Neoadjuvant og adjuvant behandling ved resektabel ikke-småcellet lungekreft (NeoCOAST-2)
En fase II, åpen, multisenter, randomisert studie av neoadjuvant og adjuvant behandling hos pasienter med resektabel, tidlig stadium (II til IIIB) ikke-småcellet lungekreft (NeoCOAST-2)
The study is intended to assess the safety and efficacy of perioperative treatment with Durvalumab in combination with Oleclumab, Monalizumab, or AZD0171 and platinum doublet chemotherapy (CTX); or Volrustomig or Rilvegostomig in combination with CTX; or Datopotamab deruxtecan (Dato-DXd) in combination with Durvalumab or Rilvegostomig and single agent platinum chemotherapy in participants with resectable, early-stage non-small cell lung cancer.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
- Legemiddel: Durvalumab
- Legemiddel: Oleclumab
- Legemiddel: Pemetrexed/Cisplatin
- Legemiddel: Pemetrexed/Carboplatin
- Legemiddel: Carboplatin/Paclitaxel
- Legemiddel: Monalizumab
- Legemiddel: Volrustomig
- Legemiddel: Dato-DXd
- Legemiddel: Carboplatin
- Legemiddel: Cisplatin
- Legemiddel: AZD0171
- Legemiddel: Rilvegostomig
Detaljert beskrivelse
This is an open-label, multi-arms, multicentre, randomised study, eligible participants will be enrolled and randomised to one of the following treatment regimens.
Arm 1: Participants will receive Oleclumab + durvalumab + CTX as neoadjuvant treatment and Oleclumab + durvalumab as adjuvant treatment.
Arm 2: Participants will receive Monalizumab + durvalumab + CTX as neoadjuvant treatment and Monalizumab + durvalumab as adjuvant treatment.
Arm 3: Participants will receive Volrustomig (Dose Exploration) + CTX as neoadjuvant treatment and Volrustomig as adjuvant treatment.
Arm 4: Participants will receive Dato-DXd + durvalumab + single agent platinum chemotherapy as neoadjuvant treatment and durvalumab as adjuvant treatment.
Arm 5: Participants will receive AZD0171 + durvalumab + CTX as neoadjuvant treatment and AZD0171 + durvalumab as adjuvant treatment.
Arm 6: Participants will receive Rilvegostomig + CTX as neoadjuvant treatment and Rilvegostomig as adjuvant treatment.
Arm 7: Participants will receive Dato-DXd + Rilvegostomig + single agent platinum chemotherapy as neoadjuvant treatment and Rilvegostomig as adjuvant treatment.
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: AstraZeneca Clinical Study Information Center
- Telefonnummer: 1-877-240-9479
- E-post: information.center@astrazeneca.com
Studer Kontakt Backup
- Navn: AstraZeneca Lung Cancer Study Locator Service
- Telefonnummer: 1-884-432-3892
- E-post: az-lcsl@careboxhealth.com
Studiesteder
-
-
-
Ghent, Belgia, 9000
- Fullført
- Research Site
-
Ghent, Belgia, 9000
- Rekruttering
- Research Site
-
Roeselare, Belgia, 8800
- Rekruttering
- Research Site
-
-
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G 1Z2
- Fullført
- Research Site
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3E 0V9
- Rekruttering
- Research Site
-
-
Quebec
-
Montreal, Quebec, Canada, H2X 3E4
- Rekruttering
- Research Site
-
Montreal, Quebec, Canada, H2W 1S6
- Rekruttering
- Research Site
-
-
-
-
Arkansas
-
Little Rock, Arkansas, Forente stater, 72205
- Rekruttering
- Research Site
-
-
California
-
Los Angeles, California, Forente stater, 90095
- Rekruttering
- Research Site
-
Oakland, California, Forente stater, 94611
- Tilbaketrukket
- Research Site
-
-
Connecticut
-
New Haven, Connecticut, Forente stater, 06510
- Rekruttering
- Research Site
-
-
Florida
-
Stuart, Florida, Forente stater, 34994
- Fullført
- Research Site
-
-
Georgia
-
Gainesville, Georgia, Forente stater, 30501
- Tilbaketrukket
- Research Site
-
-
Illinois
-
Chicago, Illinois, Forente stater, 60637
- Rekruttering
- Research Site
-
-
Maryland
-
Baltimore, Maryland, Forente stater, 21231
- Rekruttering
- Research Site
-
Baltimore, Maryland, Forente stater, 21201
- Tilbaketrukket
- Research Site
-
-
Massachusetts
-
Boston, Massachusetts, Forente stater, 02215
- Rekruttering
- Research Site
-
-
Minnesota
-
Saint Louis Park, Minnesota, Forente stater, 55426
- Fullført
- Research Site
-
-
Nebraska
-
Omaha, Nebraska, Forente stater, 68124
- Rekruttering
- Research Site
-
-
New York
-
Buffalo, New York, Forente stater, 14263
- Tilbaketrukket
- Research Site
-
-
Ohio
-
Cleveland, Ohio, Forente stater, 44195
- Rekruttering
- Research Site
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Forente stater, 15212
- Rekruttering
- Research Site
-
-
Tennessee
-
Chattanooga, Tennessee, Forente stater, 37404
- Rekruttering
- Research Site
-
Memphis, Tennessee, Forente stater, 38120
- Rekruttering
- Research Site
-
Nashville, Tennessee, Forente stater, 37232
- Rekruttering
- Research Site
-
Nashville, Tennessee, Forente stater, 37203
- Rekruttering
- Research Site
-
Nashville, Tennessee, Forente stater, 37203
- Tilbaketrukket
- Research Site
-
-
Texas
-
Houston, Texas, Forente stater, 77030
- Rekruttering
- Research Site
-
Houston, Texas, Forente stater, 77090
- Avsluttet
- Research Site
-
-
Virginia
-
Fairfax, Virginia, Forente stater, 22031
- Rekruttering
- Research Site
-
-
Washington
-
Edmonds, Washington, Forente stater, 98026
- Rekruttering
- Research Site
-
Seattle, Washington, Forente stater, 98104
- Rekruttering
- Research Site
-
-
-
-
-
Avignon, Frankrike, 84902
- Rekruttering
- Research Site
-
Bobigny, Frankrike, 93009
- Tilbaketrukket
- Research Site
-
Bordeaux, Frankrike, 33076
- Rekruttering
- Research Site
-
Limoges, Frankrike, 83000
- Rekruttering
- Research Site
-
Rennes, Frankrike, 35000
- Rekruttering
- Research Site
-
Rouen, Frankrike, 76031
- Rekruttering
- Research Site
-
Suresnes, Frankrike, 92150
- Rekruttering
- Research Site
-
Toulon, Frankrike, 83000
- Aktiv, ikke rekrutterende
- Research Site
-
-
-
-
-
Dublin, Irland, D08 NHY1
- Rekruttering
- Research Site
-
Dublin, Irland, D07 R2WY
- Rekruttering
- Research Site
-
Dublin, Irland, D09 V2N0
- Rekruttering
- Research Site
-
Galway, Irland, H91 YR71
- Rekruttering
- Research Site
-
-
-
-
-
Aviano, Italia, 33081
- Rekruttering
- Research Site
-
Brescia, Italia, 25123
- Rekruttering
- Research Site
-
Catanzaro, Italia, 88100
- Tilbaketrukket
- Research Site
-
Florence, Italia, 50134
- Rekruttering
- Research Site
-
Genova, Italia, 16100
- Rekruttering
- Research Site
-
Meldola, Italia, 47014
- Rekruttering
- Research Site
-
Milan, Italia, 20162
- Rekruttering
- Research Site
-
Monza, Italia, 20900
- Rekruttering
- Research Site
-
Padova, Italia, 35128
- Rekruttering
- Research Site
-
Perugia, Italia, 06156
- Rekruttering
- Research Site
-
Pisa, Italia, 56124
- Rekruttering
- Research Site
-
Roma, Italia, 00144
- Rekruttering
- Research Site
-
Rozzano, Italia, 20089
- Rekruttering
- Research Site
-
-
-
-
-
Lisbon, Portugal, 1169-050
- Rekruttering
- Research Site
-
Lisbon, Portugal, 1099-023
- Rekruttering
- Research Site
-
Lisbon, Portugal, 1400-038
- Rekruttering
- Research Site
-
Lisbon, Portugal, 1500-650
- Rekruttering
- Research Site
-
Porto, Portugal, 4200-072
- Rekruttering
- Research Site
-
Porto, Portugal, 4099-001
- Tilbaketrukket
- Research Site
-
Porto, Portugal, 4100-180
- Fullført
- Research Site
-
-
-
-
-
A Coruña, Spania, 15006
- Rekruttering
- Research Site
-
Alicante, Spania, 03010
- Rekruttering
- Research Site
-
Barcelona, Spania, 08036
- Rekruttering
- Research Site
-
Barcelona, Spania, 8035
- Avsluttet
- Research Site
-
Córdoba, Spania, 14004
- Rekruttering
- Research Site
-
Madrid, Spania, 28040
- Rekruttering
- Research Site
-
Majadahonda, Spania, 28250
- Rekruttering
- Research Site
-
Málaga, Spania, 29010
- Rekruttering
- Research Site
-
Reus, Spania, 43204
- Rekruttering
- Research Site
-
Seville, Spania, 41009
- Rekruttering
- Research Site
-
Terrassa, Spania, 08221
- Rekruttering
- Research Site
-
Valencia, Spania, 46010
- Rekruttering
- Research Site
-
-
-
-
-
Busan, Sør -Korea, 48108
- Fullført
- Research Site
-
Chungcheongbuk-do, Sør -Korea, 28644
- Tilbaketrukket
- Research Site
-
Seongnam-si, Sør -Korea, 13496
- Rekruttering
- Research Site
-
Seoul, Sør -Korea, 03080
- Rekruttering
- Research Site
-
Seoul, Sør -Korea, 05505
- Rekruttering
- Research Site
-
Suwon, Sør -Korea, 16247
- Rekruttering
- Research Site
-
Suwon, Sør -Korea, 440-746
- Rekruttering
- Research Site
-
-
-
-
-
Liuying, Taiwan, 736
- Rekruttering
- Research Site
-
New Taipei City, Taiwan, 235
- Rekruttering
- Research Site
-
Tainan, Taiwan, 70403
- Rekruttering
- Research Site
-
Taipei, Taiwan, 10002
- Rekruttering
- Research Site
-
Taipei, Taiwan, 11217
- Rekruttering
- Research Site
-
-
-
-
-
Ankara, Tyrkia (Türkiye), 06800
- Rekruttering
- Research Site
-
Ankara, Tyrkia (Türkiye), 06010
- Rekruttering
- Research Site
-
Ankara, Tyrkia (Türkiye), 06500
- Rekruttering
- Research Site
-
Istanbul, Tyrkia (Türkiye), 34722
- Rekruttering
- Research Site
-
Izmir, Tyrkia (Türkiye), 35575
- Rekruttering
- Research Site
-
-
-
-
-
Kecskemét, Ungarn, 6000
- Rekruttering
- Research Site
-
Székesfehérvár, Ungarn, 8000
- Rekruttering
- Research Site
-
Tatabánya, Ungarn, 2800
- Fullført
- Research Site
-
Törökbálint, Ungarn, 2045
- Rekruttering
- Research Site
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Newly diagnosed NSCLC patients with resectable disease (Stage IIA to Stage IIIB).
- WHO or Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ and bone marrow function.
- Provision of tumour samples (newly acquired or archival tumour tissue [≤ 6 months old]) to confirm Programmed death-ligand 1 (PD-L1) status, epidermal growth factor receptor (EGFR), or anaplastic lymphoma kinase (ALK) status.
- Adequate pulmonary function.
Exclusion Criteria:
- Participants with sensitising EGFR mutations or ALK translocations.
- Participants with baseline PD-L1 expression status <1% (Arms 6 and 7 only).
- Active or prior documented autoimmune or inflammatory disorders.
- Uncontrolled intercurrent illness, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active bleeding diseases, serious chronic gastrointestinal conditions associated with diarrhoea, or psychiatric illness/social situations that would limit compliance with study requirement.
- History of another primary malignancy.
- Participants with small-cell lung cancer or mixed small-cell lung cancer.
- History of active primary immunodeficiency.
- History of non-infectious interstitial lung disease (ILD) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
- Participants who have preoperative radiotherapy treatment as part of their care plan.
- Participants who require or may require pneumonectomy, segmentectomies, or wedge resections, as assessed by their surgeon at baseline, to obtain potentially curative resection of primary tumour.
- QTcF (QT interval corrected by Fridericia's formula) interval ≥ 470 ms.
- Any medical contraindication to treatment with chemotherapy as listed in the local labelling.
- Participants with moderate or severe cardiovascular disease.
- Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment.
- Receipt of live attenuated vaccine within 30 days prior to the first dose of study interventions.
- Prior exposure to approved or investigational immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-TIGIT (T cell immunoreceptor with Ig and ITIM domains), anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies. Participants who received agents targeting the adenosine pathway, anti-NKG2A, anti-HLA-E agents, and anti-LIF agents are also excluded. Participants who have received previous treatment with a TROP2 targeting ADC or with another ADC containing a chemotherapy agent that inhibits TOP1 activity are also excluded.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of study interventions.
- Active or uncontrolled infections including HBA, HBV, HCV, and HIV.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Arm 1: Oleclumab + Durvalumab + Platinum doublet chemotherapy (CTX)
Participants will receive Durvalumab + Oleclumab + CTX as neoadjuvant treatment and Durvalumab + Oleclumab as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery: Carboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin |
Participants will receive Durvalumab via intravenous route.
Andre navn:
Participants will receive Oleclumab via intravenous route.
Andre navn:
Pemetrexed/Cisplatin as chemotherapy Pemetrexed/Carboplatin as chemotherapy Carboplatin/Paclitaxel, as chemotherapy |
|
Eksperimentell: Arm 2: Monalizumab + Durvalumab + CTX
Participants will receive Durvalumab + Monalizumab + CTX as neoadjuvant treatment and Durvalumab + Monalizumab as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery: Carboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin |
Participants will receive Durvalumab via intravenous route.
Andre navn:
Pemetrexed/Cisplatin as chemotherapy Pemetrexed/Carboplatin as chemotherapy Carboplatin/Paclitaxel, as chemotherapy Participants will receive Monalizumab via intravenous route.
Andre navn:
|
|
Eksperimentell: Arm 3: Volrustomig (Dose Exploration) + CTX
Participants will receive Volrustomig + CTX as neoadjuvant treatment and Volrustomig as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery: Carboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin |
Pemetrexed/Cisplatin as chemotherapy Pemetrexed/Carboplatin as chemotherapy Carboplatin/Paclitaxel, as chemotherapy Participants will receive Volrustomig via intravenous route.
Andre navn:
|
|
Eksperimentell: Arm 4: Dato-DXd + durvalumab + single agent platinum
Participants will receive Dato-DXd + durvalumab + single agent platinum as neoadjuvant treatment and durvalumab as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on physician choice of as part of their treatment regimen prior to surgery: Carboplatin or Cisplatin |
Participants will receive Durvalumab via intravenous route.
Andre navn:
Participants will receive datopotamab deruxtecan (Dato-DXd) via intravenous route. Carboplatin as chemotherapy Cisplatin as chemotherapy |
|
Eksperimentell: Arm 5: AZD0171 + durvalumab + CTX
Participants will receive AZD0171 + durvalumab + CTX as neoadjuvant treatment and AZD0171 + durvalumab as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery: Carboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin |
Participants will receive Durvalumab via intravenous route.
Andre navn:
Pemetrexed/Cisplatin as chemotherapy Pemetrexed/Carboplatin as chemotherapy Carboplatin/Paclitaxel, as chemotherapy Participants will receive AZD0171 via intravenous route. |
|
Eksperimentell: Arm 6: Rilvegostomig + CTX
Participants will receive Rilvegostomig + CTX as neoadjuvant treatment and Rilvegostomig as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery: Carboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin |
Pemetrexed/Cisplatin as chemotherapy Pemetrexed/Carboplatin as chemotherapy Carboplatin/Paclitaxel, as chemotherapy Participants will receive Rilvegostomig via intravenous route. |
|
Eksperimentell: Arm 7: Dato-DXd + Rilvegostomig + single agent platinum
Participants will receive Dato-DXd + Rilvegostomig + single agent platinum as neoadjuvant treatment and Rilvegostomig as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on physician choice of as part of their treatment regimen prior to surgery: Carboplatin or Cisplatin |
Participants will receive datopotamab deruxtecan (Dato-DXd) via intravenous route. Carboplatin as chemotherapy Cisplatin as chemotherapy Participants will receive Rilvegostomig via intravenous route. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Antall deltakere med patologisk fullstendig respons (pCR)
Tidsramme: Fra randomisering til ca. 15 uker etter første dose med studieintervensjoner
|
Fra randomisering til ca. 15 uker etter første dose med studieintervensjoner
|
|
Antall deltakere med bivirkninger (AE) og alvorlige bivirkninger (SAE)
Tidsramme: Inntil dag 90 etter siste dose med studieintervensjoner (opptil ca. 3 år)
|
Inntil dag 90 etter siste dose med studieintervensjoner (opptil ca. 3 år)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Antall deltakere som opplever et event-free survival (EFS) arrangement
Tidsramme: Opptil ca 3 år
|
Opptil ca 3 år
|
|
Antall deltakere som opplever en sykdomsfri overlevelseshendelse (DFS).
Tidsramme: Opptil ca 3 år
|
Opptil ca 3 år
|
|
Antall deltakere som har kirurgisk reseksjon
Tidsramme: Fra randomisering til ca. 15 uker etter første dose med studieintervensjoner
|
Fra randomisering til ca. 15 uker etter første dose med studieintervensjoner
|
|
Antall deltakere med stor patologisk respons (mPR)
Tidsramme: Fra randomisering til ca. 15 uker etter første dose med studieintervensjoner
|
Fra randomisering til ca. 15 uker etter første dose med studieintervensjoner
|
|
Antall deltakere med objektiv responsrate (ORR)
Tidsramme: Fra randomisering til ca. 15 uker etter første dose med studieintervensjoner
|
Fra randomisering til ca. 15 uker etter første dose med studieintervensjoner
|
|
Total overlevelse (OS)
Tidsramme: Opptil ca 3 år
|
Opptil ca 3 år
|
|
Antall deltakere med anti-studiemedikamentantistoffer (ADA)
Tidsramme: Fra randomisering til 3 måneder etter siste dose med studieintervensjoner (opptil ca. 3 år)
|
Fra randomisering til 3 måneder etter siste dose med studieintervensjoner (opptil ca. 3 år)
|
|
Baseline PD-L1 uttrykk
Tidsramme: Ved Screening/ baseline
|
Ved Screening/ baseline
|
|
Endringer i sirkulerende tumor-DNA (ctDNA)
Tidsramme: Fra randomisering til opptil 24 måneder etter siste dose med studieintervensjoner (opptil ca. 3 år)
|
Fra randomisering til opptil 24 måneder etter siste dose med studieintervensjoner (opptil ca. 3 år)
|
|
Serumkonsentrasjon av studieintervensjoner (Durvalumab/Oleclumab/Monalizumab/Volrustomig/Rilvegostomig)
Tidsramme: Fra randomisering til siste dose av studieintervensjoner (opptil ca. 3 år)
|
Fra randomisering til siste dose av studieintervensjoner (opptil ca. 3 år)
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Tina Cascone, MD, MD Anderson Cancer Center Houston, TX 77030
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter nettsted
- Neoplasmer
- Sykdommer i luftveiene
- Lungesykdommer
- Neoplasmer i luftveiene
- Thoracale neoplasmer
- Karsinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karsinom, ikke-småcellet lunge
- Aminosyrer, peptider og proteiner
- Organiske kjemikalier
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ringen
- Uorganiske kjemikalier
- Klorforbindelser
- Nitrogenforbindelser
- Koordinasjonskomplekser
- Guanin
- Hypoksantiner
- Purinoner
- Puriner
- Glutamater
- Aminosyrer, sure
- Aminosyrer
- Aminosyrer, dikarboksyl
- Platinumforbindelser
- Pemetrexed
- Karboplatin
- Cisplatin
- Durvalumab
- monalizumab
- CP -protokoll
Andre studie-ID-numre
- D9077C00001
- 2021-003369-37 (EudraCT-nummer)
- 2023-508852-21-00 (Registeridentifikator: CTIS)
- 2023 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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 Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
IPD-delingstidsramme
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Tilgangskriterier for IPD-deling
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .