Actively Recruiting
Phase II Clinical Trial Evaluating Adaptive Treatment With Cemiplimab and Chemotherapy Based on ctDNA in Advanced Non-Small Cell Lung Cancer
Led by Fundación GECP · Updated on 2025-11-19
63
Participants Needed
20
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting an open-label, non-randomised phase II clinical trial to study patients with stage IV or stage IIIB/C non-small cell lung cancer (NSCLC) who are not candidates for definitive chemotherapy, radiotherapy, or surgery. The trial aims to determine if therapy decisions guided by circulating tumor DNA (ctDNA) analysis can improve overall survival in patients who have not received prior systemic anti-cancer therapy. Participants will initially receive two cycles of Cemiplimab, given by intravenous infusion every 28 days. After evaluating their response and ctDNA levels, they will either continue with Cemiplimab alone or receive Cemiplimab combined with chemotherapy. Chemotherapy options include Carboplatin with Pemetrexed or Carboplatin with taxanes, selected by the investigator. Treatment with Cemiplimab can continue up to two years unless disease progresses or unacceptable side effects occur. Throughout the trial, patients will be closely monitored with imaging to assess tumor response and ctDNA measurements. Researchers will track overall survival as the primary outcome over 24 months following the initial treatment cycles. Secondary outcomes include progression-free survival, sites of first failure, and duration of response. The study includes a treatment period of about two years plus two years of follow-up, with total participation lasting approximately six and a half years.
CONDITIONS
Brief Title
PALACE: Cemiplimab Trial According to ctDNA Levels
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically confirmed stage IV or stage IIIB/C non-small cell lung cancer (NSCLC) not suitable for definitive chemo/radiotherapy or surgery
- No prior systemic anti-cancer therapy (except prior early-stage chemotherapy completed at least 6 months before)
- PD-L1 expression level of 50% or higher
- ECOG performance status of 0 or 1
- At least one measurable lesion by CT scan per RECIST version 1.1
- Anticipated life expectancy greater than 12 weeks
- Adequate blood, liver, and kidney function
- Ability to give informed consent and be available for treatment and follow-up
- Negative pregnancy test for women of childbearing potential within 3 days before enrollment
- Use of highly effective contraception during and for 4 months after study treatment for sexually active men and women
You will not qualify if you...
- Tumors with activating mutations in EGFR, ALK translocation, or ROS1 rearrangements sensitive to targeted therapies
- Grade 2 or higher neuropathy
- Pregnant or breastfeeding women
- Weight loss greater than 10% in the past 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 by inclusion criteria
- Prior neoadjuvant, adjuvant chemotherapy, radiotherapy, or chemoradiotherapy within 6 months before enrollment
- Mixed small cell and non-small cell lung cancer, carcinoid tumor, or large cell neuroendocrine carcinoma
- Known allergy or hypersensitivity to study drugs
- Significant comorbidities preventing chemotherapy
- Recent or ongoing significant autoimmune disease requiring immunosuppressive treatment
- Untreated active brain metastases
- Use of immunosuppressive corticosteroids within 4 weeks before first dose
- Uncontrolled hepatitis B, hepatitis C, HIV, or immunodeficiency
- History of interstitial lung disease or pneumonitis needing glucocorticoids
- History of allergic reactions to antibody treatments
- History of solid organ transplant
- Receipt of live vaccines within 30 days before first study treatment
- Unwillingness to use highly effective contraception during study and for 4 months after treatment end
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 months
Participants receive 2 cycles of Cemiplimab monotherapy administered by intravenous infusion every 28 days.
2 visits (in-person, every 28 days)
Duration - Up to 2 years
After response evaluation and ctDNA analysis, participants receive either Cemiplimab plus chemotherapy or continue Cemiplimab monotherapy until disease progression, unacceptable toxicity, loss of clinical benefit, or up to 2 years of treatment.
Monthly visits for Cemiplimab infusions; chemotherapy visits during treatment cycles as determined by investigator
Duration - Up to 2 years
Participants are monitored for up to 2 years after treatment ends to assess overall survival and other long-term outcomes.
Periodic visits for up to 2 years
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
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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