Actively Recruiting
PALACE: Cemiplimab Trial According to ctDNA Levels
Led by Fundación GECP · Updated on 2025-11-19
63
Participants Needed
20
Research Sites
335 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PALACE: Cemiplimab Trial According to ctDNA Levels
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed stage IV or stage IIIB/C non-small cell lung cancer (NSCLC) not eligible for definitive chemo/radiotherapy or surgery
- PD-L1 expression of 50% or higher
- ECOG performance status of 0 or 1
- Age 18 years or older
- No prior systemic anti-cancer therapy
- Prior adjuvant or neoadjuvant chemotherapy allowed if completed at least 6 months before enrollment
- At least one measurable lesion by CT scan according to RECIST version 1.1
- Expected life expectancy greater than 12 weeks
- Adequate blood, liver, and kidney function
- Ability to provide informed consent
- Accessible for treatment and follow-up
- Negative pregnancy test within 3 days before enrollment for women of childbearing potential
- Use of highly effective contraception by sexually active men and women of childbearing potential during treatment and for 4 months after last treatment
You will not qualify if you...
- Tumors with EGFR activating mutation, ALK translocation, or ROS1 rearrangements sensitive to targeted therapy
- Grade 2 or higher neuropathy
- Pregnant or breastfeeding women
- Weight loss over 10% in the last 3 months
- Carcinomatous meningitis
- History of other cancers within the past 3 years
- Recovery from major surgery less than 14 days before enrollment
- Active or uncontrolled infections or serious medical conditions preventing study management
- Prior antineoplastic drugs or thoracic radiotherapy not allowed except as specified
- Prior neoadjuvant, adjuvant chemotherapy, radiotherapy, or chemoradiotherapy within 6 months before enrollment
- Mixed small cell and non-small cell lung cancer, carcinoid lung tumor, or large cell neuroendocrine carcinoma
- Allergy or hypersensitivity to study drug components
- Significant comorbidities preventing chemotherapy
- Recent or ongoing autoimmune disease requiring immunosuppressive treatment
- Untreated or active brain metastases
- Immunosuppressive corticosteroids within 4 weeks before first dose
- Uncontrolled hepatitis B, hepatitis C, HIV, or immunodeficiency
- History of interstitial lung disease or pneumonitis requiring steroids
- Allergic reactions to antibody treatments
- History of solid organ transplant
- Receipt of live vaccines within 30 days before first treatment
- Unwillingness to use highly effective contraception during and after the study
AI-Screening
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Trial Site Locations
Total: 20 locations
1
Hospital General de Alicante
Alicante, Alicante, Spain, 03010
Actively Recruiting
2
Hospital General de Elche
Elche, Alicante, Spain, 03203
Actively Recruiting
3
ICO Badalona, Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Actively Recruiting
4
Hospital Universitari Vall d' Hebron
Barcelona, Barcelona, Spain, 08035
Actively Recruiting
5
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain, 08041
Actively Recruiting
6
ICO Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Actively Recruiting
7
Hospital De Basurto
Bilbao, Bilbao, Spain, 48013
Actively Recruiting
8
Hospital Universitario Jerez De La Frontera
Jerez de la Frontera, Cádiz, Spain, 11407
Not Yet Recruiting
9
Hospital Dr. Josep Trueta
Girona, Girona, Spain, 17007
Actively Recruiting
10
Hospitalario Universitario A Coruña
A Coruña, La Coruña, Spain, 15006
Actively Recruiting
11
Hospital Universitario Dr. Negrín
Las Palmas de Gran Canaria, Las Palmas, Spain, 35010
Actively Recruiting
12
Hospital Universitario Severo Ochoa
Leganés, Madrid, Spain, 28911
Actively Recruiting
13
Hospital Clínico San Carlos
Madrid, Madrid, Spain, 28040
Actively Recruiting
14
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, Spain, 28040
Actively Recruiting
15
Hospital Puerta de Hierro
Madrid, Madrid, Spain, 28222
Actively Recruiting
16
Hospital Universitario Son Espases
Palma de Mallorca, Mallorca, Spain, 07120
Actively Recruiting
17
Hospital Universitario Regional de Málaga
Málaga, Málaga, Spain, 29010
Actively Recruiting
18
Hospital Universitari Son Llatzer
Palma de Mallorca, Palma de Mallorca, Spain, 07198
Actively Recruiting
19
Hospital Universitario Salamanca
Salamanca, Salamanca, Spain, 37007
Actively Recruiting
20
Hospital General de Valencia
Valencia, Valencia, Spain, 46014
Actively Recruiting
Research Team
E
Eva Pereira
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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