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Vurder effektivitet og sikkerhed af selumetinib i kombination med docetaxel hos patienter, der modtager 2. linje behandling for v-Ki-ras2 Kirsten Rat Sarcoma Viral Onkogen Homolog (KRAS) Positiv NSCLC (SELECT-1)

6. november 2026 opdateret af: AstraZeneca

En fase III, dobbeltblind, randomiseret, placebokontrolleret undersøgelse for at vurdere effektiviteten og sikkerheden af ​​Selumetinib (AZD6244; ARRY-142886) (Hyd-sulfat) i kombination med docetaxel hos patienter, der modtager andenlinjebehandling for KRAS-mutation-Positiv Lokalt avanceret eller metastatisk ikke-småcellet lungekræft (stadium IIIB - IV) (SELECT 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

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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)

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

510

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • 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
  • Australien
      • Camperdown, Australien, 2050
        • Research Site
      • Chermside, Australien, 4032
        • Research Site
      • Darlinghurst, Australien, 2010
        • Research Site
      • Fitzroy, Australien, 3065
        • Research Site
      • Kogarah, Australien, 2217
        • Research Site
      • Kurralta Park, Australien, 5037
        • Research Site
      • Malvern, Australien, 3144
        • Research Site
      • Wendouree, Australien, 3355
        • Research Site
      • Woodville South, Australien, 5011
        • Research Site
  • Belgien
      • Brussels, Belgien, 1000
        • Research Site
      • Brussels, Belgien, 1090
        • Research Site
      • Brussels, Belgien, 1200
        • Research Site
      • Ghent, Belgien, 9000
        • Research Site
      • Leuven, Belgien, 3000
        • Research Site
      • Roeselare, Belgien, 8800
        • Research Site
  • Brasilien
      • Barretos, Brasilien, 14784-400
        • Research Site
      • Ijuí, Brasilien, 98700-000
        • Research Site
      • Pelotas, Brasilien, 096015-280
        • Research Site
      • Porto Alegre, Brasilien, 90035-003
        • Research Site
      • Porto Alegre, Brasilien, 90610-000
        • Research Site
      • São José do Rio Preto, Brasilien, 15090-000
        • Research Site
      • São Paulo, Brasilien
        • Research Site
      • São Paulo, Brasilien, 01209-000
        • Research Site
      • São Paulo, Brasilien, 01246-000
        • Research Site
  • Bulgarien
      • Plovdiv, Bulgarien, 4000
        • Research Site
      • Sofia, Bulgarien, 1233
        • Research Site
      • Sofia, Bulgarien, 1330
        • Research Site
      • Sofia, Bulgarien, 1303
        • Research Site
      • Varna, Bulgarien, 9010
        • Research Site
      • Vratsa, Bulgarien, 3000
        • Research Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Research Site
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • Research Site
      • Surrey, British Columbia, Canada, V3V 1Z2
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Research Site
    • Ontario
      • Oshawa, Ontario, Canada, L1G 2B9
        • Research Site
      • Toronto, Ontario, Canada, M5G 2M9
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Research Site
      • Québec, Quebec, Canada, G1V 4G5
        • Research Site
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Research Site
      • Saskatoon, Saskatchewan, Canada, 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
  • Det Forenede Kongerige
      • Aberdeen, Det Forenede Kongerige, AB2 2ZB
        • Research Site
      • London, Det Forenede Kongerige, SW3 6JJ
        • Research Site
      • Manchester, Det Forenede Kongerige, M20 4BX
        • Research Site
      • Nottingham, Det Forenede Kongerige, NG5 1PB
        • Research Site
      • Sutton, Det Forenede Kongerige, SM2 5PT
        • Research Site
      • Wolverhampton, Det Forenede Kongerige, WV10 0QP
        • Research Site
  • Forenede Stater
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • Research Site
    • Florida
      • Pembroke Pines, Florida, Forenede Stater, 33028
        • Research Site
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30318
        • Research Site
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637
        • Research Site
    • Louisiana
      • Metairie, Louisiana, Forenede Stater, 70006
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Research Site
      • Boston, Massachusetts, Forenede Stater, 02215
        • Research Site
      • Danvers, Massachusetts, Forenede Stater, 01923
        • Research Site
    • New York
      • New York, New York, Forenede Stater, 10032
        • Research Site
      • New York, New York, Forenede Stater, 10011
        • Research Site
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Research Site
    • Pennsylvania
      • Hershey, Pennsylvania, Forenede Stater, 17033
        • Research Site
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Research Site
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37203
        • Research Site
      • Nashville, Tennessee, Forenede Stater, 37232
        • Research Site
    • Washington
      • Seattle, Washington, Forenede Stater, 98104
        • Research Site
    • West Virginia
      • Morgantown, West Virginia, Forenede Stater, 26506
        • Research Site
  • Frankrig
      • Brest, Frankrig, 29609
        • Research Site
      • Caen, Frankrig, F-14033
        • Research Site
      • Clermont-Ferrand, Frankrig, 63003
        • Research Site
      • Dijon, Frankrig, 21079
        • Research Site
      • Lille, Frankrig, 59000
        • Research Site
      • Marseille, Frankrig, 13915
        • Research Site
      • Paris, Frankrig, 75020
        • Research Site
      • Pierre-Bénite, Frankrig, 69310
        • Research Site
      • Rennes, Frankrig, 35033
        • Research Site
      • Toulouse, Frankrig, 31059
        • Research Site
  • Holland
      • 's-Hertogenbosch, Holland, 5223 GZ
        • Research Site
      • Amsterdam, Holland, 1066 CX
        • Research Site
      • Amsterdam, Holland, 1081 HV
        • Research Site
      • Bergen op Zoom, Holland, 4624 VT
        • Research Site
      • Maastricht, Holland, 6202 AZ
        • 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
  • Italien
      • Bari, Italien, 70124
        • Research Site
      • Genova, Italien, 16100
        • Research Site
      • Livorno, Italien, 57100
        • Research Site
      • Milan, Italien, 20132
        • Research Site
      • Naples, Italien, 80131
        • Research Site
      • Orbassano, Italien, 10043
        • Research Site
      • Parma, Italien, 43126
        • Research Site
      • Perugia, Italien, 06132
        • Research Site
      • Roma, Italien, 00128
        • Research Site
      • Roma, Italien, 00144
        • Research Site
  • Mexico
      • Monterrey, Mexico, 64460
        • Research Site
      • México, Mexico, 14080
        • Research Site
  • Peru
      • Lima, Peru, 15033
        • Research Site
      • Lima, Peru, L27
        • Research Site
      • Lima, Peru, LIMA 34
        • Research Site
      • Lima, Peru, LIMA 01
        • Research Site
      • Lima, Peru, LIMA 29
        • Research Site
      • Lima, Peru, LIMA 11
        • Research Site
      • Lima, Peru, 15073
        • Research Site
      • Miraflores, Peru, 15046
        • Research Site
  • Polen
      • Brzozów, Polen, 36-200
        • Research Site
      • Bydgoszcz, Polen, 85-796
        • Research Site
      • Gdansk, Polen, 80-952
        • Research Site
      • Gdansk, Polen, 80-219
        • Research Site
      • Grudziądz, Polen, 86-300
        • Research Site
      • Krakow, Polen, 31-202
        • Research Site
      • Lubin, Polen, 59-301
        • Research Site
      • Olsztyn, Polen, 10-357
        • Research Site
      • Opole, Polen, 45-061
        • Research Site
      • Sucha Beskidzka, Polen, 34-200
        • Research Site
      • Szczecin, Polen, 70-891
        • Research Site
      • Warsaw, Polen, 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
  • Rumænien
      • Cluj-Napoca, Rumænien, 400015
        • Research Site
      • Cluj-Napoca, Rumænien, 400058
        • Research Site
  • Rusland
      • Kazan', Rusland, 420012
        • Research Site
      • Moscow, Rusland, 115478
        • Research Site
      • Moscow, Rusland, 105229
        • Research Site
      • Saint Petersburg, Rusland, 197758
        • Research Site
      • Saint Petersburg, Rusland, 194291
        • Research Site
      • Saint Petersburg, Rusland, 197342
        • Research Site
      • Volgograd, Rusland, 400138
        • Research Site
  • Spanien
      • Barcelona, Spanien, 08003
        • Research Site
      • Madrid, Spanien, 28034
        • Research Site
      • Madrid, Spanien, 28041
        • Research Site
      • Madrid, Spanien, 08035
        • Research Site
      • Málaga, Spanien, 29010
        • Research Site
      • Seville, Spanien, 41013
        • Research Site
      • Vigo(Pontevedra), Spanien, 36204
        • Research Site
      • Zaragoza, Spanien, 50009
        • Research Site
  • Sverige
      • Linköping, Sverige, 581 85
        • Research Site
      • Uppsala, Sverige, SE-751 85
        • Research Site
      • Örebro, Sverige, 701 85
        • Research Site
  • Tyrkiet (Türkiye)
      • Ankara, Tyrkiet (Türkiye), 06230
        • Research Site
      • Ankara, Tyrkiet (Türkiye), 06280
        • Research Site
      • Istanbul, Tyrkiet (Türkiye), 34662
        • Research Site
      • Istanbul, Tyrkiet (Türkiye), 34844
        • Research Site
      • Izmir, Tyrkiet (Türkiye), 35100
        • Research Site
      • Izmir, Tyrkiet (Türkiye), 35110
        • Research Site
      • Manisa, Tyrkiet (Türkiye), 45030
        • Research Site
  • Tyskland
      • Augsburg, Tyskland, 86156
        • Research Site
      • Bad Berka, Tyskland, 99437
        • Research Site
      • Cologne, Tyskland, 50937
        • Research Site
      • Dortmund, Tyskland, 44309
        • Research Site
      • Gerlingen, Tyskland, 70839
        • Research Site
      • Großhansdorf, Tyskland, 22927
        • Research Site
      • Halle, Tyskland, 06120
        • Research Site
      • Heidelberg, Tyskland, 69126
        • Research Site
      • Homburg, Tyskland, 66424
        • Research Site
      • Löwenstein, Tyskland, 74245
        • Research Site
      • Moers, Tyskland, 47441
        • Research Site
      • München, Tyskland, 81925
        • Research Site
      • Ulm, Tyskland, 89081
        • Research Site
      • Wiesbaden, Tyskland, 65199
        • Research Site
      • Würzburg, Tyskland, 97080
        • Research Site
  • Ukraine
      • Chernivtsі, Ukraine, 58013
        • Research Site
      • Dnipro, Ukraine, 49102
        • Research Site
      • Kharkiv Region, Ukraine, 61070
        • Research Site
      • Kryvyi Rih, Ukraine, 50048
        • Research Site
      • Kyiv, Ukraine, 03115
        • Research Site
      • Sumy, Ukraine, 40022
        • Research Site
      • Uzhhorod, Ukraine, 88000
        • Research Site
      • Zaporizhzhya, Ukraine, 69040
        • Research Site
  • Ungarn
      • Budapest, Ungarn, 1121
        • Research Site
      • Budapest, Ungarn, 1122
        • Research Site
      • Edelény, Ungarn, 3780
        • Research Site
      • Győr, Ungarn, 9024
        • Research Site
      • Kaposvár, Ungarn, 7400
        • Research Site
      • Miskolc, Ungarn, 3529
        • Research Site
      • Nyíregyháza, Ungarn, 4400
        • Research Site
      • Törökbálint, Ungarn, 2045
        • Research Site
  • Østrig
      • Innsbruck, Østrig, 6020
        • Research Site
      • Linz, Østrig, 4020
        • Research Site
      • Salzburg, Østrig, 5020
        • Research Site
      • Vienna, Østrig, 1160
        • Research Site
      • Vienna, Østrig, 1100
        • Research Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 130 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Medicin: Selumetinib

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

Andre navne:
  • AZD6244; ARRY-142886
Medicin: Docetaxel

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

Medicin: 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.

Andre navne:
  • Pegfilgrastim 6 mg
Eksperimentel: 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.
Medicin: Docetaxel

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

Medicin: 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.

Andre navne:
  • Pegfilgrastim 6 mg
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-Free Survival (PFS)
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival (OS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AstraZeneca

Efterforskere

  • Ledende efterforsker: Pasi Jänne, MD, Dana-Faber Cancer Institute, USA
  • Studiestol: Gabriella Mariani, MD, AstraZeneca UK, MSD

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

25. september 2013

Primær færdiggørelse (Faktiske)

7. juni 2016

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

29. august 2013

Først indsendt, der opfyldte QC-kriterier

29. august 2013

Først opslået (Anslået)

2. september 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

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

IPD-delingsadgangskriterier

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

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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