# LMS-04

Source: https://onco.cc/trials/lms-04/  
OnCo record `lms-04` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-17
- Tags: subtype-page
- Registry id: 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
- Enrolled: 150
- Result: Median PFS 12.2 vs 6.2 months (HR 0.41); overall survival also favoured the combination at later follow-up.
- Outcomes: Progression-free survival (median): Doxorubicin + trabectedin 12.2 months vs Doxorubicin 6.2 months, HR 0.41

## Sources

- ClinicalTrials.gov NCT02997358: https://clinicaltrials.gov/study/NCT02997358
- Lancet Oncology 2022: https://doi.org/10.1016/S1470-2045(22)00380-1

## Connected records

- cancers: [Leiomyosarcoma](https://onco.cc/cancers/leiomyosarcoma/), [Retroperitoneal sarcoma](https://onco.cc/cancers/retroperitoneal-sarcoma/), [Sarcomas (soft tissue, bone, GIST)](https://onco.cc/cancers/sarcoma/), [Soft tissue sarcoma of the extremity (localised and advanced)](https://onco.cc/cancers/extremity-soft-tissue-sarcoma/), [Uterine sarcoma](https://onco.cc/cancers/uterine-sarcoma/)
- drugs: [Doxorubicin](https://onco.cc/drugs/doxorubicin/), [Trabectedin](https://onco.cc/drugs/trabectedin/)

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