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

June 9, 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

Recruiting

Conditions

Non-Small Cell Lung Cancer

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

860

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 Contact

Name: AstraZeneca Clinical Study Information Center
Phone Number: 1-877-240-9479
Email: information.center@astrazeneca.com

Study Contact Backup

Name: AstraZeneca Lung Cancer Study Locator Service
Phone Number: 1-884-432-3892
Email: az-lcsl@careboxhealth.com

Study Locations

Belgium
- - Brussels, Belgium, 1160
    - Recruiting
    - Research Site
  - Edegem, Belgium, 2650
    - Recruiting
    - Research Site
  - Haine-Saint-Paul, Belgium, 7100
    - Recruiting
    - Research Site
  - Leuven, Belgium, 3000
    - Recruiting
    - Research Site
  - Liège, Belgium, 4000
    - Recruiting
    - Research Site
  - Sint-Niklaas, Belgium, 9100
    - Recruiting
    - Research Site
Brazil
- - Barretos, Brazil, 14784-400
    - Active, not recruiting
    - Research Site
  - Londrina, Brazil, 86015-520
    - Active, not recruiting
    - Research Site
  - Porto Alegre, Brazil, 91350200
    - Active, not recruiting
    - Research Site
  - Porto Velho, Brazil, 76834-899
    - Active, not recruiting
    - Research Site
  - Rio de Janeiro, Brazil, 20231-050
    - Active, not recruiting
    - Research Site
  - Santo André, Brazil, 09060-650
    - Active, not recruiting
    - Research Site
  - São Paulo, Brazil, 01310-000
    - Withdrawn
    - Research Site
  - São Paulo, Brazil, 04556-100
    - Withdrawn
    - Research Site
  - São Paulo, Brazil, 01236-030
    - Withdrawn
    - Research Site
  - São Paulo, Brazil, 01221-900
    - Active, not recruiting
    - Research Site
  - Taubaté, Brazil, 12030-200
    - Active, not recruiting
    - Research Site
Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 5G2
    - Recruiting
    - Research Site
- British Columbia
  - Kelowna, British Columbia, Canada, V1Y 5L3
    - Recruiting
    - Research Site
- Quebec
  - Laval, Quebec, Canada, H7M 3L9
    - Recruiting
    - Research Site
  - Montreal, Quebec, Canada, H4A 3J1
    - Recruiting
    - Research Site
Chile
- - Las Condes, Chile, 7560908
    - Recruiting
    - Research Site
  - Port Montt, Chile, 5500243
    - Recruiting
    - Research Site
  - Santiago, Chile, 7500713
    - Recruiting
    - Research Site
  - Santiago, Chile, 8241479
    - Recruiting
    - Research Site
  - Santiago, Chile, 7630370
    - Recruiting
    - Research Site
  - Santiago, Chile, 7520426
    - Recruiting
    - Research Site
  - Temuco, Chile, 4810218
    - Recruiting
    - Research Site
France
- - Aix-en-Provence, France, 13616
    - Recruiting
    - Research Site
  - Angers, France, 49055
    - Recruiting
    - Research Site
  - Bobigny, France, 93000
    - Recruiting
    - Research Site
  - Clermont-Ferrand, France, 63000
    - Withdrawn
    - Research Site
  - Lille, France, 59000
    - Recruiting
    - Research Site
  - Paris, France, 75014
    - Recruiting
    - Research Site
  - Pau, France, 6400
    - Recruiting
    - Research Site
  - Quimper, France, 29000
    - Recruiting
    - Research Site
  - Saint-Grégoire, France, 35760
    - Recruiting
    - Research Site
  - Saint-Quentin, France, 02321
    - Recruiting
    - Research Site
  - Vantoux, France, 57070
    - Recruiting
    - Research Site
  - Villeurbanne, France, 69100
    - Recruiting
    - Research Site
Germany
- - Berlin, Germany, 12351
    - Recruiting
    - Research Site
  - Berlin-Zehlendorf, Germany, 14165
    - Recruiting
    - Research Site
  - Braunschweig, Germany, 38114
    - Recruiting
    - Research Site
  - Chemnitz, Germany, 09116
    - Recruiting
    - Research Site
  - Cologne, Germany, 51109
    - Recruiting
    - Research Site
  - Erlangen, Germany, 91054
    - Recruiting
    - Research Site
  - Essen, Germany, 45147
    - Recruiting
    - Research Site
  - Georgsmarienhütte, Germany, 49124
    - Withdrawn
    - Research Site
  - Giessen, Germany, 35392
    - Recruiting
    - Research Site
  - Halle, Germany, 06120
    - Recruiting
    - Research Site
  - Hamburg, Germany, 21075
    - Withdrawn
    - Research Site
  - Homburg, Germany, 66421
    - Withdrawn
    - Research Site
  - Koblenz, Germany, 56073
    - Recruiting
    - Research Site
  - Krefeld, Germany, 47805
    - Recruiting
    - Research Site
  - Löwenstein, Germany, 74245
    - Recruiting
    - Research Site
  - Moers, Germany, 47441
    - Terminated
    - Research Site
  - München, Germany, 81675
    - Withdrawn
    - Research Site
  - Regensburg, Germany, 93053
    - Recruiting
    - Research Site
  - Regensburg, Germany, 93049
    - Recruiting
    - Research Site
  - Tübingen, Germany, 72076
    - Recruiting
    - Research Site
Greece
- - Athens, Greece, 12462
    - Recruiting
    - Research Site
  - Athens, Greece, 11527
    - Recruiting
    - Research Site
  - Athens, Greece, 11526
    - Recruiting
    - Research Site
  - Athens, Greece, 18547
    - Recruiting
    - Research Site
  - Holargos, Athens, Greece, 155 62
    - Recruiting
    - Research Site
  - Thessaloniki, Greece, 57001
    - Recruiting
    - Research Site
  - Thessaloniki, Greece, 55236
    - Recruiting
    - Research Site
  - Thessaloniki, Greece, 56 429
    - Recruiting
    - Research Site
Hong Kong
- - Hong Kong, Hong Kong, 150001
    - Recruiting
    - Research Site
Hungary
- - Budapest, Hungary, 1121
    - Recruiting
    - Research Site
  - Budapest, Hungary, 1122
    - Recruiting
    - Research Site
  - Deszk, Hungary, 6772
    - Recruiting
    - Research Site
  - Győr, Hungary, 9024
    - Recruiting
    - Research Site
  - Salgótarján, Hungary, 3100
    - Recruiting
    - Research Site
  - Székesfehérvár, Hungary, 8000
    - Recruiting
    - Research Site
  - Törökbálint, Hungary, 2045
    - Recruiting
    - Research Site
India
- - Ahmedabad, India, 380054
    - Completed
    - Research Site
  - Bangalore, India, 560027
    - Recruiting
    - Research Site
  - Bangalore, India, 560064
    - Recruiting
    - Research Site
  - Delhi, India, 110085
    - Recruiting
    - Research Site
  - Gurgaon, India, 122001
    - Withdrawn
    - Research Site
  - Howrah, India, 711103
    - Recruiting
    - Research Site
  - Hyderabad, India, 500032
    - Recruiting
    - Research Site
  - Jaipur, India, 302022
    - Recruiting
    - Research Site
  - Jaipur, India, 302004
    - Recruiting
    - Research Site
  - Kolkata, India, 700160
    - Recruiting
    - Research Site
  - Marg Jaipur, India, 302004
    - Recruiting
    - Research Site
  - Mohali, India, 160055
    - Completed
    - Research Site
  - Namakkal, India, 637001
    - Recruiting
    - Research Site
  - New Delhi, India, 110029
    - Recruiting
    - Research Site
  - New Delhi, India, 110005
    - Completed
    - Research Site
  - Varanasi, India, 221005
    - Recruiting
    - Research Site
Italy
- - Bergamo, Italy, 24127
    - Recruiting
    - Research Site
  - Roma, Italy, 00144
    - Recruiting
    - Research Site
  - Rozzano, Italy, 20089
    - Recruiting
    - Research Site
  - Udine, Italy, 33100
    - Withdrawn
    - Research Site
Japan
- - Bunkyō City, Japan, 113-8431
    - Recruiting
    - Research Site
  - Bunkyō City, Japan, 113-8603
    - Recruiting
    - Research Site
  - Bunkyō City, Japan, 113-8677
    - Recruiting
    - Research Site
  - Chiba, Japan, 260-8717
    - Recruiting
    - Research Site
  - Fukuoka, Japan, 812-8582
    - Recruiting
    - Research Site
  - Hidaka-shi, Japan, 350-1298
    - Recruiting
    - Research Site
  - Hirosaki-shi, Japan, 036-8563
    - Recruiting
    - Research Site
  - Itabashi-ku, Japan, 173-0003
    - Recruiting
    - Research Site
  - Kashihara-shi, Japan, 634-8522
    - Recruiting
    - Research Site
  - Kumamoto, Japan, 860-8556
    - Recruiting
    - Research Site
  - Kōtoku, Japan, 135-8550
    - Recruiting
    - Research Site
  - Matsuyama, Japan, 791-0280
    - Recruiting
    - Research Site
  - Nagoya, Japan, 464-8681
    - Recruiting
    - Research Site
  - Osaka, Japan, 545-8586
    - Recruiting
    - Research Site
  - Osakasayama-shi, Japan, 589-8511
    - Recruiting
    - Research Site
  - Sapporo, Japan, 003-0804
    - Recruiting
    - Research Site
  - Sunto-gun, Japan, 411-8777
    - Recruiting
    - Research Site
  - Tokyo, Japan, 104-0045
    - Recruiting
    - Research Site
  - Yokohama, Japan, 241-8515
    - Recruiting
    - Research Site
  - Yokohama, Japan, 221-0855
    - Recruiting
    - Research Site
Malaysia
- - Johor Bahru, Malaysia, 81100
    - Recruiting
    - Research Site
  - Kuala Lumpur, Malaysia, 59100
    - Recruiting
    - Research Site
  - Kuala Selangor, Malaysia, 46050
    - Recruiting
    - Research Site
  - Kuching, Malaysia, 93586
    - Recruiting
    - Research Site
Mexico
- - Aguascalientes, Mexico, 20230
    - Withdrawn
    - Research Site
  - Chihuahua City, Mexico, 31207
    - Recruiting
    - Research Site
  - Guadalajara, Mexico, 44280
    - Withdrawn
    - Research Site
  - Guadalajara, Mexico, 44638
    - Recruiting
    - Research Site
  - Mexico City, Mexico, 03810
    - Recruiting
    - Research Site
  - Monterrey, Mexico, 64460
    - Withdrawn
    - Research Site
  - Oaxaca City, Mexico, 68020
    - Recruiting
    - Research Site
  - San Pedro Garza García, Mexico, 66220
    - Withdrawn
    - Research Site
  - Sonora, Mexico, 83207
    - Withdrawn
    - Research Site
  - Veracruz, Mexico, 91900
    - Withdrawn
    - Research Site
Norway
- - Bodø, Norway, 8092
    - Recruiting
    - Research Site
  - Gjøvik, Norway, 2819
    - Recruiting
    - Research Site
  - Oslo, Norway, 0379
    - Recruiting
    - Research Site
  - Trondheim, Norway, 0730
    - Recruiting
    - Research Site
Philippines
- - Bacolod, Philippines, 6100
    - Withdrawn
    - Research Site
  - City of Muntinlupa, Philippines, 1780
    - Recruiting
    - Research Site
  - Iloilo City, Philippines, 5000
    - Recruiting
    - Research Site
  - Manila, Philippines, 1000
    - Withdrawn
    - Research Site
  - Pasig, Philippines, 1605
    - Withdrawn
    - Research Site
  - Quezon City, Philippines, 1100
    - Recruiting
    - Research Site
  - Quezon City, Philippines, 1112
    - Recruiting
    - Research Site
Poland
- - Bialystok, Poland, 15-027
    - Recruiting
    - Research Site
  - Gliwice, Poland, 44-102
    - Withdrawn
    - Research Site
  - Gliwice, Poland, 44-102
    - Recruiting
    - Research Site
  - Katowice, Poland, 40-074
    - Completed
    - Research Site
  - Lodz, Poland, 93-513
    - Recruiting
    - Research Site
  - Warsaw, Poland, 02-781
    - Recruiting
    - Research Site
  - Wroclaw, Poland, 53-413
    - Recruiting
    - Research Site
  - Zielona Góra, Poland, 65-046
    - Withdrawn
    - Research Site
Romania
- - Bucharest, Romania, 022328
    - Completed
    - Research Site
  - Bucharest, Romania, 050098
    - Completed
    - Research Site
  - Craiova, Romania, 200542
    - Recruiting
    - Research Site
  - Floreşti, Romania
    - Recruiting
    - Research Site
  - Iași, Romania, 700483
    - Recruiting
    - Research Site
  - Oradea, Romania, 410001
    - Recruiting
    - Research Site
  - Sibiu, Romania, 550245
    - Recruiting
    - Research Site
  - Suceava, Romania, 720214
    - Completed
    - Research Site
  - Timișoara, Romania, 300166
    - Withdrawn
    - Research Site
South Africa
- - Cape Town, South Africa, 7570
    - Withdrawn
    - Research Site
  - Johannesburg, South Africa, 2196
    - Withdrawn
    - Research Site
  - Parktown, South Africa, 2193
    - Terminated
    - Research Site
  - Pretoria, South Africa, 0084
    - Active, not recruiting
    - Research Site
  - eManzimtoti, South Africa, 4126
    - Withdrawn
    - Research Site
  - eManzimtoti, South Africa, 4126
    - Completed
    - Research Site
South Korea
- - Daegu, South Korea, 42415
    - Recruiting
    - Research Site
  - Goyang-si, South Korea, 10408
    - Recruiting
    - Research Site
  - Incheon, South Korea, 21565
    - Recruiting
    - Research Site
  - Incheon, South Korea, 21431
    - Recruiting
    - Research Site
  - Jinju, South Korea, 52727
    - Recruiting
    - Research Site
  - Seoul, South Korea, 06351
    - Recruiting
    - Research Site
  - Seoul, South Korea, 03722
    - Recruiting
    - Research Site
  - Seoul, South Korea, 07061
    - Recruiting
    - Research Site
  - Seoul, South Korea, 06273
    - Recruiting
    - Research Site
  - Seoul, South Korea, 02841
    - Withdrawn
    - Research Site
  - Suwon, South Korea, 16247
    - Recruiting
    - Research Site
Spain
- - Bilbao (Vizcaya), Spain, 48013
    - Recruiting
    - Research Site
  - Castellon, Spain, 12002
    - Recruiting
    - Research Site
  - Córdoba, Spain, 14004
    - Recruiting
    - Research Site
  - El Palmar, Spain, 30120
    - Recruiting
    - Research Site
  - Palma de Mallorca, Spain, 07010
    - Recruiting
    - Research Site
  - Sabadell (Barcelona), Spain, 08208
    - Recruiting
    - Research Site
Switzerland
- - Basel, Switzerland, 4031
    - Recruiting
    - Research Site
  - Bern, Switzerland, CH-3010
    - Recruiting
    - Research Site
  - Lausanne, Switzerland, 1011
    - Recruiting
    - Research Site
Taiwan
- - Hsinchu, Taiwan, 300
    - Recruiting
    - Research Site
  - New Taipei City, Taiwan, 220216
    - Recruiting
    - Research Site
  - Taichung, Taiwan, 40447
    - Recruiting
    - Research Site
  - Taichung, Taiwan, 40705
    - Recruiting
    - Research Site
  - Tainan, Taiwan, 704
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 10002
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 11217
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 10449
    - Recruiting
    - Research Site
  - Taoyuan, Taiwan, 333
    - Recruiting
    - Research Site
Thailand
- - Bangkok, Thailand, 10300
    - Recruiting
    - Research Site
  - Bangkok, Thailand, 10400
    - Recruiting
    - Research Site
  - Bangkok, Thailand, 10700
    - Recruiting
    - Research Site
  - Hat Yai, Thailand, 90110
    - Recruiting
    - Research Site
Turkey (Türkiye)
- - Adapazarı, Turkey (Türkiye), 54290
    - Active, not recruiting
    - Research Site
  - Ankara, Turkey (Türkiye), 6100
    - Active, not recruiting
    - Research Site
  - Ankara, Turkey (Türkiye), 06340
    - Active, not recruiting
    - Research Site
  - Antalya, Turkey (Türkiye), 07058
    - Active, not recruiting
    - Research Site
  - Edirne, Turkey (Türkiye), 22030
    - Active, not recruiting
    - Research Site
  - Istanbul, Turkey (Türkiye), 34098
    - Active, not recruiting
    - Research Site
  - Istanbul, Turkey (Türkiye), 34662
    - Active, not recruiting
    - Research Site
  - Izmir, Turkey (Türkiye), 35360
    - Active, not recruiting
    - Research Site
  - Konya, Turkey (Türkiye), 42080
    - Active, not recruiting
    - Research Site
  - Çankaya, Turkey (Türkiye), 06680
    - Active, not recruiting
    - Research Site
United Kingdom
- - Birmingham, United Kingdom, B9 5SS
    - Recruiting
    - Research Site
  - Brighton, United Kingdom, BN2 5BE
    - Recruiting
    - Research Site
  - Cambridge, United Kingdom, CB2 0QQ
    - Withdrawn
    - Research Site
  - Cardiff, United Kingdom, CF14 2TL
    - Recruiting
    - Research Site
  - Cheltenham, United Kingdom, GL53 7AN
    - Recruiting
    - Research Site
  - Edinburgh, United Kingdom, EH4 2XR
    - Recruiting
    - Research Site
  - High Heaton/Newcastle Upon Tyn, United Kingdom, NE7 7DN
    - Recruiting
    - Research Site
  - Leeds, United Kingdom, LS 9 7TF
    - Recruiting
    - Research Site
  - London, United Kingdom, SE1 9RT
    - Recruiting
    - Research Site
  - Nottingham, United Kingdom, NG5 1PB
    - Recruiting
    - Research Site
  - Truro, United Kingdom, TR1 3LJ
    - Recruiting
    - Research Site
United States
- Arizona
  - Chandler, Arizona, United States, 85224
    - Recruiting
    - Research Site
  - Phoenix, Arizona, United States, 85054
    - Suspended
    - Research Site
- California
  - Fountain Valley, California, United States, 92708
    - Recruiting
    - Research Site
  - Santa Rosa, California, United States, 95403
    - Recruiting
    - Research Site
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20016
    - Recruiting
    - Research Site
- Florida
  - Jacksonville, Florida, United States, 32224
    - Suspended
    - Research Site
  - Orlando, Florida, United States, 32804
    - Recruiting
    - Research Site
  - Saint Augustine, Florida, United States, 32086
    - Recruiting
    - Research Site
- Georgia
  - Macon, Georgia, United States, 31217
    - Suspended
    - Research Site
- Illinois
  - Elmhurst, Illinois, United States, 60126
    - Suspended
    - Research Site
  - Maywood, Illinois, United States, 60153
    - Withdrawn
    - Research Site
  - Naperville, Illinois, United States, 60540
    - Withdrawn
    - Research Site
- Kentucky
  - Louisville, Kentucky, United States, 40202
    - Suspended
    - Research Site
- Maryland
  - Baltimore, Maryland, United States, 21224
    - Recruiting
    - Research Site
  - Silver Spring, Maryland, United States, 20910
    - Suspended
    - Research Site
- Michigan
  - Ann Arbor, Michigan, United States, 48106-0995
    - Recruiting
    - Research Site
  - Detroit, Michigan, United States, 48202
    - Completed
    - Research Site
- Minnesota
  - Minneapolis, Minnesota, United States, 55407
    - Recruiting
    - Research Site
  - Rochester, Minnesota, United States, 55905
    - Suspended
    - Research Site
- Nevada
  - Reno, Nevada, United States, 89511
    - Recruiting
    - Research Site
- New Jersey
  - East Brunswick, New Jersey, United States, 08816
    - Recruiting
    - Research Site
  - Florham Park, New Jersey, United States, 07932
    - Withdrawn
    - Research Site
- New York
  - Buffalo, New York, United States, 14221
    - Withdrawn
    - Research Site
  - Johnson City, New York, United States, 13790
    - Withdrawn
    - Research Site
- North Carolina
  - Asheville, North Carolina, United States, 28805
    - Withdrawn
    - Research Site
  - Asheville, North Carolina, United States, 28806
    - Withdrawn
    - Research Site
  - Charlotte, North Carolina, United States, 28204
    - Withdrawn
    - Research Site
  - Winston-Salem, North Carolina, United States, 27157
    - Withdrawn
    - Research Site
- Ohio
  - Columbus, Ohio, United States, 43219
    - Withdrawn
    - Research Site
  - Columbus, Ohio, United States, 43214
    - Recruiting
    - Research Site
  - Maumee, Ohio, United States, 43537
    - Recruiting
    - Research Site
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73102
    - Recruiting
    - Research Site
- Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15212
    - Recruiting
    - Research Site
- South Carolina
  - Charleston, South Carolina, United States, 29401
    - Suspended
    - Research Site
- Tennessee
  - Chattanooga, Tennessee, United States, 37404
    - Recruiting
    - Research Site
  - Nashville, Tennessee, United States, 37232
    - Recruiting
    - Research Site
  - Nashville, Tennessee, United States, 37203
    - Recruiting
    - Research Site
- Texas
  - Fort Sam Houston, Texas, United States, 78234
    - Recruiting
    - Research Site
  - Kingwood, Texas, United States, 77339
    - Withdrawn
    - Research Site
- Virginia
  - Arlington, Virginia, United States, 22205
    - Recruiting
    - Research Site
  - Fort Belvoir, Virginia, United States, 22060
    - Recruiting
    - Research Site
- Washington
  - Spokane Valley, Washington, United States, 99216
    - Recruiting
    - Research Site
- Wisconsin
  - Appleton, Wisconsin, United States, 54911
    - Recruiting
    - Research Site
Vietnam
- - Hanoi, Vietnam, 100000
    - Recruiting
    - Research Site
  - Hanoi, Vietnam, 10000
    - Recruiting
    - Research Site
  - Ho Chi Minh City, Vietnam, 700000
    - Recruiting
    - 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

Description

INCLUSION CRITERIA:

Participant must be ≥ 18 years at the time of screening.
Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease
Provision of a tumour tissue sample obtained prior to CRT
Documented tumour PD-L1 status ≥ 1% by central lab
Documented EGFR and ALK wild-type status (local or central).
Patients must not have progressed following definitive, platinum-based, concurrent chemoradiotherapy
Participants must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy
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.
WHO performance status of 0 or 1 at randomization
Adequate organ and marrow function

EXCLUSION CRITERIA:

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.
Mixed small cell and non-small cell lung cancer histology.
Participants who receive sequential (not inclusive of induction) chemoradiation therapy for locally advanced (Stage III) unresectable NSCLC.
Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based cCRT.
Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy (excluding alopecia).
Participants with ≥ grade 2 pneumonitis from prior chemoradiation therapy.
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
Active or prior documented autoimmune or inflammatory disorders (with exceptions)
Active EBV infection, or known or suspected chronic active EBV infection at screening
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

Number of Arms

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 8 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%.	Up to 8 years after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Approximately 12 weeks after last IP dose
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)	Approximately 12 weeks after last IP dose.
Progression Free Survival (PFS) Time Frame: Up to 8 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%	Up to 8 years after randomization
Overall Survival (OS) Time Frame: Approximately 8 years after randomization	Overall Survival (OS)	Approximately 8 years after randomization
Objective Response Rate (ORR) Time Frame: Approximately 8 years after randomization	Objective Response Rate (ORR) per RECIST 1.1 as assessed by BICR	Approximately 8 years after randomization
Duration of Response (DoR) Time Frame: Approximately 8 years after randomization	Duration of Response (DoR) using BICR assessment according to RECIST 1.1	Approximately 8 years after randomization
Time from randomization to second progression (PFS2) Time Frame: Approximately 8 years after randomization	Time from randomization to second progression (PFS2)	Approximately 8 years after randomization
Time from randomization to first date of distant metastasis or death (TTDM) Time Frame: Approximately 8 years after randomization	Time from randomization until the first date of distant metastasis or death in the absence of distant metastasis (TTDM).	Approximately 8 years after randomization
Time to first subsequent therapy (TFST) Time Frame: Approximately 8 years after randomization	Time to first subsequent therapy (TFST)	Approximately 8 years after randomization
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)	Approximately 6, 12, 18 and 24 months after randomization
Time to deterioration in pulmonary symptoms (TTFCD) Time Frame: Approximately 8 years after randomization	Time to deterioration in pulmonary symptoms (TTFCD)	Approximately 8 years after randomization
PFS investigator Time Frame: Up to 8 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	Up to 8 years after randomization
OS 24 Time Frame: Approximately 24 months after randomization	Overall Survival (OS) at 24 months	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

1-844-432-3892 Lung Cancer Study Locator details to CT.gov for the US sites only

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 (Estimated)

July 12, 2028

Study Completion (Estimated)

October 1, 2030

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)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

June 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

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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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Non-Small Cell Lung Cancer

Clinical Trials on Durvalumab

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