{"entity":{"id":"nct03157128","kind":"trial","name":"A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRET","aka":["LIBRETTO-001"],"tldr":"A phase 1/2 trial of Selpercatinib in non-small-cell lung cancer and small-cell lung cancer, run by Eli Lilly and Company, active and no longer recruiting.","summary":"A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001) is a phase 1/2 interventional study registered as NCT03157128 by Eli Lilly and Company, with 857 participants enrolled, started 2017-05-02 and due to reach its primary completion in 2025-02-14. Interventions recorded: LOXO-292. Conditions listed: Non-Small Cell Lung Cancer, Medullary Thyroid Cancer, Colon Cancer, Any Solid Tumor. Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03157128","url":"https://clinicaltrials.gov/study/NCT03157128"},{"label":"LIBRETTO-001 (New England Journal of Medicine 2020)","url":"https://doi.org/10.1056/NEJMoa2005653"},{"label":"NICE TA1042: selpercatinib for previously treated RET fusion-positive advanced non-small-cell lung cancer","url":"https://www.nice.org.uk/guidance/ta1042"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","thyroid","ret-fusion-nsclc","medullary-thyroid-cancer"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["selpercatinib"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":["libretto-431","arrow-thyroid"],"people":[],"bottlenecks":[],"keyPapers":["paper-libretto-001-selpercatinib-nsclc-nejm-2020","paper-nct03157128-j-clin-oncol-2024-update"],"journals":[],"dependsOn":[],"notes":["In the first 105 consecutively enrolled patients with RET fusion-positive non-small-cell lung cancer who had had at least platinum-based chemotherapy, objective response was 64 percent (95 percent confidence interval 54 to 73) with median duration of response 17.5 months and 63 percent of responses ongoing at a median 12.1 months. Among 39 previously untreated patients, response was 85 percent (70 to 94) with 90 percent ongoing at six months, and among 11 patients with measurable central nervous system metastases, intracranial response was 91 percent (59 to 100). Grade 3 or higher events were hypertension (14 percent), raised alanine aminotransferase (12 percent) and aspartate aminotransferase (10 percent); 12 of 531 patients (2 percent) discontinued for a drug-related event (New England Journal of Medicine 2020)."],"nct":"NCT03157128","phase":"1/2","setting":"A Phase 1/2 Study of Oral Selpercatinib (LOXO-292) in Patients With Advanced Solid Tumors, Including RET Fusion-Positive Solid Tumors, Medullary Thyroid Cancer, and Other Tumors With RET Activation (LIBRETTO-001)","sponsor":"Eli Lilly and Company","result":"Objective response 64 percent after platinum chemotherapy and 85 percent in previously untreated RET fusion-positive non-small-cell lung cancer; intracranial response 91 percent.","started":"2017-05-02","startedType":"actual","yearReported":2026,"enrolled":857,"enrolledBasis":"registry","outcomes":[{"endpoint":"Phase 2: Objective Response Rate (ORR) Based on Independent Review Committee (IRC) Assessment","primary":true,"unit":"%","arms":[{"name":"Phase 2, Cohort 1: RET Fusion Solid Tumor","n":307,"value":62.9,"note":"95% CI 57.2 to 68.3; Figures from the ClinicalTrials.gov results section (first posted 2026-04-16), not from a publication"},{"name":"Phase 2, Cohort 2: RET Fusion Solid Tumor Without Standard Therapy","n":74,"value":79.7,"note":"95% CI 68.8 to 88.2"},{"name":"Phase 2, Cohort 3: RET Mutant MTC","n":143,"value":77.6,"note":"95% CI 69.9 to 84.2"},{"name":"Phase 2, Cohort 4: RET Mutant MTC Without Standard Therapy","n":116,"value":82.8,"note":"95% CI 74.6 to 89.1"},{"name":"Phase 2, Cohort 5: Advanced RET Altered Solid Tumor","n":201,"value":57.2,"note":"95% CI 50.1 to 64.2"},{"name":"Phase 2, Cohort 6: RET Inhibitor-Discontinued Participants","n":16,"value":31.3,"note":"95% CI 11.0 to 58.7"}],"source":"https://clinicaltrials.gov/study/NCT03157128?tab=results"}]},"route":"/trials/nct03157128/","neighbours":{"cancer":[{"id":"lung-cancer","kind":"cancer","name":"Lung cancer (all types)","route":"/cancers/lung-cancer/"},{"id":"medullary-thyroid-cancer","kind":"cancer","name":"Medullary thyroid cancer","route":"/cancers/medullary-thyroid-cancer/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"ret-fusion-nsclc","kind":"cancer","name":"RET fusion-positive non-small-cell lung cancer","route":"/cancers/ret-fusion-nsclc/"},{"id":"sclc","kind":"cancer","name":"Small-cell lung cancer","route":"/cancers/sclc/"},{"id":"thyroid","kind":"cancer","name":"Thyroid cancer","route":"/cancers/thyroid/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"selpercatinib","kind":"drug","name":"Selpercatinib","route":"/drugs/selpercatinib/"}],"company":[{"id":"eli-lilly","kind":"company","name":"Eli Lilly (incl. Loxo)","route":"/companies/eli-lilly/"}],"trial":[{"id":"arrow-thyroid","kind":"trial","name":"ARROW (thyroid cohorts)","route":"/trials/arrow-thyroid/"},{"id":"libretto-431","kind":"trial","name":"LIBRETTO-431","route":"/trials/libretto-431/"}],"paper":[{"id":"paper-nct03157128-j-clin-oncol-2024-update","kind":"paper","name":"Durability of Response With Selpercatinib in Patients With RET -Activated Thyroid Cancer: Long-Term Safety and Efficacy From LIBRETTO-001","route":"/key-papers/paper-nct03157128-j-clin-oncol-2024-update/"},{"id":"paper-libretto-001-selpercatinib-nsclc-nejm-2020","kind":"paper","name":"LIBRETTO-001: selpercatinib in RET fusion-positive non-small-cell lung cancer","route":"/key-papers/paper-libretto-001-selpercatinib-nsclc-nejm-2020/"}]}}