TriangleNCT03157128 · CITED IN SOURCE DOCUMENTS
A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001)
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE1, PHASE2
- Status at capture
- ACTIVE NOT RECRUITING
- Registry last update
- 2026-04-16
This is an open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of selpercatinib (also known as LOXO-292) administered orally to participants with advanced solid tumors, including rearranged during transfection (RET)-fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Phase 1: Maximum Tolerated Dose (MTD)
Phase 1: Recommended Phase 2 Dose (RP2D)
Phase 2: Objective Response Rate (ORR) Based on Independent Review Committee (IRC) Assessment
Phase 1: Number of Participants With a Treatment-Related Adverse Event(s) (TRAE[s])
Phase 1: Number of Participants With an Abnormal Laboratory Values
Phase 2: Overall Response Rate (ORR) Based on RECIST 1.1 or RANO, as Appropriate to Tumor Type
Phase 2: ORR (by Investigator)
Phase 2: Best Change in Tumor Size From Baseline (by IRC and Investigator)
Phase 2: Duration of Response (DOR; by IRC and Investigator)
Phase 2: Central Nervous System (CNS) ORR (by IRC)
Phase 2: CNS DOR (by IRC)
Phase 2: Time to Any and Best Response (by IRC and Investigator)
Phase 2: CBR (by IRC and Investigator)
Phase 2: PFS (by IRC and Investigator)
Phase 2: Overall Survival (OS)
Phase 2: Percentage of Participants With Any Serious Adverse Event (SAE[s])
Phase 2: Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve of LOXO-292 (Selpercatinib)
Phase 2: PK: Maximum Concentration (Cmax) of LOXO-292 (Selpercatinib)
Phase 1: Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours
Phase 1: Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax)
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Key Inclusion Criteria: For Phase 1: * 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, or in the opinion of the Investigator, are not candidates for or would be unlikely to tolerate or derive significant clinical benefit from standard therapy, or * Decline standard therapy * Prior multikinase inhibitors (MKIs) with anti-RET activity are allowed * A RET gene alteration is not required initially. Once adequate PK exposure is achieved, evidence of RET gene alteration in tumor and/or blood is required as identified through molecular assays, as performed for clinical evaluation * Measurable or non-measurable disease as determined by RECIST 1.1 or RANO as appropriate to tumor type * Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2 or Lansky Performance Score (LPS) greater than or equal to (≥) 40 percent (%) (age less than \[\<\] 16 years) with no sudden deterioration 2 weeks prior to the first dose of study treatment * Adequate hematologic, hepatic and renal function * Life expectancy of at least 3 months For Phase 2: As for phase 1 with the following modifications: * For Cohort 1: Participants must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the Investigator, would be unlikely to tolerate or derive clinical benefit from appropriate standard of care therapy * Cohorts 1 and 2: * Enrollment will be restricted to participants with evidence of a RET gene alteration in tumor * At least one measurable lesion as defined by RECIST 1.1 or RANO, as appropriate to tumor type and not previously irradiated * Cohorts 3 and 4: Enrollment closed * Cohort 5: * Cohorts 1-4 without measurable disease * MCT not meeting the requirements for Cohorts 3 or 4 * MTC syndrome spectrum cancers (e.g., MTC, pheochromocytoma), cancers with neuroendocrine features/differentiation, or poorly differentiated thyroid cancers with other RET alteration/activation may be allowed with prior Sponsor approval * cfDNA positive for a RET gene alteration not known to be present in a tumor sample * Cohort 6: Participants who otherwise are eligible for Cohorts 1, 2 or 5 who discontinued another RET inhibitor may be eligible with prior Sponsor approval * Cohort 7: Participants with a histologically confirmed stage IB-IIIA NSCLC and a RET fusion; determined to be medically operable and tumor deemed resectable by a thoracic surgical oncologist, without prior systemic treatment for NSCLC Key Exclusion Criteria (Phase 1 and Phase 2): * Phase 2 Cohorts 1 and 2: an additional known oncogenic driver * Cohorts 3 and 4: Enrollment closed * Cohorts 1, 2 and 5: prior treatment with a selective RET inhibitor Notes: Participants otherwise eligible for Cohorts 1, 2, and 5 who discontinued another selective RET inhibitor may be eligible for Phase 2 Cohort 6 with prior Sponsor approval * Investigational agent or anticancer therapy (including chemotherapy, biologic therapy, immunotherapy, anticancer Chinese medicine or other anticancer herbal remedy) within 5 half-lives or 2 weeks (whichever is shorter) prior to planned start of LOXO-292 (selpercatinib). In addition, no concurrent investigational anti-cancer therapy is permitted Note: Potential exception for this exclusion criterion will require a valid scientific justification and approval from the Sponsor * Major surgery (excluding placement of vascular access) within 2 weeks prior to planned start of LOXO-292 (selpercatinib) * Radiotherapy with a limited field of radiation for palliation within 1 week of planned start of LOXO-292 (selpercatinib), with the exception of participants receiving radiation to more than 30% of the bone marrow or with a wide field of radiation, which must be completed at least 4 weeks prior to the first dose of study treatment * Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy * Symptomatic primary CNS tumor, metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression. Participants are eligible if neurological symptoms and CNS imaging are stable and steroid dose is stable for 14 days prior to the first dose of LOXO-292 (selpercatinib) and no CNS surgery or radiation has been performed for 28 days, 14 days if stereotactic radiosurgery (SRS) * Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of LOXO-292 (selpercatinib) or prolongation of the QT interval corrected (QTcF) greater than (\>) 470 milliseconds (msec) * Participants with implanted pacemakers may enter the study without meeting QTc criteria due to nonevaluable measurement if it is possible to monitor for QT changes. * Participants with bundle branch block may be considered for study entry if QTc is appropriate by a formula other than Fridericia's and if it is possible to monitor for QT changes. * Required treatment with certain strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers and certain prohibited concomitant medications * Phase 2 Cohort 7 (neoadjuvant treatment): Participant must not have received prior systemic therapy for NSCLC.
- healthy Volunteers
- false
- minimum Age
- 12 Years
- sex
- ALL
- std Ages
- CHILD
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Participants received Selpercatinib 20 milligrams (mg) administered orally once daily (QD), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- intervention Names
- Drug: LOXO-292
- label
- Phase 1: 20 mg Selpercatinib QD
- type
- EXPERIMENTAL
- description
- Participants received Selpercatinib 20 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- intervention Names
- Drug: LOXO-292
- label
- Phase 1: 20 mg Selpercatinib BID
- type
- EXPERIMENTAL
- description
- Participants received Selpercatinib 40 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- intervention Names
- Drug: LOXO-292
- label
- Phase 1: 40 mg Selpercatinib BID
- type
- EXPERIMENTAL
- description
- Participants received Selpercatinib 60 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- intervention Names
- Drug: LOXO-292
- label
- Phase 1: 60 mg Selpercatinib BID
- type
- EXPERIMENTAL
- description
- Participants received Selpercatinib 160 milligrams (mg) administered orally once daily (QD), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- intervention Names
- Drug: LOXO-292
- label
- Phase 1: 160 mg Selpercatinib QD
- type
- EXPERIMENTAL
- description
- Participants received Selpercatinib 80 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- intervention Names
- Drug: LOXO-292
- label
- Phase 1: 80 mg Selpercatinib BID
- type
- EXPERIMENTAL
- description
- Participants received Selpercatinib 120 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- intervention Names
- Drug: LOXO-292
- label
- Phase 1: 120 mg Selpercatinib BID
- type
- EXPERIMENTAL
- description
- Participants received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- intervention Names
- Drug: LOXO-292
- label
- Phase 1: 160 mg Selpercatinib BID
- type
- EXPERIMENTAL
- description
- Participants received Selpercatinib 200 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- intervention Names
- Drug: LOXO-292
- label
- Phase 1: 200 mg Selpercatinib BID
- type
- EXPERIMENTAL
- description
- Participants received Selpercatinib 240 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- intervention Names
- Drug: LOXO-292
- label
- Phase 1: 240 mg Selpercatinib BID
- type
- EXPERIMENTAL
- description
- Participants with Rearranged during transfection (RET) Fusion solid tumor progressed on/intolerant to standard first line therapy received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- intervention Names
- Drug: LOXO-292
- label
- Phase 2, Cohort 1: RET Fusion Solid Tumor
- type
- EXPERIMENTAL
- description
- Participants with RET Fusion solid tumor without standard first line therapy received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- intervention Names
- Drug: LOXO-292
- label
- Phase 2, Cohort 2: RET Fusion Solid Tumor Without Standard Therapy
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Phase 1: 120 mg Selpercatinib BID
- Phase 1: 160 mg Selpercatinib BID
- Phase 1: 160 mg Selpercatinib QD
- Phase 1: 20 mg Selpercatinib BID
- Phase 1: 20 mg Selpercatinib QD
- Phase 1: 200 mg Selpercatinib BID
- Phase 1: 240 mg Selpercatinib BID
- Phase 1: 40 mg Selpercatinib BID
- Phase 1: 60 mg Selpercatinib BID
- Phase 1: 80 mg Selpercatinib BID
- Phase 2, Cohort 1: RET Fusion Solid Tumor
- Phase 2, Cohort 2: RET Fusion Solid Tumor Without Standard Therapy
- description
- Oral LOXO-292
- name
- LOXO-292
- other Names
- Selpercatinib
- LY3527723
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 857
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- The MTD is defined as the highest dose level at which none of the first 3 treated patients, or not more than 1 of the first 6 treated patients, experiences a DLT. A DLT is any adverse events that starts on or after first administration of study drug, as defined by National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. * Any Grade(G) ≥3 nonhematologic toxicity, excluding * G3 AST, ALT, and/or total bilirubin elevation for \<7 days. * G3 neutropenia \<7 days * G3 thrombocytopenia without clinically significant bleeding * G3 or G4 lymphopenia. * First occurrence of G3 or G4 electrolyte abnormalities * G3 fatigue, weakness, nausea; other manageable constitutional symptom * G3 or G4 vomiting or diarrhea that lasts for \<48hours with antiemetic/antidiarrheal medication in case of G3 and \<24 hours in case of G4 * G4 manageable constitutional symptom.
- measure
- Phase 1: Maximum Tolerated Dose (MTD)
- time Frame
- Cycle 1 (cycle length = 28 days)
- description
- Phase 1: RP2D
- measure
- Phase 1: Recommended Phase 2 Dose (RP2D)
- time Frame
- Cycle 1 (cycle length = 28 days)
- description
- Objective Response Rate was defined as the percentage of participants with best overall response of confirmed response (CR), or Partial response (PR). Response was confirmed by a repeat assessment no less than 28 days. * CR is defined as disappearance of all target lesions. * PR is defined as at least a 30% decrease in the sum of diameter (LD for non-nodal lesions and short axis diameter \[SAD\] for nodal lesions) of target lesions, taking as reference the baseline sum LD. ORR was assessed by independent review committee (IRC) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. 95% confidence interval was calculated using Clopper-Pearson method.
- measure
- Phase 2: Objective Response Rate (ORR) Based on Independent Review Committee (IRC) Assessment
- time Frame
- Approximately for up to 7 years 8 months
- secondary Outcomes
- description
- Phase 1: Number of Participants with a TRAE(s) is reported.
- measure
- Phase 1: Number of Participants With a Treatment-Related Adverse Event(s) (TRAE[s])
- time Frame
- Up to 28 days
- measure
- Phase 1: Number of Participants With an Abnormal Laboratory Values
- time Frame
- Up to 28 days
- description
- Phase 2: ORR based on RECIST 1.1 or RANO, as Appropriate to Tumor Type
- measure
- Phase 2: Overall Response Rate (ORR) Based on RECIST 1.1 or RANO, as Appropriate to Tumor Type
- time Frame
- Approximately for up to 9 years 8 months
- description
- Phase 2: ORR (by Investigator)
- measure
- Phase 2: ORR (by Investigator)
- time Frame
- Approximately for up to 9 years 8 months
- description
- Phase 2: Best Change in Tumor Size from Baseline (by IRC and Investigator)
- measure
- Phase 2: Best Change in Tumor Size From Baseline (by IRC and Investigator)
- time Frame
- Approximately for up to 9 years 8 months
- description
- Phase 2: DOR (by IRC and Investigator)
- measure
- Phase 2: Duration of Response (DOR; by IRC and Investigator)
- time Frame
- Approximately for up to 9 years 8 months
- description
- Phase 2: CNS ORR (by IRC)
- measure
- Phase 2: Central Nervous System (CNS) ORR (by IRC)
- time Frame
- Approximately for up to 9 years 8 months
- description
- Phase 2: CNS DOR (by IRC)
- measure
- Phase 2: CNS DOR (by IRC)
- time Frame
- Approximately for up to 9 years 8 months
- description
- Phase 2: Time to Any and Best Response (by IRC and Investigator)
- measure
- Phase 2: Time to Any and Best Response (by IRC and Investigator)
- time Frame
- Approximately for up to 9 years 8 months
- description
- Phase 2: CBR (by IRC and Investigator)
- measure
- Phase 2: CBR (by IRC and Investigator)
- time Frame
- Approximately for up to 9 years 8 months
- description
- Phase 2: PFS (by IRC and Investigator)
- measure
- Phase 2: PFS (by IRC and Investigator)
- time Frame
- Approximately for up to 9 years 8 months
- description
- Phase 2: OS
- measure
- Phase 2: Overall Survival (OS)
- time Frame
- Approximately for up to 9 years 8 months
Full study description
- brief Summary
- This is an open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of selpercatinib (also known as LOXO-292) administered orally to participants with advanced solid tumors, including rearranged during transfection (RET)-fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation.
- detailed Description
- This is an open-label, multi-center Phase 1/2 study in participants with advanced solid tumors, including RET fusion-positive solid tumors, MTC, and other tumors with RET activation. The trial will be conducted in 2 parts: Phase 1 (dose escalation - completed) and phase 2 (dose expansion). Participants with advanced cancer are eligible if they have progressed on or are intolerant to available standard therapies, or no standard or available curative therapy exists, or in the opinion of the Investigator, they would be unlikely to tolerate or derive significant clinical benefit from appropriate standard of care therapy, or they declined standard therapy. A dose of 160 milligrams (mg) twice a day (BID) has been selected as the recommended phase 2 dose (RP2D). Approximately 875 participants with advanced solid tumors harboring a RET gene alteration in tumor and/or blood will be enrolled to one of six phase 2 cohorts: * Cohort 1: Advanced RET fusion positive solid tumor other than NSCLC or thyroid cancer for participants who progressed on or intolerant to first line therapy (open) * Cohort 2: Advanced RET fusion positive solid tumor other than NSCLC or thyroid cancer for treatment naïve participants (open) * Cohort 3: Advanced RET-mutant MTC participants who progressed on or intolerant to first line therapy (closed) * Cohort 4: Advanced RET-mutant MTC participants who are treatment naïve (closed) * Cohort 5: Advanced RET-altered solid tumor for participants other than NSCLC or thyroid cancer and RET-mutant MEN2 spectrum tumors (e.g. pheochromocytoma) otherwise ineligible for cohorts 1-4. See details in inclusion/exclusion criteria (open) * Cohort 6: Participants otherwise eligible for Cohorts 1-5 who discontinued another RET inhibitor due to intolerance may be eligible with prior Sponsor approval (closed)
Source references
- references
- citation
- Gautschi O, Park K, Solomon BJ, Tomasini P, Loong HH, De Braud F, Goto K, Peterson P, Barker S, Liming K, Oxnard GR, Frimodt-Moller B, Drilon A. Selpercatinib in RET Fusion-Positive Non-Small Cell Lung Cancer: Final Safety and Efficacy, Including Overall Survival, From the LIBRETTO-001 Phase I/II Trial. J Clin Oncol. 2025 May 20;43(15):1758-1764. doi: 10.1200/JCO-24-02076. Epub 2025 Feb 21.
- pmid
- 39983053
- type
- DERIVED
- citation
- Raez LE, Massey AC, Barker SS, Peterson PM, Liming K, Pennell NA. Long-term safety of selpercatinib for Rearranged during transfection (RET)-activated advanced solid tumors in LIBRETTO-001: differing patterns of adverse events over time. Oncologist. 2024 Dec 6;29(12):1068-1078. doi: 10.1093/oncolo/oyae282.
- pmid
- 39471424
- type
- DERIVED
- citation
- Wirth LJ, Brose MS, Subbiah V, Worden F, Solomon B, Robinson B, Hadoux J, Tomasini P, Weiler D, Deschler-Baier B, Tan DSW, Maeda P, Lin Y, Singh R, Bayt T, Drilon A, Cassier PA. Durability of Response With Selpercatinib in Patients With RET-Activated Thyroid Cancer: Long-Term Safety and Efficacy From LIBRETTO-001. J Clin Oncol. 2024 Sep 20;42(27):3187-3195. doi: 10.1200/JCO.23.02503. Epub 2024 Aug 2.
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- 39094065
- type
- DERIVED
- citation
- Deschler-Baier B, Krebs M, Kroiss M, Chatterjee M, Gundel D, Kestler C, Kerscher A, Kunzmann V, Appenzeller S, Maurus K, Rosenwald A, Bargou R, Gerhard-Hartmann E, Venkataramani V. Rapid response to selpercatinib in RET fusion positive pancreatic neuroendocrine carcinoma confirmed by smartwatch. NPJ Precis Oncol. 2024 Jul 31;8(1):167. doi: 10.1038/s41698-024-00659-x.
- pmid
- 39085487
- type
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- citation
- Deschler-Baier B, Konda B, Massarelli E, Hu MI, Wirth LJ, Xu X, Wright J, Clifton-Bligh RJ. Clinical Activity of Selpercatinib in RET-mutant Pheochromocytoma. J Clin Endocrinol Metab. 2025 Feb 18;110(3):e600-e606. doi: 10.1210/clinem/dgae283.
- pmid
- 38661071
- type
- DERIVED
- citation
- Subbiah V, Burris HA 3rd, Kurzrock R. Revolutionizing cancer drug development: Harnessing the potential of basket trials. Cancer. 2024 Jan;130(2):186-200. doi: 10.1002/cncr.35085. Epub 2023 Nov 7.
- pmid
- 37934000
- type
- DERIVED
- citation
- Duke ES, Bradford D, Marcovitz M, Amatya AK, Mishra-Kalyani PS, Nguyen E, Price LSL, Fourie Zirkelbach J, Li Y, Bi Y, Kraft J, Dorff SE, Scepura B, Stephenson M, Ojofeitimi I, Nair A, Han Y, Tezak Z, Lemery SJ, Pazdur R, Larkins E, Singh H. FDA Approval Summary: Selpercatinib for the Treatment of Advanced RET Fusion-Positive Solid Tumors. Clin Cancer Res. 2023 Sep 15;29(18):3573-3578. doi: 10.1158/1078-0432.CCR-23-0459.
- pmid
- 37265412
- type
- DERIVED
- citation
- Murciano-Goroff YR, Falcon CJ, Lin ST, Chacko C, Grimaldi G, Liu D, Wilhelm C, Iasonos A, Drilon A. Central Nervous System Disease in Patients With RET Fusion-Positive NSCLC Treated With Selpercatinib. J Thorac Oncol. 2023 May;18(5):620-627. doi: 10.1016/j.jtho.2023.01.008. Epub 2023 Jan 16.
- pmid
- 36657661
- type
- DERIVED
- citation
- Drilon A, Subbiah V, Gautschi O, Tomasini P, de Braud F, Solomon BJ, Shao-Weng Tan D, Alonso G, Wolf J, Park K, Goto K, Soldatenkova V, Szymczak S, Barker SS, Puri T, Bence Lin A, Loong H, Besse B. Selpercatinib in Patients With RET Fusion-Positive Non-Small-Cell Lung Cancer: Updated Safety and Efficacy From the Registrational LIBRETTO-001 Phase I/II Trial. J Clin Oncol. 2023 Jan 10;41(2):385-394. doi: 10.1200/JCO.22.00393. Epub 2022 Sep 19.
- pmid
- 36122315
- type
- DERIVED
- citation
- Subbiah V, Wolf J, Konda B, Kang H, Spira A, Weiss J, Takeda M, Ohe Y, Khan S, Ohashi K, Soldatenkova V, Szymczak S, Sullivan L, Wright J, Drilon A. Tumour-agnostic efficacy and safety of selpercatinib in patients with RET fusion-positive solid tumours other than lung or thyroid tumours (LIBRETTO-001): a phase 1/2, open-label, basket trial. Lancet Oncol. 2022 Oct;23(10):1261-1273. doi: 10.1016/S1470-2045(22)00541-1. Epub 2022 Sep 12.
- pmid
- 36108661
- type
- DERIVED
- citation
- Rolfo C, Hess LM, Jen MH, Peterson P, Li X, Liu H, Lai Y, Sugihara T, Kiiskinen U, Vickers A, Summers Y. External control cohorts for the single-arm LIBRETTO-001 trial of selpercatinib in RET+ non-small-cell lung cancer. ESMO Open. 2022 Aug;7(4):100551. doi: 10.1016/j.esmoop.2022.100551. Epub 2022 Aug 2.
- pmid
- 35930972
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- DERIVED
- citation
- Subbiah V, Gainor JF, Oxnard GR, Tan DSW, Owen DH, Cho BC, Loong HH, McCoach CE, Weiss J, Kim YJ, Bazhenova L, Park K, Daga H, Besse B, Gautschi O, Rolfo C, Zhu EY, Kherani JF, Huang X, Kang S, Drilon A. Intracranial Efficacy of Selpercatinib in RET Fusion-Positive Non-Small Cell Lung Cancers on the LIBRETTO-001 Trial. Clin Cancer Res. 2021 Aug 1;27(15):4160-4167. doi: 10.1158/1078-0432.CCR-21-0800. Epub 2021 Jun 4.
- pmid
- 34088726
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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Preserved source evidence · Independent clinical review pending · Not medical advice