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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223319

Enrollment

450

Registered

2016-09-14

Start date

2016-12-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant pleural mesothelioma

Interventions

investigational material(s) Generic name etc : Nintedanib INN of investigational material : BIBF 1120 Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female patients age 20 years or older 2. Histologically confirmed malignant pleural mesothelioma (MPM) 3. Life expectancy of at least 3 months in the opinion of the investigator etc.

Exclusion criteria

Exclusion criteria: 1. Previous systemic chemotherapy for MPM 2. Prior treatment with nintedanib or any other prior line of therapy 3. Significant cardiovascular diseases etc.

Design outcomes

Primary

Measure	Time frame
efficacy Progression free survival measured from the time of randomisation to the time of disease progression or death of any cause, whichever occurs earlier	—

Secondary

Measure	Time frame
efficacy Overall survival measured from the time of randomisation to the time of death of any cause efficacy Objective response according to modified RECIST analysed by objective response rate	—

Countries

Africa, Asia except Japan, Europe, Japan, North America, Oceania, South America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026