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. 2022 May 11;14(5):1040. doi: 10.3390/pharmaceutics14051040

Table 1.

Tyrosine Kinase Inhibitors approved in ongoing clinical trials for Thyroid Cancer.

Clinical Trial Title Study Start: Conditions Interventions Study Type: Outcome Measures
NCT05182931 A Prospective, Multi-Centre Trial of TKI Redifferentiation Therapy in Patients with RAIR Thyroid Cancer (I-FIRST Study) March 2022 Thyroid Cancer Dabrafenib 75 MG Trametinib 2 MG Interventional
Phase 2

  • PFS as assessed by RECIST 1.1 criteria at 6 and 12 months in participants who proceed to l131 treatment

  • PFS by RECIST 1.1 criteria at 6 and 12 months in all participants and a control population (SELECT study)

  • Objective response rate by RECIST 1.1 criteria in all treated participants

  • ORR of treated participants
NCT02657551 A Study Using Regorafenib as Second- or Third-Line Therapy in Metastatic MTC January 2016 Thryoid Cancer Regorafenib Interventional Phase 2

  • PFS

  • Biomarkers associated with response
NCT04521348 Multiple Target Kinase Inhibitor and Anti-Programmed Death-1 Antibody in Patients with Advanced Thyroid Cancer December 2019 Thryoid Cancer Multiple tyrosine kinase inhibitor (mTKI) combined with anti-PD-1 antibody Interventional
Phase 2

  • ORR

  • PFS

  • DOR

  • DCR

  • TTR
NCT04321954 Lenvatinib in Locally Advanced Invasive Thyroid Cancer March 2021 Differentiated Thyroid Cancer Advanced Cancer Lenvatinib Interventional
Phase 2

  • ORR R0/R1 resection rate

  • Number of participants with treatment-related adverse events as assessed by CTCAE v 5.0
NCT04560127 Camrelizumab in Combination with Apatinib in Patients with RAI-refractory Differentiated Thyroid Cancer September 2020 Radioactive Iodine-refractory Differentiated Thyroid Cancer Camrelizumab combination with Apatinib Interventional
Phase 2

  • PFS

  • OR

  • OS

  • DCR

  • TTP

  • AE
NCT04554680 Clinical Trial in RAI-Refractory Thyroid Carcinoma December 2020 Thryoid Cancer Dabrafenib and Trametinib Interventional
Phase 2

  • OR

  • PFS
NCT05007093 Study on the Treatment of DTC with Anlotinib December 2020 Differentiated Thyroid Cancer Anlotinib hydrochloride Interventional
Phase 2

  • TTR

  • PFS
NCT04952493 Anlotinib or Penpulimab in Combination with RAI for DTC July 2019 Differentiated Thyroid Cancer Anlotinib +I 131 Penpulimab Interventional
Phase 2

  • ORR

  • DCR

  • PFS
NCT04238624 Study of Cemiplimab Combined with Dabrafenib and Trametinib in People With ATC January 2020 Anaplastic Thyroid Cancer with BRAF Gene Mutation Dabrafenib Trametinib Interventional
Phase 2

  • ORR

  • PFS

  • OS
NCT04787328 A Study of HA121-28 Tablets in Patients With MTC July 2021 Medullary Thyroid Carcinoma HA121-28 tablets Interventional
Phase 2

  • ORR

  • PFS

  • DOR

  • OS
NCT04544111 PDR001 Combination Therapy for RAI-Refractory Thyroid Cancer September 2020 Follicular, Poorly Differentiated Carcinoma Trametinib, Dabrafenib, PDR001 Interventional
Phase 2

  • ORR

  • PFS

  • OS
NCT04061980 Encorafenib and Binimetinib with or Without Nivolumab in Treating Patients with Metastatic RAI-Refractory BRAF Mutant Thyroid Cancer October 2020 BRAF V600E Mutation Present Refractory Thyroid Carcinoma Binimetinib Encorafenib Nivolumab Interventional
Phase 2

  • ORR

  • PFS

  • DOR
NCT05102292 The Efficacy and Safety of HLX208 in Advanced ATC With BRAF V600 Mutation December 2021 Anaplastic Thyroid Cancer HLX208 Interventional
Phase 1
Phase 2

  • ORR

  • PFS

  • OR
NCT04739566 Dabrafenib and Trametinib Combination as a Neoadjuvant Strategy in BRAF-positive ATC January 2021 Anaplastic Thyroid Cancer Dabrafenib and Trametinib Interventional
Phase 2

  • ORR

  • OS

  • PFS
NCT04675710 Pembrolizumab, Dabrafenib, and Trametinib Before Surgery for the Treatment of BRAF- Mutated ATC June 2021 Anaplastic Thyroid Cancer Dabrafenib Pembrolizumab Trametinib Interventional
Phase 2

  • ORR

  • OS

  • PFS
NCT04161391 Study of TPX-0046, A RET/SRC Inhibitor in Adult Subjects with Advanced Solid Tumors Harboring RET Fusions or Mutations December 2019 Medullary Thyroid Cancer TPX-0046 Interventional
Phase 1
Phase 2

  • ORR

  • AEs
NCT04579757 Surufatinib in Combination with Tislelizumab in Subjects with Advanced Solid Tumors March 2021 Anaplastic Thyroid Cancer Surufatinib Tislelizumab Interventional
Phase 1
Phase 2

  • ORR

  • OS

  • PFS

  • DOR

  • Maximum plasma concentrations of surufatinib and tislelizumab with blood sampling

Abbreviations: Overall response rate (ORR); Overall survival (OS); Progression-free survival (PFS); Duration of Response (DOR); Disease Control Rate (DCR); Time to response (TTR); Time to Progression (TTP); Adverse events (AE); Overall response (OR).