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Non Small Cell Lung Cancer MetastaticPhase 2PALACENCT06917573

PALACE: Cemiplimab Trial According to ctDNA Levels

A Phase 2 study testing Cemiplimab, Carboplatin and Paclitaxel in people with Non Small Cell Lung Cancer Metastatic and Lung Diseases, run by Fundación GECP at 20 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cemiplimab, Carboplatin and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
20 sitesSpain
Study dates
29 Jul 2025to 30 Dec 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

20 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Eva Pereira contact

+34934302006

secretaria@gecp.org

20 sites in 1 country

Spain20 sites, 20 recruiting

  • Hospitalario Universitario A Coruña

    A Coruña, La Coruña, 15006

    Rosario García Campelo, MD

    Rosario García Campelo, MD

    Recruiting

  • Hospital General de Alicante

    Alicante, Alicante, 03010

    Bartomeu Massutí, MD

    Bartomeu Massutí, MD

    Recruiting

  • ICO Badalona, Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

    Marc Cucurull, MD

    Marc Cucurull, MD

    Recruiting

  • Hospital Universitari Vall d' Hebron

    Barcelona, Barcelona, 08035

    Patricia Iranzo, MD

    Patricia Iranzo, MD

    Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Barcelona, 08041

    Sergio Martínez Recio, MD

    Sergio Martínez Recio, MD

    Recruiting

  • Hospital De Basurto

    Bilbao, Bilbao, 48013

    Mª Angeles Sala González, MD

    Mª Angeles Sala González, MD

    Recruiting

  • Hospital General de Elche

    Elche, Alicante, 03203

    Javier David Benitez Fuentes, MD

    Javier David Benitez Fuentes, MD

    Recruiting

  • Hospital Dr. Josep Trueta

    Girona, Girona, 17007

    Joaquim Bosch, MD

    Joaquim Bosch

    Recruiting

  • Hospital Universitario Jerez De La Frontera

    Jerez de la Frontera, Cádiz, 11407

    Mª Ángeles Moreno, MD

    Mª Ángeles Moreno, MD

    Not yet recruiting

  • ICO Hospitalet

    L'Hospitalet de Llobregat, Barcelona, 08908

    Ernest Nadal, MD

    Ernest Nadal, MD

    Recruiting

  • Hospital Universitario Dr. Negrín

    Las Palmas de Gran Canaria, Las Palmas, 35010

    David Aguiar, MD

    David Aguiar

    Recruiting

  • Hospital Universitario Severo Ochoa

    Leganés, Madrid, 28911

    Ana López, MD

    Ana López, MD

    Recruiting

  • Hospital Clínico San Carlos

    Madrid, Madrid, 28040

    Carlos Aguado, MD

    Carlos Aguado, MD

    Recruiting

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, Madrid, 28040

    Manuel Dómine, MD

    Manuel Dómine, MD

    Recruiting

  • Hospital Puerta de Hierro

    Madrid, Madrid, 28222

    Virginia Calvo, MD

    Virginia Calvo, MD

    Recruiting

  • Hospital Universitario Regional de Málaga

    Málaga, Málaga, 29010

    Vanesa Gutiérrez, MD

    Vanesa Gutiérrez, MD

    Recruiting

  • Hospital Universitario Son Espases

    Palma de Mallorca, Mallorca, 07120

    Raquel Marsé

    Raquel Marsé, MD

    Recruiting

  • Hospital Universitari Son Llatzer

    Palma de Mallorca, Palma de Mallorca, 07198

    Juan Coves Sarto, MD

    Juan Coves Sarto, MD

    Recruiting

  • Hospital Universitario Salamanca

    Salamanca, Salamanca, 37007

    Alejandro Olivares Hernández, MD

    Alejandro Olivares Hernández, MD

    Recruiting

  • Hospital General de Valencia

    Valencia, Valencia, 46014

    Paula Espinosa, MD

    Paula Espinosa, MD

    Recruiting

Other trials in Spain

About this study

Official title: 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.

Read the 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 definitive chemo/radiotherapy or surgical resection non-small cell lung cancer (NSCLC) per the 8th edition TNM with no prior systemic anti-cancer therap.

Patients will be treated with Cemiplimab for 2 cycles and after response evaluation and ctDNA levels analysis, patients will be treated with Cemiplimab plus chemotherapy or cemiplimab monotherapy depending on response and ctDNA levels.

The primary research goal is to determine whether therapy decision making based on ctDNA analysis improves overall survival.

Patient accrual is expected to be completed within 1.5 years excluding a run-in-period of 4-6 months. An estimated treatment period of 2 years, 2 years of follow-up and the preparation of the final report and the close out visit are expected to extend the study duration to a total of 6.5 years.

Keywords
Cemiplimab, ctDNA levels, Chemotherapy, Non-resectable non-small cell lung cancer
Medical subject headings
Lung Diseases, Carcinoma, Non-Small-Cell Lung, Respiratory Tract Neoplasms, Thoracic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CemiplimabDrug

    Also called REGN2810

    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.

  • CarboplatinDrug

    Also called Paraplatin, Carboplatine

    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.

  • PaclitaxelDrug

    Also called Taxol

    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.

Study groups in NCT06917573
Study groupRoleWhat they receive
ExperimentalExperimentalA. 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.
Receives: Drug: Cemiplimab; Drug: Carboplatin; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From the date of the end of two cycles of Cemiplimab treatment until 24 months

Secondary outcomes (3)

  1. To assess the efficacy of the treatment in terms of the Progression Free Survival (PFS) at 12 months

    PFS defined as the time from enrollment to the first occurrence of disease progression or death from any cause as determined by the investigator according to RECIST v1.1

    Measured: From the date of the end of treatment until 12 months

  2. To evaluate the sites of first failure

    To evaluate the sites of first relapse or progression

    Measured: From the date of the end of treatment until the date of last follow up, assessed up to 24 months

  3. Duration of response (DOR)

    To evaluate the efficacy of cemiplimab as measured by investigator. Assessed as duration of response (DOR) according to RECIST v1.1

    Measured: From date of documentation of tumor response until date of first documented progression, assessed up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2025
  2. Study start29 Jul 2025
  3. Primary completion30 Dec 2031 (estimated)
  4. Study completion30 Dec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
63 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06917573
Sponsor's protocol ID
GECP 22/01_PALACE
Other IDs
2024-518812-38-00
Acronym
PALACE
Status last verified
Nov 2025
First submitted
1 Apr 2025
Last updated
19 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cemiplimab, Carboplatin and Paclitaxel in people with Non Small Cell Lung Cancer Metastatic and Lung Diseases, run by Fundación GECP at 20 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eva Pereira (+34934302006, secretaria@gecp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine whether therapy decision making based on ctDNA analysis improves overall survival (time frame: From the date of the end of two cycles of Cemiplimab treatment until 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06917573.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.

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