Portal de investigación
Estudio en fase II, multicéntrico, abierto, de combinaciones de sacituzumab govitecán como primera línea de tratamiento en pacientes con cáncer de pulmón no microcítico (CPNM) metastásico o avanzado sin alteraciones genómicas de utilidad clínica.
Datos básicos
- Código:
- GS-US-576-6220
- Protocolo:
- GS-US-576-6220
- EUDRACT:
- 2021-004280-27
- NCT:
- Centro:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Dotación:
- Año de incio:
- 2023
- Año de finalización:
- 2024
Objetivos del proyecto
Objetivo Principal: - Evaluar la tasa de respuesta objetiva (TRO) de sacituzumab govitecán (SG) en combinación con pembrolizumab o pembrolizumab más un derivado del platino. - Determinar la dosis recomendada para la fase II (DRF2) de SG en combinación con pembrolizumab más un derivado del platino. Objetivos Secundarios: Evaluar el efecto de SG en combinación con pembrolizumab o pembrolizumab más un derivado del platino en lo siguiente: -Supervivencia libre de progresión (SSP). -Supervivencia global (SGl). -Duración de la respuesta (DdR). -Tasa de control de la enfermedad (TCE). -Seguridad y tolerabilidad.
Documentos
- No hay documentos
Grupos
Financiadores - Promotores
Resultados del Ensayo Clínico
[[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] 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
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
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
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
Comparison of protocols with respiratory-gated (4D) motion compensation in PET/CT: open-source package for quantification of phantom image quality.
Martinez-Movilla, Andrea; (...); Carles, Montserrat
Article. 10.1186/s40658-022-00509-4. 2022
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
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
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 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
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
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
Genotypic Characteristics and Resistance Mutations in Advanced ALK plus NSCLC: The ALK-PATHFINDER Study
Lopez Castro, R.; (...); Ponce Aix, S.
Meeting Abstract. 2023
How can artificial intelligence optimize value-based contracting?
Poveda, Jose Luis; (...); Medrano, Ignacio H.
Letter. 10.1186/s40545-022-00475-3. 2022
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
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
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
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
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
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
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
Primary Cutaneous Lymphoma Registry of the Spanish Academy of Dermatology and Venereology (AEDV): Data for the First 5 Years.
Falkenhain-Lopez, D; (...); Ortiz-Romero, P L
Article. 10.1016/j.ad.2022.11.010. 2023
Quantitative evaluation of a non-CT based attenuation correction method for a new dedicated brain PET
Gandia-Ferrero, M.; (...); Marti-Bonmati, L.
Meeting Abstract. 2022
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 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
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
Sequential treatment of High-risk Neuroblastoma combining I-131 MIBG high-dose and Topotecan. First experience
Orrego, N.; (...); Bello-Arques, P.
Meeting Abstract. 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
Spinocerebellar Ataxia 36 is a Frequent Cause of Hereditary Ataxia in Eastern Spain
Baviera-Munoz, Raquel; (...); Bataller, Luis
Article. 10.1002/mdc3.13740. 2023
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
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