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
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