This is a multicenter phase II study enrolling treatment- naïve patients with metastatic or recurrent squamous carcinoma of the lung
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Written informed consent and any locally required authorization obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
Age > 18 years at the time of study entry.
Histologically or cytologically (cell blocks only; smears are not acceptable) documented pulmonary squamous carcinoma.
Patients with a sensitizing mutation in the epidermal growth factor receptor (EGFR) gene, or with anaplastic lymphoma kinase (EML4-ALK) translocations or with ROS1 proto-oncogene receptor tyrosine kinase (ROS1) translocations. EGFR mutations, ALK and ROS1 translocations will be assessed in never- smoker patients
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
Parallel
Cemiplimab 350 mg IV
DrugOver approximately 30 min +/- 10 min. Day 1 every 21 days
Paclitaxel 200 mg/sqm IV
DrugOver approximately 180 min. Day 1 every 21 days
Carboplatin AUC 5 IVa
DrugOver approximately 15-30 min. Day 1 every 21 days
Cisplatin 80 mg/sqm IV
DrugOver approximately 20 min. Day 1 every 21 days
Gemcitabine 1000 mg/sqm a
DrugOver approximately 30 min. Day 1 and 8 every 21 days
Carboplatin AUC 6 IVb
DrugOver approximately 15-30 min. Day 1 every 21 days
Gemcitabine 1200 mg/sqm b
DrugOver approximately 30 min. Day 1 and 8 every 21 days
The primary endpoint is the Overall Survival (OS)
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.
Secondary outcomes
Median OS that will be measured from the date of registration to the date of death by any cause.
Secondary Outcome
Survival rate at 3 year and 5 years will be analysed
Secondary Outcome
Progression Free Survival (PFS) that will be measured from the date of registration to the date of disease progression
Secondary Outcome
Objective Response Rate (ORR) that will be defined as the sum of complete response (CR)+ partial response (PR), based on the Investigator's assessment according to standard RECIST 1.1 criteria. Patients with no tumor assessment after baseline will be classified as non-responders.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
