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Not yet recruitingNCT07770074Updated Oct 15, 2026

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

An observational study in Radioiodine-refractory Differentiated Thyroid Cancer, sponsored by Novartis Pharmaceuticals. Not yet recruiting. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by Novartis Pharmaceuticals (part of Novartis) · Observational

Updated Oct 15, 2026Start date movedPrimary completion moved+1 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
200
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Radioiodine-refractory Differentiated Thyroid Cancer

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Keywords

  • Radioiodine-refractory Differentiated Thyroid Cancer
  • BRAF V600E mutation
  • Dabrafenib
  • Trametinib
  • Second-line systematic therapy
03

In context

Thyroid Neoplasms

785 studies on the registry are indexed under Thyroid Neoplasms; 204 are open to participants now.

This study's planned enrollment of 200 is above the median of 178 across 241 observational studies indexed under Thyroid Neoplasms.

Browse Thyroid Neoplasms studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.

Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.

Browse Novartis Pharmaceuticals studies →All Novartis studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult RAI-R DTC patients from the rEHR database in China.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • RAI-R DTC Cohort

    Adult patients diagnosed with RAI-R DTC.

06

What researchers measure

Primary outcomes

  1. Proportion of Patients Receiving Second-line Systematic Therapy

    Second-line systematic therapy includes lenvatinib, anlotinib, sorafenib, donafenib, and D+T.

    Time frame: Up to 6 years

  2. Duration of Second-line Systematic Therapy

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

    Time frame: Up to 6 years

Secondary outcomes

  1. 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.

    Time frame: Baseline

  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

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

    Time frame: Baseline

  6. Duration Between First Diagnosis of DTC and Treatment Initiation

    Time frame: Baseline

  7. 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.

    Time frame: Baseline, up to 6 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Start is estimated for Jan 2027; primary completion for Jan 2027, 0 months later.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 15, 2026: start Oct 2026 → Jan 2027, primary completion Oct 2026 → Jan 2027 and completion Oct 2026 → Jan 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 10, 2026
First posted
Aug 18, 2026
StartEst.
Jan 4, 2027was Oct 2026
Primary completionEst.
Jan 5, 2027was Oct 2026
CompletionEst.
Jan 5, 2027was Oct 2026
Last update
Oct 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Oct 8, 2026→Jan 4, 2027
Oct 15, 2026
Primary completion
Oct 31, 2026→Jan 5, 2027
Oct 15, 2026
Study completion
Oct 31, 2026→Jan 5, 2027
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    Start date Oct 8, 2026→Jan 4, 2027
    Primary completion Oct 31, 2026→Jan 5, 2027
    Study completion Oct 31, 2026→Jan 5, 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07770074
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Aug 18, 2026
Start date
Jan 4, 2027 (estimated)
Primary completion
Jan 5, 2027 (estimated)
Completion
Jan 5, 2027 (estimated)
Last update
Oct 15, 2026

Study contacts

Novartis Pharmaceuticals
Contact
novartis.email@novartis.com
+41613241111
Novartis Pharmaceuticals
Contact
Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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