Pleural Epithelioid MesotheliomaPhase 1/2NECIMNCT07121374
NEoadjuvant Chemotherapy and Immunotherapy for a Selected Group of Inoperable Pleural Mesothelioma Patients (NECIM): a Feasibility Study
A Phase 1/2 study testing Neoadjuvant chemo-immunotherapy and Extended pleurectomy/decortication in case of reaching operability in people with Pleural Epithelioid Mesothelioma and Mesothelioma; Pleura, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
The goal of this clinical trial is to evaluate whether a combination of chemotherapy and immunotherapy can make surgery possible in adults with inoperable pleural mesothelioma (a type of cancer affecting the lung lining). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Epithelioid Mesothelioma, Mesothelioma; Pleura, Neoadjuvant Chemoimmunotherapy
- What is being tested?
- Neoadjuvant chemo-immunotherapy and Extended pleurectomy/decortication in case of reaching operability
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Jul 2025to Jul 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capable of written informed consent and adherence to study procedures
- Pathologically confirmed PM (epithelioid), cT2-3 N0-1 M0 according to UICC TNM 9 and considered inoperable by the Multidisciplinary Tumor Board of UZA/UZG at the start of the trail. They only enter the second surgical stage when becoming operable after neoadjuvant therapy
- Aged 18 years or older
- World Health Organization (WHO) Performance Status 0-1
- Fit for systemic chemotherapy, immunotherapy and surgery according to good clinical practice
- No pregnancy allowed: women of childbearing potential have to take adequate contraception to avoid pregnancy; men need to take adequate contraception (usage of a condom) to avoid pregnancy in female partners
Who cannot join
- Operable PM patients according to TNM 9 criteria (T1) or inoperable PM patients who will not have a chance to become operable after neoadjuvant treatment according to TNM 9 criteria (some T3, all T4, N2-3, M1)
- Contralateral mediastinal (N2) or distant metastatic disease (evaluated by PET and chest CT)
- Patients unfit for systemic chemotherapy, immunotherapy or intrathoracic surgery. Patients with an active autoimmune disease or who have had prior splenectomy, an active/acute infection requiring antibiotics, a chronic infection (e.g. HIV, hepatitis B or C) or have a serious cardiac disease are unfit for systemic therapy because their immune system is not properly functioning
- Hypersensitivity or contraindications to the active substance or to any of the excipients of the medications (platinum salts, pemetrexed, ipilimumab, nivolumab) used in this study
- Concurrent active malignancy other than basal cell carcinoma of the skin or in situ carcinoma of the cervix including brain metastases
- Prior treatment with chemotherapy, immunotherapy, surgery (except for diagnostic thoracoscopy) or thoracic RT (including prophylactic tract irradiation)
- Patients with significantly altered mental status or with psychological, familial, sociological or geographical conditions potential hampering compliance with the study as decided by the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Antwerp
Edegem, Antwerp, 2650
Hendriks Prof. J. Hendriks, MD. PhD., +3238214361, jeroen.hendriks@uza.be
About this study
The goal of this clinical trial is to evaluate whether a combination of chemotherapy and immunotherapy can make surgery possible in adults with inoperable pleural mesothelioma (a type of cancer affecting the lung lining). The main questions it aims to answer are:
Can two cycles of neoadjuvant chemotherapy and dual immunotherapy, followed by surgery, be completed safely and effectively?
Read more
Does this treatment allow previously inoperable patients to become eligible for surgery and improve survival outcomes?
Participants will:
Receive two cycles of chemotherapy (cisplatin or carboplatin and pemetrexed)
Receive dual immunotherapy (nivolumab and ipilimumab)
Undergo evaluation by a multidisciplinary team to determine if surgery is possible
If operable, undergo extended pleurectomy/decortication surgery
Be followed for one year to assess side effects, quality of life, and survival
- Being tested
- Neoadjuvant chemo-immunotherapy, Extended pleurectomy/decortication in case of reaching operability
- Keywords
- NECIM
- Medical subject headings
- Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant chemo-immunotherapyDrug
Neoadjuvant chemotherapy (2 cycles of cisplatin OR carboplatin accord healthcare- investigator's choice - PLUS pemetrexed fresenius AND immunotherapy (2 cycles of Opdivo PLUS 1 cycle of Yervoy for inoperable T2-T3 TNM 9 patients with PM
Extended pleurectomy/decortication in case of reaching operabilityProcedure or surgery
After the systemic treatment the surgery will follow if patient is operable.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | systemic treatment and surgery Receives: Drug: Neoadjuvant chemo-immunotherapy; Procedure: Extended pleurectomy/decortication in case of reaching operability |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the percentage of successful completion of a neoadjuvant double chemotherapy / double immunotherapy regimen followed by surgery in a selected group of T2-T3 (according to TNM 9) patients with pleural mesothelioma.
The primary endpoint is the rate of success, which is defined as a composite endpoint of feasibility, efficacy and safety consisting of:
Feasibility is defined at week 17 +/- 2 weeks after start of treatment and involves the successful completion of 2 cycles of neoadjuvant immunotherapy and chemotherapy, being selected as operable thereafter, and having extended pleurectomy/decortication (P/D).
AND Efficacy is defined as being alive and without signs of progressive disease at week 17 +/- 2 weeks after start of treatment AND Safety is defined as absence of grade 3-4 residual toxicity from systemic treatment and complete resolution of major complications (grade III - V) after surgery according to the Ottawa Thoracic Surgery Morbidity and Mortality Classification at week 17 +/- 2 weeks after start of treatment Patients who are still inoperable after successful completion of 2 cycles of neoadjuvant immunotherapy and chemotherapy are considered failure for the primary endp
Measured: The primary end point will be measured on week 17 +/-2 weeks
Secondary outcomes (4)
Toxicity of the neoadjuvant double chemotherapy / double immunotherapy regimen and surgery.
Toxicity, assessed by CTC-AE scores. Chemotherapy and immunotherapy-related toxicity assessed using the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. At the end of Treatment on week 17 ± 2 weeks). The CTCAE Grade (1-5); higher scores indicate more severe adverse events.
Measured: The End of Treatment will be at 17 weeks
Toxicity of the neoadjuvant double chemotherapy / double immunotherapy regimen and surgery.
Toxicity, assessed by the Ottawa scores for surgery.
Postoperative surgical complications are assessed using the Ottawa Thoracic Morbidity and Mortality Classification. At End of Treatment on week 17 ± 2 weeks, including postoperative period. The Ottawa classification Grade (I-V); higher grades indicate more severe complications.
Measured: The End of Treatment will be at 17 weeks
Efficay of neoadjuvant double chemotherapy / double immunotherapy regimen in inoperable T2-3 PM patients.
Efficacy, assessed by the percentage of T2 and T3 PM patients becoming operable after double neoadjuvant chemotherapy and immunotherapy which is defined by the radiology department using the TNM 9 criteria.
Measured: operability will be evaluated after systemic treatment on week 7-9.
Quality of life during the neoadjuvant double chemotherapy / double immunotherapy regimen and surgery.
Quality of life, assessed by the EQ-5D-5L score. The EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L), a standardized instrument for measuring health-related quality of life. The EQ-5D-5L consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with 5 response levels. In addition, it includes a visual analogue scale (EQ-VAS) for self-rated health.
Time Frame: At baseline, Day 1 of each treatment cycle, pre-surgery, End of Treatment (Week 17 ± 2 weeks), and follow-up visits at Weeks 13, 26, 39, and 52 after EoT.
Measured: at week 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start22 Jul 2025
- Primary completionJun 2028 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural Epithelioid MesotheliomaStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ghent, Kom Op Tegen Kanker
- Responsible party
- Principal investigator, Jeroen Hendriks, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121374
- Sponsor's protocol ID
- 2387
- Other IDs
- 2023-504302-11-02, 2023
- Acronym
- NECIM
- Status last verified
- Aug 2025
- First submitted
- 25 Jul 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEoadjuvant Chemotherapy and Immunotherapy for a Selected Group of Inoperable Pleural Mesothelioma Patients (NECIM): a Feasibility Study
- ClinicalTrials.gov ID
- NCT07121374
- Acronym / sponsor ID
- NECIM / 2387
- Keywords
- NECIM
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- University Hospital, Ghent, Kom Op Tegen Kanker
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 13 Aug 2025 (actual)
- 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.
The goal of this clinical trial is to evaluate whether a combination of chemotherapy and immunotherapy can make surgery possible in adults with inoperable pleural mesothelioma (a type of cancer affecting the lung lining). The main questions it aims to answer are:
Can two cycles of neoadjuvant chemotherapy and dual immunotherapy, followed by surgery, be completed safely and effectively?
Does this treatment allow previously inoperable patients to become eligible for surgery and improve survival outcomes?
Participants will:
Receive two cycles of chemotherapy (cisplatin or carboplatin and pemetrexed)
Receive dual immunotherapy (nivolumab and ipilimumab)
Undergo evaluation by a multidisciplinary team to determine if surgery is possible
If operable, undergo extended pleurectomy/decortication surgery
Be followed for one year to assess side effects, quality of life, and survival
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Neoadjuvant chemo-immunotherapy, Procedure: Extended pleurectomy/decortication in case of reaching operabilitysystemic treatment and surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Capable of written informed consent and adherence to study procedures
- Pathologically confirmed PM (epithelioid), cT2-3 N0-1 M0 according to UICC TNM 9 and considered inoperable by the Multidisciplinary Tumor Board of UZA/UZG at the start of the trail. They only enter the second surgical stage when becoming operable after neoadjuvant therapy
- Aged 18 years or older
- World Health Organization (WHO) Performance Status 0-1
- Fit for systemic chemotherapy, immunotherapy and surgery according to good clinical practice
Key exclusion criteria (7 listed)
- Operable PM patients according to TNM 9 criteria (T1) or inoperable PM patients who will not have a chance to become operable after neoadjuvant treatment according to TNM 9 criteria (some T3, all T4, N2-3, M1)
- Contralateral mediastinal (N2) or distant metastatic disease (evaluated by PET and chest CT)
- Patients unfit for systemic chemotherapy, immunotherapy or intrathoracic surgery. Patients with an active autoimmune disease or who have had prior splenectomy, an active/acute infection requiring antibiotics, a chronic infection (e.g. HIV, hepatitis B or C) or have a serious cardiac disease are unfit for systemic therapy because their immune system is not properly functioning
- Hypersensitivity or contraindications to the active substance or to any of the excipients of the medications (platinum salts, pemetrexed, ipilimumab, nivolumab) used in this study
- Concurrent active malignancy other than basal cell carcinoma of the skin or in situ carcinoma of the cervix including brain metastases
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 |
|---|---|---|
| Neoadjuvant chemo-immunotherapyNeoadjuvant chemotherapy (2 cycles of cisplatin OR carboplatin accord healthcare- investigator's choice - PLUS pemetrexed fresenius AND immunotherapy (2 cycles of Opdivo PLUS 1 cycle of Yervoy for inoperable T2-T3 TNM 9 patients with PM | Drug | Treatment |
| Extended pleurectomy/decortication in case of reaching operabilityAfter the systemic treatment the surgery will follow if patient is operable. | Procedure or surgery | Treatment |
Primary outcome
To assess the percentage of successful completion of a neoadjuvant double chemotherapy / double immunotherapy regimen followed by surgery in a selected group of T2-T3 (according to TNM 9) patients with pleural mesothelioma.
Time frame: The primary end point will be measured on week 17 +/-2 weeks
The primary endpoint is the rate of success, which is defined as a composite endpoint of feasibility, efficacy and safety consisting of: Feasibility is defined at week 17 +/- 2 weeks after start of treatment and involves the successful completion of 2 cycles of neoadjuvant immunotherapy and chemotherapy, being selected as operable thereafter, and having extended pleurectomy/decortication (P/D). AND Efficacy is defined as being alive and without signs of progressive disease at week 17 +/- 2 weeks after start of treatment AND Safety is defined as absence of grade 3-4 residual toxicity from systemic treatment and complete resolution of major complications (grade III - V) after surgery according to the Ottawa Thoracic Surgery Morbidity and Mortality Classification at week 17 +/- 2 weeks after start of treatment Patients who are still inoperable after successful completion of 2 cycles of neoadjuvant immunotherapy and chemotherapy are considered failure for the primary endp
4 secondary outcomes
Toxicity of the neoadjuvant double chemotherapy / double immunotherapy regimen and surgery.
Time frame: The End of Treatment will be at 17 weeks
Toxicity of the neoadjuvant double chemotherapy / double immunotherapy regimen and surgery.
Time frame: The End of Treatment will be at 17 weeks
Efficay of neoadjuvant double chemotherapy / double immunotherapy regimen in inoperable T2-3 PM patients.
Time frame: operability will be evaluated after systemic treatment on week 7-9.
Quality of life during the neoadjuvant double chemotherapy / double immunotherapy regimen and surgery.
Time frame: at week 17
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Neoadjuvant chemo-immunotherapy and Extended pleurectomy/decortication in case of reaching operability in people with Pleural Epithelioid Mesothelioma and Mesothelioma; Pleura, run by University Hospital, Antwerp at 1 site in Belgium.
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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. J. Hendriks, MD. PhD. (+3238214361, jeroen.hendriks@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the percentage of successful completion of a neoadjuvant double chemotherapy / double immunotherapy regimen followed by surgery in a selected group of T2-T3 (according to TNM 9) patients with pleural mesothelioma. (time frame: The primary end point will be measured on week 17 +/-2 weeks). 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 13 Aug 2025.