NEoadjuvant Chemotherapy and Immunotherapy for a Selected Group of Inoperable Pleural Mesothelioma Patients (NECIM): a Feasibility Study

Launched by UNIVERSITY HOSPITAL, ANTWERP · Aug 8, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for adults with a type of lung cancer called pleural mesothelioma, which affects the lining around the lungs and is currently considered too advanced to be removed by surgery. The study aims to see if giving two rounds of chemotherapy combined with immunotherapy (a treatment that helps the immune system fight cancer) before surgery can shrink the cancer enough to make surgery possible and improve patients’ chances of survival. The researchers want to find out if this treatment plan is safe and if it helps patients who were previously told surgery wasn’t an option.

People who might be eligible for this study are adults diagnosed with a specific type of pleural mesothelioma that’s currently inoperable but might become operable after treatment. Participants need to be healthy enough for chemotherapy, immunotherapy, and surgery, and able to follow the study’s procedures. During the trial, patients will receive two cycles of chemotherapy drugs along with two immunotherapy medicines, then be carefully evaluated by a team of doctors to decide if surgery can be done. If surgery is possible, they will have an operation to remove as much of the cancer as possible. After treatment, patients will be followed for one year to check for side effects, quality of life, and how well they do overall. This study is currently recruiting participants and is open to both men and women who meet the criteria.

Gender

ALL

Eligibility criteria

• 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 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