| Study Title | NCT Number | Status | Interventions | Conditions | Sponsor or Collaborator | Phase | Laste Update posted | Mechanism of action | Inclusion criteria (for more visit the clinical trials website) |
|---|---|---|---|---|---|---|---|---|---|
| A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001) | NCT03157128 | Recruiting | Drug: LOXO-292 | Non-Small Cell Lung Cancer| Medullary Thyroid Cancer| Colon Cancer| Any Solid Tumor | Loxo Oncology, Inc.| Eli Lilly and Company | 1, 2 | 8/8/2022 | Selpercatinib, 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 kinase | Phase 1: 12 Years and older. Participants with a locally advanced or metastatic solid tumor that has progressed on or is intolerant to standard therapy, or for which no standard therapy exists. Prior multikinase inhibitors (MKIs) with anti-RET activity are allowed. A RET gene alteration is not required initially. Once adequate pharmacokinetics exposure is achieved, evidence of RET gene alteration is required. |
| Selpercatinib for the Treatment of Advanced Solid Tumors, Lymphomas, or Histiocytic Disorders With Activating RET Gene Alterations, a Pediatric MATCH Treatment Trial | NCT04320888 | Recruiting | Drug: Selpercatinib | >40 conditions | National Cancer Institute (NCI)|Children's Oncology Group | 2 | 9/19/2022 | Selpercatinib, 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 kinase | 12 Months to 21 Years. Patient must have enrolled onto APEC1621SC (The Pediatric MATCH Screening Trial) and must have been given a treatment assignment to MATCH to APEC1621N based on the presence of an actionable mutation. |
| A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC) | NCT04819100 | Recruiting | Drug: Selpercatinib | Drug: Placebo | Carcinoma, Non-Small-Cell Lung | Loxo Oncology, Inc.| Eli Lilly and Company | 2 | 9/21/2022 | Selpercatinib, 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 kinase | 18 Years and older. Stage IB, II, or IIIA NSCLC. Must have an activating RET gene fusion in tumor. Must have received definitive locoregional therapy with curative intent (surgery or radiotherapy) for Stage IB, II, or IIIA NSCLC. Must have undergone the available anti-cancer therapy or not be suitable for it. |
| Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD) | NCT03944772 | Recruiting | Drug: 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 deruxtecan | Non-Small-Cell Lung | AstraZeneca | 2 | 9/26/2022 | Selpercatinib, 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 kinase | 18 Years to 130 Years. Locally advanced or metastatic NSCLC not amenable to curative surgery or radiotherapy at study entry. Histologically or cytologically confirmed adenocarcinoma of the lung harboring EGFR mutation(s). Received only one line of therapy, with single-agent osimertinib, for advanced NSCLC. Evidence of radiological disease progression on first-line monotherapy with osimertinib. |
Current RET Clinical Trials
Clinical trials of first generation RET inhibitors in all RET positive solid tumors
Clinical trials of first generation RET inhibitors in NSCLC
| Study Title | NCT Number | Status | Interventions | Conditions | Sponsor or Collaborator | Phases | Last Update Posted | Mechanism of action | Inclusion criteria (for more info visit the clinical trials website) | Available patient matierlas |
|---|---|---|---|---|---|---|---|---|---|---|
| Testing the Use of Targeted Treatment for RET Positive Advanced Non-small Cell Lung Cancer | NCT05364645 | Recruiting | Drug: Carboplatin| Drug: Pemetrexed| Drug: Selpercatinib | Non-Small Cell Lung Cancer | Southwest Oncology Group| National Cancer Institute (NCI) | 2 | 8/12/22 | 18 Years to 130 Years. Locally advanced or metastatic NSCLC not amenable to curative surgery or radiotherapy at study entry. Histologically or cytologically confirmed adenocarcinoma of the lung harboring EGFR mutation(s). Received only one line of therapy, with single-agent osimertinib, for advanced NSCLC. Evidence of radiological disease progression on first-line monotherapy with osimertinib. | 18 Years and older. Must have stage IV or recurrent disease. Participants must have been assigned to S1900F based on biomarker analysis of tissue and/or blood and determined to have RET fusion-positive NSCLC. Participants must have received and developed disease progression during or after an anti-RET inhibitors treatment. | SWOG patient materials |
| A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer | NCT04194944 | Recruiting | Drug: Selpercatinib| Drug: Carboplatin| Drug: Cisplatin| Drug: Pemetrexed| Drug: Pembrolizumab | Non-Small Cell Lung Cancer | Loxo Oncology, Inc.| Eli Lilly and Company | 3 | 9/9/22 | |||
| A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) | NCT04222972 | Recruiting | Drug: Pralsetinib| Drug: Carboplatin| Drug: Cisplatin| Drug: Pemetrexed| Drug: Pembrolizumab| Drug: Gemcitabine| Drug: Paclitaxel| Drug: Nab-Paclitaxel | Non-Small Cell Lung Cancer | Hoffmann-La Roche | 3 | 9/6/22 | Pralsetinib is a highly potent, selective RET inhibitor for the treatment of patients with cancers that harbor abnormalities in the RET kinase. | 18 Years and older. Participant has locally advanced or metastatic NSCLC. Participant must have a documented RET-fusion. Participant should not have received any prior anticancer therapy for metastatic disease. | |
| A Study of Multiple Therapies in Biomarker-Selected Patients With Resectable Stages IB-III Non-Small Cell Lung Cancer | NCT04302025 | Recruiting | Drug: Alectinib| Drug: Entrectinib| Drug: Vemurafenib| Drug: Cobimetinib| Drug: Pralsetinib| Drug: Atezolizumab| Drug: SBRT|Procedure: Resection| Drug: Chemotherapy | Non-Small Cell Lung Cancer | Genentech, Inc.| Blueprint Medicines Corporation| Chugai Pharmaceutical Co.| Hoffmann-La Roche | 2 | 12/7/22 | Pralsetinib is a highly potent, selective RET inhibitor for the treatment of patients with cancers that harbor abnormalities in the RET kinase. | 18 Years and older. Inclusion Criteria for Neoadjuvant Therapy: NSCLC: Stage IB, IIA, IIB, IIIA, or selected IIIB, including T3N2, or T4. Molecular testing showing RET fusion. |
Clinical trials looking at next generation RET inhibitors in NSCLC and other RET positive solid tumors
| Study Title | NCT Number | Status | Interventions | Conditions | Sponsor or Collaborator | Phase | Last Update Posted | Mechanism of action | Inclusion 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 Abnormalities | NCT04683250 | Recruiting | Drug: TAS0953/HM06 | RET-altered Non Small Cell Lung Cancer| RET-altered Solid Tumors | Helsinn Healthcare SA| ICON Clinical Research | 1, 2 | 4/14/22 | TAS0953/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. | |
| A Study of LOXO-260 in Cancer Patients With a Change in a Particular Gene (RET) That Has Not Responded to Treatment | NCT05241834 | Recruiting | Drug: LOXO-260 | Carcinoma, Non-Small-Cell Lung| Thyroid Neoplasms | Eli Lilly and Company| Loxo Oncology, Inc. | 1 | 8/17/22 | LOXO-260 is a selective inhibitor of the RET receptor tyrosine kinase that has activity against both solvent front and gatekeeper mutations | 18 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 Malignancies | NCT05443126 | Recruiting | Drug: EP0031 | Advanced Solid Tumor | Ellipses Pharma | 1, 2 | 12/2/22 | EP0031 selectively binds to various RET fusions and mutations, including solvent front resistance mutations | 18 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. | Patient Information |
| A Study of APS03118 in Adult Patients With Unresectable Locally Advanced or Metastatic Solid Tumors Harboring RET Mutations or Fusions | NCT05653869 | Recruiting | Drug: APS03118 | RET-altered Solid Tumors | Applied Pharmaceutical Science, Inc. | 1 | APS03118 is a novel next-generation RET inhibitor which is potent against a range of RET fusions and mutations including both solvent front and gatekeeper resistance mutations. | 18 Years and older. Have histological or cytological confirmation of unresectable locally advanced or metastatic solid tumors harboring oncogenic RET mutations or fusions. | ||
| A Study of Amivantamab (JNJ-61186372) Among Participants With Advanced NSCLC Harboring ALK, ROS1, and RET Gene Fusions in Combination With Tyrosine Kinase Inhibitors (TKIs). | NCT05845671 | Recruiting | Drug: Amivantamab | RET-altered Non Small Cell Lung Cancer | University of Colorado, Denver and Janssen Research & Development, LLC | 1, 2 | In many of these cases, increased activation of the (epidermal growth factor receptor (ERBB) or mesenchymal-epithelial transition (cMet) pathways appears to be a bypass signaling mechanism that allows cancer cells to circumvent the selective pressure from TKIs. Amivantamab is a bispecific antibody that binds to the extracellular domains of EGFR and MET. | 18 Years to 90 Years. Participant has locally advanced (unresectable) or metastatic NSCLC with a known RET fusion. Participants must have clinical progression on at least one prior RET therapy. They must be on a RET inhibitor at the same dose for at least 3 months prior to enrolling on this study. RET inhibitors that will be considered include but not limited to selpercatinib and pralsetinib. The patient cannot have received an EGFR TKI (e.g. osimertinib, afatinib), EGFR-directed monoclonal antibody (e.g. cetuximab), MET-inhibitor (e.g., tepotinib, capmatinib, telisotuzumab vedotin, etc.) at any point prior to study entry. |
Clinical trials looking at other RET inhibitors in NSCLC and other solid tumors
| Study Title | NCT Number | Status | Interventions | Conditions | Sponsor or Collaborator | Phase | Last Updated Post | Mechanism of action | Inclusion criteria (for more info visit the clinical trials website) |
|---|---|---|---|---|---|---|---|---|---|
| Study of HA121-28 in Patients With Non-Small Cell Lung Cancer | NCT05117658 | Recruiting | Drug: HA121-28 tablet | Non-Small Cell Lung Cancer | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | 2 | 8/4/22 | HA121-28 is a highly potent, multi-targeted tyrosine kinase inhibitor with RET as its main target | Aged 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 Tumors | NCT05278364 | Recruiting | Drug: SY-5007 | Non-Small Cell Lung Cancer| Medullary Thyroid Cancer| Solid Tumor | Shouyao Holdings (Beijing) Co. LTD | 1 | 3/18/22 | Oral RET selective Inhibitor | 18 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 Tumors | NCT05451602 | Recruiting | Drug: HEC169096 | Advanced Solid Tumor | Sunshine Lake Pharma Co., Ltd. | 1, 2 | 10/27/22 | Highly-selective RET Inhibitor | 18 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 Tumors | NCT05207787 | Recruiting | Drug: HS-10365 | Solid Tumor | Jiangsu Hansoh Pharmaceutical Co., Ltd. | 1 | 1/26/22 | Small molecular, oral potent, selective RET inhibitor | 18 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 Cancer | NCT01582191 | Recruiting | Drug: Everolimus| Drug: Vandetanib | Advanced Malignant Neoplasm| Metastatic Malignant Neoplasm| Recurrent Malignant Neoplasm| Refractory Malignant Neoplasm | M.D. Anderson Cancer Center| National Cancer Institute (NCI) | 1 | 6/30/22 | A multi-kinase inhibitor of epidermal growth factor receptor [EGFR], vascular endothelial growth factor receptor [VEGFR] and ret proto-oncogene [RET] inhibitor | 18 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 Activity | NCT01639508 | Recruiting | Drug: Cabozantinib | Non-Small Cell Lung Cancer | Memorial Sloan Kettering Cancer Center| Exelixis | 2 | 6/23/22 | Cabozantinib 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 body | 18 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 Title | NCT Number | Status | Interventions | Conditions | Sponsor or Colaborator | Phase | Last Update Posted | Mechanism of action | Inclusion 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 Trial | NCT04322591 | Recruiting | Drug: Chemotherapy | Drug: Chemotherapy Plus PD-1 Antibody | Non-Small Cell Lung Cancer | Hunan Province Tumor Hospital | 3/2/22 | PD-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 Title | NCT Number | Status | Interventions | Conditions | Sponsor or Colaborator | Phase | Last Update Posted | Mechanism of action | Inclusion criteria (for more info visit the clinical trials website) |
|---|---|---|---|---|---|---|---|---|---|
| Selpercatinib Before Surgery for the Treatment of RET-Altered Thyroid Cancer | NCT04759911 | Recruiting | Drug: Selpercatinib | Thyroid Cancer | M.D. Anderson Cancer Center | 2 | 7/18/22 | Selpercatinib, 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 kinase | 12 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 Cancer | NCT04211337 | Recruiting | Drug: Selpercatinib| Drug: Cabozantinib| Drug: Vandetanib | Medullary Thyroid Cancer | Loxo Oncology, Inc.| Eli Lilly and Company | 3 | 9/9/22 | Selpercatinib, 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 kinase | 12 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) Tumors | NCT03899792 | Recruiting | Drug: LOXO-292 | Medullary Thyroid Cancer| Infantile Myofibromatosis| Infantile Fibrosarcoma| Papillary Thyroid Cancer|Soft Tissue Sarcoma | Loxo Oncology, Inc.| Eli Lilly and Company | 1, 2 | 7/8/22 | Selpercatinib, 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 kinase | 6 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 Title | NCT Number | Status | Interventions | Conditions | Sponsor or Colaborator | Phase | Last Update Posted | Inclusion criteria (for more info visit the clinical trials website) |
|---|---|---|---|---|---|---|---|---|
| Real Word European Registry of NTRK Fusions and Other Rare Actionable Fusions (TRacKING) | NCT04921553 | Data collection and quality of life questionnaire | Cancer RET Gene Translocation | Centre Leon Berard | Observational | 8/2/21 | 18 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.