PALACE: Cemiplimab Trial According to ctDNA Levels

Inclusion Criteria

• •Histologically confirmed stage IV or stage IIIB/C not candidates for definitive chemo/radiotherapy or surgical resection non-small cell lung cancer (NSCLC) per the 8th edition TNM with no prior systemic anti-cancer therapy
• •PDL1 ≥50%
• •ECOG performance status 0-1
• •Patients aged ≥ 18 years
• •Prior adjuvant or neoadjuvant chemotherapy for early stage is permitted if completed at least 6 months prior to enrolment
• •Presence of at least one measurable lesion by CT-scan per RECIST version 1.1
• •Anticipated life expectancy \>12 weeks
• •Correct hematological, hepatic and renal function
• •Patient consent must be obtained in the appropriate manner as established in the applicable local and regulatory requirements
• •Patients must be accessible for treatment and follow-up
• •Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must have a negative serum or urine pregnancy test within 3 days before enrolment.
• •All sexually active men and women of childbearing potential must use a highly effective contraceptive method during the study treatment and for a period of at least 4 months following the last administration of trial drugs
• •Patients who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy, or chemo-radiotherapy with curative intent for non-metastatic disease less than 6 months before enrollment since the last chemotherapy, radiotherapy, or chemo-radiotherapy
• •Patients with a combination of small cell lung cancer and non-small cell lung cancer, a carcinoid lung tumor or large cell neuroendocrine carcinoma
• •Has known allergy or hypersensitivity to components of study drug
• •Significant comorbidities that preclude the administration of chemotherapy according to the investigator's criteria
• •Ongoing or recent evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments
• •Untreated brain metastasis(es) that may be considered active
• •Immunosuppressive corticosteroid doses within 4 weeks prior to the first dose of cemiplimab
• •Uncontrolled infection with hepatitis B or hepatitis C or human immunodeficiency virus; or diagnosis of immunodeficiency
• •History of interstitial lung disease or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management.
• •History of documented allergic reactions or acute hypersensitivity reactions attributed to antibody treatments
• •Patients with a history of solid organ transplant
• •Receipt of live vaccines within 30 days of first study treatment
• •Women of childbearing potential, or sexually active men, who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment prior to the start of the first treatment, during the study, and for at least 4 months after the last dose.