Clinical trial · Interventional
Nintedanib (BIBF 1120) in Mesothelioma
LUME-Meso: Double Blind, Randomised, Multicentre, Phase II/III Study of Nintedanib in Combination With Pemetrexed / Cisplatin Followed by Continuing Nintedanib Monotherapy Versus Placebo in Combination With Pemetrexed / Cisplatin Followed by Continuing Placebo Monotherapy for the Treatment of Patients With Unresectable Malignant Pleural Mesothelioma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase II/III confirmatory study designed to evaluate the safety and efficacy of nintedanib (BIBF 1120) in combination + (pemetrexed / cisplatin) followed by nintedanib (BIBF 1120) versus placebo + pemetrexed / cisplatin followed by placebo for the treatment of patients with unresectable malignant pleural mesothelioma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mesothelioma | Malignant Mesothelioma | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Nintedanib | Drug | Nintedanib | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo + pemetrexed/cisplatin
- description
- Placebo controlled arm
- interventionNames
- Drug: Pemetrexed
- Drug: Cisplatin
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Nintedanib 200mg + pemetrexed/cisplatin
- description
- Experimental arm
- interventionNames
- Drug: Nintedanib
- Drug: Cisplatin
- Drug: Pemetrexed
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Histologically confirmed malignant pleural mesothelioma (MPM) (Epithelioid or biphasic subtype for Phase II patients; epithelioid subtype only for Phase III patients) * Life expectancy of at least 3 months in the opinion of the investigator * Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 * Measurable disease according to modified RECIST (Response Evaluation Criteria In Solid Tumours) criteria Exclusion criteria: * Previous systemic chemotherapy for MPM * Prior treatment with nintedanib or any other prior line of therapy * Phase II patients with sarcomatoid subtype MPM or Phase III patients with biphasic or sarcomatoid subtype MPM * Patients with symptomatic neuropathy * Radiotherapy (except extremities) within 3 months prior to baseline imaging * Active brain metastases (e.g. stable for \< 4 weeks) * Radiographic evidence of cavitary or necrotic tumours or local invasion of major blood vessels by MPM * Significant cardiovascular diseases * Inadequate hematologic, renal, or hepatic function
References
Publications (1)
- DERIVEDScagliotti GV, Gaafar R, Nowak AK, Nakano T, van Meerbeeck J, Popat S, Vogelzang NJ, Grosso F, Aboelhassan R, Jakopovic M, Ceresoli GL, Taylor P, Orlandi F, Fennell DA, Novello S, Scherpereel A, Kuribayashi K, Cedres S, Sorensen JB, Pavlakis N, Reck M, Velema D, von Wangenheim U, Kim M, Barrueco J, Tsao AS. Nintedanib in combination with pemetrexed and cisplatin for chemotherapy-naive patients with advanced malignant pleural mesothelioma (LUME-Meso): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet Respir Med. 2019 Jul;7(7):569-580. doi: 10.1016/S2213-2600(19)30139-0. Epub 2019 May 15. PMID 31103412