A phase 2, randomized, double-blind, placebo-controlled study to investigate the efficacy, safety and tolerability of ponsegromab in patients with cancer, cachexia, and elevated concentrations of GDF-15, followed by an optional open-label treatment period.

Datos básicos

Código:
C3651003
Protocolo:
C3651003
EUDRACT:
2022-003016-87
NCT:
Centro:
HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Dotación:
Año de incio:
2023
Año de finalización:
ENSAYO CLÍNICO

Documentos

  • No hay documentos

Participantes

Grupos

Financiadores - Promotores

PFIZER, S.A.

Resultados del Ensayo Clínico


[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

  • Open Access.

[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

  • Open Access.

[Translated article] New challenges in advanced therapies.

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

Article. 10.1016/j.farma.2024.05.001. 2024

  • Open Access.

[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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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


Evaluation of pneumatosis intestinalis as a complication of lung transplantation

Ripolles, V. Belloch; (...); Marti-Bonmati, Y. L.

Article. 10.1016/j.rx.2023.01.006. 2024

  • Open Access.

Evaluation of pneumatosis intestinalis as a complication of lung transplantation.

Belloch Ripollés V; (...); Martí-Bonmatí L

Article. 10.1016/j.rxeng.2023.01.013. 2024

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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


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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

Immunogenicity of COVID-19 vaccines in lung cancer patients.

Provencio M; (...); Calvo V

Article. 10.1016/j.lungcan.2023.107323. 2023

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

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

Article. 10.3390/antibiotics13080706. 2024

  • Open Access.

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

  • Open Access.

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

  • Open Access.

New challenges of advanced therapies.

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

Article. 10.1016/j.farma.2023.11.008. 2024

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

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

Review. 10.3390/biology12091159. 2023

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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


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