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

Sponsor
Gruppo Oncologico Italiano di Ricerca Clinica
Study ID
NCT07418931
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Advanced Squamous Non-Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
May 31, 2026
Status verified
Jan 2026
Primary completion
May 31, 2028
Completion
Nov 30, 2030

Study Design

Enrollment
108 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CDA activity < 7.2 U/mg
    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
  • Experimental: CDA activity ≥ 7.2 U/mg
    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
  • Experimental: CDA activity < 7.2 U/mg (at investigator's choice)
    At Investigator's choice: Carboplatin AUC 5 day 1 + Gemcitabine 1000 mg/sqm on days 1 and 8 every 21 days for 4 cycles plus Cemiplimab 350 mg every 3 weeks followed by Cemiplimab 350 mg every 3 weeks until disease progression or unacceptable toxicity or a maximum of 108 weeks

Primary Outcome Measure

The primary endpoint is the Overall Survival (OS) [ Time Frame: Four years ]

Central Contacts