hypercoagulability syndrome); Retinal diseases such as RPED;
- Patients with interstitial lung disease or interstitial pneumonia, including clinically significant radiation pneumonitis (i.e. affecting daily living activities or requiring intervention treatment);
- Positive for human immunodeficiency virus (HIV) antibodies, syphilis antibodies (Anti TP), hepatitis C virus (HCV) antibodies and HCV RNA, hepatitis B virus surface antigen (HBsAg) and HBV DNA (HBsAg positivity requires further testing for HBV DNA, HBV DNA ≥ 200 IU/ml, or ≥ 103 copies/ml);
- History of allogeneic bone marrow transplantation or organ transplantation;
- There are uncontrollable active infectious diseases (such as intravenous drip of antibiotics, antifungal or antiviral drugs) within 2 weeks before the first administration, or fever of unknown cause>38.5 ° C occurs during screening/before the first administration;
- Irreversible electrolyte abnormalities (hypokalemia, hypomagnesemia, hypocalcemia detected by blood biochemistry);
- Neuromuscular diseases related to CK elevation in the past or present (such as inflammatory myopathy, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy, rhabdomyolysis syndrome);
- Arterial/venous thrombotic events that occur within 6 months prior to the first use of medication, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
- Within 4 weeks prior to the first use of medication, the occurrence of Grade 3 bleeding symptoms as defined in the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0);
- Patients with a history of other malignant tumors within the past 5 years, except for those who have been completely cured of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and cervical carcinoma in situ, and/or any malignant tumor patients who have been cured without disease or have had no disease for at least 5 consecutive years;
- Individuals who are known to be allergic to any component of the investigational drug;
- Have a clear history of neurological or mental disorders, including epilepsy and dementia;
- Central nervous system (CNS) metastasis;
- Prior to drug administration, all relevant anti-tumor treatment toxicity reactions (excluding hair loss, skin pigmentation, grade 1 chemotherapy related peripheral neurotoxicity, grade 2 toxicity caused by immune checkpoint inhibitors such as elevated blood glucose or hypothyroidism) did not recover to ≤ grade 1 levels (as determined by NCI CTCAE v5.0);
- Uncontrolled concomitant diseases, including but not limited to severe diabetes (fasting blood glucose>250 mg/dl or 13.9 mmol/L), or other serious diseases requiring systemic treatment;
- Vaccination with live or attenuated vaccine within 4 weeks prior to the first dose (note: if enrolled, subjects must not receive live vaccine during the study treatment period and within 30 days after the last dose of the study drug);
- For premenopausal female subjects (postmenopausal female patients must have been menopausal for at least 12 months to be considered infertile), the pregnancy test result is positive; During the study period and at least 30 days after the last administration of the study drug, reproductive age subjects (including male subjects' reproductive age female spouses) who are expected to become pregnant, breastfeed, or unwilling to use effective contraceptive measures;
- Patients who are known to be allergic to the components of the investigational drug or its analogues;
- Patients who are receiving intravenous or oral medications that affect CYP isoenzymes (strong inducers and inhibitors of CYP2C9 and CYP3A4) and cannot discontinue the protocol at least one week before starting study treatment and during the study period; I am currently taking drugs with a narrow therapeutic window that are metabolized by CYP1A2;
- Inability to swallow capsules or intractable nausea and vomiting, malabsorption, extracorporeal bile diversion, or any significant small bowel resection that may hinder the full absorption of the study drug;
- Other situations that researchers consider unsuitable for inclusion. If accompanied by family or social factors, it may affect the safety of the subjects or the collection of data and samples.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Dongmei Ji, M.D, 021-64175590 ext. 83650, jidongmei2000@hotmail.com
Yu-Long Wang, M.D, yulongwang@fudan.edu.cn
About this study
Official title: A Prospective, Single-Arm, Open-Label, Single-Center Phase II Exploratory Clinical Study to Evaluate the Efficacy and Safety of Tunlametinib in Subjects With NRAS-Mutant Locally Advanced or Metastatic Thyroid Cancer
This phase II trial evaluates Tunlametinib (MEK inhibitor) ± PD-1 in NRAS-mutant advanced thyroid cancer.
Key Objectives:
Read more
Assess efficacy (ORR by RECIST v1.1) Evaluate safety profiles
Study Design:
Single-arm, single-center 4 cohorts based on:
- Histology (differentiated vs. poorly/undifferentiated)
- Prior therapy status
Treatment:
- Cohorts 1-2: Tunlametinib monotherapy (12mg BID)
- Cohorts 3-4: Tunlametinib + PD-1 (commercially available)
Key Procedures:
Screening: NRAS testing + full staging (CT/MRI/PET) Monitoring: q3-week labs, q9-week imaging Follow-up: 30-day safety visit + q3-month survival tracking
Endpoints:
Primary: ORR Secondary: Safety (CTCAE), PFS, DoR
Unique Aspects:
First study targeting NRAS in thyroid cancer with MEK+PD-1 Includes rare aggressive subtypes (poorly/undifferentiated)
Read the detailed description
Research Objective:
To evaluate the efficacy and safety of Tunlametinib (monotherapy or in combination with PD-1 mAb) in patients with locally advanced or metastatic NRAS-mutant thyroid cancer.
Study Endpoints:
Primary Endpoint:
Objective response rate (ORR) assessed per RECIST v1.1 (sum of partial and complete response rates).
Secondary Endpoints:
Efficacy:
Disease control rate (DCR) Duration of response (DoR) Time to response (TTR) Progression-free survival (PFS) Overall survival (OS), 6-month survival rate, 12-month survival rate
Safety:
Adverse events (AEs): Type, incidence, severity (graded by NCI-CTCAE v5.0), duration, and relationship to study treatment
Study Design:
This is a prospective, single-arm, open-label, single-center Phase II exploratory trial evaluating Tunlametinib ± PD-1 mAb in NRAS-mutant thyroid cancer.
Study Phases:
Screening: ≤28 days prior to enrollment (informed consent to baseline assessments).
Treatment: Until disease progression, intolerable toxicity, consent withdrawal, or investigator decision.
Follow-up:
Safety visit at 30 days (±7) post-treatment. Survival follow-up every 3 months (telephone/medical records).
Cohorts \& Treatment:
Cohort 1 (n=10): Untreated, radioactive iodine-refractory, differentiated thyroid cancer.
Cohort 2 (n=10): Previously treated, radioactive iodine-refractory, differentiated thyroid cancer.
Regimen: Tunlametinib 12 mg BID (3-week cycles).
Cohort 3 (n=10): Untreated, poorly differentiated/anaplastic thyroid cancer.
Cohort 4 (n=10): Previously treated, poorly differentiated/anaplastic thyroid cancer.
Regimen: Tunlametinib 12 mg BID + PD-1 mAb(commercially available; per approved labeling).
Dose Adjustments:
Tunlametinib: Stepwise reduction (12 mg → 9 mg → 6 mg BID) for intolerance. Re-escalation permitted if toxicity resolves (e.g., 6 mg → 9 mg after ≥6 weeks).
PD-1: Adjusted per investigator judgment and drug labeling.
Efficacy Assessments:
Imaging (CT/MRI) every 9 weeks (3 cycles) per RECIST v1.1. Real-time ORR analysis by investigators and sponsor (Shanghai Kezhou Pharmaceutical).
Follow-up Procedures:
Safety visit: Day 30 (±7) post-treatment (vitals, labs, AE assessment). Survival follow-up: Quarterly until death/loss to follow-up/study termination.
- Conditions
- Radioactive Iodine-refractory, Differentiated Thyroid Cancer With NRAS Mutation, Advanced PDTC or ATC With NRAS Mutation
- Being tested
- Tunlametinib, Tunlametinib+PD-1 mAb
- Keywords
- NRAS mutant, Locally advanced thyroid cancer, Thyroid cancer, Metastatic thyroid cancer
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TunlametinibDrug
Locally advanced or metastatic radioactive iodine refractory NRAS mutant differentiated thyroid cancer
Tunlametinib+PD-1 mAbDrug
Locally advanced or metastatic NRAS mutant poor-differentiated, undifferentiated thyroid cancer
| Study group | Role | What they receive |
|---|---|---|
| Locally advanced or metastatic thyroid cancer with NRAS mutation | Experimental | Progressive locally advanced or metastatic radioactive iodine refractory NRAS mutant thyroid cancer Receives: Drug: Tunlametinib; Drug: Tunlametinib+PD-1 mAb |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Complete remission rate and partial remission rate
Measured: up to approximately 3-5 years
Secondary outcomes (5)
Disease Control Rate
Complete remission rate and partial remission rate and stable disease rate
Measured: up to approximately 3-5 years
Duration of Response
Time from the date of first partial remission or complete remission to the date of disease progression, or death of any cause, or date of lost follow-up, whichever comes first, otherwise subject data were censored at time last known disease free.
Measured: up to approximately 3-5 years
Time to Response
Time from the initiation of the treatment to the first remission
Measured: up to approximately 3-5 years
Progression-free Survival
Time from the date of enrollment to of disease progression, or death of any cause, or date of lost follow-up, whichever comes first, otherwise subject data were censored at time last known disease free.
Measured: up to approximately 3-5 years
Overall Survival
Time from the date of enrollment to data of death from any cause, or date of lost follow-up, whichever comes first, and otherwise censored at time last known alive.
Measured: up to approximately 3-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start27 May 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radioactive Iodine-refractory, Differentiated Thyroid Cancer With NRAS MutationStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Dongmei, Fudan University
- Investigators
- Yu-Long Wang, M.D, Principal investigator, Fudan UniversityQing-Hai Ji, M.D, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970353
- Sponsor's protocol ID
- IIT-085-TC-002
- Status last verified
- Aug 2025
- First submitted
- 6 May 2025
- Last updated
- 7 Aug 2025
- 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 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm, Open-Label, Single-Center Phase II Exploratory Clinical Study to Evaluate the Efficacy and Safety of Tunlametinib in Subjects With NRAS-Mutant Locally Advanced or Metastatic Thyroid Cancer
- ClinicalTrials.gov ID
- NCT06970353
- Acronym / sponsor ID
- IIT-085-TC-002
- Conditions
- Radioactive Iodine-refractory, Differentiated Thyroid Cancer With NRAS Mutation, Advanced PDTC or ATC With NRAS Mutation
- Keywords
- NRAS mutant, Locally advanced thyroid cancer, Thyroid cancer, Metastatic thyroid cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 27 May 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2031 (estimated)
- First posted
- 14 May 2025 (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 phase II trial evaluates Tunlametinib (MEK inhibitor) ± PD-1 in NRAS-mutant advanced thyroid cancer.
Key Objectives:
Assess efficacy (ORR by RECIST v1.1) Evaluate safety profiles
Study Design:
Single-arm, single-center 4 cohorts based on:
- Histology (differentiated vs. poorly/undifferentiated)
- Prior therapy status
Treatment:
- Cohorts 1-2: Tunlametinib monotherapy (12mg BID)
- Cohorts 3-4: Tunlametinib + PD-1 (commercially available)
Key Procedures:
Screening: NRAS testing + full staging (CT/MRI/PET) Monitoring: q3-week labs, q9-week imaging Follow-up: 30-day safety visit + q3-month survival tracking
Endpoints:
Primary: ORR Secondary: Safety (CTCAE), PFS, DoR
Unique Aspects:
First study targeting NRAS in thyroid cancer with MEK+PD-1 Includes rare aggressive subtypes (poorly/undifferentiated)
Detailed description
Research Objective:
To evaluate the efficacy and safety of Tunlametinib (monotherapy or in combination with PD-1 mAb) in patients with locally advanced or metastatic NRAS-mutant thyroid cancer.
Study Endpoints:
Primary Endpoint:
Objective response rate (ORR) assessed per RECIST v1.1 (sum of partial and complete response rates).
Secondary Endpoints:
Efficacy:
Disease control rate (DCR) Duration of response (DoR) Time to response (TTR) Progression-free survival (PFS) Overall survival (OS), 6-month survival rate, 12-month survival rate
Safety:
Adverse events (AEs): Type, incidence, severity (graded by NCI-CTCAE v5.0), duration, and relationship to study treatment
Study Design:
This is a prospective, single-arm, open-label, single-center Phase II exploratory trial evaluating Tunlametinib ± PD-1 mAb in NRAS-mutant thyroid cancer.
Study Phases:
Screening: ≤28 days prior to enrollment (informed consent to baseline assessments).
Treatment: Until disease progression, intolerable toxicity, consent withdrawal, or investigator decision.
Follow-up:
Safety visit at 30 days (±7) post-treatment. Survival follow-up every 3 months (telephone/medical records).
Cohorts \& Treatment:
Cohort 1 (n=10): Untreated, radioactive iodine-refractory, differentiated thyroid cancer.
Cohort 2 (n=10): Previously treated, radioactive iodine-refractory, differentiated thyroid cancer.
Regimen: Tunlametinib 12 mg BID (3-week cycles).
Cohort 3 (n=10): Untreated, poorly differentiated/anaplastic thyroid cancer.
Cohort 4 (n=10): Previously treated, poorly differentiated/anaplastic thyroid cancer.
Regimen: Tunlametinib 12 mg BID + PD-1 mAb(commercially available; per approved labeling).
Dose Adjustments:
Tunlametinib: Stepwise reduction (12 mg → 9 mg → 6 mg BID) for intolerance. Re-escalation permitted if toxicity resolves (e.g., 6 mg → 9 mg after ≥6 weeks).
PD-1: Adjusted per investigator judgment and drug labeling.
Efficacy Assessments:
Imaging (CT/MRI) every 9 weeks (3 cycles) per RECIST v1.1. Real-time ORR analysis by investigators and sponsor (Shanghai Kezhou Pharmaceutical).
Follow-up Procedures:
Safety visit: Day 30 (±7) post-treatment (vitals, labs, AE assessment). Survival follow-up: Quarterly until death/loss to follow-up/study termination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Locally advanced or metastatic thyroid cancer with NRAS mutation | Experimental | Drug: Tunlametinib, Drug: Tunlametinib+PD-1 mAbProgressive locally advanced or metastatic radioactive iodine refractory NRAS mutant thyroid cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients voluntarily join this study and sign an informed consent form;
- Age: ≥ 18 years old, male or female not limited;
- For locally advanced or recurrent/metastatic thyroid cancer diagnosed by histology and unable to undergo curative surgery, one of the following requirements must be met:
- Have undergone NGS testing (at our hospital or an external hospital), and be able to find that the test report or medical history has recorded a positive result for NRAS mutation in the gene test.
- ECOG score 0-2 points; According to RECIST v1.1 evaluation, there is at least one assessable lesion;
Key exclusion criteria (28 listed)
- Within 4 weeks before the first medication, major surgery (excluding biopsy and outpatient minor surgery, such as placement of vascular access) or severe trauma occurred;
- There are clinical symptoms of third interstitial fluid accumulation that cannot be controlled by drainage or other methods (such as a large amount of pleural fluid or ascites);
- Cardiovascular and cerebrovascular diseases with impaired heart function or significant clinical significance, including but not limited to any of the following:
- Within 6 months prior to the start of treatment, acute coronary syndrome occurred, including acute myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, and stent implantation;
- Previous or screening retinal diseases, such as retinal vein occlusion (RVO), retinal artery occlusion, retinal vasculitis, diabetes retinopathy, hypertensive retinopathy, retinal telangiectasia (Costs disease), retinal pigment epithelial detachment (RPED), etc; Risk factors for RVO during screening (such as uncontrolled glaucoma or high intraocular pressure, history of high viscosity or hypercoagulability syndrome); Retinal diseases such as RPED;
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 |
|---|---|---|
| TunlametinibLocally advanced or metastatic radioactive iodine refractory NRAS mutant differentiated thyroid cancer | Drug | Locally advanced or metastatic thyroid cancer with NRAS mutation |
| Tunlametinib+PD-1 mAbLocally advanced or metastatic NRAS mutant poor-differentiated, undifferentiated thyroid cancer | Drug | Locally advanced or metastatic thyroid cancer with NRAS mutation |
Primary outcome
Objective Response Rate
Time frame: up to approximately 3-5 years
Complete remission rate and partial remission rate
5 secondary outcomes
Disease Control Rate
Time frame: up to approximately 3-5 years
Duration of Response
Time frame: up to approximately 3-5 years
Time to Response
Time frame: up to approximately 3-5 years
Progression-free Survival
Time frame: up to approximately 3-5 years
Overall Survival
Time frame: up to approximately 3-5 years
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 7 Aug 2025.
- Individual participant dataSharing planned: No
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.
Yu-Long Wang, M.D principal investigator
Fudan University
Qing-Hai Ji, M.D principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tunlametinib and Tunlametinib+PD-1 mAb in people with Radioactive Iodine-refractory, Differentiated Thyroid Cancer With NRAS Mutation and Advanced PDTC or ATC With NRAS Mutation, run by Fudan University at 1 site 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 15 inclusion and 28 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 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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, M.D (021-64175590 ext. 83650, jidongmei2000@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: up to approximately 3-5 years). 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 7 Aug 2025.