Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07770074

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

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Radioiodine-refractory Differentiated Thyroid Cancer

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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/exclusion criteria may apply.

Treatment and study plan

Primary outcomes

  1. 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.

  2. Duration of Second-line Systematic Therapy

    Time frame: Up to 6 years

    Duration of therapy with lenvatinib, anlotinib, sorafenib, donafenib, and D+T.

Secondary outcomes

  1. Proportion of Patients by Demographics and Clinical Characteristics

    Time frame: 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.

  2. Age

    Time frame: Baseline

  3. Proportion of Patients Who had Surgery Prior to Second-line Systematic Therapy

    Time frame: Baseline

  4. Proportion of Patients Who Received 131I Radioiodine Therapy Prior to Second-line Systematic Therapy

    Time frame: Baseline

  5. Proportion of Patients by First-line Therapy

    Time frame: Baseline

    Proportion of patients who received first-line lenvatinib, anlotinib, sorafenib, donafenib, and D+T.

  6. Duration Between First Diagnosis of DTC and Treatment Initiation

    Time frame: Baseline

  7. Proportion of Patients by Timing and Method of BRAF Testing

    Time frame: Baseline, up to 6 years

    Timing categories include at initial diagnosis, at recurrence or metastasis, prior to second-line initiation, and other/unknown.

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

+41613241111

Novartis Pharmaceuticals

CONTACT

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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)

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 18, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.