Tests cemiplimab, guided by tumor DNA levels, in advanced lung cancer

Trial details

Who runs it

Fundación GECP

Trial code

NCT06917573EU 2024-518812-38-00

Record updated

19 November 2025

Original description

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.Read full original descriptionShow less

Phase II Clinical Trial With an Adaptive Design According to Response to Cemiplimab Monotherapy Using ctDNA and Subsequent Treatment With Chemotherapy (CT) and Cemiplimab or Cemiplimab Monotherapy in First Line Advanced NSCLC Patients

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.

Inclusion: 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.

Exclusion: Patients with a weight loss >10% within the previous 3 months; Patients must have recovered from a major surgery at least 14 days prior to enrolment; Prior treatment with antineoplasic drugs or thoracic radiotherapy for any reason different from the ones specific in the inclusion criteria; 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; 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; Immunosuppressive corticosteroid doses within 4 weeks prior to the first dose of cemiplimab; 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; Patients with a history of other malignant diseases within the past 3 years; Patients with active or uncontrolled infections or with serious medical conditions or disorders that may not allow patient management as established in the protocol; 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; 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; Patients whose tumors harbor an activating mutation in EGFR, ALK translocation, or ROS Proto-Oncogene 1 (ROS1) rearrangements sensitive to available targeted inhibitor therapy; Patients with grade ≥2 neuropathy; Pregnant or breastfeeding women; Patients with carcinomatous meningitis; Untreated brain metastasis(es) that may be considered active.

ClinicalTrials.gov NCT06917573 · EU CTIS 2024-518812-38-00