Trial Assessing Fianlimab Plus Cemiplimab Plus Chemotherapy or Cemiplimab Plus Chemotherapy in Patients With Pleural Mesothelioma

This is a multicentre, phase IIR, double non-comparative arm trial, with an initial safety run for the anti-LAG3 arm. Approximately 40 sites will participate in the study and will enroll 126 patients with treatment-naive, unresectable malignant PM. Treatment will be administered in 21-day cycles and will continue until disease progression, unacceptable toxicity, withdrawal of consent or for 2 years immunotherapy maximum. Once the patient discontinues study treatment, the treatment period will end and the patient will enter the follow-up period. No cross-over is allowed between arms.

NCT Number	NCT07234058
Lead Sponsor	Intergroupe Francophone de Cancerologie Thoracique Collaborators: Regeneron Pharmaceuticals
Conditions	Pleural Mesotheliomas
Enrollment	126 participants
Start Date	2026-04-02
Primary Completion	2028-05 (estimated)
Study Completion	2029-09 (estimated)
Updated on ClinicalTrials.gov	2026-08-11