Not Yet RecruitingPhase 2

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

Italy108 participantsStarted 2026-05

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. The patient has no history of intracranial haemorrhage, spinal cord haemorrhage or haemorrhagic intracranial lesions
✕. At least 14 days between the end of stereotactic radiotherapy or whole brain radiotherapy and initiation of study treatment, or at least 28 days between neurosurgical resection and initiation of study treatment
✕. The patient is on a dose of corticosteroids ≤ 10 mg of oral prednisone or equivalent; anticonvulsant therapy at a stable dose is permitted
✕. Metastases are limited to the cerebellum or the supratentorial region (i.e., no metastases to the midbrain, pons, medulla or spinal cord)
✕. There is no evidence of interim progression between completion of CNS directed therapy (if administered) and initiation of study treatment.
✕. Patients with vitiligo or alopecia
✕. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
✕. Any chronic skin condition that does not require systemic therapy. Patients without active disease in the last 5 years may be included but only after consultation with the study physician

The primary endpoint is the Overall Survival (OS)

Timeframe: Four years

NCT IDNCT07418931

SponsorGruppo Oncologico Italiano di Ricerca Clinica

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-05

Carmelo Tibaldi, MD

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. The patient has no history of intracranial haemorrhage, spinal cord haemorrhage or haemorrhagic intracranial lesions
✕. At least 14 days between the end of stereotactic radiotherapy or whole brain radiotherapy and initiation of study treatment, or at least 28 days between neurosurgical resection and initiation of study treatment
✕. The patient is on a dose of corticosteroids ≤ 10 mg of oral prednisone or equivalent; anticonvulsant therapy at a stable dose is permitted
✕. Metastases are limited to the cerebellum or the supratentorial region (i.e., no metastases to the midbrain, pons, medulla or spinal cord)
✕. There is no evidence of interim progression between completion of CNS directed therapy (if administered) and initiation of study treatment.
✕. Patients with vitiligo or alopecia
✕. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
✕. Any chronic skin condition that does not require systemic therapy. Patients without active disease in the last 5 years may be included but only after consultation with the study physician