drugset / Trial / NCT07121374

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

NCT07121374

NaSingle-groupOpen-labelTreatment

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

Timeline

Start
2025-07-22
Primary completion
2028-06
Completion
2029-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule
Subject Cisplatin Other / unclassified
Subject Ipilimumab Monoclonal antibody
Subject Nivolumab Monoclonal antibody
Subject Pemetrexed Small molecule