A Real-World Study of Second-line Therapies Among Radioiodine-refractory Differentiated Thyroid Cancer (RAI-R DTC) Patients

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)

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07770074

Enrollment

200

Registered

2026-08-18

Start date

2026-10-08

Completion date

2026-10-31

Last updated

2026-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radioiodine-refractory Differentiated Thyroid Cancer

Keywords

Radioiodine-refractory Differentiated Thyroid Cancer, BRAF V600E mutation, Dabrafenib, Trametinib, Second-line systematic therapy

Brief 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. This is a non-interventional study using secondary data derived from a real-world Electronic Health Record (rEHR) database in China.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

• 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/

Design outcomes

Primary

Measure	Time frame	Description
Proportion of Patients Receiving Second-line Systematic Therapy	Up to 6 years	Second-line systematic therapy includes lenvatinib, anlotinib, sorafenib, donafenib, and D+T.
Duration of Second-line Systematic Therapy	Up to 6 years	Duration of therapy with lenvatinib, anlotinib, sorafenib, donafenib, and D+T.

Secondary

Measure	Time frame	Description
Proportion of Patients by Demographics and Clinical Characteristics	Baseline	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.
Age	Baseline	—
Proportion of Patients Who had Surgery Prior to Second-line Systematic Therapy	Baseline	—
Proportion of Patients Who Received 131I Radioiodine Therapy Prior to Second-line Systematic Therapy	Baseline	—
Proportion of Patients by First-line Therapy	Baseline	Proportion of patients who received first-line lenvatinib, anlotinib, sorafenib, donafenib, and D+T.
Duration Between First Diagnosis of DTC and Treatment Initiation	Baseline	—
Proportion of Patients by Timing and Method of BRAF Testing	Baseline, up to 6 years	Timing categories include at initial diagnosis, at recurrence or metastasis, prior to second-line initiation, and other/unknown.

Contacts

CONTACTNovartis Pharmaceuticals

novartis.email@novartis.com+41613241111

STUDY_DIRECTORNovartis Pharmaceuticals

Novartis Pharmaceuticals

Outcome results