{"entity":{"id":"lms-04","kind":"trial","name":"LMS-04","aka":[],"tldr":"In leiomyosarcoma, adding trabectedin to doxorubicin roughly doubled the time the disease stayed controlled, the first randomised first-line gain in this sarcoma in decades.","summary":"LMS-04 randomised 150 patients with metastatic or unresectable uterine or soft tissue leiomyosarcoma to six cycles of doxorubicin plus trabectedin followed by trabectedin maintenance, or doxorubicin alone. Median progression-free survival was 12.2 months with the combination versus 6.2 months with doxorubicin (hazard ratio 0.41), with more haematological toxicity, and later follow-up also reported improved overall survival. Published in Lancet Oncology in 2022, it established doxorubicin plus trabectedin as a first-line standard for fit patients with leiomyosarcoma and as the model for histology-specific sarcoma trials.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02997358","url":"https://clinicaltrials.gov/study/NCT02997358"},{"label":"Lancet Oncology 2022","url":"https://doi.org/10.1016/S1470-2045(22)00380-1"}],"tags":["subtype-page"],"related":[],"cancers":["leiomyosarcoma","uterine-sarcoma","extremity-soft-tissue-sarcoma","retroperitoneal-sarcoma","sarcoma"],"sections":[],"technologies":[],"targets":[],"drugs":["doxorubicin","trabectedin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02997358","phase":"3","setting":"Metastatic or unresectable leiomyosarcoma, first line: doxorubicin plus trabectedin (then trabectedin maintenance) versus doxorubicin","sponsor":"French Sarcoma Group / Centre Leon Berard","result":"Median PFS 12.2 vs 6.2 months (HR 0.41); overall survival also favoured the combination at later follow-up.","yearReported":2022,"enrolled":150,"outcomes":[{"endpoint":"Progression-free survival (median)","primary":true,"unit":"months","arms":[{"name":"Doxorubicin + trabectedin","value":12.2},{"name":"Doxorubicin","value":6.2}],"hr":0.41,"ci":[0.29,0.58],"p":"<0.0001","source":"https://doi.org/10.1016/S1470-2045(22)00380-1"}]},"route":"/trials/lms-04/","neighbours":{"cancer":[{"id":"leiomyosarcoma","kind":"cancer","name":"Leiomyosarcoma","route":"/cancers/leiomyosarcoma/"},{"id":"retroperitoneal-sarcoma","kind":"cancer","name":"Retroperitoneal sarcoma","route":"/cancers/retroperitoneal-sarcoma/"},{"id":"sarcoma","kind":"cancer","name":"Sarcomas (soft tissue, bone, GIST)","route":"/cancers/sarcoma/"},{"id":"extremity-soft-tissue-sarcoma","kind":"cancer","name":"Soft tissue sarcoma of the extremity (localised and advanced)","route":"/cancers/extremity-soft-tissue-sarcoma/"},{"id":"uterine-sarcoma","kind":"cancer","name":"Uterine sarcoma","route":"/cancers/uterine-sarcoma/"}],"drug":[{"id":"doxorubicin","kind":"drug","name":"Doxorubicin","route":"/drugs/doxorubicin/"},{"id":"trabectedin","kind":"drug","name":"Trabectedin","route":"/drugs/trabectedin/"}]}}