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- Projectes i Estudis Clínics
- Estudio en fase II aleatorizado, doble ciego, controlado con placebo, para evaluar la eficacia y la seguridad de inupadenant en combinación con carboplatino y pemetrexed en adultos con cáncer de pulmón no microcítico y no epidermoide que han progresado con la inmunoterapia.
Estudio en fase II aleatorizado, doble ciego, controlado con placebo, para evaluar la eficacia y la seguridad de inupadenant en combinación con carboplatino y pemetrexed en adultos con cáncer de pulmón no microcítico y no epidermoide que han progresado con la inmunoterapia.
Dades bàsiques
- Protocol:
- A2A-005
- EURDRACT:
- 2021-005487-22
- NCT:
- Centre:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Any inici:
- 2022
- Any de finalització:
Objectius del projecte
Objetivo Principal: Parte 1 (determinación de la dosis): • Evaluar la seguridad y la tolerabilidad de inupadenant en combinación con carboplatino y pemetrexed. • Identificar la dosis recomendada para la fase II (DRF2) de inupadenant que se usará en combinación con carboplatino y pemetrexed en la parte 2 del estudio. Parte 2 (aleatorizada): • Evaluar la eficacia del CLH de inupadenant en combinación con carboplatino y pemetrexed comparada con la eficacia del placebo en combinación con carboplatino y pemetrexed. Objetivos Secundarios: Solo parte 1: • Evaluar la eficacia de inupadenant en combinación con carboplatino y pemetrexed. Solo parte 2: • Evaluar la seguridad y la tolerabilidad de inupadenant en combinación con carboplatino y pemetrexed comparado con el placebo en combinación con ambos fármacos. • Evaluar medidas adicionales de la eficacia de inupadenant en combinación con carboplatino y pemetrexed comparado con el placebo en combinación con ambos fármacos. • Evaluar el efecto de inupadenant en combinación con carboplatino y pemetrexed comparado con el placebo en combinación con ambos fármacos en el tiempo hasta la aparición o el empeoramiento de los síntomas específicos de cáncer de pulmón. Partes 1 y 2: • Evaluar la farmacocinética del inupadenant y el metabolito activo EOS100612 en combinación con carboplatino y pemetrexed. Consulten la Sección 2 del Protocolo para conocer otros objetivos secundarios.
Documents
- No hi ha documents
Grups d'Investigació
Finançadors - Promotors
Resultats de l'Assaig Clínic
[Translated article] Cybersecurity: a priority for pharmacy services in the age of artificial intelligence
Marin, Cayetano M. Hernandez, Monte-Boquet, Emilio, Andres, Jose Luis Poveda
Editorial Material. 10.1016/j.farma.2024.08.009. 2024
[Translated article] Good humanisation practices in the healthcare of patients with rare diseases in Pharmacy Services
Company Albir MJ, Andrés JLP, Solsona MDE
Article. 10.1016/j.farma.2023.10.004. 2024
[Translated article] New challenges in advanced therapies.
Megías-Vericat JE; (...); Poveda Andrés JL
Article. 10.1016/j.farma.2024.05.001. 2024
[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
Alveolar capillary dysplasia with misalignment of the pulmonary veins: A surgical lung biopsy and autopsy in a full-term newborn.
Rodríguez García C; (...); Mancheño Franch N
Article. 10.1016/j.patol.2024.06.005. 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
Arthritis, Pulmonary Cysts and Renal Insufficiency: COPA Syndrome.
Balaguer Cartagena MN, Fonfría Esparcia C, Anguera de Francisco G
Article. 10.1016/j.arbres.2024.04.005. 2024
Assessing the value of moderate-to-severe atopic dermatitis treatment using multi-criteria decision analysis (MCDA).
Pereyra-Rodríguez JJ; (...); Ortiz de Frutos FJ
Letter. 10.1111/jdv.19432. 2023
Avelumab in Combination With Cetuximab and Chemotherapy as First-Line Treatment for Patients With Advanced Squamous NSCLC.
Andric, Zoran; (...); Ciardiello, Fortunato
Article. 10.1016/j.jtocrr.2022.100461. 2023
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
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
COST-EFFECTIVENESS ANALYSIS OF DIFELIKEFALIN FOR THE TREATMENT OF CHRONIC KIDNEY DISEASE ASSOCIATED-PRURITUS IN SPAIN
Sanchez-Alvarez, Emilio E.; (...); Hernaez Colque, M.
Meeting Abstract. 2024
Cybersecurity, a priority for pharmacy services in the age of artificial intelligence.
Hernández Marín CM, Monte-Boquet E, Poveda Andrés JL
Editorial Material. 10.1016/j.farma.2024.08.001. 2024
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
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 of a predictive model for early detection of lung cancer: SREAL-eLUNG study
Vidal, O. J. Juan; (...); Martinez, B. Valdivieso
Meeting Abstract. 2023
ECONOMIC BURDEN OF ADVANCED NON-SMALL-CELL LUNG CANCER (NSCLC) PATIENTS HARBORING KRASG12C MUTATION IN SPAIN
Fernandez-Barcelo, C.; (...); Sampietro-Colom, L.
Meeting Abstract. 2023
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
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
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 Chemotherapy Versus Chemotherapy Alone for Metastatic NSCLC in CheckMate 9LA: 3-Year Clinical Update and Outcomes in Patients With Brain Metastases or Select Somatic Mutations
Paz-Ares, Luis G.; (...); Carbone, David P.
Article. 10.1016/j.jtho.2022.10.014. 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
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
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
How can artificial intelligence optimize value-based contracting?
Poveda, Jose Luis; (...); Medrano, Ignacio H.
Letter. 10.1186/s40545-022-00475-3. 2022
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
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 KRASG12C mutation
Mok, Tony S. K.; (...); Barlesi, Fabrice
Meeting Abstract. 10.1200/JCO.2024.42.17_suppl.LBA8509. 2024
Manipulación de fármacos para su administración por gastrostomía endoscópica percutánea en pacientes con esclerosis lateral amiotrófica y nutrición enteral.
Vázquez Polo A; (...); Vázquez Costa JF
Article. 10.20960/nh.03946. 2022
National Survey on the Use of Mobile Applications in Patients with Hemophilia and Other Coagulopathies
Eduardo Megias, Juan; (...); Poveda Andres, Jose Luis
Meeting Abstract. 10.1182/blood-2022-169938. 2022
New challenges of advanced therapies.
Megías-Vericat JE; (...); Poveda Andrés JL
Article. 10.1016/j.farma.2023.11.008. 2024
NIVIPI-BRAIN, A Phase II Study of Nivolumab plus Ipilimumab Combined with Chemotherapy for Patients with NSCLC and Synchronous Brain Metastases
Nadal, E.; (...); Bruna, J.
Meeting Abstract. 2022
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
Observational study to evaluate discontinuation of monotherapy with cobicistat-boosted darunavir in patients with human immunodeficiency virus
Solana-Altabella, Antonio; (...); Poveda-Andres, Jose Luis
Article. 10.1097/MD.0000000000032208. 2022
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
RET Fusion Testing in Patients With NSCLC: The RETING Study.
Conde, Esther; (...); Lopez-Rios, Fernando
Article. 10.1016/j.jtocrr.2024.100653. 2024
RET Fusion Testing with FISH and Real-Time PCR: a Comparison with RNA-Based Next-Generation Sequencing in RET Positive NSCLC
Hernandez, S.; (...); Conde, E.
Meeting Abstract. 2022
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
SEOM-GECP Clinical guidelines for diagnosis, treatment and follow-up of small-cell lung cancer (SCLC) (2022).
Garcia-Campelo, Rosario; (...); Domine, Manuel
Article. 10.1007/s12094-023-03216-3. 2023
Sex differences in the diagnosis, treatment and prognosis of cancer: the rationale for an individualised approach.
Vera, Ruth; (...); del Alba, Aranzazu Gonzalez
Article. 10.1007/s12094-023-03112-w. 2023
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
Survival outcomes in ALK-positive NSCLC patients (p) treated 1st line brigatinib and impact of the ALK fusion variant
Provencio-Pulla, Mariano; (...); Romero, Atocha
Meeting Abstract. 2023
Tarlatamab for Patients with Previously Treated Small-Cell Lung Cancer.
Ahn MJ; (...); Paz-Ares L
Article. 10.1056/NEJMoa2307980. 2023
Technical Validation and Clinical Implications of Ultrasensitive PCR Approaches for EGFR-Thr790Met Mutation Detection in Pretreatment FFPE Samples and in Liquid Biopsies from Non-Small Cell Lung Cancer Patients
Simarro, Javier; (...); Palanca, Sarai
Article. 10.3390/ijms23158526. 2022
The association of salivary caffeine levels with serum concentrations in premature infants with apnea of prematurity
Garcia-Robles, Ana; (...); Saenz Gonzalez, Pilar
Article. 10.1007/s00431-022-04628-z. 2022
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
Translation of a tissue epigenetic signature to circulating free DNA suggests BCAT1 as a potential noninvasive diagnostic biomarker for lung cancer
Palanca-Ballester, Cora; (...); Sandoval, Juan
Article. 10.1186/s13148-022-01334-3. 2022
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