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Current Clinical Trials

Clinical trials of first generation RET inhibitors in all RET positive solid tumors

Study TitleNCT NumberStatusInterventionsConditionsSponsor or CollaboratorPhaseLaste Update posted
A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001)NCT03157128RecruitingDrug: LOXO-292Non-Small Cell Lung Cancer| Medullary Thyroid Cancer| Colon Cancer| Any Solid TumorLoxo Oncology, Inc.| Eli Lilly and Company1, 28/8/2022
Selpercatinib for the Treatment of Advanced Solid Tumors, Lymphomas, or Histiocytic Disorders With Activating RET Gene Alterations, a Pediatric MATCH Treatment TrialNCT04320888RecruitingDrug: Selpercatinib>40 conditionsNational Cancer Institute (NCI)|Children's Oncology Group29/19/2022
A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC)NCT04819100RecruitingDrug: Selpercatinib | Drug: PlaceboCarcinoma, Non-Small-Cell LungLoxo Oncology, Inc.| Eli Lilly and Company29/21/2022
Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)NCT03944772RecruitingDrug: Osimertinib| Drug: Savolitinib| Drug: Gefitinib| Drug: Necitumumab| Drug: Durvalumab| Drug: Carboplatin| Drug: Pemetrexed| Drug: Alectinib| Drug: Selpercatinib| Drug: Selumetinib| Drug: Etoposide| Drug: Cisplatin| Drug: Datopotamab deruxtecanNon-Small-Cell LungAstraZeneca29/26/2022

Clinical trials of first generation RET inhibitors in NSCLC

Study TitleNCT NumberStatusInterventionsConditionsSponsor or CollaboratorPhasesLast Update Posted
Testing the Use of Targeted Treatment for RET Positive Advanced Non-small Cell Lung CancerNCT05364645RecruitingDrug: Carboplatin| Drug: Pemetrexed| Drug: SelpercatinibNon-Small Cell Lung CancerSouthwest Oncology Group| National Cancer Institute (NCI)28/12/22
A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung CancerNCT04194944RecruitingDrug: Selpercatinib| Drug: Carboplatin| Drug: Cisplatin| Drug: Pemetrexed| Drug: PembrolizumabNon-Small Cell Lung CancerLoxo Oncology, Inc.| Eli Lilly and Company39/9/22
A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)NCT04222972RecruitingDrug: Pralsetinib| Drug: Carboplatin| Drug: Cisplatin| Drug: Pemetrexed| Drug: Pembrolizumab| Drug: Gemcitabine| Drug: Paclitaxel| Drug: Nab-PaclitaxelNon-Small Cell Lung CancerHoffmann-La Roche39/6/22
A Study of Multiple Therapies in Biomarker-Selected Patients With Resectable Stages IB-III Non-Small Cell Lung CancerNCT04302025

RecruitingDrug: Alectinib| Drug: Entrectinib| Drug: Vemurafenib| Drug: Cobimetinib| Drug: Pralsetinib| Drug: Atezolizumab| Drug: SBRT|Procedure: Resection| Drug: ChemotherapyNon-Small Cell Lung CancerGenentech, Inc.| Blueprint Medicines Corporation| Chugai Pharmaceutical Co.| Hoffmann-La Roche212/7/22

Clinical trials looking at next generation RET inhibitors in NSCLC and other RET positive solid tumors

Study TitleNCT NumberStatusInterventionsConditionsSponsor or CollaboratorPhaseLast Update PostedMechanism of actionInclusion criteria (for more info visit the clinical trials web)Available patient materials
Study of RET Inhibitor TAS0953/HM06 in Patients With Advanced Solid Tumors With RET Gene AbnormalitiesNCT04683250RecruitingDrug: TAS0953/HM06RET-altered Non Small Cell Lung Cancer| RET-altered Solid TumorsHelsinn Healthcare SA| ICON Clinical Research1, 24/14/22TAS0953/HM06 is a structurally distinct RET-specific inhibitor that is effective against RET solvent front (G810) and gatekeeper (V804) mutations.18 Years and older. RET-altered advanced solid tumors. Documented progression of disease following existing therapies.
Study of TPX-0046, A RET/SRC Inhibitor in Adult Subjects With Advanced Solid Tumors Harboring RET Fusions or MutationsNCT04161391RecruitingDrug: TPX-0046Non-Small Cell Lung Cancer| Medullary Thyroid Cancer| RET Gene Mutation| Metastatic Solid Tumor| Advanced Solid TumorTurning Point Therapeutics, Inc.1, 23/14/22TPX-0046 is a structurally differentiated RET inhibitor that is potent against a range of RET solvent front mutations (G810)18 Years and older. Advanced/metastatic solid tumors harboring oncogenic RET fusions or mutations, who either have disease progression on, or are intolerant to standard therapy.
A Study of LOXO-260 in Cancer Patients With a Change in a Particular Gene (RET) That Has Not Responded to TreatmentNCT05241834RecruitingDrug: LOXO-260Carcinoma, Non-Small-Cell Lung| Thyroid NeoplasmsEli Lilly and Company| Loxo Oncology, Inc.18/17/22LOXO-260 is a selective inhibitor of the RET receptor tyrosine kinase that has activity against both solvent front and gatekeeper mutations18 Years and older. Patients 12 years and older may be enrolled in Phase 1b for countries and sites where approved. Locally advanced, unresectable and/or metastatic cancer. Evidence of a previously documented RET fusion (solid tumors) or RET mutation. Patients who have received a prior selective RET inhibitor.
A Study of EP0031-101 in Patients With Advanced RET-altered MalignanciesNCT05443126RecruitingDrug: EP0031Advanced Solid TumorEllipses Pharma1, 212/2/22EP0031 selectively binds to various RET fusions and mutations, including solvent front resistance mutations18 Years and older (or age ≥ 20 as required by local regulation). Advanced Solid Tumor. Patients with RET-altered tumors who have progressed following first- generation selective RET inhibitor (SRI) therapy and patients with RET-altered tumors with no prior SRI therapy.Study Consent Form

Study Protocol Synopsis

Clinical trials looking at other RET inhibitors in NSCLC and other solid tumors

Study TitleNCT NumberStatusInterventionsConditionsSponsor or CollaboratorPhaseLast Updated PostMechanism of actionInclusion criteria (for more info visit the clinical trials website)
Study of HA121-28 in Patients With Non-Small Cell Lung CancerNCT05117658RecruitingDrug: HA121-28 tabletNon-Small Cell Lung CancerCSPC ZhongQi Pharmaceutical Technology Co., Ltd.28/4/22HA121-28 is a highly potent, multi-targeted tyrosine kinase inhibitor with RET as its main targetAged 18 ~ 75 years old. Patients with confirmed unresectable locally advanced or metastatic NSCLC. RET gene fusion. Progressive disease after at least one line of standard therapy.
A Phase I Study to Evaluate the Safety, Pharmacokinetics and Efficacy of SY-5007 in Patients With Advanced Solid TumorsNCT05278364RecruitingDrug: SY-5007Non-Small Cell Lung Cancer| Medullary Thyroid Cancer| Solid TumorShouyao Holdings (Beijing) Co. LTD13/18/22Oral RET selective Inhibitor18 Years and older. Dose-escalation Part: patients must have confirmed advanced solid tumors with RET alteration (fusion or mutation) and have progressed after standard therapy, or no standard or available curative therapy exists. Dose-expansion Part: Patients with advanced tumor must have confirmed RET alteration, and either have progressed after standard therapy or no standard/ available curative therapy exists.
HEC169096 in Participants With Advanced Solid TumorsNCT05451602RecruitingDrug: HEC169096Advanced Solid TumorSunshine Lake Pharma Co., Ltd.1, 210/27/22Highly-selective RET Inhibitor18 Years and older. Phase 1: diagnosed non-resectable advanced solid tumor. Phase 2: All participants must have an oncogenic RET-rearrangement/fusion or mutation solid tumor.
Phase 1 Study of the HS-10365 in Patients With Advanced Solid TumorsNCT05207787RecruitingDrug: HS-10365Solid TumorJiangsu Hansoh Pharmaceutical Co., Ltd.11/26/22Small molecular, oral potent, selective RET inhibitor18 Years and older. Locally advanced or metastatic cancer patients for who that standard treatment is invalid, unavailable or intolerable. Enrollment will be restricted to participants with evidence of a RET gene alteration.
Vandetanib and Everolimus in Treating Patients With Advanced or Metastatic CancerNCT01582191RecruitingDrug: Everolimus| Drug: VandetanibAdvanced Malignant Neoplasm| Metastatic Malignant Neoplasm| Recurrent Malignant Neoplasm| Refractory Malignant NeoplasmM.D. Anderson Cancer Center| National Cancer Institute (NCI)16/30/22A multi-kinase inhibitor of epidermal growth factor receptor [EGFR], vascular endothelial growth factor receptor [VEGFR] and ret proto-oncogene [RET] inhibitor18 Years and older. Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or who have no standard therapy available.
Cabozantinib in Patients With RET Fusion-Positive Advanced Non-Small Cell Lung Cancer and Those With Other Genotypes: ROS1 or NTRK Fusions or Increased MET or AXL ActivityNCT01639508RecruitingDrug: CabozantinibNon-Small Cell Lung CancerMemorial Sloan Kettering Cancer Center| Exelixis26/23/22Cabozantinib is an oral medicine that inhibits of RET, ROS1, NTRK, MET, and AXL. Also this drug interferes with other cell pathways that also cause cancer cells to grow, form new blood vessels, and spread to other organs of the body18 Years and older. Diagnosis of non-small cell lung carcinoma that is metastatic or unresectable. Documented presence: Group A: KIF5B/RET or related variant RET fusions. GROUP D: RET-fusion post-progression on selective RET inhibitor.

Clinical trials looking at immunotherapy in RET NSCLC

Study TitleNCT NumberStatusInterventionsConditionsSponsor or ColaboratorPhaseLast Update PostedMechanism of actionInclusion criteria (for more info visit the clinical trials website)
Chemotherapy or Chemotherapy Plus PD-1 Antibody in RET Fusion Positive Advanced NSCLC Patitnts: the POSEIDON TrialNCT04322591RecruitingDrug: Chemotherapy | Drug: Chemotherapy Plus PD-1 AntibodyNon-Small Cell Lung CancerHunan Province Tumor Hospital3/2/22PD-1 antibody: A monoclonal antibody directed against the cell surface receptor PD-1 with potential anti-neoplastic effects by restoring immune function through the activation of T-cells.18 Years and older. Advanced non-squamous non-small cell lung cancer (NSCLC). RET fusion positive.

Clinical trials looking at first Generation RET inhibitors for RET-altered thyroid cancers

Study TitleNCT NumberStatusInterventionsConditionsSponsor or ColaboratorPhaseLast Update PostedMechanism of actionInclusion criteria (for more info visit the clinical trials website)
Selpercatinib Before Surgery for the Treatment of RET-Altered Thyroid CancerNCT04759911RecruitingDrug: SelpercatinibThyroid CancerM.D. Anderson Cancer Center27/18/22Selpercatinib, also known as LOXO-292, is a highly selective and potent, oral inhibitor for the treatment of patients with cancers that harbor abnormalities in the RET kinase12 years and older. Patients with RET-altered thyroid cancer who present with locally advanced primary tumor. Medullary thyroid carcinoma, papillary thyroid carcinoma, poorly differentiated thyroid carcinoma, or anaplastic thyroid carcinoma. Having an activating RET gene alteration (fusion or mutation). Prior multikinase inhibitors with anti-RET activity are allowed.
A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid CancerNCT04211337RecruitingDrug: Selpercatinib| Drug: Cabozantinib| Drug: VandetanibMedullary Thyroid CancerLoxo Oncology, Inc.| Eli Lilly and Company39/9/22Selpercatinib, also known as LOXO-292, is a highly selective and potent, oral inhibitor for the treatment of patients with cancers that harbor abnormalities in the RET kinase12 years and older. Patients with RET-altered thyroid cancer who present with locally advanced primary tumor. Medullary thyroid carcinoma, papillary thyroid carcinoma, poorly differentiated thyroid carcinoma, or anaplastic thyroid carcinoma. Having an activating RET gene alteration (fusion or mutation). Prior multikinase inhibitors with anti-RET activity are allowed.
A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) TumorsNCT03899792RecruitingDrug: LOXO-292Medullary Thyroid Cancer| Infantile Myofibromatosis| Infantile Fibrosarcoma| Papillary Thyroid Cancer|Soft Tissue SarcomaLoxo Oncology, Inc.| Eli Lilly and Company1, 27/8/22Selpercatinib, also known as LOXO-292, is a highly selective and potent, oral inhibitor for the treatment of patients with cancers that harbor abnormalities in the RET kinase6 Months to 21 Years. Advanced or metastatic solid or primary CNS tumor which has failed standard of care therapies. Evidence of an activating RET gene alteration in the tumor and/or blood.

Data collection studies for RET-altered cancers

Study TitleNCT NumberStatusInterventionsConditionsSponsor or ColaboratorPhaseLast Update PostedInclusion criteria (for more info visit the clinical trials website)
Real Word European Registry of NTRK Fusions and Other Rare Actionable Fusions (TRacKING)NCT04921553Data collection and quality of life questionnaireCancer RET Gene TranslocationCentre Leon BerardObservational8/2/2118 Years and older.Patient with histologically-confirmed cancer. Patient harboring a rare actionable fusion. Availability of clinical and demographic data, information on treatment and clinical outcome. Patient should understand, sign and date the written voluntary informed consent form.

SOURCE: clinicaltrials.gov

In addition to the list above, My Cancer Genome is a great resource for a complete list of current RET clinical trials. Click the button below to view the current list of clinical trials.

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