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.

Trial Details

NCT ID
NCT07234058
Phase
PHASE2
Sponsor
Intergroupe Francophone de Cancerologie Thoracique
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Cemiplimab
  • Fianlimab
  • Pemetrexed (Alimta)
  • Cisplatin
  • Carboplatin (AUC 5)
Locations (sample)
  • Aix-en-Provence, France|43.5283,5.44973
  • Amiens, France|49.9,2.3
  • Angers, France|47.47156,-0.55202
  • Avignon, France|43.94834,4.80892
  • Besançon, France|47.24878,6.01815

Key Eligibility Criteria

  • Signed written Informed Consent.
  • Subjects must have signed and dated an IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This …
  • Subjects must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing.
  • Histological diagnosis (no cytology allowed, thoracoscopy biopsy recommended).

For full eligibility, visit ClinicalTrials.gov.

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