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Evaluar la eficacia y la seguridad de selumetinib en combinación con docetaxel en pacientes que reciben tratamiento de segunda línea para v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC (SELECT-1)

6 de noviembre de 2026 actualizado por: AstraZeneca

Estudio de fase III, doble ciego, aleatorizado, controlado con placebo para evaluar la eficacia y la seguridad de selumetinib (AZD6244; ARRY-142886) (sulfato de hidrógeno) en combinación con docetaxel, en pacientes que reciben tratamiento de segunda línea para la mutación positiva de KRAS Cáncer de pulmón de células no pequeñas localmente avanzado o metastásico (Estadio IIIB - IV) (SELECCIONE 1)

The purpose of this study is to assess the efficacy of selumetinib in combination with docetaxel (75mg/m2) vs placebo in combination with docetaxel (75mg/m2) in patients with locally advance or metastatic NSCLCs that harbor mutations of KRAS. This study will also assess the PK, safety, patient reported outcomes (PRO) and tolerability profile of the selumetinib/docetaxel combination, compared to placebo in combination with docetaxel

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

A Phase III, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination with Docetaxel, in Patients receiving second line treatment for KRAS Mutation-Positive Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV) (SELECT-1)

Tipo de estudio

Intervencionista

Inscripción (Actual)

510

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Augsburg, Alemania, 86156
        • Research Site
      • Bad Berka, Alemania, 99437
        • Research Site
      • Cologne, Alemania, 50937
        • Research Site
      • Dortmund, Alemania, 44309
        • Research Site
      • Gerlingen, Alemania, 70839
        • Research Site
      • Großhansdorf, Alemania, 22927
        • Research Site
      • Halle, Alemania, 06120
        • Research Site
      • Heidelberg, Alemania, 69126
        • Research Site
      • Homburg, Alemania, 66424
        • Research Site
      • Löwenstein, Alemania, 74245
        • Research Site
      • Moers, Alemania, 47441
        • Research Site
      • München, Alemania, 81925
        • Research Site
      • Ulm, Alemania, 89081
        • Research Site
      • Wiesbaden, Alemania, 65199
        • Research Site
      • Würzburg, Alemania, 97080
        • Research Site
  • Argentina
      • Buenos Aires, Argentina, 1426
        • Research Site
      • Ciudad de Buenos Aires, Argentina, C1025ABI
        • Research Site
      • Ciudad de Buenos Aires, Argentina, 1180
        • Research Site
      • Córdoba, Argentina, 5000
        • Research Site
      • Rosario, Argentina, S2000KZE
        • Research Site
  • Australia
      • Camperdown, Australia, 2050
        • Research Site
      • Chermside, Australia, 4032
        • Research Site
      • Darlinghurst, Australia, 2010
        • Research Site
      • Fitzroy, Australia, 3065
        • Research Site
      • Kogarah, Australia, 2217
        • Research Site
      • Kurralta Park, Australia, 5037
        • Research Site
      • Malvern, Australia, 3144
        • Research Site
      • Wendouree, Australia, 3355
        • Research Site
      • Woodville South, Australia, 5011
        • Research Site
  • Austria
      • Innsbruck, Austria, 6020
        • Research Site
      • Linz, Austria, 4020
        • Research Site
      • Salzburg, Austria, 5020
        • Research Site
      • Vienna, Austria, 1160
        • Research Site
      • Vienna, Austria, 1100
        • Research Site
  • Brasil
      • Barretos, Brasil, 14784-400
        • Research Site
      • Ijuí, Brasil, 98700-000
        • Research Site
      • Pelotas, Brasil, 096015-280
        • Research Site
      • Porto Alegre, Brasil, 90035-003
        • Research Site
      • Porto Alegre, Brasil, 90610-000
        • Research Site
      • São José do Rio Preto, Brasil, 15090-000
        • Research Site
      • São Paulo, Brasil
        • Research Site
      • São Paulo, Brasil, 01209-000
        • Research Site
      • São Paulo, Brasil, 01246-000
        • Research Site
  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • Research Site
      • Sofia, Bulgaria, 1233
        • Research Site
      • Sofia, Bulgaria, 1330
        • Research Site
      • Sofia, Bulgaria, 1303
        • Research Site
      • Varna, Bulgaria, 9010
        • Research Site
      • Vratsa, Bulgaria, 3000
        • Research Site
  • Bélgica
      • Brussels, Bélgica, 1000
        • Research Site
      • Brussels, Bélgica, 1090
        • Research Site
      • Brussels, Bélgica, 1200
        • Research Site
      • Ghent, Bélgica, 9000
        • Research Site
      • Leuven, Bélgica, 3000
        • Research Site
      • Roeselare, Bélgica, 8800
        • Research Site
  • Canadá
    • Alberta
      • Edmonton, Alberta, Canadá, T6G 1Z2
        • Research Site
    • British Columbia
      • Kelowna, British Columbia, Canadá, V1Y 5L3
        • Research Site
      • Surrey, British Columbia, Canadá, V3V 1Z2
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canadá, B3H 1V7
        • Research Site
    • Ontario
      • Oshawa, Ontario, Canadá, L1G 2B9
        • Research Site
      • Toronto, Ontario, Canadá, M5G 2M9
        • Research Site
    • Quebec
      • Montreal, Quebec, Canadá, H4A 3J1
        • Research Site
      • Québec, Quebec, Canadá, G1V 4G5
        • Research Site
    • Saskatchewan
      • Regina, Saskatchewan, Canadá, S4T 7T1
        • Research Site
      • Saskatoon, Saskatchewan, Canadá, S7N 4H4
        • Research Site
  • Chile
      • Santiago, Chile, 7520349
        • Research Site
      • Santiago, Chile, 8360160
        • Research Site
      • Santiago, Chile, 7500921
        • Research Site
      • Santiago, Chile, 8380456
        • Research Site
      • Santiago, Chile, 8420383
        • Research Site
      • Santiago, Chile, 7630370
        • Research Site
  • España
      • Barcelona, España, 08003
        • Research Site
      • Madrid, España, 28034
        • Research Site
      • Madrid, España, 28041
        • Research Site
      • Madrid, España, 08035
        • Research Site
      • Málaga, España, 29010
        • Research Site
      • Seville, España, 41013
        • Research Site
      • Vigo(Pontevedra), España, 36204
        • Research Site
      • Zaragoza, España, 50009
        • Research Site
  • Estados Unidos
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045
        • Research Site
    • Florida
      • Pembroke Pines, Florida, Estados Unidos, 33028
        • Research Site
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30318
        • Research Site
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60637
        • Research Site
    • Louisiana
      • Metairie, Louisiana, Estados Unidos, 70006
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02114
        • Research Site
      • Boston, Massachusetts, Estados Unidos, 02215
        • Research Site
      • Danvers, Massachusetts, Estados Unidos, 01923
        • Research Site
    • New York
      • New York, New York, Estados Unidos, 10032
        • Research Site
      • New York, New York, Estados Unidos, 10011
        • Research Site
    • North Carolina
      • Durham, North Carolina, Estados Unidos, 27710
        • Research Site
    • Pennsylvania
      • Hershey, Pennsylvania, Estados Unidos, 17033
        • Research Site
      • Philadelphia, Pennsylvania, Estados Unidos, 19107
        • Research Site
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37203
        • Research Site
      • Nashville, Tennessee, Estados Unidos, 37232
        • Research Site
    • Washington
      • Seattle, Washington, Estados Unidos, 98104
        • Research Site
    • West Virginia
      • Morgantown, West Virginia, Estados Unidos, 26506
        • Research Site
  • Francia
      • Brest, Francia, 29609
        • Research Site
      • Caen, Francia, F-14033
        • Research Site
      • Clermont-Ferrand, Francia, 63003
        • Research Site
      • Dijon, Francia, 21079
        • Research Site
      • Lille, Francia, 59000
        • Research Site
      • Marseille, Francia, 13915
        • Research Site
      • Paris, Francia, 75020
        • Research Site
      • Pierre-Bénite, Francia, 69310
        • Research Site
      • Rennes, Francia, 35033
        • Research Site
      • Toulouse, Francia, 31059
        • Research Site
  • Hungría
      • Budapest, Hungría, 1121
        • Research Site
      • Budapest, Hungría, 1122
        • Research Site
      • Edelény, Hungría, 3780
        • Research Site
      • Győr, Hungría, 9024
        • Research Site
      • Kaposvár, Hungría, 7400
        • Research Site
      • Miskolc, Hungría, 3529
        • Research Site
      • Nyíregyháza, Hungría, 4400
        • Research Site
      • Törökbálint, Hungría, 2045
        • Research Site
  • Israel
      • Beersheba, Israel, 8410101
        • Research Site
      • Haifa, Israel, 31096
        • Research Site
      • Kfar Saba, Israel, 4428164
        • Research Site
      • Petah Tikva, Israel, 49100
        • Research Site
      • Tel Aviv, Israel, 64239
        • Research Site
      • Tel HaShomer, Israel, 52621
        • Research Site
  • Italia
      • Bari, Italia, 70124
        • Research Site
      • Genova, Italia, 16100
        • Research Site
      • Livorno, Italia, 57100
        • Research Site
      • Milan, Italia, 20132
        • Research Site
      • Naples, Italia, 80131
        • Research Site
      • Orbassano, Italia, 10043
        • Research Site
      • Parma, Italia, 43126
        • Research Site
      • Perugia, Italia, 06132
        • Research Site
      • Roma, Italia, 00128
        • Research Site
      • Roma, Italia, 00144
        • Research Site
  • México
      • Monterrey, México, 64460
        • Research Site
      • México, México, 14080
        • Research Site
  • Países Bajos
      • 's-Hertogenbosch, Países Bajos, 5223 GZ
        • Research Site
      • Amsterdam, Países Bajos, 1066 CX
        • Research Site
      • Amsterdam, Países Bajos, 1081 HV
        • Research Site
      • Bergen op Zoom, Países Bajos, 4624 VT
        • Research Site
      • Maastricht, Países Bajos, 6202 AZ
        • Research Site
  • Perú
      • Lima, Perú, 15033
        • Research Site
      • Lima, Perú, L27
        • Research Site
      • Lima, Perú, LIMA 34
        • Research Site
      • Lima, Perú, LIMA 01
        • Research Site
      • Lima, Perú, LIMA 29
        • Research Site
      • Lima, Perú, LIMA 11
        • Research Site
      • Lima, Perú, 15073
        • Research Site
      • Miraflores, Perú, 15046
        • Research Site
  • Polonia
      • Brzozów, Polonia, 36-200
        • Research Site
      • Bydgoszcz, Polonia, 85-796
        • Research Site
      • Gdansk, Polonia, 80-952
        • Research Site
      • Gdansk, Polonia, 80-219
        • Research Site
      • Grudziądz, Polonia, 86-300
        • Research Site
      • Krakow, Polonia, 31-202
        • Research Site
      • Lubin, Polonia, 59-301
        • Research Site
      • Olsztyn, Polonia, 10-357
        • Research Site
      • Opole, Polonia, 45-061
        • Research Site
      • Sucha Beskidzka, Polonia, 34-200
        • Research Site
      • Szczecin, Polonia, 70-891
        • Research Site
      • Warsaw, Polonia, 02-781
        • Research Site
  • Portugal
      • Amadora, Portugal, 2720-276
        • Research Site
      • Coimbra, Portugal, 3040-316
        • Research Site
      • Lisbon, Portugal, 1769-001
        • Research Site
      • Lisbon, Portugal, 1099-023
        • Research Site
      • Porto, Portugal, 4200-319
        • Research Site
      • Porto, Portugal, 4100-180
        • Research Site
      • Vila Nova de Gaia, Portugal, 4434-502
        • Research Site
  • Reino Unido
      • Aberdeen, Reino Unido, AB2 2ZB
        • Research Site
      • London, Reino Unido, SW3 6JJ
        • Research Site
      • Manchester, Reino Unido, M20 4BX
        • Research Site
      • Nottingham, Reino Unido, NG5 1PB
        • Research Site
      • Sutton, Reino Unido, SM2 5PT
        • Research Site
      • Wolverhampton, Reino Unido, WV10 0QP
        • Research Site
  • Rumania
      • Cluj-Napoca, Rumania, 400015
        • Research Site
      • Cluj-Napoca, Rumania, 400058
        • Research Site
  • Rusia
      • Kazan', Rusia, 420012
        • Research Site
      • Moscow, Rusia, 115478
        • Research Site
      • Moscow, Rusia, 105229
        • Research Site
      • Saint Petersburg, Rusia, 197758
        • Research Site
      • Saint Petersburg, Rusia, 194291
        • Research Site
      • Saint Petersburg, Rusia, 197342
        • Research Site
      • Volgograd, Rusia, 400138
        • Research Site
  • Suecia
      • Linköping, Suecia, 581 85
        • Research Site
      • Uppsala, Suecia, SE-751 85
        • Research Site
      • Örebro, Suecia, 701 85
        • Research Site
  • Turquía (Türkiye)
      • Ankara, Turquía (Türkiye), 06230
        • Research Site
      • Ankara, Turquía (Türkiye), 06280
        • Research Site
      • Istanbul, Turquía (Türkiye), 34662
        • Research Site
      • Istanbul, Turquía (Türkiye), 34844
        • Research Site
      • Izmir, Turquía (Türkiye), 35100
        • Research Site
      • Izmir, Turquía (Türkiye), 35110
        • Research Site
      • Manisa, Turquía (Türkiye), 45030
        • Research Site
  • Ucrania
      • Chernivtsі, Ucrania, 58013
        • Research Site
      • Dnipro, Ucrania, 49102
        • Research Site
      • Kharkiv Region, Ucrania, 61070
        • Research Site
      • Kryvyi Rih, Ucrania, 50048
        • Research Site
      • Kyiv, Ucrania, 03115
        • Research Site
      • Sumy, Ucrania, 40022
        • Research Site
      • Uzhhorod, Ucrania, 88000
        • Research Site
      • Zaporizhzhya, Ucrania, 69040
        • Research Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 130 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Provision of signed, written and dated informed consent prior to any study specific procedures
  • Male or female, aged 18 years or older
  • Histological or cytological confirmation of locally advanced or metastatic NSCLC (IIIB-IV)
  • KRAS mutation positive tumour sample as determined by the designated testing laboratory
  • Failure of 1st line anti-cancer therapy due to radiological documentation of disease progression in advanced disease or subsequent relapse of disease following 1st line therapy

Exclusion Criteria:

  • Mixed small cell and non-small cell lung cancer histology.
  • Received >1 prior anti-cancer drug regimen for advanced or metastatic NSCLC. Patients who develop disease progression while on switch maintenance therapy (maintenance using an agent not in the first-line regimen) will not be eligible.
  • Receiving or have received systemic anti-cancer therapy within 30 days prior to starting study treatment
  • Other concomitant anti-cancer therapy agents excepts steroids
  • Prior treatment with a Mitogen-Activated protein Kinase (MEK) inhibitor or any docetaxel-containing regimen (prior treatment with paclitaxel is acceptable).
  • Last radiation therapy within 4 weeks prior starting study treatment, or limited field of radiation for palliation within 7 days of the first dose of study treatment

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Selumetinib + Docetaxel

Three 25mg Selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
Droga: Selumetinib

Three 25 mg selumetinib capsules (Hyd-Sulfate) be administered orally, twice daily, (total dose 75 mg dose bd) on an uninterrupted schedule.

Otros nombres:
  • AZD6244; ARRY-142886
Droga: Docetaxel

Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.

Droga: Pegylated G-CSF

All patients will receive pegylated Granulocyte Colony Stimulating Factor (G-CSF) at least 24 hours after administration of every docetaxel dose and not within 14 days prior to the next docetaxel administration.

Otros nombres:
  • Pegfilgrastim 6 mg
Experimental: Placebo + Docetaxel

Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
Droga: Docetaxel

Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.

Droga: Pegylated G-CSF

All patients will receive pegylated Granulocyte Colony Stimulating Factor (G-CSF) at least 24 hours after administration of every docetaxel dose and not within 14 days prior to the next docetaxel administration.

Otros nombres:
  • Pegfilgrastim 6 mg
Droga: Placebo

Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Progression-Free Survival (PFS)
Periodo de tiempo: Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)

Progression free survival is defined as the time from randomisation until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)
Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall Survival (OS)
Periodo de tiempo: Measured at baseline until date of death due to any cause. Estimated final completion : approximately 3.5 years after FSI

Overall Survival is defined as the time from the date of randomisation until death due to any cause.
Measured at baseline until date of death due to any cause. Estimated final completion : approximately 3.5 years after FSI
Objective Response Rate (ORR)
Periodo de tiempo: Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)

ORR is defined as the number (%) of subjects with at least one overall visit response of complete response (CR) or partial response (PR). Per RECIST v1.1 for target lesions and assessed by CT/MRI: CR - disappearance of all target lesions; PR - >=30% decrease in the sum of the longest diameter of target lesion. (Non-target lesion and new lesion results are also taken into account for the overall visit result)
Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)
Duration of Response (DoR)
Periodo de tiempo: Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)

Duration of response is defined as the time from the date of first documented response until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)
Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)
Symptom Improvement Rate Using Average Symptom Burden Index (ASBI) of the Lung Cancer Symptom Scale (LCSS)
Periodo de tiempo: Measured from date of randomisation until 30 days post treatment discontinuation or 30 days post progression (if study treatment is discontinued before progression). Estimated final completion : approximately 3 years after first subject in (FSI)

The symptom improvement rate will be defined as the number (%) of patients with two consecutive assessments at least 18 days apart (ie 21 days allowing a visit window of 3 days) which showed a clinically meaningful improvement in symptoms from baseline (defined as a decrease in the ASBI from baseline ≥10). LCSS-Lung Cancer Symptom Scale; ASBI-Average symptom burden index.
Measured from date of randomisation until 30 days post treatment discontinuation or 30 days post progression (if study treatment is discontinued before progression). Estimated final completion : approximately 3 years after first subject in (FSI)
Time to Symptom Progression Using Average Symptom Burden Index (ASBI) of the Lung Cancer Symptom Scale (LCSS)
Periodo de tiempo: Measured from date of randomisation until 30 days post treatment discontinuation or 30 days post progression (if study treatment is discontinued before progression). Estimated final completion : approximately 3 years after first subject in (FSI)

Time to symptom progression will be defined as the time from randomization until the date of first clinically meaningful symptom deterioration (defined as an increase in the ASBI from baseline ≥10), or death (by any cause). LCSS-Lung Cancer Symptom Scale; ASBI-Average symptom burden index.
Measured from date of randomisation until 30 days post treatment discontinuation or 30 days post progression (if study treatment is discontinued before progression). Estimated final completion : approximately 3 years after first subject in (FSI)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

AstraZeneca

Investigadores

  • Investigador principal: Pasi Jänne, MD, Dana-Faber Cancer Institute, USA
  • Silla de estudio: Gabriella Mariani, MD, AstraZeneca UK, MSD

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

25 de septiembre de 2013

Finalización primaria (Actual)

7 de junio de 2016

Finalización del estudio (Estimado)

31 de diciembre de 2026

Fechas de registro del estudio

Enviado por primera vez

29 de agosto de 2013

Primero enviado que cumplió con los criterios de control de calidad

29 de agosto de 2013

Publicado por primera vez (Estimado)

2 de septiembre de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

6 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • D1532C00079
  • 2013-001676-38 (Número EudraCT)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Marco de tiempo para compartir IPD

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Criterios de acceso compartido de IPD

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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