# LUME-Meso

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

## TL;DR

LUME-Meso randomised 458 patients with epithelioid pleural mesothelioma to first-line cisplatin and pemetrexed with nintedanib or placebo. The phase 2 progression signal for the multi-kinase inhibitor vanished in phase 3, with no delay in progression and no gain in life, a lesson in the unreliability of small phase 2 signals in this disease.

## Summary

LUME-Meso, trial NCT01907100 sponsored by Boehringer Ingelheim and reported in 2019, found that the phase 2 progression signal for the multi-kinase inhibitor nintedanib vanished in phase 3. It randomised 458 patients with epithelioid pleural mesothelioma to nintedanib or placebo with first-line cisplatin and pemetrexed and found no difference in progression-free survival and no survival benefit. OnCo links it to mesothelioma, nintedanib and pemetrexed. The record treats it as a lesson in the unreliability of small randomised phase 2 progression signals in mesothelioma, and why such signals so often fail to replicate in this disease is the open question.

## Fields

- Kind: Trial
- Status: negative
- Last checked: 2026-09-07
- Tags: lesson:phase-2-pfs-signal
- Registry id: NCT01907100
- Phase: 2/3
- Setting: Epithelioid pleural mesothelioma, first line: cisplatin-pemetrexed ± nintedanib
- Sponsor: Boehringer Ingelheim
- Enrolled: 458
- Result: PFS HR 1.01, negative.
- Outcomes: Progression-free survival: Nintedanib + chemotherapy 6.8 months vs Placebo + chemotherapy 7 months, HR 1.01

## Sources

- ClinicalTrials.gov NCT01907100: https://clinicaltrials.gov/study/NCT01907100

## Connected records

- cancers: [Mesothelioma](https://onco.cc/cancers/mesothelioma/)
- technologies: [Anti-angiogenic therapy](https://onco.cc/technologies/antiangiogenic/), [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- drugs: [Nintedanib](https://onco.cc/drugs/nintedanib/), [Pemetrexed](https://onco.cc/drugs/pemetrexed/)
- companies: [Boehringer Ingelheim](https://onco.cc/companies/boehringer-ingelheim/)

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