NCT07418931

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Patients will receive chemotherapy plus Cemiplimab according to the baseline CDA enzymatic activity measured baseline in plasma samples by spectrophotometric assay: Patients with low CDA activity (\< 7.2 U/mg) will receive: Cisplatin 80 mg/sqm on day 1 + Gemcitabine 1200 mg/sqm on days 1 and 8 and Cemiplimab 350 mg on day 1 administered every 3 weeks for 4 cycles followed by Cemiplimab 350 mg every 3 weeks until disease progression or unacceptable toxicity or a maximum of 108 weeks; or of investigator's choice: Carboplatin AUC 5 day 1 + Gemcitabine 1000 mg/sqm on days 1 and 8 and Cemiplimab 350 mg on day 1 administered every 21 days for 4 cycles followed by Cemiplimab 350 mg every 3 weeks until disease progression or unacceptable toxicity or a maximum of 108 weeks Patients with high CDA activity (≥ 7.2 U/mg) will receive carboplatin at an area under the concentration-time curve of 6 mg/mL/min IV (day 1) + paclitaxel 200 mg/sqm on days 1 and Cemiplimab 350 mg on day 1 administered every 21 days for 4 cycles followed by Cemiplimab 350 mg every 3 weeks until disease progression or unacceptable toxicity or a maximum of 108 weeks.

Conditions

• Advanced Squamous Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Cemiplimab 350 mg IV	Over approximately 30 min +/- 10 min. Day 1 every 21 days
DRUG	Paclitaxel 200 mg/sqm IV	Over approximately 180 min. Day 1 every 21 days
DRUG	Carboplatin AUC 5 IVa	Over approximately 15-30 min. Day 1 every 21 days
DRUG	Cisplatin 80 mg/sqm IV	Over approximately 20 min. Day 1 every 21 days
DRUG	Gemcitabine 1000 mg/sqm a	Over approximately 30 min. Day 1 and 8 every 21 days
DRUG	Carboplatin AUC 6 IVb	Over approximately 15-30 min. Day 1 every 21 days
DRUG	Gemcitabine 1200 mg/sqm b	Over approximately 30 min. Day 1 and 8 every 21 days

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-05-01
• Completion: 2030-11-01
• First posted: 2026-02-18
• Last updated: 2026-02-18

Locations

15 sites across 1 country: Italy