Radioiodine-refractory Differentiated Thyroid CancerNCT07770074
A Real-World Study of Second-line Therapies Among Radioiodine-refractory Differentiated Thyroid Cancer (RAI-R DTC) Patients
An observational study of Radioiodine-refractory Differentiated Thyroid Cancer, run by Novartis Pharmaceuticals.
Trial summary
This study aims to assess patient characteristics and treatment patterns of second-line systematic therapies, including BRAF V600E mutation-guided dabrafenib plus trametinib (D+T) and MKIs, among Chinese adult patients with RAI-R DTC. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Radioiodine-refractory Differentiated Thyroid Cancer
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 4 Jan 2027to 5 Jan 2027
- Phase
- Observational
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult RAI-R DTC patients from the rEHR database in China.
Who may be able to join
- Patients with a diagnosis of thyroid cancer.
- Patients with a pathological confirmation of differentiated thyroid cancer (DTC).
- Patients who initiated either MKI monotherapy (lenvatinib, sorafenib, anlotinib, donafenib, apatinib, sunitinib, cabozantinib, pralsetinib) or D+T combination therapy between January 1, 2019 and December 31, 2025 (or the data cutoff date).
- Patients with no curative-intent thyroid cancer surgery within 3 months after initiation of systematic therapy.
Who cannot join
- Patients participating in a blinded interventional clinical trial, or any open-label observational study involving D+T or MKI, during the study period.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
About this study
Official title: Real-World Evidence of Second-line Systematic Therapy With BRAF V600E Mutation-guided Dabrafenib + Trametinib or Mutation-agnostic Multi-targeted Tyrosine Kinase Inhibitors (MKIs) in Radioiodine-refractory Differentiated Thyroid Cancer (RAI-R DTC)
This study aims to assess patient characteristics and treatment patterns of second-line systematic therapies, including BRAF V600E mutation-guided dabrafenib plus trametinib (D+T) and MKIs, among Chinese adult patients with RAI-R DTC. This is a non-interventional study using secondary data derived from a real-world Electronic Health Record (rEHR) database in China.
- Keywords
- Radioiodine-refractory Differentiated Thyroid Cancer, BRAF V600E mutation, Dabrafenib, Trametinib, Second-line systematic therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RAI-R DTC Cohort | Adult patients diagnosed with RAI-R DTC. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Receiving Second-line Systematic Therapy
Second-line systematic therapy includes lenvatinib, anlotinib, sorafenib, donafenib, and D+T.
Measured: Up to 6 years
Duration of Second-line Systematic Therapy
Duration of therapy with lenvatinib, anlotinib, sorafenib, donafenib, and D+T.
Measured: Up to 6 years
Secondary outcomes (7)
Proportion of Patients by Demographics and Clinical Characteristics
Demographics and clinical characteristics include sex/gender, Tumor Node Metastasis (TNM) stage, BRAF V600E and co-mutation status, presence of distant metastasis, and MKI tolerability-related comorbidities.
Measured: Baseline
Age
Measured: Baseline
Proportion of Patients Who had Surgery Prior to Second-line Systematic Therapy
Measured: Baseline
Proportion of Patients Who Received 131I Radioiodine Therapy Prior to Second-line Systematic Therapy
Measured: Baseline
Proportion of Patients by First-line Therapy
Proportion of patients who received first-line lenvatinib, anlotinib, sorafenib, donafenib, and D+T.
Measured: Baseline
Duration Between First Diagnosis of DTC and Treatment Initiation
Measured: Baseline
Proportion of Patients by Timing and Method of BRAF Testing
Timing categories include at initial diagnosis, at recurrence or metastasis, prior to second-line initiation, and other/unknown.
Measured: Baseline, up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start4 Jan 2027 (estimated)
- Primary completion5 Jan 2027 (estimated)
- Study completion5 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radioiodine-refractory Differentiated Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770074
- Sponsor's protocol ID
- CDRB436J1CN01
- Status last verified
- Oct 2026
- First submitted
- 10 Aug 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Evidence of Second-line Systematic Therapy With BRAF V600E Mutation-guided Dabrafenib + Trametinib or Mutation-agnostic Multi-targeted Tyrosine Kinase Inhibitors (MKIs) in Radioiodine-refractory Differentiated Thyroid Cancer (RAI-R DTC)
- ClinicalTrials.gov ID
- NCT07770074
- Acronym / sponsor ID
- CDRB436J1CN01
- Keywords
- Radioiodine-refractory Differentiated Thyroid Cancer, BRAF V600E mutation, Dabrafenib, Trametinib, Second-line systematic therapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 4 Jan 2027 (estimated)
- Primary completion
- 5 Jan 2027 (estimated)
- Study completion
- 5 Jan 2027 (estimated)
- First posted
- 18 Aug 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 study aims to assess patient characteristics and treatment patterns of second-line systematic therapies, including BRAF V600E mutation-guided dabrafenib plus trametinib (D+T) and MKIs, among Chinese adult patients with RAI-R DTC. This is a non-interventional study using secondary data derived from a real-world Electronic Health Record (rEHR) database in China.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RAI-R DTC Cohort | – | –Adult patients diagnosed with RAI-R DTC. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult RAI-R DTC patients from the rEHR database in China.
Key inclusion criteria (4 listed)
- Patients with a diagnosis of thyroid cancer.
- Patients with a pathological confirmation of differentiated thyroid cancer (DTC).
- Patients who initiated either MKI monotherapy (lenvatinib, sorafenib, anlotinib, donafenib, apatinib, sunitinib, cabozantinib, pralsetinib) or D+T combination therapy between January 1, 2019 and December 31, 2025 (or the data cutoff date).
- Patients with no curative-intent thyroid cancer surgery within 3 months after initiation of systematic therapy.
Key exclusion criteria (2 listed)
- Patients participating in a blinded interventional clinical trial, or any open-label observational study involving D+T or MKI, during the study period.
- Other protocol-defined inclusion/exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of Patients Receiving Second-line Systematic Therapy
Time frame: Up to 6 years
Second-line systematic therapy includes lenvatinib, anlotinib, sorafenib, donafenib, and D+T.
Duration of Second-line Systematic Therapy
Time frame: Up to 6 years
Duration of therapy with lenvatinib, anlotinib, sorafenib, donafenib, and D+T.
7 secondary outcomes
Proportion of Patients by Demographics and Clinical Characteristics
Time frame: Baseline
Age
Time frame: Baseline
Proportion of Patients Who had Surgery Prior to Second-line Systematic Therapy
Time frame: Baseline
Proportion of Patients Who Received 131I Radioiodine Therapy Prior to Second-line Systematic Therapy
Time frame: Baseline
Proportion of Patients by First-line Therapy
Time frame: Baseline
Duration Between First Diagnosis of DTC and Treatment Initiation
Time frame: Baseline
Proportion of Patients by Timing and Method of BRAF Testing
Time frame: Baseline, up to 6 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 15 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.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
An observational study of Radioiodine-refractory Differentiated Thyroid Cancer, run by Novartis Pharmaceuticals.
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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Receiving Second-line Systematic Therapy (time frame: Up to 6 years). The study lists 2 primary outcomes in all. 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 15 Oct 2026.