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CECYDE: Cemiplimab Plus Chemotherapy in Advanced Squamous NSCLC
NCT07418931Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- May 2026
- Primary completion
- May 2028
- Countries
- 1
- Sponsor
- Gruppo Oncologico Italiano di Ricerca Clinica
- Modality
- Immune Checkpoint Inhibitors, Antibody Conjugates, Engineered Antibody Formats
- Drugs
- cemiplimab
- Conditions
- squamous cell carcinoma of the lung (SCCL)
01
Overview
Phase 2, open-label trial of cemiplimab in squamous cell carcinoma of the lung (SCCL) (3 arms), sponsored by Gruppo Oncologico Italiano di Ricerca Clinica. Primary endpoint: Overall Survival at 4 years. Planned start May 2026; status: not yet recruiting.
02
Design
3 arms- Study design
- Non-randomizedOpen-label
CDA activity < 7.2 U/mg
Cemiplimab + Cisplatin + Gemcitabine
CDA activity ≥ 7.2 U/mg
Cemiplimab + Carboplatin + Paclitaxel
CDA activity < 7.2 U/mg (Investigator's choice)
Cemiplimab + Carboplatin + Gemcitabine
03
Who it enrols
Patients must be adults with stage IV or recurrent pulmonary squamous carcinoma, treatment-naïve for metastatic disease, with known PD-L1 status, ECOG PS 0-1, and adequate organ function. Patients with EGFR, ALK, or ROS1 mutations, active autoimmune diseases, or symptomatic brain metastases are excluded.
04
Endpoints
Primary
Overall Survival
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