NEMO (EORTC 08112-LCG): Nintedanib maintenance in mesothelioma
Research type
Research Study
Full title
Nintedanib as maintenance treatment of malignant pleural mesothelioma (NEMO): a double-blind randomized phase II study of the EORTC Lung Cancer Group
IRAS ID
232257
Contact name
Sanjay Popat
Contact email
Sponsor organisation
European Organisation for Research and Treatment of Cancer
Eudract number
2016-000521-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 2 days
Research summary
This study is for adults who have malignant pleural mesothelioma that cannot be removed by surgery, and have already had chemotherapy.
People at this stage of the disease would usually be monitored and receive no further treatment unless the cancer started growing again.
The purpose of this study is to find out whether giving the drug nintedanib at this timepoint is better at working against this disease than a placebo ('dummy treatment' containing no active ingredient). This is measured by the length of time that participants live with the disease before it gets worse (progression-free survival).
Malignant pleural mesothelioma is a rare cancer with a poor prognosis. No treatments being investigated have so far established a role in treating the disease after chemotherapy, so there is a need to investigate alternative treatments to improve survival in this group of people.
The study will compare the effects of nintedanib with placebo using clinical examinations, regular scans and blood tests.
This study will take place in NHS sites in the UK as part of a wider international study. The study is sponsored and coordinated by a non-profit organisation called the EORTC (European Organisation for Research and Treatment of Cancer), based in Brussels.
Summary of study results:
We enrolled patients with malignant pleural mesothelioma untreated previously, and inoperable. They had a good organ function, stable health conditions, no contraindications to nintedanib, feeling good and without marked functional decline. These patients were randomly assigned to either nintedanib (200mg twice a day) or placebo (dummy treatment). The treatment was administered until loss of clinical benefit, occurrence of severe side effects, or death. The main goal was to see how long patients lived without their disease getting worse (progression free survival, PFS). The other goals included the impact of treatment on patients’ survival, estimation of treatment benefit in all enrolled patients, the tolerance to treatment, and the duration of benefit.
The study was stopped early due to poor accrual with 37 patients enrolled (18 to nintedanib arm and 19 to placebo). Severe side effects (grade 3 or higher) were observed in 27.8% of patients receiving nintedanib compared to 10.5% with placebo. No deaths due to side effects were observed. Despite closing early, the study suggests that nintedanib might be worse than placebo. In average treatment duration was 11.8 weeks for nintedanib and 24.3 weeks for placebo. The worsening of disease was observed at 3.4 months for nintedanib and 4.6 months for placebo. In average, the survival of patients was 13.1 months for nintedanib and 38.9 months for placebo.REC name
London - South East Research Ethics Committee
REC reference
18/LO/0039
Date of REC Opinion
25 Jan 2018
REC opinion
Favourable Opinion