Malignant Pleural MesotheliomaPhase 2NEMONCT02863055
Nintedanib as Switch Maintenance Treatment of Pleural Malignant Mesothelioma
A Phase 2 study testing Nintedanib in people with Malignant Pleural Mesothelioma, run by European Organisation for Research and Treatment of Cancer - EORTC at 9 sites in 3 countries.
Trial summary
This is a multicenter, randomized, 1:1, double blinded phase II trial. Patients with unresectable malignant pleural mesothelioma (MPM) will be randomized between arm A: nintedanib and arm B:placebo Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Malignant Pleural Mesothelioma
- What is being tested?
- Nintedanib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 4 Feb 2018to 10 Jan 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological diagnosis of unresectable Malignant Pleural Mesothelioma (MPM);
- Response or Stable disease according to modified RECIST criteria [48] after first line platinum-pemetrexed chemotherapy for 4-6 cycles;
- Last platinum chemotherapy dose administered within 60 days (i.e. randomization must occur within 60 days from the last dose of the last cycle of platinum-pemetrexed chemotherapy);
- Age >18 years;
- ECOG performance status (PS) 0-2;
- Life expectancy of at least 12 weeks in the opinion of the investigator;
- Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of first dose
Who cannot join
- prior systemic anticancer therapy including cytotoxic therapy or immune-checkpoint inhibitor, for MPM, other than first line platinum-based doublet chemotherapy;
- previous extra-pleural pneumonectomy (other forms of previous surgery eg pleurectomy are acceptable);
- previous Vascular Endothelial Growth Factor (VEGF) inhibitors (eg bevacizumab, sorafenib, etc);
- treatment with other investigational drugs or treatment in another clinical interventional trial within the past 4 weeks before start of therapy or concomitantly with the trial;
- patients that, in the opinion of the investigator, have reduced performance status by 2 ECOG levels (e.g. PS 0 to 2 or PS 1 to 3) from beginning to completion of 1st line chemotherapy;
- radiotherapy (with the exception of palliative radiotherapy) during study or within 4 weeks of start of study drug;
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- known brain metastasis or lepto-meningeal disease. Patients with suspicious neurological symptoms should undergo a CT scan/MRI of the brain to exclude brain metastasisNo active brain metastases (e.g. stable for < 4 weeks;, no adequate previous treatment with radiotherapy;, symptomatic, requiring treatment with anti-convulsants; dexamethasone therapy will be allowed if administered as stable dose for at least one month before randomization); patients with suspicious neurological symptoms should undergo a CT scan/MRI of the brain to assess brain metastasis;
- leptomeningeal metastases;
- significant weight loss (> 10 %) within the past 6 weeks prior to treatment in the present trial;
- pre-existing clinically significant ascites and/or clinically significant pleural effusion;
- active or history of bleeding complications that would prevent anti-angiogenic therapy
- centrally located tumors with radiographic evidence (CT or MRI) of local invasion of major blood vessels; typical mediastinal pleural involvement with mesothelioma remains eligible;
- clinically active cancer other than mesothelioma within 5 years prior to start of study treatment;
- radiographic evidence of cavitatory or necrotic tumors;
- unstoppable use of therapeutic anticoagulation (except low dose heparin and/or heparin flush as needed for maintenance of an indwelling intravenous device) or antiplatelet therapy (except for chronic low-dose therapy with acetylsalicylic acid =325mg per day);
- clinically significant cardiovascular diseases (i.e. hypertension not controlled by medical therapy, unstable angina, history of myocardial infarction within the past 6 months, congestive New York Heart Association (NYHA) II, serious cardiac arrhythmia, clinically significant pericardial effusion)
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
United Kingdom6 sites
Royal Marsden Hospital
Chelsea
Royal Marsden Hospital - Kingston
Kingston
Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital
Sheffield
NHS South Tyneside-South Tyneside District Hospital
South Shields
Royal Marsden Hospital
Sutton
Manchester University NHS Foundation Trust - UHSM-Wythenshawe Hospital
Wythenshawe, Manchester, M23 9LT
About this study
Official title: Nintedanib as Maintenance Treatment of Pleural Malignant Mesothelioma (NEMO): a Randomized Double Blinded Phase II Study of the EORTC Lung Cancer Group
This is a multicenter, randomized, 1:1, double blinded phase II trial. Patients with unresectable malignant pleural mesothelioma (MPM) will be randomized between arm A: nintedanib and arm B:placebo
Read the detailed description
This is a multicenter, prospective, double blinded, randomized, two-arm phase II trial aiming to evaluate nintedanib treatment as switch maintenance in patients with unresectable MPM.
After signing of the informed consent and upon confirmation of all eligibility criteria, patients will be randomized 1:1 to:
- Arm A: twice daily nintedanib at a dose of 200 mg until progression or unacceptable toxicities.
- Arm B: matched placebo.
Response evaluation will be performed through CT scans every 8 weeks.
- Conditions
- Malignant Pleural Mesothelioma
- Being tested
- Nintedanib, Placebo
- Keywords
- MPM, Unresectable, Phase II, Randomized, Maintenance
- Medical subject headings
- Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NintedanibDrug
Nintedanib 200 mg administered twice daily
PlaceboDrug
Matching placebo administered twice daily
| Study group | Role | What they receive |
|---|---|---|
| Nintedanib | Experimental | 200 mg twice a day per os Receives: Drug: Nintedanib |
| Placebo | Placebo comparator | Placebo match twice a day per os Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
From randomization until progression or death
Measured: 6 months
Secondary outcomes (2)
Overall survival
From randomization until progression or death
Measured: 12 months
Overall Response Rate
Response according to modified RECIST
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study start4 Feb 2018
- Primary completion12 Oct 2023
- Study completion10 Jan 2024
Why it stopped: lack of scientific relevance (change in the treatment landscape) and poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural MesotheliomaStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Sanjay Popat, PhD, MD, Principal investigator, Royal Marsden NHS Foundation TrustOmar Abdel-Rahman, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02863055
- Sponsor's protocol ID
- EORTC-08112
- Acronym
- NEMO
- Status last verified
- Sep 2025
- First submitted
- 8 Aug 2016
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nintedanib as Maintenance Treatment of Pleural Malignant Mesothelioma (NEMO): a Randomized Double Blinded Phase II Study of the EORTC Lung Cancer Group
- ClinicalTrials.gov ID
- NCT02863055
- Acronym / sponsor ID
- NEMO / EORTC-08112
- Conditions
- Malignant Pleural Mesothelioma
- Keywords
- MPM, Unresectable, Phase II, Randomized, Maintenance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of scientific relevance (change in the treatment landscape) and poor recruitment
- Enrolment
- 37 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- 4 Feb 2018 (actual)
- Primary completion
- 12 Oct 2023 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 11 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, 1:1, double blinded phase II trial. Patients with unresectable malignant pleural mesothelioma (MPM) will be randomized between arm A: nintedanib and arm B:placebo
Detailed description
This is a multicenter, prospective, double blinded, randomized, two-arm phase II trial aiming to evaluate nintedanib treatment as switch maintenance in patients with unresectable MPM.
After signing of the informed consent and upon confirmation of all eligibility criteria, patients will be randomized 1:1 to:
- Arm A: twice daily nintedanib at a dose of 200 mg until progression or unacceptable toxicities.
- Arm B: matched placebo.
Response evaluation will be performed through CT scans every 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nintedanib | Experimental | Drug: Nintedanib200 mg twice a day per os |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo match twice a day per os |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histological diagnosis of unresectable Malignant Pleural Mesothelioma (MPM);
- Response or Stable disease according to modified RECIST criteria [48] after first line platinum-pemetrexed chemotherapy for 4-6 cycles;
- Last platinum chemotherapy dose administered within 60 days (i.e. randomization must occur within 60 days from the last dose of the last cycle of platinum-pemetrexed chemotherapy);
- Age >18 years;
- ECOG performance status (PS) 0-2;
Key exclusion criteria (16 listed)
- prior systemic anticancer therapy including cytotoxic therapy or immune-checkpoint inhibitor, for MPM, other than first line platinum-based doublet chemotherapy;
- previous extra-pleural pneumonectomy (other forms of previous surgery eg pleurectomy are acceptable);
- previous Vascular Endothelial Growth Factor (VEGF) inhibitors (eg bevacizumab, sorafenib, etc);
- treatment with other investigational drugs or treatment in another clinical interventional trial within the past 4 weeks before start of therapy or concomitantly with the trial;
- patients that, in the opinion of the investigator, have reduced performance status by 2 ECOG levels (e.g. PS 0 to 2 or PS 1 to 3) from beginning to completion of 1st line chemotherapy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NintedanibNintedanib 200 mg administered twice daily | Drug | Nintedanib |
| PlaceboMatching placebo administered twice daily | Drug | Placebo |
Primary outcome
Progression-free survival
Time frame: 6 months
From randomization until progression or death
2 secondary outcomes
Overall survival
Time frame: 12 months
Overall Response Rate
Time frame: 6 months
Results and safety
The study was stopped early (reason given: lack of scientific relevance (change in the treatment landscape) and poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjay Popat, PhD, MD principal investigator
Royal Marsden NHS Foundation Trust
Omar Abdel-Rahman, MD principal investigator
Ain Shams University
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nintedanib in people with Malignant Pleural Mesothelioma, run by European Organisation for Research and Treatment of Cancer - EORTC at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom, Belgium, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: lack of scientific relevance (change in the treatment landscape) and poor recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.