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Bedöm effektivitet och säkerhet av Selumetinib i kombination med docetaxel hos patienter som får 2:a linjens behandling för v-Ki-ras2 Kirsten Rat Sarkom Viral Onkogen Homolog (KRAS) Positiv NSCLC (SELECT-1)

6 november 2026 uppdaterad av: AstraZeneca

En fas III, dubbelblind, randomiserad, placebokontrollerad studie för att bedöma effektiviteten och säkerheten av Selumetinib (AZD6244; ARRY-142886) (Hyd-sulfat) i kombination med docetaxel, hos patienter som får andrahandsbehandling för KRAS-mutation-Positiv Lokalt avancerad eller metastaserad icke-småcellig lungcancer (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

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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)

Studietyp

Interventionell

Inskrivning (Faktisk)

510

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • 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
  • 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
  • Frankrike
      • Brest, Frankrike, 29609
        • Research Site
      • Caen, Frankrike, F-14033
        • Research Site
      • Clermont-Ferrand, Frankrike, 63003
        • Research Site
      • Dijon, Frankrike, 21079
        • Research Site
      • Lille, Frankrike, 59000
        • Research Site
      • Marseille, Frankrike, 13915
        • Research Site
      • Paris, Frankrike, 75020
        • Research Site
      • Pierre-Bénite, Frankrike, 69310
        • Research Site
      • Rennes, Frankrike, 35033
        • Research Site
      • Toulouse, Frankrike, 31059
        • Research Site
  • Förenta staterna
    • Colorado
      • Aurora, Colorado, Förenta staterna, 80045
        • Research Site
    • Florida
      • Pembroke Pines, Florida, Förenta staterna, 33028
        • Research Site
    • Georgia
      • Atlanta, Georgia, Förenta staterna, 30318
        • Research Site
    • Illinois
      • Chicago, Illinois, Förenta staterna, 60637
        • Research Site
    • Louisiana
      • Metairie, Louisiana, Förenta staterna, 70006
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02114
        • Research Site
      • Boston, Massachusetts, Förenta staterna, 02215
        • Research Site
      • Danvers, Massachusetts, Förenta staterna, 01923
        • Research Site
    • New York
      • New York, New York, Förenta staterna, 10032
        • Research Site
      • New York, New York, Förenta staterna, 10011
        • Research Site
    • North Carolina
      • Durham, North Carolina, Förenta staterna, 27710
        • Research Site
    • Pennsylvania
      • Hershey, Pennsylvania, Förenta staterna, 17033
        • Research Site
      • Philadelphia, Pennsylvania, Förenta staterna, 19107
        • Research Site
    • Tennessee
      • Nashville, Tennessee, Förenta staterna, 37203
        • Research Site
      • Nashville, Tennessee, Förenta staterna, 37232
        • Research Site
    • Washington
      • Seattle, Washington, Förenta staterna, 98104
        • Research Site
    • West Virginia
      • Morgantown, West Virginia, Förenta staterna, 26506
        • 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
  • Kanada
    • Alberta
      • Edmonton, Alberta, Kanada, T6G 1Z2
        • Research Site
    • British Columbia
      • Kelowna, British Columbia, Kanada, V1Y 5L3
        • Research Site
      • Surrey, British Columbia, Kanada, V3V 1Z2
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Kanada, B3H 1V7
        • Research Site
    • Ontario
      • Oshawa, Ontario, Kanada, L1G 2B9
        • Research Site
      • Toronto, Ontario, Kanada, M5G 2M9
        • Research Site
    • Quebec
      • Montreal, Quebec, Kanada, H4A 3J1
        • Research Site
      • Québec, Quebec, Kanada, G1V 4G5
        • Research Site
    • Saskatchewan
      • Regina, Saskatchewan, Kanada, S4T 7T1
        • Research Site
      • Saskatoon, Saskatchewan, Kanada, S7N 4H4
        • Research Site
  • Mexiko
      • Monterrey, Mexiko, 64460
        • Research Site
      • México, Mexiko, 14080
        • Research Site
  • Nederländerna
      • 's-Hertogenbosch, Nederländerna, 5223 GZ
        • Research Site
      • Amsterdam, Nederländerna, 1066 CX
        • Research Site
      • Amsterdam, Nederländerna, 1081 HV
        • Research Site
      • Bergen op Zoom, Nederländerna, 4624 VT
        • Research Site
      • Maastricht, Nederländerna, 6202 AZ
        • 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
  • Rumänien
      • Cluj-Napoca, Rumänien, 400015
        • Research Site
      • Cluj-Napoca, Rumänien, 400058
        • Research Site
  • Ryssland
      • Kazan', Ryssland, 420012
        • Research Site
      • Moscow, Ryssland, 115478
        • Research Site
      • Moscow, Ryssland, 105229
        • Research Site
      • Saint Petersburg, Ryssland, 197758
        • Research Site
      • Saint Petersburg, Ryssland, 194291
        • Research Site
      • Saint Petersburg, Ryssland, 197342
        • Research Site
      • Volgograd, Ryssland, 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
  • Storbritannien
      • Aberdeen, Storbritannien, AB2 2ZB
        • Research Site
      • London, Storbritannien, SW3 6JJ
        • Research Site
      • Manchester, Storbritannien, M20 4BX
        • Research Site
      • Nottingham, Storbritannien, NG5 1PB
        • Research Site
      • Sutton, Storbritannien, SM2 5PT
        • Research Site
      • Wolverhampton, Storbritannien, WV10 0QP
        • Research Site
  • Sverige
      • Linköping, Sverige, 581 85
        • Research Site
      • Uppsala, Sverige, SE-751 85
        • Research Site
      • Örebro, Sverige, 701 85
        • Research Site
  • Turkiet (Türkiye)
      • Ankara, Turkiet (Türkiye), 06230
        • Research Site
      • Ankara, Turkiet (Türkiye), 06280
        • Research Site
      • Istanbul, Turkiet (Türkiye), 34662
        • Research Site
      • Istanbul, Turkiet (Türkiye), 34844
        • Research Site
      • Izmir, Turkiet (Türkiye), 35100
        • Research Site
      • Izmir, Turkiet (Türkiye), 35110
        • Research Site
      • Manisa, Turkiet (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
  • Ukraina
      • Chernivtsі, Ukraina, 58013
        • Research Site
      • Dnipro, Ukraina, 49102
        • Research Site
      • Kharkiv Region, Ukraina, 61070
        • Research Site
      • Kryvyi Rih, Ukraina, 50048
        • Research Site
      • Kyiv, Ukraina, 03115
        • Research Site
      • Sumy, Ukraina, 40022
        • Research Site
      • Uzhhorod, Ukraina, 88000
        • Research Site
      • Zaporizhzhya, Ukraina, 69040
        • Research Site
  • Ungern
      • Budapest, Ungern, 1121
        • Research Site
      • Budapest, Ungern, 1122
        • Research Site
      • Edelény, Ungern, 3780
        • Research Site
      • Győr, Ungern, 9024
        • Research Site
      • Kaposvár, Ungern, 7400
        • Research Site
      • Miskolc, Ungern, 3529
        • Research Site
      • Nyíregyháza, Ungern, 4400
        • Research Site
      • Törökbálint, Ungern, 2045
        • Research Site
  • Österrike
      • Innsbruck, Österrike, 6020
        • Research Site
      • Linz, Österrike, 4020
        • Research Site
      • Salzburg, Österrike, 5020
        • Research Site
      • Vienna, Österrike, 1160
        • Research Site
      • Vienna, Österrike, 1100
        • Research Site

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 130 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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
Läkemedel: Selumetinib

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

Andra namn:
  • AZD6244; ARRY-142886
Läkemedel: Docetaxel

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

Läkemedel: 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.

Andra namn:
  • Pegfilgrastim 6 mg
Experimentell: 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.
Läkemedel: Docetaxel

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

Läkemedel: 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.

Andra namn:
  • Pegfilgrastim 6 mg
Läkemedel: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Progression-Free Survival (PFS)
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall Survival (OS)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

AstraZeneca

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

25 september 2013

Primärt slutförande (Faktisk)

7 juni 2016

Avslutad studie (Beräknad)

31 december 2026

Studieregistreringsdatum

Först inskickad

29 augusti 2013

Först inskickad som uppfyllde QC-kriterierna

29 augusti 2013

Första postat (Beräknad)

2 september 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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

Tidsram för IPD-delning

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

Kriterier för IPD Sharing Access

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-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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