A Study of Selpercatinib (LY3527723) in Participants With Advanced Solid Tumors Including RET Fusion-positive Solid Tumors, Medullary Thyroid Cancer and Other Tumors With RET Activation
NCT ID: NCT04280081
Last Updated: 2025-04-20
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2
77 participants
INTERVENTIONAL
2020-03-16
2027-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Selpercatinib
Selpercatinib 160 milligrams (mg) administered orally twice daily (BID).
Selpercatinib
Administered orally
Interventions
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Selpercatinib
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Evidence of a RET gene alteration in tumor and/or blood.
* Measurable or non-measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2, with no sudden deterioration 2 weeks prior to the first dose of study treatment.
* Archived tumor tissue sample available for cohort 1 and 2.
* Cohorts 1 and 2: failed or intolerant to standard of care.
* Cohorts 1-2: enrollment will be restricted to participants with evidence of a RET gene alteration in tumor (i.e., not just blood). However, a positive germline DNA test for a RET gene mutation as defined in the protocol is acceptable in the absence of tumor tissue testing for participants with MTC.
* Cohorts 1-2: at least one measurable lesion as defined by RECIST v1.1 and not previously irradiated (unless progressive disease for the irradiated lesion\[s\] has been radiographically documented).
Exclusion Criteria
* Prior treatment with a selective RET inhibitor(s) (including investigational selective RET inhibitor(s), such as BLU-667, RXDX-105, etc).
* Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
* Any unresolved toxicities from prior therapy greater than common terminology criteria for adverse events (CTCAE) Grade 1 except where otherwise noted in this eligibility criteria at the time of starting study treatment with the exception of alopecia and Grade 2, prior platinum therapy-related neuropathy.
* Symptomatic primary central nervous system (CNS) tumor, symptomatic CNS metastasis, leptomeningeal carcinomatosis, or untreated spinal cord compression.
* Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of selpercatinib or prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF) \> 470 milliseconds.
* History of Human Immunodeficiency Virus (known HIV 1/2 antibodies positive); participants with unknown HIV status do not need to be tested.
* History of active hepatitis B (known positive hepatitis B surface antigen \[HbsAg\] and quantitative hepatitis B DNA greater than the upper limit of detection of the assay) or C (known positive hepatitis C antibody and quantitative hepatitis C RNA greater than the upper limit of detection of the assay); participants with unknown hepatitis B/hepatitis C status do not need to be tested.
* Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing intercurrent illness, such as hypertension or diabetes, despite optimal treatment. Screening for chronic conditions is not required.
* Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug.
* Uncontrolled symptomatic hyperthyroidism or hypothyroidism
* Uncontrolled symptomatic hypercalcemia or hypocalcemia.
* Concurrent use of drugs known to prolong QTc.
* Pregnancy or lactation. Breast-feeding should be interrupted when selpercatinib is started; breast-feeding can be resumed 3 months after discontinuation of selpercatinib.
* Active second malignancy other than minor treatment of indolent cancers with prior sponsor approval.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
The First Affiated Hospital Of Guangzhou Medical University
Guangzhou, Guangdong, China
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, China
Hunan Cancer Hospital
Changsha, Hunan, China
Jilin Cancer Hospital
Changchun, Jilin, China
Jinan Central Hospital
Jinan, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Shanghai Chest Hospital
Shanghai, Shanghai/China, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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References
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Lu S, Cheng Y, Huang D, Sun Y, Wu L, Zhou C, Zhou J, Guo Y, Shao J, Zhang W. Selpercatinib in Chinese patients with RET-fusion-positive non-small-cell lung cancer: updated efficacy and safety analysis from the LIBRETTO-321 phase II trial. Ther Adv Med Oncol. 2025 Jan 1;17:17588359241307199. doi: 10.1177/17588359241307199. eCollection 2025.
Lu S, Zheng X, Sun Y, Huang D, Wu L, Ji Q, Zhou C, Zhou J, Guo Y, Ge M, Ding D, Shao J, Zhang W, Gao M, Cheng Y. Patient-reported outcomes following selpercatinib treatment in Chinese patients with advanced RET fusion-positive non-small-cell lung cancer and thyroid cancer, and RET-mutant medullary thyroid cancer in the phase II LIBRETTO-321 trial. Ther Adv Med Oncol. 2023 Aug 25;15:17588359231189429. doi: 10.1177/17588359231189429. eCollection 2023.
Cheng Y, Huang D, Zhou J, Zhou C, Sun Y, Wu L, Guo Y, Jingxin S, Zhang W, Lu S. Intracranial Activity of Selpercatinib in Chinese Patients With Advanced RET Fusion-Positive Non-Small-Cell Lung Cancer in the Phase II LIBRETTO-321 Trial. JCO Precis Oncol. 2023 Jun;7:e2200708. doi: 10.1200/PO.22.00708.
Zheng X, Ji Q, Sun Y, Ge M, Zhang B, Cheng Y, Lei S, Shi F, Guo Y, Li L, Chen L, Shao J, Zhang W, Gao M. Efficacy and safety of selpercatinib in Chinese patients with advanced RET-altered thyroid cancers: results from the phase II LIBRETTO-321 study. Ther Adv Med Oncol. 2022 Aug 29;14:17588359221119318. doi: 10.1177/17588359221119318. eCollection 2022.
Lu S, Cheng Y, Huang D, Sun Y, Wu L, Zhou C, Guo Y, Shao J, Zhang W, Zhou J. Efficacy and safety of selpercatinib in Chinese patients with advanced RET fusion-positive non-small-cell lung cancer: a phase II clinical trial (LIBRETTO-321). Ther Adv Med Oncol. 2022 Jul 28;14:17588359221105020. doi: 10.1177/17588359221105020. eCollection 2022.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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J2G-GH-JZJK
Identifier Type: OTHER
Identifier Source: secondary_id
17492
Identifier Type: -
Identifier Source: org_study_id
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