Differentiated Thyroid Cancer (DTC)Phase 3NCT04940052
Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Previously Treated Patients With Metastatic, Radio-active Iodine Refractory BRAF V600E Mutation Positive Differentiated Thyroid Cancer
A Phase 3 study testing Dabrafenib and Trametinib in people with Differentiated Thyroid Cancer (DTC), run by Novartis Pharmaceuticals at 41 sites in 11 countries.
Trial summary
The purpose of this study is to assess the efficacy and safety of dabrafenib in combination with trametinib for treating adult patients with locally advanced or metastatic Differentiated Thyroid Cancer (DTC) harboring the BRAFV600E mutation, who are refractory to radioactive iodine (RAI) therapy and have experienced… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Differentiated Thyroid Cancer (DTC)
- What is being tested?
- Dabrafenib and Trametinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 41 sitesin 11 countries
- Study dates
- 15 Nov 2021to 25 May 2027
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Male or female ≥ 18 years of age at time of informed consent
- Histologically or cytologically confirmed diagnosis of advanced/metastatic differentiated thyroid carcinoma
- Radioactive-iodine refractory disease
- BRAF V600E mutation-positive tumor sample as per central laboratory result
- Has progressed on at least 1 but not more than 2 prior VEGFR targeted therapies
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- At least one measurable lesion as defined by RECIST v1.1.
Who cannot join
- Anaplastic or medullary carcinoma of the thyroid
- Previous treatment with a BRAF inhibitor and/or a MEK inhibitor
- Concomitant RET Fusion-Positive Thyroid Cancer
- Treatment with any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before randomization
- Treatment with any type of anticancer antibody (including investigational antibody) or systemic chemotherapy within 4 weeks before randomization
- Treatment with radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before randomization
- A history or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy
- Other inclusion/exclusion criteria may apply.
Trial locations and contacts
41 sites in 11 countries.
41 sites in 11 countries
China16 sites
Novartis Investigative Site
Beijing, 100036
Novartis Investigative Site
Beijing, 100730
Novartis Investigative Site
Changchun, Jilin, 130033
Novartis Investigative Site
Changsha, Hunan, 410013
Novartis Investigative Site
Chengdu, Sichuan, 610041
Novartis Investigative Site
Fuzhou, Fujian, 350014
Novartis Investigative Site
Guangzhou, 510060
Novartis Investigative Site
Nanjing, Jiangsu, 210006
Novartis Investigative Site
Nanjing, Jiangsu, 210009
Novartis Investigative Site
Shanghai, 200233
Novartis Investigative Site
Tianjin, Tianjin Municipality, 300121
Novartis Investigative Site
Tianjin, 300052
Novartis Investigative Site
Tianjin, 300480
Novartis Investigative Site
Wuhan, Hubei, 430022
Novartis Investigative Site
Xuzhou, Jiangsu, 221003
Novartis Investigative Site
Zhengzhou, Henan, 450008
South Korea4 sites
Novartis Investigative Site
Seoul, 03080
Novartis Investigative Site
Seoul, 05505
Novartis Investigative Site
Seoul, 06351
Novartis Investigative Site
Seoul, 06591
Turkey (Türkiye)4 sites
Novartis Investigative Site
Adana, Yuregir, 01250
Novartis Investigative Site
Ankara, Yenimahalle, 06500
Novartis Investigative Site
Edirne, Merkez, 22030
Novartis Investigative Site
Istanbul, Fatih, 34098
Brazil3 sites
Novartis Investigative Site
Blumenau, Santa Catarina, 89015-200
Novartis Investigative Site
Rio de Janiero, Rio de Janeiro, 20231-050
Novartis Investigative Site
São Paulo, São Paulo, 01246-000
India3 sites
Novartis Investigative Site
Chennai, 600020
Novartis Investigative Site
Hisar, Haryana, 125005
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, 110029
Malaysia3 sites
Novartis Investigative Site
George Town, Pulau Pinang, 10450
Novartis Investigative Site
Kuala Lumpur, 59100
Novartis Investigative Site
Kuching, Sarawak, 93586
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Northwestern University Med School
Chicago, Illinois, 60611
Canada2 sites
Novartis Investigative Site
Edmonton, Alberta, T6G 1Z2
Novartis Investigative Site
London, Ontario, N6A 5W9
Taiwan2 sites
Novartis Investigative Site
Tainan, 704302
Novartis Investigative Site
Taipei, 10002
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Dabrafenib Plus Trametinib in Previously Treated Patients With Locally Advanced or Metastatic, Radio-active Iodine Refractory BRAFV600E Mutation-positive Differentiated Thyroid Cancer (DTC)
The purpose of this study is to assess the efficacy and safety of dabrafenib in combination with trametinib for treating adult patients with locally advanced or metastatic Differentiated Thyroid Cancer (DTC) harboring the BRAFV600E mutation, who are refractory to radioactive iodine (RAI) therapy and have experienced disease progression following one or two prior VEGFR-targeted treatments.
Read the detailed description
This is a global, multicenter, randomized, double-blind, placebo-controlled Phase III study designed to evaluate the efficacy and safety of dabrafenib plus trametinib in adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC) that is positive for the BRAF V600E mutation, refractory to radioactive iodine (RAI), and has progressed following prior vascular endothelial growth factor receptor (VEGFR) targeted therapy.
After eligibility assessment, patients will be randomized in a 2:1 ratio to receive either dabrafenib plus trametinib or placebo. Patients will be stratified by the number of prior VEGFR targeted therapies (one versus two) and prior lenvatinib treatment (yes versus no).
The scientific objective guiding the primary estimand is based on progression-free survival (PFS) as per blinded independent review committee (BIRC) assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
This study will enroll approximately 150 patients.
Patients randomized to the placebo arm who experience disease progression as per RECIST 1.1 confirmed by BIRC and meet eligibility criteria will have the option to cross over to the open-label combination of dabrafenib plus trametinib.
Treatment may continue beyond RECIST 1.1 disease progression (confirmed by BIRC) if, in the investigator's judgment, there is evidence of clinical benefit and the patient wishes to remain on study treatment. In cases where there is a discrepancy between local site determination and BIRC (for example, disease progression determined locally but not by BIRC), the patient should not be discontinued from study treatment until progression is confirmed by BIRC or, at a minimum, until one additional tumor assessment has been completed, provided this is clinically acceptable.
After treatment discontinuation, all patients will be followed for safety and efficacy evaluations during the post-treatment follow-up period. Subsequently, patient status will be collected every 12 weeks as part of survival follow-up.
This study is ongoing, and enrollment was completed on 09-May-2024. The primary analysis was performed after all patients had either completed at least 16 weeks of treatment or discontinued early, and after approximately 95 PFS events had occurred.
- Conditions
- Differentiated Thyroid Cancer (DTC)
- Being tested
- Dabrafenib, Trametinib, Trametinib Placebo, Dabrafenib placebo
- Keywords
- Differentiated Thyroid Cancer (DTC), Locally advanced or metastatic differentiated thyroid cancer, radio active iodine refractory, previously targeted therapy, B-Raf proto-oncogene, serine/threonine kinase (BRAF), BRAFV600E mutation, Dabrafenib (DRB436), trametinib (TMT212)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DabrafenibDrug
Also called DRB436
Dabrafenib 150 mg capsule administered orally twice a day (BID)
TrametinibDrug
Also called TMT212
Trametinib 2 mg tablet administered once a day (QD)
Trametinib PlaceboDrug
matching placebo tablet for Trametinib 2 mg will be administered orally once a day (QD)
Dabrafenib placeboDrug
matching placebo capsule for Dabrafenib 150 mg will be administered orally twice a day (BID)
| Study group | Role | What they receive |
|---|---|---|
| Dabrafenib plus Trametinib | Experimental | Eligible participants will receive Dabrafenib 150 mg twice a day (BID) and Trametinib 2 mg once a day (QD) until disease progression as per RECIST 1.1 as confirmed by blinded independent review committee (BIRC), unacceptable toxicity, pregnancy, loss of clinical benefit as determined by the investigator, withdrawal of consent, lost to follow-up, death, or study termination by the sponsor. Receives: Drug: Dabrafenib; Drug: Trametinib |
| Dabrafenib Placebo plus Trametinib Placebo | Placebo comparator | Eligible participants will receive matching placebo for Dabrafenib 150 mg twice a day (BID) and matching placebo for Trametinib 2 mg once a day (QD) until disease progression as per RECIST 1.1 as confirmed by blinded independent review committee (BIRC), unacceptable toxicity, pregnancy, loss of clinical benefit as determined by the investigator, withdrawal of consent, lost to follow-up, death, or study termination by the sponsor. Receives: Drug: Trametinib Placebo; Drug: Dabrafenib placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Progression Free Survival (PFS) was defined as the time from the date of randomization to the date of the first documented progression according to RECIST 1.1 based on Blinded Independent Review Committee (BIRC) assessment, or death due to any cause.
The primary analysis was conducted after all patients had either completed a minimum of 16 weeks of treatment or discontinued earlier, and following the occurrence of approximately 95 PFS events (Data cut-off date for the primary analysis was 22 January 2025).
Measured: From randomization to first documented progression or deaths, whichever comes first, assessed up to approximately 3 years
Secondary outcomes (5)
Overall Response Rate (ORR)
Overall Response Rate (ORR) was defined as the proportion of participants who had a Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) according to RECIST 1.1.
Measured: From randomization assessed through Primary Analysis Cut-off date (approximately 3 years)
Overall Survival (OS)
Overall Survival (OS) is defined as the time from the date of randomization to the date of death due to any cause.
Measured: From randomization to death assessed up to approximately 5 years
Duration of Response (DOR)
Duration of Response (DOR) applied only to patients whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR) according to RECIST 1.1. The start date was defined as the date of the first documented confirmed CR or PR, and the end date corresponded to the date of the first documented confirmed progression or death from any cause. Patients who remained without progression or death from any cause were censored at the date of their last adequate tumor assessment prior to the initiation of any new antineoplastic therapy.
Measured: From the first documented complete or partial response to the first documented progression or death, assessed up to Primary Analysis Cut-off date (approximately 3 years)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
The distribution of adverse events will be conducted through the analysis of frequencies for treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs), based on the monitoring of relevant clinical and laboratory safety parameters. Treatment-emergent adverse events (TEAEs) in this study will be defined as events that begin after the first dose of study treatment and continue until 30 days after the last dose, or events that are present prior to the first dose and increase in severity based on preferred term within 30 days following the last dose.
Measured: Throughout study completion, an average 5 years
Number of Participants With Trametinib Associated Serous Retinopathy Ocular Events
Analysis of the optical coherence tomography data was performed to assess the incidence, type, and severity of trametinib-associated serous retinopathy ocular events, using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grading system: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening), and Grade 5 (death related to adverse event).
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start15 Nov 2021
- Primary completion22 Jan 2025
- Study completion25 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Differentiated Thyroid Cancer (DTC)Studies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Patients will be randomized in a 2:1 ratio to either dabrafenib plus trametinib or placebo. Patients will be stratified by number of prior VEGFR targeted therapy (1 versus 2) and prior Lenvatinib treatment (yes versus no).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 153 participants (actual)
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
- NCT04940052
- Sponsor's protocol ID
- CDRB436J12301
- Status last verified
- Sep 2026
- First submitted
- 22 Jun 2021
- Last updated
- 21 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Publications
Gao M, Park YJ, Lin CC, Krzyzanowska MK, Li Z, Tsai HJ, Shi F, Qin J, Choong SH, Lin Y, Zhang Y, Kang JH, Hoff AO, Tan M, Roughton M, Paul M, Wirth LJ. Efficacy and safety of dabrafenib plus trametinib in adults with differentiated thyroid cancer: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2026 Aug;27(8):994-1003. doi: 10.1016/S1470-2045(26)00133-6. Epub 2026 Jul 13.
PubMed 42442381
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Dabrafenib Plus Trametinib in Previously Treated Patients With Locally Advanced or Metastatic, Radio-active Iodine Refractory BRAFV600E Mutation-positive Differentiated Thyroid Cancer (DTC)
- ClinicalTrials.gov ID
- NCT04940052
- Acronym / sponsor ID
- CDRB436J12301
- Conditions
- Differentiated Thyroid Cancer (DTC)
- Keywords
- Differentiated Thyroid Cancer (DTC), Locally advanced or metastatic differentiated thyroid cancer, radio active iodine refractory, previously targeted therapy, B-Raf proto-oncogene, serine/threonine kinase (BRAF), BRAFV600E mutation, Dabrafenib (DRB436), trametinib (TMT212)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 22 Jan 2025 (actual)
- Study completion
- 25 May 2027 (estimated)
- First posted
- 25 Jun 2021 (actual)
- Results
- Posted 22 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy and safety of dabrafenib in combination with trametinib for treating adult patients with locally advanced or metastatic Differentiated Thyroid Cancer (DTC) harboring the BRAFV600E mutation, who are refractory to radioactive iodine (RAI) therapy and have experienced disease progression following one or two prior VEGFR-targeted treatments.
Detailed description
This is a global, multicenter, randomized, double-blind, placebo-controlled Phase III study designed to evaluate the efficacy and safety of dabrafenib plus trametinib in adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC) that is positive for the BRAF V600E mutation, refractory to radioactive iodine (RAI), and has progressed following prior vascular endothelial growth factor receptor (VEGFR) targeted therapy.
After eligibility assessment, patients will be randomized in a 2:1 ratio to receive either dabrafenib plus trametinib or placebo. Patients will be stratified by the number of prior VEGFR targeted therapies (one versus two) and prior lenvatinib treatment (yes versus no).
The scientific objective guiding the primary estimand is based on progression-free survival (PFS) as per blinded independent review committee (BIRC) assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
This study will enroll approximately 150 patients.
Patients randomized to the placebo arm who experience disease progression as per RECIST 1.1 confirmed by BIRC and meet eligibility criteria will have the option to cross over to the open-label combination of dabrafenib plus trametinib.
Treatment may continue beyond RECIST 1.1 disease progression (confirmed by BIRC) if, in the investigator's judgment, there is evidence of clinical benefit and the patient wishes to remain on study treatment. In cases where there is a discrepancy between local site determination and BIRC (for example, disease progression determined locally but not by BIRC), the patient should not be discontinued from study treatment until progression is confirmed by BIRC or, at a minimum, until one additional tumor assessment has been completed, provided this is clinically acceptable.
After treatment discontinuation, all patients will be followed for safety and efficacy evaluations during the post-treatment follow-up period. Subsequently, patient status will be collected every 12 weeks as part of survival follow-up.
This study is ongoing, and enrollment was completed on 09-May-2024. The primary analysis was performed after all patients had either completed at least 16 weeks of treatment or discontinued early, and after approximately 95 PFS events had occurred.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized in a 2:1 ratio to either dabrafenib plus trametinib or placebo. Patients will be stratified by number of prior VEGFR targeted therapy (1 versus 2) and prior Lenvatinib treatment (yes versus no).
| Arm | Type | Receives |
|---|---|---|
| Dabrafenib plus Trametinib | Experimental | Drug: Dabrafenib, Drug: TrametinibEligible participants will receive Dabrafenib 150 mg twice a day (BID) and Trametinib 2 mg once a day (QD) until disease progression as per RECIST 1.1 as confirmed by blinded independent review committee (BIRC), unacceptable toxicity, pregnancy, loss of clinical benefit as determined by the investigator, withdrawal of consent, lost to follow-up, death, or study termination by the sponsor. |
| Dabrafenib Placebo plus Trametinib Placebo | Placebo comparator | Drug: Trametinib Placebo, Drug: Dabrafenib placeboEligible participants will receive matching placebo for Dabrafenib 150 mg twice a day (BID) and matching placebo for Trametinib 2 mg once a day (QD) until disease progression as per RECIST 1.1 as confirmed by blinded independent review committee (BIRC), unacceptable toxicity, pregnancy, loss of clinical benefit as determined by the investigator, withdrawal of consent, lost to follow-up, death, or study termination by the sponsor. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed informed consent
- Male or female ≥ 18 years of age at time of informed consent
- Histologically or cytologically confirmed diagnosis of advanced/metastatic differentiated thyroid carcinoma
- Radioactive-iodine refractory disease
- BRAF V600E mutation-positive tumor sample as per central laboratory result
Key exclusion criteria (8 listed)
- Anaplastic or medullary carcinoma of the thyroid
- Previous treatment with a BRAF inhibitor and/or a MEK inhibitor
- Concomitant RET Fusion-Positive Thyroid Cancer
- Treatment with any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before randomization
- Treatment with any type of anticancer antibody (including investigational antibody) or systemic chemotherapy within 4 weeks before randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DabrafenibAlso: DRB436Dabrafenib 150 mg capsule administered orally twice a day (BID) | Drug | Dabrafenib plus Trametinib |
| TrametinibAlso: TMT212Trametinib 2 mg tablet administered once a day (QD) | Drug | Dabrafenib plus Trametinib |
| Trametinib Placebomatching placebo tablet for Trametinib 2 mg will be administered orally once a day (QD) | Drug | Dabrafenib Placebo plus Trametinib Placebo |
| Dabrafenib placebomatching placebo capsule for Dabrafenib 150 mg will be administered orally twice a day (BID) | Drug | Dabrafenib Placebo plus Trametinib Placebo |
Primary outcome
Progression Free Survival (PFS)
Time frame: From randomization to first documented progression or deaths, whichever comes first, assessed up to approximately 3 years
Progression Free Survival (PFS) was defined as the time from the date of randomization to the date of the first documented progression according to RECIST 1.1 based on Blinded Independent Review Committee (BIRC) assessment, or death due to any cause. The primary analysis was conducted after all patients had either completed a minimum of 16 weeks of treatment or discontinued earlier, and following the occurrence of approximately 95 PFS events (Data cut-off date for the primary analysis was 22 January 2025).
5 secondary outcomes
Overall Response Rate (ORR)
Time frame: From randomization assessed through Primary Analysis Cut-off date (approximately 3 years)
Overall Survival (OS)
Time frame: From randomization to death assessed up to approximately 5 years
Duration of Response (DOR)
Time frame: From the first documented complete or partial response to the first documented progression or death, assessed up to Primary Analysis Cut-off date (approximately 3 years)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Throughout study completion, an average 5 years
Number of Participants With Trametinib Associated Serous Retinopathy Ocular Events
Time frame: Up to approximately 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42442381Gao M, Park YJ, Lin CC, Krzyzanowska MK, Li Z, Tsai HJ, Shi F, Qin J, Choong SH, Lin Y, Zhang Y, Kang JH, Hoff AO, Tan M, Roughton M, Paul M, Wirth LJ. Efficacy and safety of dabrafenib plus trametinib in adults with differentiated thyroid cancer: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2026 Aug;27(8):994-1003. doi: 10.1016/S1470-2045(26)00133-6. Epub 2026 Jul 13.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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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. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
41 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dabrafenib and Trametinib in people with Differentiated Thyroid Cancer (DTC), run by Novartis Pharmaceuticals at 41 sites in 11 countries.
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 8 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in China, South Korea, Turkey (Türkiye), Brazil, India and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: From randomization to first documented progression or deaths, whichever comes first, assessed up to approximately 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04940052, which also lists 1 linked publication.
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 21 Sep 2026.