Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
63 participants
INTERVENTIONAL
2025-07-29
2031-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental
A. 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.
Cemiplimab
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.
Carboplatin
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.
Paclitaxel
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.
Interventions
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Cemiplimab
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.
Carboplatin
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.
Paclitaxel
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Fundación GECP
OTHER
Responsible Party
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Principal Investigators
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Mariano Provencio, MD
Role: STUDY_CHAIR
Fundación GECP President
Locations
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Hospital General de Alicante
Alicante, Alicante, Spain
Hospital General de Elche
Elche, Alicante, Spain
ICO Badalona, Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitari Vall d' Hebron
Barcelona, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
ICO Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital De Basurto
Bilbao, Bilbao, Spain
Hospital Universitario Jerez De La Frontera
Jerez de la Frontera, Cádiz, Spain
Hospital Dr. Josep Trueta
Girona, Girona, Spain
Hospitalario Universitario A Coruña
A Coruña, La Coruña, Spain
Hospital Universitario Dr. Negrín
Las Palmas de Gran Canaria, Las Palmas, Spain
Hospital Universitario Severo Ochoa
Leganés, Madrid, Spain
Hospital Clínico San Carlos
Madrid, Madrid, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, Spain
Hospital Puerta de Hierro
Madrid, Madrid, Spain
Hospital Universitario Son Espases
Palma de Mallorca, Mallorca, Spain
Hospital Universitario Regional de Málaga
Málaga, Málaga, Spain
Hospital Universitari Son Llatzer
Palma de Mallorca, Palma de Mallorca, Spain
Hospital Universitario Salamanca
Salamanca, Salamanca, Spain
Hospital General de Valencia
Valencia, Valencia, Spain
Countries
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Central Contacts
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Facility Contacts
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Bartomeu Massutí, MD
Role: primary
Javier David Benitez Fuentes, MD
Role: primary
Marc Cucurull, MD
Role: primary
Patricia Iranzo, MD
Role: primary
Sergio Martínez Recio, MD
Role: primary
Ernest Nadal, MD
Role: primary
Mª Angeles Sala González, MD
Role: primary
Mª Ángeles Moreno, MD
Role: primary
Joaquim Bosch, MD
Role: primary
Rosario García Campelo, MD
Role: primary
David Aguiar, MD
Role: primary
Ana López, MD
Role: primary
Carlos Aguado, MD
Role: primary
Manuel Dómine, MD
Role: primary
Virginia Calvo, MD
Role: primary
Raquel Marsé
Role: primary
Vanesa Gutiérrez, MD
Role: primary
Juan Coves Sarto, MD
Role: primary
Alejandro Olivares Hernández, MD
Role: primary
Paula Espinosa, MD
Role: primary
Related Links
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Description Web page of the sponsor where users can find more information about Fundación GECP studies
Other Identifiers
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2024-518812-38-00
Identifier Type: CTIS
Identifier Source: secondary_id
GECP 22/01_PALACE
Identifier Type: -
Identifier Source: org_study_id
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