Status:
RECRUITING
PALACE: Cemiplimab Trial According to ctDNA Levels
Lead Sponsor:
Fundación GECP
Conditions:
Non Small Cell Lung Cancer Metastatic
Lung Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 canc...
Detailed Description
This is an open-label, non-randomised, phase II, multicenter clinical trial. The total sample size is 63 patients. The population to be included are stage IV or stage IIIB/C not candidates for definit...
Eligibility Criteria
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 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 a weight loss \>10% within the previous 3 months
- Patients with carcinomatous meningitis
- Patients with a history of other malignant diseases within the past 3 years
- Patients must have recovered from a major surgery at least 14 days prior to enrolment
- Patients with active or uncontrolled infections or with serious medical conditions or disorders that may not allow patient management as established in the protocol
- 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
- 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.
Key Trial Info
Start Date :
July 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2031
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT06917573
Start Date
July 29 2025
End Date
December 30 2031
Last Update
November 19 2025
Active Locations (20)
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1
Hospital General de Alicante
Alicante, Alicante, Spain, 03010
2
Hospital General de Elche
Elche, Alicante, Spain, 03203
3
ICO Badalona, Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
4
Hospital Universitari Vall d' Hebron
Barcelona, Barcelona, Spain, 08035