Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Durvalumab vs placebo med stereootaktisk kroppsstrålebehandling i tidlig stadium uoperert ikke-småcellet lungekreft (NSCLC) pasienter / Osimertinib etter SBRT hos pasienter med tidlig stadium uoperert NSCLC som har en EGFR-mutasjon (PACIFIC-4)

6. november 2026 oppdatert av: AstraZeneca

En fase III, randomisert, placebokontrollert, dobbeltblind, multisenter, internasjonal studie av Durvalumab med stereootaktisk kroppsstrålebehandling (SBRT) for behandling av pasienter med uoperert stadium I/II, lymfeknute-negativ ikke-småcellet Lungekreft (PACIFIC-4/RTOG-3515) Osimertinib etter SBRT, en enkeltarmskohort for pasienter med uoperert stadium I/II, lymfeknute-negativ NSCLC med en sensibiliserende EGFR-mutasjon

This is a Phase III, randomized, placebo-controlled, double-blind, multi-center study assessing the efficacy and safety of durvalumab with SoC SBRT versus placebo with SoC SBRT in patients with unresected clinical Stage I/II lymph node-negative (T1 to T3N0M0) NSCLC.

An additional cohort will assess Osimertinib following SBRT in patients with early stage unresected T1 to T3N0M0 NSCLC harbouring an EGFR mutation.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Patients with Stage I/II lymph node negative NSCLC and confirmed to meet all eligibility criteria will be randomized 1:1 to receive either Durvalumab + SoC SBRT or placebo + SoC SBRT.

The primary objective of main cohort is to assess the efficacy of Durvalumab with SoC SBRT compared to placebo with SoC SBRT in terms of PFS. Key secondary is to assess the efficacy of Durvalumab with SoC SBRT compared to placebo with SoC SBRT in terms of Overall Survival (OS).

In addition, a study cohort with a sufficient number of patients harboring an EGFR-TKI sensitizing mutation, will receive Osimertinib treatment after completion of SoC SBRT as definitive treatment of Stage I/II lymph node-negative NSCLC. The primary objective of Osimertinib cohort is to assess efficacy of Osimertinib following SoC SBRT in terms of 4-year PFS. Key secondary objectives include safety, OS and efficacy of Osimertininb treatment with SBRT.

Studietype

Intervensjonell

Registrering (Faktiske)

724

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Australia
      • Clayton, Australia, 3168
        • Research Site
  • Belgia
      • Aalst, Belgia, 9300
        • Research Site
      • Charleroi, Belgia, 6060
        • Research Site
      • Edegem, Belgia, 2650
        • Research Site
      • Ghent, Belgia, 9000
        • Research Site
      • Leuven, Belgia, 3000
        • Research Site
  • Brasil
      • Barretos, Brasil, 14784-400
        • Research Site
      • Porto Alegre, Brasil, 90110-270
        • Research Site
      • Recife, Brasil, 52010-075
        • Research Site
      • Rio de Janeiro, Brasil, 22271-110
        • Research Site
      • São Paulo, Brasil, 01327-001
        • Research Site
      • Volta Redonda, Brasil, 27258-000
        • Research Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Research Site
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Research Site
      • Toronto, Ontario, Canada, M5G 2M9
        • Research Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H2X 3E4
        • Research Site
  • Forente stater
    • Alabama
      • Tuscaloosa, Alabama, Forente stater, 35401
        • Research Site
    • Arizona
      • Chandler, Arizona, Forente stater, 85224
        • Research Site
      • Phoenix, Arizona, Forente stater, 85004
        • Research Site
      • Tucson, Arizona, Forente stater, 85719
        • Research Site
    • California
      • Duarte, California, Forente stater, 91010
        • Research Site
      • Long Beach, California, Forente stater, 90806
        • Research Site
      • Los Angeles, California, Forente stater, 90095
        • Research Site
      • San Diego, California, Forente stater, 92123
        • Research Site
    • Delaware
      • Newark, Delaware, Forente stater, 10709
        • Research Site
    • District of Columbia
      • Washington D.C., District of Columbia, Forente stater, 20010
        • Research Site
    • Florida
      • Bay Pines, Florida, Forente stater, 33744
        • Research Site
      • Jacksonville, Florida, Forente stater, 32256
        • Research Site
      • Miami Beach, Florida, Forente stater, 33140
        • Research Site
      • Orlando, Florida, Forente stater, 32804
        • Research Site
    • Georgia
      • Atlanta, Georgia, Forente stater, 30322
        • Research Site
      • Atlanta, Georgia, Forente stater, 30342
        • Research Site
    • Illinois
      • Chicago, Illinois, Forente stater, 60612
        • Research Site
      • Chicago, Illinois, Forente stater, 60637
        • Research Site
      • Chicago, Illinois, Forente stater, 60611
        • Research Site
      • Decatur, Illinois, Forente stater, 62526
        • Research Site
      • Elmhurst, Illinois, Forente stater, 60126
        • Research Site
      • Naperville, Illinois, Forente stater, 60540
        • Research Site
    • Indiana
      • Fort Wayne, Indiana, Forente stater, 46845
        • Research Site
    • Iowa
      • Cedar Rapids, Iowa, Forente stater, 52403
        • Research Site
      • Iowa City, Iowa, Forente stater, 52242
        • Research Site
    • Kentucky
      • Elizabethtown, Kentucky, Forente stater, 42701
        • Research Site
      • Lexington, Kentucky, Forente stater, 40503
        • Research Site
      • Louisville, Kentucky, Forente stater, 40202
        • Research Site
    • Louisiana
      • Metairie, Louisiana, Forente stater, 70006
        • Research Site
      • New Orleans, Louisiana, Forente stater, 70121
        • Research Site
    • Maine
      • South Portland, Maine, Forente stater, 04106
        • Research Site
    • Maryland
      • Annapolis, Maryland, Forente stater, 21401
        • Research Site
      • Baltimore, Maryland, Forente stater, 21201
        • Research Site
      • Rosedale, Maryland, Forente stater, 21237
        • Research Site
      • Silver Spring, Maryland, Forente stater, 20910
        • Research Site
      • Towson, Maryland, Forente stater, 21204
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02215
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48197
        • Research Site
      • Detroit, Michigan, Forente stater, 48201
        • Research Site
      • Royal Oak, Michigan, Forente stater, 48073
        • Research Site
    • Minnesota
      • Duluth, Minnesota, Forente stater, 55805
        • Research Site
      • Rochester, Minnesota, Forente stater, 55905
        • Research Site
    • Missouri
      • St Louis, Missouri, Forente stater, 63110
        • Research Site
    • Nebraska
      • Omaha, Nebraska, Forente stater, 68105
        • Research Site
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89169
        • Research Site
    • New Hampshire
      • Lebanon, New Hampshire, Forente stater, 03756
        • Research Site
    • New Jersey
      • Camden, New Jersey, Forente stater, 08103
        • Research Site
      • Paramus, New Jersey, Forente stater, 07652
        • Research Site
    • New York
      • Albany, New York, Forente stater, 12206
        • Research Site
      • East Syracuse, New York, Forente stater, 13057
        • Research Site
      • New Hyde Park, New York, Forente stater, 11042
        • Research Site
      • New York, New York, Forente stater, 10016
        • Research Site
      • Rochester, New York, Forente stater, 14642
        • Research Site
      • Stony Brook, New York, Forente stater, 11794
        • Research Site
      • Syracuse, New York, Forente stater, 13210
        • Research Site
      • The Bronx, New York, Forente stater, 10461
        • Research Site
      • The Bronx, New York, Forente stater, 10467
        • Research Site
    • North Carolina
      • Winston-Salem, North Carolina, Forente stater, 27157
        • Research Site
    • North Dakota
      • Grand Forks, North Dakota, Forente stater, 58201
        • Research Site
    • Ohio
      • Akron, Ohio, Forente stater, 44304
        • Research Site
      • Blue Ash, Ohio, Forente stater, 45242
        • Research Site
      • Cincinnati, Ohio, Forente stater, 45219
        • Research Site
      • Cleveland, Ohio, Forente stater, 44106
        • Research Site
    • Oregon
      • Portland, Oregon, Forente stater, 97213
        • Research Site
      • Portland, Oregon, Forente stater, 97210
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • Research Site
      • Pittsburgh, Pennsylvania, Forente stater, 15212
        • Research Site
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29425
        • Research Site
    • South Dakota
      • Sioux Falls, South Dakota, Forente stater, 57105
        • Research Site
      • Watertown, South Dakota, Forente stater, 57201
        • Research Site
    • Texas
      • Austin, Texas, Forente stater, 78745
        • Research Site
      • Dallas, Texas, Forente stater, 75235
        • Research Site
      • Houston, Texas, Forente stater, 77030
        • Research Site
      • Sherman, Texas, Forente stater, 75090
        • Research Site
    • Vermont
      • Burlington, Vermont, Forente stater, 05401
        • Research Site
    • Virginia
      • Richmond, Virginia, Forente stater, 23249
        • Research Site
    • Washington
      • Bellingham, Washington, Forente stater, 98225
        • Research Site
      • Seattle, Washington, Forente stater, 98195
        • Research Site
      • Spokane Valley, Washington, Forente stater, 99216
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, Forente stater, 53226
        • Research Site
  • Frankrike
      • Bron, Frankrike, 69677
        • Research Site
      • Dijon, Frankrike, 21079
        • Research Site
      • Lyon, Frankrike, 69317
        • Research Site
      • Nantes, Frankrike, 44202
        • Research Site
      • Pierre-Bénite, Frankrike, 69310
        • Research Site
      • Toulouse, Frankrike, 31000
        • Research Site
      • Villejuif, Frankrike, 94805
        • Research Site
  • Hellas
      • Athens, Hellas, 11527
        • Research Site
      • Athens, Hellas, 11526
        • Research Site
      • Thessaloniki, Hellas, 55236
        • Research Site
  • Israel
      • Haifa, Israel, 31096
        • Research Site
      • Jerusalem, Israel, 91120
        • Research Site
      • Kfar Saba, Israel, 95847
        • Research Site
      • Petah Tikva, Israel, 49100
        • Research Site
      • Ramat Gan, Israel, 52621
        • Research Site
      • Tel Aviv, Israel, 64239
        • Research Site
  • Italia
      • Florence, Italia, 50134
        • Research Site
      • Genova, Italia, 16132
        • Research Site
      • Milan, Italia, 20132
        • Research Site
      • Orbassano, Italia, 10043
        • Research Site
      • Padova, Italia, 35128
        • Research Site
      • Pavia, Italia, 27100
        • Research Site
      • Roma, Italia, 00128
        • Research Site
      • Rozzano, Italia, 20089
        • Research Site
  • Japan
      • Akashi-shi, Japan, 673-8558
        • Research Site
      • Bunkyō City, Japan, 113-8677
        • Research Site
      • Chūōku, Japan, 104-0045
        • Research Site
      • Fukuoka, Japan, 812-8582
        • Research Site
      • Hirosaki-shi, Japan, 036-8563
        • Research Site
      • Hiroshima, Japan, 734-8551
        • Research Site
      • Kobe, Japan, 650-0047
        • Research Site
      • Niigata, Japan, 951-8566
        • Research Site
      • Osaka, Japan, 541-8567
        • Research Site
      • Sakaishi, Japan, 591-8555
        • Research Site
      • Sapporo, Japan, 060-8648
        • Research Site
      • Sunto-gun, Japan, 411-8777
        • Research Site
      • Toyoake-shi, Japan, 470-1192
        • Research Site
      • Yokohama, Japan, 241-8515
        • Research Site
  • Kina
      • Beijing, Kina, 100142
        • Research Site
      • Beijing, Kina, 100021
        • Research Site
      • Changchun, Kina, 130021
        • Research Site
      • Changsha, Kina, 410013
        • Research Site
      • Chengdu, Kina, 610042
        • Research Site
      • Fuzhou, Kina, 350005
        • Research Site
      • Hangzhou, Kina, 310022
        • Research Site
      • Hangzhou, Kina, 310002
        • Research Site
      • Hefei, Kina, 230031
        • Research Site
      • Jinan, Kina, 250117
        • Research Site
      • Nanjing, Kina, 210009
        • Research Site
      • Shanghai, Kina, 200032
        • Research Site
      • Shanghai, Kina, 200433
        • Research Site
      • Shanghai, Kina, 200030
        • Research Site
      • Shanghai, Kina, 200002
        • Research Site
      • Shenyang, Kina, 100003
        • Research Site
      • Suzhou, Kina, 215006
        • Research Site
      • Wenzhou, Kina, 325000
        • Research Site
      • Wuhan, Kina, 430022
        • Research Site
      • Wuhan, Kina, 430030
        • Research Site
      • Zhengzhou, Kina, 450008
        • Research Site
  • Nederland
      • Amsterdam, Nederland, 1081 HV
        • Research Site
      • Groningen, Nederland, 9713 GZ
        • Research Site
      • Utrecht, Nederland, 3584 CX
        • Research Site
  • Polen
      • Bydgoszcz, Polen, 85-796
        • Research Site
      • Elblag, Polen, 02-300
        • Research Site
      • Gdansk, Polen, 80-952
        • Research Site
      • Katowice, Polen, 40-514
        • Research Site
      • Lodz, Polen, 93-513
        • Research Site
      • Warsaw, Polen, 02-781
        • Research Site
  • Puerto Rico
      • Hato Rey, Puerto Rico, 00917
        • Research Site
  • Russland
      • Kazan, Tatarstan, Russland, 420029
        • Research Site
      • Moscow, Russland, 115478
        • Research Site
      • Moscow, Russland, 105229
        • Research Site
      • Moscow, Russland, 119421
        • Research Site
      • Saint Petersburg, Russland, 197758
        • Research Site
      • Ufa, Russland, 450054
        • Research Site
      • Yekaterinburg, Russland, 620905
        • Research Site
  • Spania
      • Badajoz, Spania, 6006
        • Research Site
      • Barcelona, Spania, 08041
        • Research Site
      • L'Hospitalet de Llobregat, Spania, 08907
        • Research Site
      • Madrid, Spania, 28034
        • Research Site
      • Madrid, Spania, 28046
        • Research Site
      • Madrid, Spania, 28041
        • Research Site
      • Madrid, Spania, 28040
        • Research Site
      • Málaga, Spania, 29010
        • Research Site
      • San Sebastián, Spania, 20014
        • Research Site
      • Santiago de Compostela, Spania, 15706
        • Research Site
      • Seville, Spania, 41013
        • Research Site
      • Valencia, Spania, 46010
        • Research Site
      • Zaragoza, Spania, 50009
        • Research Site
  • Storbritannia
      • Birmingham, Storbritannia, B9 5SS
        • Research Site
      • Leeds, Storbritannia, LS9 7TF
        • Research Site
      • London, Storbritannia, EC1A 7BE
        • Research Site
      • Manchester, Storbritannia, M20 4BX
        • Research Site
  • Sør -Korea
      • Cheongju-si, Sør -Korea, 28644
        • Research Site
      • Goyang-si, Sør -Korea, 10408
        • Research Site
      • Gyeonggi-do, Sør -Korea, 13620
        • Research Site
      • Seoul, Sør -Korea, 03722
        • Research Site
      • Seoul, Sør -Korea, 05505
        • Research Site
      • Seoul, Sør -Korea, 06351
        • Research Site
  • Tyrkia (Türkiye)
      • Ankara, Tyrkia (Türkiye), 06520
        • Research Site
      • Ankara, Tyrkia (Türkiye), 06010
        • Research Site
      • Istanbul, Tyrkia (Türkiye), 34214
        • Research Site
      • Izmir, Tyrkia (Türkiye), 35340
        • Research Site
      • Kocaeli, Tyrkia (Türkiye), 41400
        • Research Site
  • Tyskland
      • Dresden, Tyskland, 01307
        • Research Site
      • Göttingen, Tyskland, 37075
        • Research Site
      • Halle, Tyskland, 06120
        • Research Site
      • Hanover, Tyskland, 30459
        • Research Site
      • Heidelberg, Tyskland, 69126
        • Research Site
      • Homburg, Tyskland, 66424
        • Research Site
      • Regensburg, Tyskland, 93053
        • Research Site
      • Trier, Tyskland, 54292
        • Research Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 130 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Main Cohort Key Inclusion Criteria:

  1. Age ≥18 years
  2. Planned SoC SBRT as definitive treatment
  3. World Health Organization (WHO)/ECOG PS of 0, 1 or 2
  4. Life expectancy of at least 12 weeks
  5. Body weight >30 kg
  6. Submission of tumor tissue sample if available
  7. Adequate organ and marrow function required
  8. Patients with central or peripheral lesions are eligible
  9. Staging studies must be done during screening (PET-CT within 10 weeks)
  10. Patients with a history of metachronous NSCLC and synchronous lesions are eligible with some exceptions

Main Cohort Key Exclusion Criteria:

  1. Mixed small cell and non-small cell cancer
  2. History of allogeneic organ transplantation
  3. History of another primary malignancy with exceptions
  4. History of active primary immunodeficiency
  5. Epidermal growth factor receptor local testing is strongly recommended prior to enrollment. Patients with a tumor harboring an EGFRm per local testing will be excluded from the main cohort
  6. Prior exposure to immune-mediated therapy with exceptions

Osimertinib Cohort Key Inclusion Criteria

  1. Age ≥18 years
  2. Planned SoC SBRT as definitive treatment
  3. WHO/ECOG PS of 0, 1, or 2
  4. Patients with central or peripheral lesions are eligible
  5. Patients with a history of metachronous NSCLC and synchronous lesions are eligible with some exceptions
  6. Staging studies must be done during screening (PET-CT within 10 weeks)
  7. Submission of tumor tissue sample if available
  8. Confirmation by local laboratory that the tumor harbors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R)
  9. Adequate bone marrow reserve or organ function required
  10. Female patients should be using highly effective contraceptive measures
  11. Male patients should be asked to use barrier contraceptives (ie, condoms) during sex with all partners during the trial and avoid procreation

Osimertinib Cohort Key Exclusion Criteria

  1. Mixed small cell and non-small cell cancer

  2. Patients with known or increased risk factor for QTc prolongation

  3. Treatment with any of the following:

    • Preoperative or adjuvant platinum-based or other chemotherapy for the disease under investigation
    • Prior treatment with neoadjuvant or adjuvant EGFR TKI
    • Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4

  4. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib

  5. Any of the following cardiac criteria

    • Mean resting corrected QT interval >470 msec, obtained from 3 ECGs
    • Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG.
    • Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, or unexplained -sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval
    • Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: SoC SBRT + Durvalumab Therapy (Main Cohort)

SBRT

Durvalumab (PD-L1 monoclonal antibody) 1500 mg every 4 weeks [q4w] intravenously [iv] for up to 26 cycles or until progression or other discontinuation criteria are met.
Legemiddel: Durvalumab

Durvalumab 1500 mg every 4 weeks [q4w] intravenously [iv] for up to 26 cycles or until progression or other discontinuation criteria are met.

Andre navn:
  • MEDI4736
Placebo komparator: SoC SBRT + Placebo Therapy (Main Cohort)

SBRT

Placebo (matching placebo for infusion) every 4 weeks iv for up to 26 cycles or until progression or other discontinuation criteria are met.
Annen: Placebo

Matching placebo for infusion every 4 weeks iv for up to 26 cycles or until progression or other discontinuation criteria are met.
Eksperimentell: SoC SBRT + Osimertinib Therapy (Osimertinib cohort, single-arm, open-label separate cohort)

SBRT

Osimertinib 80mg every day [qd] for oral administration up to 36 months or until progression. Osimertinib treatment should start within 7 to 14 days after completion of SBRT
Legemiddel: (Osimertinib cohort, single-arm, open-label separate cohort)

Osimertinib 80 mg every day [qd] orally for up to 36 months or until progression or other discontinuation criteria are met. Osimertinib treatment should start from 7 to 14 days after completion of SBRT

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1 in subpopulation of patients with Stage I/II NSCLC
Tidsramme: from randomization up to 6 years

Main Cohort
from randomization up to 6 years
4-year Progression-Free Survival (4y-PFS) by ICR according to RECIST 1.1 criteria
Tidsramme: from treatment start up to 5 years

Osimertinib Cohort
from treatment start up to 5 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression-Free Survival (PFS) assessed by BICR per RECIST 1.1 in all randomised patients with Stage I/II NSCLC
Tidsramme: from randomization up to 6 years

Main Cohort
from randomization up to 6 years
Overall Survival (OS)
Tidsramme: from randomization up to 7 years

Main Cohort
from randomization up to 7 years
Concentration of durvalumab in serum such as peak concentration and trough
Tidsramme: 12 weeks after last dose

Main Cohort
12 weeks after last dose
Detection of ADA neutralising antibodies titers
Tidsramme: up to 6 months after last dose

Main Cohort
up to 6 months after last dose
Health-related quality of life in patients treated with durvalumab with SoC SBRT compared to placebo with SoC SBRT using the EORTC QLQ-C30
Tidsramme: from randomization up to 7 years

Main Cohort
from randomization up to 7 years
Proportion of patients alive and progression free at 24 months from randomisation (PFS24) assessed by BICR according to RECIST 1.1
Tidsramme: at 24 months following randomization

Main Cohort
at 24 months following randomization
Time to progression (TTP) assessed by BICR according to RECIST 1.1
Tidsramme: from randomization up to 6 years

Main Cohort
from randomization up to 6 years
Time to death or distant metastasis (TTDM) assessed by BICR according to RECIST 1.1
Tidsramme: from randomization up to 6 years

Main Cohort
from randomization up to 6 years
Time from randomisation to second progression (PFS2) as defined by local standard clinical practice
Tidsramme: from randomization up to 7 years

Main Cohort
from randomization up to 7 years
Assessment of AEs by CTCAE v 5.0 as measures of the safety and tolerability of Durvalumab with SoC SBRT compared to placebo with SoC SBRT
Tidsramme: up to 3 months after last dose

Main Cohort
up to 3 months after last dose
Assessment of AEs by CTCAE v 5.0 as measures of the safety, tolerability and compliance of osimertinib with SoC SBRT therapy
Tidsramme: Up to 35 days after last dose

Osimertinib Cohort
Up to 35 days after last dose
WHO performance status
Tidsramme: from treatment start up to 5 years

Osimertinib Cohort
from treatment start up to 5 years
ECG QT interval
Tidsramme: Up to 156 weeks of treatment or treatment discontinuation

Osimertinib Cohort
Up to 156 weeks of treatment or treatment discontinuation
Overall Survival
Tidsramme: from treatment start up to 5 years

Osimertinib Cohort
from treatment start up to 5 years
Time To Progression (TTP)
Tidsramme: from treatment start up to 5 years

Osimertinib Cohort
from treatment start up to 5 years
Time to CNS progression
Tidsramme: from treatment start up to 5 years

Osimertinib Cohort
from treatment start up to 5 years
PFS2
Tidsramme: from treatment start up to 5 years

Osimertinib Cohort
from treatment start up to 5 years
Site(s) of disease progression
Tidsramme: from treatment start up to 5 years

Osimertinib Cohort
from treatment start up to 5 years
PFS by ICR using RECIST 1.1
Tidsramme: from treatment start up to 5 years

Osimertinib Cohort
from treatment start up to 5 years

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Lung cancer mortality
Tidsramme: from treatment start up to 5 years

Osimertinib Cohort
from treatment start up to 5 years
Lung Cancer Mortality
Tidsramme: from randomization Up to 5 years

Main Cohort
from randomization Up to 5 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

AstraZeneca

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

6. mars 2019

Primær fullføring (Antatt)

31. oktober 2028

Studiet fullført (Antatt)

31. oktober 2028

Datoer for studieregistrering

Først innsendt

25. januar 2019

Først innsendt som oppfylte QC-kriteriene

5. februar 2019

Først lagt ut (Faktiske)

6. februar 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • D9103C00001
  • 2018 (U.S. NIH-stipend/kontrakt)
  • 2018-002572-41 (EudraCT-nummer)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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.

Tilgangskriterier for IPD-deling

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 Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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. .

Abonnere