PALACE: Cemiplimab Trial According to ctDNA Levels
PALACE
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
2 other identifiers
interventional
63
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2025
Longer than P75 for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2025
CompletedFirst Posted
Study publicly available on registry
April 8, 2025
CompletedStudy Start
First participant enrolled
July 29, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2031
November 19, 2025
November 1, 2025
6.4 years
April 1, 2025
November 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine whether therapy decision making based on ctDNA analysis improves overall survival
Test whether the addition of chemotherapy in patients receiving Cemiplimab, based on the ctDNA levels after two cycles of Cemiplimab, improves overall survival (OS) at 24 months. OS defined as the time from enrolment to death from any cause.
From the date of the end of two cycles of Cemiplimab treatment until 24 months
Secondary Outcomes (3)
To assess the efficacy of the treatment in terms of the Progression Free Survival (PFS) at 12 months
From the date of the end of treatment until 12 months
To evaluate the sites of first failure
From the date of the end of treatment until the date of last follow up, assessed up to 24 months
Duration of response (DOR)
From date of documentation of tumor response until date of first documented progression, assessed up to 24 months
Study Arms (1)
Experimental
EXPERIMENTALA. Cemiplimab monotherapy \- Cemiplimab Cemiplimab will be administered in monotherapy for 2 cycles. After 2 cycles of treatment and after response evaluation according to RECIST criteria and ctDNA quantification, patient will receive cemiplimab + chemotherapy or continue treatment with cemiplimab monotherapy Cemiplimab monotherapy will be administered until disease progression, unacceptable toxicity, loss of clinical benefit as judged by the investigator or up to a maximum of 2 years of treatment. B. Cemiplimab + chemotherapy The treatment with chemotherapy will be selected according to investigator's choice. Carboplatin and Pemetrexed or Carboplatin plus taxanes is recommended.
Interventions
Patients will receive Cemiplimab administered by IV infusion over 30 minutes every 28 days (Q3W) until disease progression, unacceptable toxicity, loss of clinical benefit as judged by the investigator or up to a maximum of 2 years of treatment. Structure: is a high affinity hinge-stabilized IgG4P human antibody to the PD-1receptor (PDCD1, CD279) that blocks PD 1/PD L1 mediated T cell inhibition. Binding of the PD-1 ligands PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Route of administration: Intravenous infusion.
Patients will receive Carboplatin administered by IV infusion for 2 cycles. Structure: The cis-diamino (cyclobutane-1, 1 dicarboxylate) platin. Stability: 24 hours at ambient temperature in 5% glucose, glucosaline or physiologic saline. It is recommended not to dilute with chlorinated solutions since this could affect the carboplatin. Route of administration: Intravenous infusion.
Patients will receive Paclitaxel administered by IV infusion for 2 cycles. Structure: A diterpene whose composition is: 5b, 20- epoxy-1, 2a, 4,7b, 10b, 13a-hexahidroxytax-11-en 9 one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)- N-benzoyl-3-phenylisoserine. Stability: Concentrations of 0.3-1.2 mg/ml in 5% dextrose or normal saline have demonstrated chemical and physical stability for more than 27 hours at ambient temperature (25ºC approximately). The intact vial must be stored between 15º and 25ºC. Guidelines of Paclitaxel administration: Paclitaxel must be administered by infusion over 3 hours in dextrose (D5W) or normal saline (NS). The concentration must not exceed 1.2 mg/ml.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fundación GECPlead
Study Sites (20)
Hospital General de Alicante
Alicante, Alicante, 03010, Spain
Hospital General de Elche
Elche, Alicante, 03203, Spain
ICO Badalona, Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital Universitari Vall d' Hebron
Barcelona, Barcelona, 08035, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08041, Spain
ICO Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
Hospital De Basurto
Bilbao, Bilbao, 48013, Spain
Hospital Universitario Jerez De La Frontera
Jerez de la Frontera, Cádiz, 11407, Spain
Hospital Dr. Josep Trueta
Girona, Girona, 17007, Spain
Hospitalario Universitario A Coruña
A Coruña, La Coruña, 15006, Spain
Hospital Universitario Dr. Negrín
Las Palmas de Gran Canaria, Las Palmas, 35010, Spain
Hospital Universitario Severo Ochoa
Leganés, Madrid, 28911, Spain
Hospital Clínico San Carlos
Madrid, Madrid, 28040, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, 28040, Spain
Hospital Puerta de Hierro
Madrid, Madrid, 28222, Spain
Hospital Universitario Son Espases
Palma de Mallorca, Mallorca, 07120, Spain
Hospital Universitario Regional de Málaga
Málaga, Málaga, 29010, Spain
Hospital Universitari Son Llatzer
Palma de Mallorca, Palma de Mallorca, 07198, Spain
Hospital Universitario Salamanca
Salamanca, Salamanca, 37007, Spain
Hospital General de Valencia
Valencia, Valencia, 46014, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mariano Provencio, MD
Fundación GECP President
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2025
First Posted
April 8, 2025
Study Start
July 29, 2025
Primary Completion (Estimated)
December 30, 2031
Study Completion (Estimated)
December 30, 2031
Last Updated
November 19, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share