A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC (PACIFIC-8)

August 26, 2026 updated by: AstraZeneca

A Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre, International Study of Durvalumab Plus Domvanalimab(AB154) in Participants With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer Whose Disease Has Not Progressed Following Definitive Platinum-based Concurrent Chemoradiation Therapy

This is a Phase III, randomised, double-blind, placebo-controlled, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) and domvanalimab (AB154) compared with durvalumab plus placebo in adults with locally advanced (Stage III), unresectable NSCLC whose disease has not progressed following definitive platinum-based cCRT.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

791

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1160
        • Research Site
      • Edegem, Belgium, 2650
        • Research Site
      • Haine-Saint-Paul, Belgium, 7100
        • Research Site
      • Leuven, Belgium, 3000
        • Research Site
      • Liège, Belgium, 4000
        • Research Site
      • Sint-Niklaas, Belgium, 9100
        • Research Site
  • Brazil
      • Barretos, Brazil, 14784-400
        • Research Site
      • Londrina, Brazil, 86015-520
        • Research Site
      • Porto Alegre, Brazil, 91350200
        • Research Site
      • Porto Velho, Brazil, 76834-899
        • Research Site
      • Rio de Janeiro, Brazil, 20231-050
        • Research Site
      • Santo André, Brazil, 09060-650
        • Research Site
      • São Paulo, Brazil, 01221-900
        • Research Site
      • Taubaté, Brazil, 12030-200
        • Research Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Research Site
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • Research Site
    • Quebec
      • Laval, Quebec, Canada, H7M 3L9
        • Research Site
      • Montreal, Quebec, Canada, H4A 3J1
        • Research Site
  • Chile
      • Las Condes, Chile, 7560908
        • Research Site
      • Port Montt, Chile, 5500243
        • Research Site
      • Santiago, Chile, 7500713
        • Research Site
      • Santiago, Chile, 7630370
        • Research Site
      • Santiago, Chile, 8241479
        • Research Site
      • Santiago, Chile, 7520426
        • Research Site
      • Temuco, Chile, 4810218
        • Research Site
  • France
      • Aix-en-Provence, France, 13616
        • Research Site
      • Angers, France, 49055
        • Research Site
      • Bobigny, France, 93000
        • Research Site
      • Lille, France, 59000
        • Research Site
      • Paris, France, 75014
        • Research Site
      • Pau, France, 6400
        • Research Site
      • Quimper, France, 29000
        • Research Site
      • Saint-Grégoire, France, 35760
        • Research Site
      • Saint-Quentin, France, 02321
        • Research Site
      • Vantoux, France, 57070
        • Research Site
      • Villeurbanne, France, 69100
        • Research Site
  • Germany
      • Berlin, Germany, 12351
        • Research Site
      • Berlin-Zehlendorf, Germany, 14165
        • Research Site
      • Braunschweig, Germany, 38114
        • Research Site
      • Chemnitz, Germany, 09116
        • Research Site
      • Cologne, Germany, 51109
        • Research Site
      • Erlangen, Germany, 91054
        • Research Site
      • Essen, Germany, 45147
        • Research Site
      • Giessen, Germany, 35392
        • Research Site
      • Halle, Germany, 06120
        • Research Site
      • Koblenz, Germany, 56073
        • Research Site
      • Krefeld, Germany, 47805
        • Research Site
      • Löwenstein, Germany, 74245
        • Research Site
      • Moers, Germany, 47441
        • Research Site
      • Regensburg, Germany, 93053
        • Research Site
      • Regensburg, Germany, 93049
        • Research Site
      • Tübingen, Germany, 72076
        • Research Site
  • Greece
      • Athens, Greece, 11527
        • Research Site
      • Athens, Greece, 18547
        • Research Site
      • Athens, Greece, 12462
        • Research Site
      • Athens, Greece, 11526
        • Research Site
      • Holargos, Athens, Greece, 155 62
        • Research Site
      • Thessaloniki, Greece, 56 429
        • Research Site
      • Thessaloniki, Greece, 57001
        • Research Site
      • Thessaloniki, Greece, 55236
        • Research Site
  • Hong Kong
      • Hong Kong, Hong Kong, 150001
        • Research Site
  • Hungary
      • Budapest, Hungary, 1121
        • Research Site
      • Budapest, Hungary, 1122
        • Research Site
      • Deszk, Hungary, 6772
        • Research Site
      • Győr, Hungary, 9024
        • Research Site
      • Salgótarján, Hungary, 3100
        • Research Site
      • Székesfehérvár, Hungary, 8000
        • Research Site
      • Törökbálint, Hungary, 2045
        • Research Site
  • India
      • Ahmedabad, India, 380054
        • Research Site
      • Bangalore, India, 560027
        • Research Site
      • Bangalore, India, 560064
        • Research Site
      • Delhi, India, 110085
        • Research Site
      • Howrah, India, 711103
        • Research Site
      • Hyderabad, India, 500032
        • Research Site
      • Jaipur, India, 302004
        • Research Site
      • Jaipur, India, 302022
        • Research Site
      • Kolkata, India, 700160
        • Research Site
      • Marg Jaipur, India, 302004
        • Research Site
      • Mohali, India, 160055
        • Research Site
      • Namakkal, India, 637001
        • Research Site
      • New Delhi, India, 110029
        • Research Site
      • New Delhi, India, 110005
        • Research Site
      • Varanasi, India, 221005
        • Research Site
  • Italy
      • Bergamo, Italy, 24127
        • Research Site
      • Roma, Italy, 00144
        • Research Site
      • Rozzano, Italy, 20089
        • Research Site
  • Japan
      • Bunkyō City, Japan, 113-8431
        • Research Site
      • Bunkyō City, Japan, 113-8603
        • Research Site
      • Bunkyō City, Japan, 113-8677
        • Research Site
      • Chiba, Japan, 260-8717
        • Research Site
      • Fukuoka, Japan, 812-8582
        • Research Site
      • Hidaka-shi, Japan, 350-1298
        • Research Site
      • Hirosaki-shi, Japan, 036-8563
        • Research Site
      • Itabashi-ku, Japan, 173-0003
        • Research Site
      • Kashihara-shi, Japan, 634-8522
        • Research Site
      • Kumamoto, Japan, 860-8556
        • Research Site
      • Kōtoku, Japan, 135-8550
        • Research Site
      • Matsuyama, Japan, 791-0280
        • Research Site
      • Nagoya, Japan, 464-8681
        • Research Site
      • Osaka, Japan, 545-8586
        • Research Site
      • Osakasayama-shi, Japan, 589-8511
        • Research Site
      • Sapporo, Japan, 003-0804
        • Research Site
      • Sunto-gun, Japan, 411-8777
        • Research Site
      • Tokyo, Japan, 104-0045
        • Research Site
      • Yokohama, Japan, 241-8515
        • Research Site
      • Yokohama, Japan, 221-0855
        • Research Site
  • Malaysia
      • Johor Bahru, Malaysia, 81100
        • Research Site
      • Kuala Lumpur, Malaysia, 59100
        • Research Site
      • Kuala Selangor, Malaysia, 46050
        • Research Site
      • Kuching, Malaysia, 93586
        • Research Site
  • Mexico
      • Chihuahua City, Mexico, 31207
        • Research Site
      • Guadalajara, Mexico, 44638
        • Research Site
      • Mexico City, Mexico, 03810
        • Research Site
      • Oaxaca City, Mexico, 68020
        • Research Site
  • Norway
      • Bodø, Norway, 8092
        • Research Site
      • Gjøvik, Norway, 2819
        • Research Site
      • Oslo, Norway, 0379
        • Research Site
      • Trondheim, Norway, 0730
        • Research Site
  • Philippines
      • City of Muntinlupa, Philippines, 1780
        • Research Site
      • Iloilo City, Philippines, 5000
        • Research Site
      • Quezon City, Philippines, 1112
        • Research Site
      • Quezon City, Philippines, 1100
        • Research Site
  • Poland
      • Bialystok, Poland, 15-027
        • Research Site
      • Gliwice, Poland, 44-102
        • Research Site
      • Katowice, Poland, 40-074
        • Research Site
      • Lodz, Poland, 93-513
        • Research Site
      • Warsaw, Poland, 02-781
        • Research Site
      • Wroclaw, Poland, 53-413
        • Research Site
  • Romania
      • Bucharest, Romania, 050098
        • Research Site
      • Bucharest, Romania, 022328
        • Research Site
      • Craiova, Romania, 200542
        • Research Site
      • Floreşti, Romania
        • Research Site
      • Iași, Romania, 700483
        • Research Site
      • Oradea, Romania, 410001
        • Research Site
      • Sibiu, Romania, 550245
        • Research Site
      • Suceava, Romania, 720214
        • Research Site
  • South Africa
      • Parktown, South Africa, 2193
        • Research Site
      • Pretoria, South Africa, 0084
        • Research Site
      • eManzimtoti, South Africa, 4126
        • Research Site
  • South Korea
      • Daegu, South Korea, 42415
        • Research Site
      • Goyang-si, South Korea, 10408
        • Research Site
      • Incheon, South Korea, 21565
        • Research Site
      • Incheon, South Korea, 21431
        • Research Site
      • Jinju, South Korea, 52727
        • Research Site
      • Seoul, South Korea, 03722
        • Research Site
      • Seoul, South Korea, 06273
        • Research Site
      • Seoul, South Korea, 06351
        • Research Site
      • Seoul, South Korea, 07061
        • Research Site
      • Suwon, South Korea, 16247
        • Research Site
  • Spain
      • Bilbao (Vizcaya), Spain, 48013
        • Research Site
      • Castellon, Spain, 12002
        • Research Site
      • Córdoba, Spain, 14004
        • Research Site
      • El Palmar, Spain, 30120
        • Research Site
      • Palma de Mallorca, Spain, 07010
        • Research Site
      • Sabadell (Barcelona), Spain, 08208
        • Research Site
  • Switzerland
      • Basel, Switzerland, 4031
        • Research Site
      • Bern, Switzerland, CH-3010
        • Research Site
      • Lausanne, Switzerland, 1011
        • Research Site
  • Taiwan
      • Hsinchu, Taiwan, 300
        • Research Site
      • New Taipei City, Taiwan, 220216
        • Research Site
      • Taichung, Taiwan, 40705
        • Research Site
      • Taichung, Taiwan, 40447
        • Research Site
      • Tainan, Taiwan, 704
        • Research Site
      • Taipei, Taiwan, 10002
        • Research Site
      • Taipei, Taiwan, 10449
        • Research Site
      • Taipei, Taiwan, 11217
        • Research Site
      • Taoyuan, Taiwan, 333
        • Research Site
  • Thailand
      • Bangkok, Thailand, 10300
        • Research Site
      • Bangkok, Thailand, 10400
        • Research Site
      • Bangkok, Thailand, 10700
        • Research Site
      • Hat Yai, Thailand, 90110
        • Research Site
  • Turkey (Türkiye)
      • Adapazarı, Turkey (Türkiye), 54290
        • Research Site
      • Ankara, Turkey (Türkiye), 06340
        • Research Site
      • Ankara, Turkey (Türkiye), 6100
        • Research Site
      • Antalya, Turkey (Türkiye), 07058
        • Research Site
      • Edirne, Turkey (Türkiye), 22030
        • Research Site
      • Istanbul, Turkey (Türkiye), 34098
        • Research Site
      • Istanbul, Turkey (Türkiye), 34662
        • Research Site
      • Izmir, Turkey (Türkiye), 35360
        • Research Site
      • Konya, Turkey (Türkiye), 42080
        • Research Site
      • Çankaya, Turkey (Türkiye), 06680
        • Research Site
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Research Site
      • Brighton, United Kingdom, BN2 5BE
        • Research Site
      • Cardiff, United Kingdom, CF14 2TL
        • Research Site
      • Cheltenham, United Kingdom, GL53 7AN
        • Research Site
      • Edinburgh, United Kingdom, EH4 2XR
        • Research Site
      • High Heaton/Newcastle Upon Tyn, United Kingdom, NE7 7DN
        • Research Site
      • Leeds, United Kingdom, LS 9 7TF
        • Research Site
      • London, United Kingdom, SE1 9RT
        • Research Site
      • Nottingham, United Kingdom, NG5 1PB
        • Research Site
      • Truro, United Kingdom, TR1 3LJ
        • Research Site
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Research Site
      • Phoenix, Arizona, United States, 85054
        • Research Site
    • California
      • Fountain Valley, California, United States, 92708
        • Research Site
      • Santa Rosa, California, United States, 95403
        • Research Site
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20016
        • Research Site
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Research Site
      • Orlando, Florida, United States, 32804
        • Research Site
      • Saint Augustine, Florida, United States, 32086
        • Research Site
    • Georgia
      • Macon, Georgia, United States, 31217
        • Research Site
    • Illinois
      • Elmhurst, Illinois, United States, 60126
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Research Site
      • Silver Spring, Maryland, United States, 20910
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48106-0995
        • Research Site
      • Detroit, Michigan, United States, 48202
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Research Site
      • Rochester, Minnesota, United States, 55905
        • Research Site
    • Nevada
      • Reno, Nevada, United States, 89511
        • Research Site
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816
        • Research Site
    • Ohio
      • Columbus, Ohio, United States, 43214
        • Research Site
      • Maumee, Ohio, United States, 43537
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
        • Research Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Research Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Research Site
      • Nashville, Tennessee, United States, 37203
        • Research Site
      • Nashville, Tennessee, United States, 37232
        • Research Site
    • Texas
      • Fort Sam Houston, Texas, United States, 78234
        • Research Site
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Research Site
      • Fort Belvoir, Virginia, United States, 22060
        • Research Site
    • Washington
      • Spokane Valley, Washington, United States, 99216
        • Research Site
    • Wisconsin
      • Appleton, Wisconsin, United States, 54911
        • Research Site
  • Vietnam
      • Hanoi, Vietnam, 100000
        • Research Site
      • Hanoi, Vietnam, 10000
        • Research Site
      • Ho Chi Minh City, Vietnam, 700000
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

INCLUSION CRITERIA:

  1. Participant must be ≥ 18 years at the time of screening.
  2. Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease
  3. Provision of a tumour tissue sample obtained prior to CRT
  4. Documented tumour PD-L1 status ≥ 1% by central lab
  5. Documented EGFR and ALK wild-type status (local or central).
  6. Patients must not have progressed following definitive, platinum-based, concurrent chemoradiotherapy
  7. Participants must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy
  8. Participants must have received a total dose of radiation of 60 Gy ±10% (54 Gy to 66 Gy) as part of the chemoradiation therapy, to be randomised. Radiation therapy should be administered by intensity modulated RT (preferred) or 3D-conforming technique.
  9. WHO performance status of 0 or 1 at randomization
  10. Adequate organ and marrow function

EXCLUSION CRITERIA:

  1. History of another primary malignancy, except for:

    • Malignancies treated with curative intent and adequate follow-up with no known active disease and have not required active treatment within the past 3 years before the first dose of study intervention and of low potential risk of recurrence.
    • Adequately resected non melanoma skin cancer or lentigo maligna without evidence of disease .
    • Adequately treated carcinoma in situ, including Ta tumors without evidence of disease.
  2. Mixed small cell and non-small cell lung cancer histology.
  3. Participants who receive sequential (not inclusive of induction) chemoradiation therapy for locally advanced (Stage III) unresectable NSCLC.
  4. Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based cCRT.
  5. Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy (excluding alopecia).
  6. Participants with ≥ grade 2 pneumonitis from prior chemoradiation therapy.
  7. History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or idiopathic pneumonitis - regardless of time of onset prior to randomisation. Evidence of active non-CRT induced pneumonitis (≥ Grade 2), active pneumonia, active ILD, active or recently treated pleural effusion, or current pulmonary fibrosis
  8. Active or prior documented autoimmune or inflammatory disorders (with exceptions)
  9. Active EBV infection, or known or suspected chronic active EBV infection at screening
  10. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: Durvalumab + Domvanalimab
Durvalumab and domvanalimab as an IV infusion q4w, starting on Day 1 for up to a maximum of 12 months
Drug: Durvalumab
Durvalumab IV (Intravenous infusion)
Drug: Domvanalimab
Domvanalimab IV (Intravenous infusion)
Active Comparator: Arm B: Durvalumab + Placebo
Durvalumab + placebo as an IV infusion q4w starting on Day 1 for up to a maximum of 12 months
Drug: Durvalumab
Durvalumab IV (Intravenous infusion)
Other: Placebo
Placebo IV (Intravenous infusion)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: Up to 5 years after randomization

Defined as time from randomisation until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause in participants with PD-L1 TC ≥ 50%.

Outcomes measures were applicable with the previous version of the protocol. The study objectives are considered descriptive rather than confirmatory according to the protocol amendment.
Up to 5 years after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: Up to 5 years after randomization

Defined as time from randomisation until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause in participants with PD-L1 TC ≥ 1%

Outcomes measures were applicable with the previous version of the protocol. The study objectives are considered descriptive rather than confirmatory according to the protocol amendment.
Up to 5 years after randomization
Overall Survival (OS)
Time Frame: Approximately 5 years after randomization

Overall Survival (OS)

Outcomes measures were applicable with the previous version of the protocol. The study objectives are considered descriptive rather than confirmatory according to the protocol amendment.
Approximately 5 years after randomization
Objective Response Rate (ORR)
Time Frame: Approximately 5 years after randomization

Objective Response Rate (ORR) per RECIST 1.1 as assessed by BICR

Outcomes measures were applicable with the previous version of the protocol. The study objectives are considered descriptive rather than confirmatory according to the protocol amendment.
Approximately 5 years after randomization
Duration of Response (DoR)
Time Frame: Approximately 5 years after randomization

Duration of Response (DoR) using BICR assessment according to RECIST 1.1

Outcomes measures were applicable with the previous version of the protocol. The study objectives are considered descriptive rather than confirmatory according to the protocol amendment.
Approximately 5 years after randomization
Time from randomization to second progression (PFS2)
Time Frame: Approximately 5 years after randomization

Time from randomization to second progression (PFS2)

Outcomes measures were applicable with the previous version of the protocol. The study objectives are considered descriptive rather than confirmatory according to the protocol amendment.
Approximately 5 years after randomization
Time from randomization to first date of distant metastasis or death (TTDM)
Time Frame: Approximately 5 years after randomization

Time from randomization until the first date of distant metastasis or death in the absence of distant metastasis (TTDM).

Outcomes measures were applicable with the previous version of the protocol. The study objectives are considered descriptive rather than confirmatory according to the protocol amendment.
Approximately 5 years after randomization
Time to first subsequent therapy (TFST)
Time Frame: Approximately 5 years after randomization

Time to first subsequent therapy (TFST)

Outcomes measures were applicable with the previous version of the protocol. The study objectives are considered descriptive rather than confirmatory according to the protocol amendment.
Approximately 5 years after randomization
Concentration of Durvalumab and Domvanalimab
Time Frame: Approximately 12 weeks after last IP dose

The pharmacokinetics (PK) of Durvalumab and Domvanalimab as determined by concentration

Outcomes measures were applicable with the previous version of the protocol. The study objectives are considered descriptive rather than confirmatory according to the protocol amendment.
Approximately 12 weeks after last IP dose
PFS6, PFS12, PFS18, PFS24
Time Frame: Approximately 6, 12, 18 and 24 months after randomization

PFS at 6, 12, 18 and 24 months (proportion per Kaplan-Meier)

Outcomes measures were applicable with the previous version of the protocol. The study objectives are considered descriptive rather than confirmatory according to the protocol amendment.
Approximately 6, 12, 18 and 24 months after randomization
Anti-Drug Antibodies (ADAs)
Time Frame: Approximately 12 weeks after last IP dose.

The immunogenicity of Durvalumab and domvanalimab as assessed by presence of Anti-Drug Antibodies (ADAs)

Outcomes measures were applicable with the previous version of the protocol. The study objectives are considered descriptive rather than confirmatory according to the protocol amendment.
Approximately 12 weeks after last IP dose.
Time to deterioration in pulmonary symptoms (TTFCD)
Time Frame: Approximately 5 years after randomization

Time to deterioration in pulmonary symptoms (TTFCD)

Outcomes measures were applicable with the previous version of the protocol. The study objectives are considered descriptive rather than confirmatory according to the protocol amendment.
Approximately 5 years after randomization
PFS investigator
Time Frame: Up to 5 years after randomization

Defined as time from randomisation until progression per RECIST 1.1 as assessed by Investigator or death due to any cause in participants

Outcomes measures were applicable with the previous version of the protocol. The study objectives are considered descriptive rather than confirmatory according to the protocol amendment.
Up to 5 years after randomization
OS 24
Time Frame: Approximately 24 months after randomization

Overall Survival (OS) at 24 months

Outcomes measures were applicable with the previous version of the protocol. The study objectives are considered descriptive rather than confirmatory according to the protocol amendment.
Approximately 24 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Arcus Biosciences, Inc.

Investigators

  • Principal Investigator: Hidehito Horinouchi, MD, PhD, National Cancer Center Hospital
  • Principal Investigator: Alexander Spira, MD, PhD, Virginia Cancer Specialists Research Institute
  • Principal Investigator: Jinming Yu, MD, PhD, Shandong Cancer Hospital And Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2022

Primary Completion (Actual)

August 10, 2026

Study Completion (Estimated)

September 8, 2027

Study Registration Dates

First Submitted

January 11, 2022

First Submitted That Met QC Criteria

January 26, 2022

First Posted (Actual)

January 27, 2022

Study Record Updates

Last Update Posted (Actual)

August 28, 2026

Last Update Submitted That Met QC Criteria

August 26, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9075C00001
  • 2021-004327-32 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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