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Ensayo clínico Fase II de quimio-inmunoterapia neoadyuvante seguida de tratamiento adyuvante según el estado de resección para el tratamiento de pacientes con cáncer de pulmón no microcítico (CPNM) con diagnóstico de tumor de Pancoast. Un estudio exploratorio multicéntrico.

Ensayo clínico Fase II de quimio-inmunoterapia neoadyuvante seguida de tratamiento adyuvante según el estado de resección para el tratamiento de pacientes con cáncer de pulmón no microcítico (CPNM) con diagnóstico de tumor de Pancoast. Un estudio exploratorio multicéntrico.

Dades bàsiques

Protocol:: GECP22/02
EURDRACT:: 2022-003717-11
NCT:
Centre:: HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Any inici:: 2023
Any de finalització:

ENSAYO CLÍNICO

Objectius del projecte

Objetivo Principal: Complete resection rate after induction treatment with chemotherapy plus nivolumab Resección completa (R0) definida como la ausencia de tumor residual. Objetivos Secundarios: - Supervivencia global (SG) a los 24 meses - Supervivencia libre de enfermedad (DFS) a los 24 meses - Tasa de respuesta objetiva al tratamiento (ORR), Tasa de control de la enfermedad (DCR) y Duración de la respuesta (DOR) - Respuesta patológica: pCR, MPR, porcentaje de Residual Tumor Viable (RTV%) en el tumor primario - Seguridad y tolerabilidad del tratamiento - Estudio del valor pronóstico del ctDNA basal (asociación de niveles basales con PFS y OS)

Documents

No hi ha documents

Participants

Natalia Benito Zazo

Investigador Colaborador
Irene Torres Espallardo

Investigador Colaborador
Juan Eduardo Megías Vericat

Investigador Colaborador
Óscar José Juan Vidal

Investigador Colaborador
Consuelo Olivas Arroyo

Investigador Colaborador
Francisco De Asís Aparisi Aparisi

Investigador Principal
José Luis Poveda Andrés

Investigador Colaborador
Maria Del Mar Melero Moreno

Investigador Colaborador
Fernando Aparici Robles

Investigador Colaborador
Ainhoa Carreres Ortega

Investigador Colaborador
Guillermo Suay Montagud

Investigador Colaborador
Octavio Antonio Ballesta López

Investigador Colaborador
Ana Maria Yepes Agudelo

Investigador Colaborador
Sonia Gines Cardenas

Investigador Colaborador
Africa Almendros Riaza

Investigador Colaborador
Basilio Mateo Quiñonero

Investigador Colaborador
Oussama Bardouz Gouguasse

Investigador Colaborador
Juan Genovés Monzó

Data Manager / Study Coordinator
Maria Del Pilar Morcillo Toledo

Investigador Colaborador
Jaime Castella Malondo

Investigador Colaborador
María Carmen Alcácer Esteve

Data Manager / Study Coordinator
Cristina Ferrando Juan

Investigador Colaborador

Veure tots els Investigadors

Grups d'Investigació

Unidad Mixta de Investigación Cerebrovascular

Leader

Juan Bautista Salom Sanvalero
Farmacogenética

Investigador Principal

María José Herrero Cervera
Investigacion Biomédica en Imagen (GIBI 2-30)

Investigador Principal

Leonor Cerdá Alberich
Núcleo de investigación traslacional integrado Urológico de Valencia (NITIUV)

Leader

César David Vera Donoso
Unidad de Biomarcadores y Medicina de Precisión (UBYMP)

Leader

Agustín Lahoz Rodríguez
Unidad de Descubrimiento de Fármacos (UDF)

Investigador Principal

Leonor Puchades Carrasco
Inmunoterapia y Biomodelos de Autoinmunidad

Investigador Principal

Sara María García Gil-Perotín
Grupo de Investigación de Farmacia

Investigador Principal

Javier García Pellicer

Finançadors - Promotors

FUNDACIÓN GECP

Resultats de l'Assaig Clínic

Publicacions en Revistes 94

[[Tranaslated article]]Primary Cutaneous Lymphoma Registry of the Spanish Academy of Dermatology and Venereology (AEDV): Data for the First 5 Years.

López DF; (...); Ortiz-Romero, P. L.

Article. 10.1016/j.ad.2022.11.013. 2023

[Translated article] Pharmacokinetic-guided switching from standard half-life factor VIII to extended half-life pegylated factor VIII in haemophilia A therapy in clinical practice.

Chovi-Trull, Maria; (...); Andres, Jose Luis Poveda

Article. 10.1016/j.farma.2024.12.007. 2025

[Translated article] Real-world effectiveness and safety of nivolumab in patients with relapsed or refractory classical Hodgkin lymphoma.

Fernandez, Laura Lorente; (...); Andres, Jose Luis Poveda

Article. 10.1016/j.farma.2024.09.006. 2024

A Gadolinium(III) Complex Based on Pyridoxine Molecule with Single-Ion Magnet and Magnetic Resonance Imaging Properties.

Orts-Arroyo, Marta; (...); Martinez-Lillo, Jose

Article. 10.3390/ijms25042112. 2024

Amivantamab plus chemotherapy with and without lazertinib in EGFR-mutant advanced NSCLC after disease progression on osimertinib: primary results from the phase III MARIPOSA-2 study.

Passaro, A; (...); Cho, B C

Article. 10.1016/j.annonc.2023.10.117. 2024

Capmatinib vs docetaxel as second- or third-line (2/3L) therapy in patients (pts) with METex14-mutated advanced NSCLC (aNSCLC): The GeoMETry-III trial

Vidal, O. J. Juan; (...); Wolf, J.

Meeting Abstract. 10.1016/j.annonc.2023.09.2424. 2023

Clinical experience of whole body and tumour dosimetry of 131-I-mIBG treatment for pediatric patients

Espallardo, I. Torres; (...); Prado-Wohlwend, S.

Meeting Abstract. 2023

ComBat harmonization in different PET imaging scenarios

Gandia-Ferrero, M.; (...); Marti-Bonmati, L.

Meeting Abstract. 2023

Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.

Montoro-Ronsano JB; (...); Soto-Ortega I

Article. 10.1016/j.farma.2023.01.003. 2023

Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.

Montoro-Ronsano, Jose Bruno; (...); Soto-Ortega, Inmaculada

Article. 10.1016/j.farma.2023.04.002. 2023

Correction to: SEOM-GECP Clinical guidelines for diagnosis, treatment and follow-up of small-cell lung cancer (SCLC) (2022).

García-Campelo R; (...); Dómine M

Correction. 10.1007/s12094-023-03290-7. 2023

Characterization of patients with advanced non-small-cell lung cancer (NSCLC) harboring KRASG12C mutation and their associated direct healthcare costs in Spanish routine clinical practice (SILK study)

Aransay, N. Reguart; (...); Vila, A. Lloansi

Meeting Abstract. 10.1016/j.annonc.2023.09.2442. 2023

Chronological and Biological Age as a Response Factor to Immune Checkpoint Inhibitors in Advanced Non-Small Cell Lung Cancer

Suay, G.; (...); Juan-Vidal, O.

Meeting Abstract. 2024

Datopotamab Deruxtecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III TROPION-Lung01 Study.

Ahn, Myung-Ju; (...); Sands, Jacob

Article. 10.1200/JCO-24-01544. 2024

Datopotamab Deruxtecan Vs Docetaxel in Patients with Non-Small Cell Lung Cancer: Final Overall Survival from TROPION-Lung01

Sands, J.; (...); Ahn, M-J

Meeting Abstract. 2024

DeepCERES: A deep learning method for cerebellar lobule segmentation using ultra-high resolution multimodal MRI.

Morell-Ortega, Sergio; (...); Manjon, Jose V

Article. 10.1016/j.neuroimage.2025.121063. 2025

Determining value in the treatment of activated PI3Kdelta syndrome in Spain: a multicriteria decision analysis from the perspective of key stakeholders.

Abad, Maria Reyes; (...); Gil, Alicia

Article. 10.33393/grhta.2024.3041. 2024

Determining what represents value in the treatment of prurigo nodularis and its key unmet needs in Spain through Multi-Criteria Decision Analysis

Silvestre, Juan Francisco; (...); Serra-Baldrich, Esther

Article. 10.1002/jvc2.275. 2024

Development and testing of a mobile app for systematic collection of patient-reported outcomes (PROs) in patients with hemophilia.

Megias-Vericat, J E; (...); Poveda Andres, J L

Letter. 10.1016/j.thromres.2024.109122. 2024

Efficacy and safety of MCLA-129, an anti-EGFR/c-MET bispecific antibody, in non-small-cell lung cancer (NSCLC) with c-METexon 14 skipping mutations (METex14).

Brandao, Mariana da Rocha Almeida; (...); Felip, Enriqueta

Meeting Abstract. 2024

Enhancing the First-Pass Effect in Acute Stroke: The Impact of Stent Retriever Characteristics

Murias, Eduardo; (...); Vega, Pedro

Article. 10.3390/jcm13113123. 2024

European Society of Medical Oncology (ESMO) guidelines for oncogene-addicted metastatic non-small cell lung cancer (NSCLC): a personalized treatment for each patient.

Suay, Guillermo, Aparisi, Francisco, Juan-Vidal, Oscar

Article. 10.21037/cco-23-100. 2024

Executive dysfunction and cortical variations among intimate partner violence perpetrators and the association with sexism.

Romero-Martinez, Angel; (...); Moya-Albiol, Luis

Article. 10.1093/scan/nsae046. 2024

Expert Consensus on the Management of Adverse Events of Lorlatinib in the Treatment of ALK+ Advanced Non-small Cell Lung Cancer.

Arriola E; (...); Felip E

Article. 10.1007/s40261-024-01379-7. 2024

FAMetA: a mass isotopologue-based tool for the comprehensive analysis of fatty acid metabolism.

Alcoriza-Balaguer MI; (...); Lahoz A

Article. 10.1093/bib/bbad064. 2023

First-line (1L) nivolumab (N) plus ipilimumab (I) plus chemotherapy (C) vs C alone in patients (pts) with metastatic NSCLC (mNSCLC) from CheckMate 9LA: 4-y clinical update and outcomes by tumor histologic subtype (THS)

Carbone, David Paul; (...); Reck, Martin

Meeting Abstract. 2023

First-line (1L) nivolumab (N) plus ipilimumab (I) plus chemotherapy (C) vs C alone in patients (pts) with metastatic NSCLC (mNSCLC) from CheckMate 9LA: 4-y clinical update and outcomes by tumor histologic subtype (THS).

Carbone, David Paul; (...); Reck, Martin

Meeting Abstract. 10.1200/JCO.2023.41.17_suppl.LBA9023. 2023

First-line Nivolumab (N) plus Ipilimumab (I) plus Chemotherapy (C) in Metastatic NSCLC (mNSCLC): CheckMate 9LA 4-Year Clinical Update

Baclin, Firas; (...); Reck, Martin

Meeting Abstract. 2024

First-line nivolumab plus ipilimumab for metastatic non-small cell lung cancer, including patients with ECOG performance status 2 and other special populations: CheckMate 817.

Ready, Neal E.; (...); Paz-Ares, Luis

Article. 10.1136/jitc-2022-006127. 2023

First-line nivolumab plus ipilimumab with two cycles of chemotherapy versus chemotherapy alone (four cycles) in metastatic non-small cell lung cancer: CheckMate 9LA 2-year patient-reported outcomes.

Reck, Martin; (...); Carbone, David P.

Article. 10.1016/j.ejca.2023.01.015. 2023

Five-year outcomes with first-line (1L) nivolumab plus ipilimumab plus chemotherapy (N plus I plus C) vs C in patients (pts) with metastatic NSCLC (mNSCLC) in CheckMate 9LA.

Reck, Martin; (...); Paz-Ares, Luis G.

Meeting Abstract. https://doi.org/10.1200/JCO.2024.42.16_suppl.8560. 2024

Five-year outcomes with first-line nivolumab plus ipilimumab with 2 cycles of chemotherapy versus 4 cycles of chemotherapy alone in patients with metastatic non-small cell lung cancer in the randomized CheckMate 9LA trial.

Reck M; (...); Paz-Ares LG

Article. 10.1016/j.ejca.2024.114296. 2024

Four-year clinical update and treatment switching-adjusted outcomes with first-line nivolumab plus ipilimumab with chemotherapy for metastatic non-small cell lung cancer in the CheckMate 9LA randomized trial.

Carbone DP; (...); Reck M

Article. 10.1136/jitc-2023-008189. 2024

Free automatic software for quality assurance of computed tomography calibration, edges and radiomics metrics reproducibility.

Saborido-Moral, Juan D.; (...); Carles, Montserrat

Article. 10.1016/j.ejmp.2023.103153. 2023

FURTHER: A global study to evaluate furmonertinib in patients with EGFR mutant NSCLC including uncommon EGFR mutations (FURMO-002)

Le, Xiuning; (...); Wang, Jie

Meeting Abstract. https://doi.org/10.1200/JCO.2024.42.16_suppl.TPS8666. 2024

FURTHER: A Global, Randomized Study of Firmonertinib at Two Dose Levels in TKI-Naive, Advanced NSCLC with EGFR PACC Mutations

Le, X.; (...); Wang, J.

Meeting Abstract. 2024

GALLANT-1: GB1211 galectin-3 (Gal-3) inhibitor plus atezolizumab (atz) for first line treatment in patients (pts) with advanced/metastatic non-small cell lung cancer (NSCLC)

Aparisi Aparisi, F. D. A.; (...); Ghiringhelli, F.

Meeting Abstract. 10.1016/j.annonc.2023.09.2491. 2023

Genetic Variants Associated with Biological Treatment Response in Inflammatory Bowel Disease: A Systematic Review.

Plaza J; (...); Moret-Tatay I

Article. 10.3390/ijms25073717. 2024

Genotypic Characteristics and Resistance Mutations in Advanced ALK plus NSCLC: The ALK-PATHFINDER Study

Lopez Castro, R.; (...); Ponce Aix, S.

Meeting Abstract. 2023

Gray matter volume differences in intimate partner violence perpetrators and its role in explaining dropout and recidivism

Romero-Martinez, Angel; (...); Moya-Albiol, Luis

Article. 10.1016/j.jpsychires.2024.09.019. 2024

Health-Related Quality of Life (HRQoL) Outcomes with Adagrasib vs Docetaxel in KRASG12C-Mutated Advanced NSCLC in KRYSTAL-12

Felip, E.; (...); Duruisseaux, M.

Meeting Abstract. https://doi.org/10.1016/j.jtho.2024.09.056. 2024

Immune checkpoint inhibitors as first-line treatment for brain metastases in stage IV NSCLC patients without driver mutations

Suay, Guillermo; (...); Lahoz, Agustin

Review. 10.1016/j.canlet.2024.217317. 2024

Immunogenicity of COVID-19 vaccines in lung cancer patients.

Provencio M; (...); Calvo V

Article. 10.1016/j.lungcan.2023.107323. 2023

Impact of Molecular Testing Using Next-Generation Sequencing in the Clinical Management of Patients with Non-Small Cell Lung Cancer in a Public Healthcare Hospital.

Simarro, Javier; (...); Palanca, Sarai

Article. 10.3390/cancers15061705. 2023

Incidence and Risk Factors for Development of Cardiac Toxicity in Adult Patients with Newly Diagnosed Acute Myeloid Leukemia

Boluda, Blanca; (...); Montesinos, Pau

Article. 10.3390/cancers15082267. 2023

Is erenumab an efficient alternative for the prevention of episodic and chronic migraine in Spain? Results of a cost-effectiveness analysis.

Pozo-Rosich P; (...); Irimia P

Article. 10.1186/s10194-024-01747-w. 2024

Isavuconazole Pharmacokinetics in Critically Ill Patients: Relationship with Clinical Effectiveness and Patient Safety.

Martin-Cerezuela, Maria; (...); Ramirez Galleymore, Paula

Article. 10.3390/antibiotics13080706. 2024

KRYSTAL-12: Phase 3 study of adagrasib versus docetaxel in patients with previously treated advanced/metastatic non-small cell lung cancer (NSCLC) harboring a KRAS^G12C mutation

Mok, Tony S. K.; (...); Barlesi, Fabrice

Meeting Abstract. 10.1200/JCO.2024.42.17_suppl.LBA8509. 2024

Mental, emotional and social dimensions of quality of life and their relationship with physical and functional status in adults with haemophilia.

Rodríguez MA; (...); Chimeno-Hernández A

Article. 10.1016/j.thromres.2024.109181. 2024

New challenges of advanced therapies.

Megías-Vericat JE; (...); Poveda Andrés JL

Article. 10.1016/j.farma.2023.11.008. 2024

Novel Combinations of Immunotherapies or DNA Damage Repair Inhibitors in Platinum-Refractory Extensive-Stage Small-Cell Lung Cancer: The Phase II BALTIC Study.

Reinmuth, Niels; (...); Bondarenko, Igor

Article. 10.1158/1078-0432.CCR-24-0013. 2024

Objective Image Quality Comparison Between Brain-Dedicated PET and PET/CT Scanners.

Gandia-Ferrero MT; (...); Martí-Bonmatí L

Article. 10.1007/s10916-023-01984-7. 2023

ODs with a positive TPR conclusion, not subject to a conditional approval, and approved without requering a pass would be more likely to be reimbursed in Spain.

Poveda JL; (...); Badia X

Article. 10.1186/s13023-022-02610-4. 2023

Omics-Based Approaches for the Characterization of Pompe Disease Metabolic Phenotypes

Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor

Review. 10.3390/biology12091159. 2023

OPTIMIZING MANAGEMENT AND OUTCOMES OF ACTIVATED PHOSPHOINOSITIDE 3-KINASE DELTA SYNDROME (APDS) IN SPAIN: BEWAYAPDS PROJECT

Flores-Moreno, S.; (...); Gil, A.

Meeting Abstract. 2024

Pharmacogenetics in Response to Biological Agents in Inflammatory Bowel Disease: A Systematic Review.

Ballesta-Lopez, Octavio; (...); Poveda-Andres, Jose Luis

Article. 10.3390/ijms26041760. 2025

Phase II Trial of Atezolizumab Combined With Carboplatin and Pemetrexed for Patients With Advanced Nonsquamous Non-Small-Cell Lung Cancer With Untreated Brain Metastases (Atezo-Brain, GECP17/05).

Nadal E; (...); Bruna J

Article. 10.1200/JCO.22.02561. 2023

Plain language summary: tarlatamab for patients with previously treated small cell lung cancer.

Ahn, Myung-Ju; (...); Paz-Ares, Luis

Article. 10.1080/14796694.2024.2402152. 2024

Presence of good humanization practices in the healthcare of patients with rare diseases in Pharmacy Services

Company Albir MJ, Poveda Andrés JL, Edo Solsona MD

Article. 10.1016/j.farma.2023.06.0131130. 2024

Real-world outcomes of first-line pembrolizumab (Pem) for metastatic non-small cell lung cancer (mNSCLC) with >= 50% expression of programmed cell death-ligand 1 (PD-L1): A multicentre retrospective study

Perea, J.; (...); Gaudens, P. Capdevila

Meeting Abstract. 2023

Relationship between neuroimaging and emotion recognition in Mild Cognitive Impairment patients.

Gandia-Ferrero, Maria Teresa; (...); Marti-Bonmati, Luis

Article. 10.1016/j.bbr.2023.114844. 2024

RET Fusion Testing in Patients With NSCLC: The RETING Study.

Conde, Esther; (...); Lopez-Rios, Fernando

Article. 10.1016/j.jtocrr.2024.100653. 2024

Sacituzumab govitecan (SG) vs docetaxel (doc) in patients (pts) with metastatic non-small cell lung cancer (mNSCLC) previously treated with platinum (PT)-based chemotherapy (chemo) and PD(L)-1inhibitors (IO): Primary results from the phase 3 EVOKE-01 study.

Paz-Ares, Luis G.; (...); Garassino, Marina Chiara

Meeting Abstract. 10.1200/JCO.2024.42.17_suppl.LBA8500. 2024

Sacituzumab Govitecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III EVOKE-01 Study.

Paz-Ares, Luis G.; (...); Garassino, Marina Chiara

Article. 10.1200/JCO.24.00733. 2024

Sacituzumab Govitecan vs Docetaxel in Patients with mNSCLC Non-responsive to Last Anti-PD-(L)1containing Regimen: EVOKE-01

Garassino, M. C.; (...); Paz-Ares, L. G.

Meeting Abstract. 2024

Sex Differences in the Efficacy of Immune Checkpoint Inhibitors in Neoadjuvant Therapy of Non-Small Cell Lung Cancer: A Meta-Analysis

Suay, Guillermo; (...); Juan-Vidal, Oscar

Review. 10.3390/cancers15184433. 2023

Spatially Preserved Multi-Region Transcriptomic Subtyping and Biomarkers of Chemoimmunotherapy Outcome in Extensive-Stage Small Cell Lung Cancer.

Peressini M; (...); Zugazagoitia J

Article. 10.1158/1078-0432.CCR-24-0104. 2024

The role of intimate partner violence perpetrators' resting state functional connectivity in treatment compliance and recidivism.

Romero-Martinez, Angel; (...); Moya-Albiol, Luis

Article. 10.1038/s41598-024-52443-3. 2024

The S-REAL study: Spanish real-world data on unresectable stage III NSCLC patients treated with durvalumab after chemoradiotherapy.

Gomez Rueda, Ana; (...); Garrido, Pilar

Article. 10.1007/s12094-024-03404-9. 2024

The value of the reflective discussion in decision-making using multi-criteria decision analysis (MCDA): an example of determining the value contribution of tabelecleucel for the treatment of the Epstein Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD).

Badia, Xavier; (...); Valles, Joan-Antoni

Article. 10.1186/s13023-024-03324-5. 2024

Toxic-metabolic encephalopathy induced by metronidazole and disulfiram: classics never die.

Chovi-Trull, Maria; (...); Poveda-Andres, Jose Luis

Article. 10.1136/ejhpharm-2024-004184. 2024

VALUE CRITERIA FOR OUTCOMES BASED MANAGED ENTRY AGREEMENT OF CAR-T IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM) THROUGH MCDA

Poveda, J. L.; (...); Lizan, L.

Meeting Abstract. 2023

Y-90 PET/MR imaging optimization with a Bayesian penalized likelihood reconstruction algorithm.

Calatayud-Jordan, Jose; (...); Torres-Espallardo, Irene

Article. 10.1007/s13246-024-01452-7. 2024

Ensayo clínico Fase II de quimio-inmunoterapia neoadyuvante seguida de tratamiento adyuvante según el estado de resección para el tratamiento de pacientes con cáncer de pulmón no microcítico (CPNM) con diagnóstico de tumor de Pancoast. Un estudio exploratorio multicéntrico.

Dades bàsiques

Objectius del projecte

Documents

Participants

Grups d'Investigació

Finançadors - Promotors

Resultats de l'Assaig Clínic

Campos d'Estudi

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