NEoadjuvant Chemotherapy and Immunotherapy for a Selected Group of Inoperable Pleural Mesotheliom… (NCT07121374) | Clinical Trial Compass
RecruitingPhase 1/2
NEoadjuvant Chemotherapy and Immunotherapy for a Selected Group of Inoperable Pleural Mesothelioma Patients (NECIM): a Feasibility Study
Belgium37 participantsStarted 2025-07-22
Plain-language 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). 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 contraindicat…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: The primary end point will be measured on week 17 +/-2 weeks