A Multicenter Open-label Phase II Study of Cemiplimab Plus Chemotherapy, Selected on the Basis of Baseline Cytidine Deaminase Activity, in Advanced Squamous Non-small Cell Lung Cancer - CECYDE Study

NCT07418931 Phase 2 NOT_YET_RECRUITING

This is a multicenter phase II study enrolling treatment- naïve patients with metastatic or recurrent squamous carcinoma of the lung

Details

Lead sponsor	Gruppo Oncologico Italiano di Ricerca Clinica
Phase	Phase 2
Status	NOT_YET_RECRUITING
Enrolment	108
Start date	2026-05
Completion	2030-11

Conditions

• Advanced Squamous Non-Small Cell Lung Cancer

Interventions

• Cemiplimab 350 mg IV
• Paclitaxel 200 mg/sqm IV
• Carboplatin AUC 5 IVa
• Cisplatin 80 mg/sqm IV
• Gemcitabine 1000 mg/sqm a
• Carboplatin AUC 6 IVb
• Gemcitabine 1200 mg/sqm b

Primary outcomes

• The primary endpoint is the Overall Survival (OS) — Four years
  The OS will be measured from the date of registration to the date of death by any cause and will be analyzed as survival rate at 1 year.

Countries

Italy