PALACE: Cemiplimab Trial According to ctDNA Levels
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is an open-label, non-randomised, phase II, multicenter clinical trial. 63 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 will be enrolled in this trial to determine whether therapy decision making based on ctDNA analysis improves overall survival.
Eligibility Criteria
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 sexuall