Non-Small Cell Lung CancerPhase 3PACIFIC-8NCT05211895

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

A Phase 3 study testing Durvalumab and Domvanalimab in people with Non-Small Cell Lung Cancer, run by AstraZeneca at 226 sites in 28 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-Small Cell Lung Cancer
What is being tested?: Durvalumab and Domvanalimab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 791 participants
Where: 226 sitesin 28 countries
Study dates: 18 Feb 2022to 8 Sep 2027
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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.

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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.

Trial locations and contacts

226 sites in 28 countries.

Country

City, postcode or hospital

226 sites in 28 countries

United States32 sites

Research Site
Ann Arbor, Michigan, 48106-0995
Research Site
Appleton, Wisconsin, 54911
Research Site
Baltimore, Maryland, 21224
Research Site
Chandler, Arizona, 85224
Research Site
Charleston, South Carolina, 29401
Research Site
Chattanooga, Tennessee, 37404
Research Site
Columbus, Ohio, 43214
Research Site
Detroit, Michigan, 48202
Research Site
East Brunswick, New Jersey, 08816
Research Site
Elmhurst, Illinois, 60126
Research Site
Fairfax, Virginia, 22031
Research Site
Fort Belvoir, Virginia, 22060
Research Site
Fort Sam Houston, Texas, 78234
Research Site
Fountain Valley, California, 92708
Research Site
Jacksonville, Florida, 32224
Research Site
Louisville, Kentucky, 40202
Research Site
Macon, Georgia, 31217
Research Site
Maumee, Ohio, 43537
Research Site
Minneapolis, Minnesota, 55407
Research Site
Nashville, Tennessee, 37203
Research Site
Nashville, Tennessee, 37232
Research Site
Oklahoma City, Oklahoma, 73102
Research Site
Orlando, Florida, 32804
Research Site
Phoenix, Arizona, 85054
Research Site
Pittsburgh, Pennsylvania, 15212
Research Site
Reno, Nevada, 89511
Research Site
Rochester, Minnesota, 55905
Research Site
Saint Augustine, Florida, 32086
Research Site
Santa Rosa, California, 95403
Research Site
Silver Spring, Maryland, 20910
Research Site
Spokane Valley, Washington, 99216
Research Site
Washington D.C., District of Columbia, 20016

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Japan20 sites

Research Site
Bunkyō City, 113-8431
Research Site
Bunkyō City, 113-8603
Research Site
Bunkyō City, 113-8677
Research Site
Chiba, 260-8717
Research Site
Fukuoka, 812-8582
Research Site
Hidaka-shi, 350-1298
Research Site
Hirosaki-shi, 036-8563
Research Site
Kashihara-shi, 634-8522
Research Site
Kōtoku, 135-8550
Research Site
Kumamoto, 860-8556
Research Site
Matsuyama, 791-0280
Research Site
Nagoya, 464-8681
Research Site
Osaka, 545-8586
Research Site
Osakasayama-shi, 589-8511
Research Site
Sapporo, 003-0804
Research Site
Sunto-gun, 411-8777
Research Site
tabashi City, 173-0003
Research Site
Tokyo, 104-0045
Research Site
Yokohama, 221-0855
Research Site
Yokohama, 241-8515

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Germany16 sites

Research Site
Berlin, 12351
Research Site
Berlin-Zehlendorf, 14165
Research Site
Braunschweig, 38114
Research Site
Chemnitz, 09116
Research Site
Cologne, 51109
Research Site
Erlangen, 91054
Research Site
Essen, 45147
Research Site
Giessen, 35392
Research Site
Halle, 06120
Research Site
Koblenz, 56073
Research Site
Krefeld, 47805
Research Site
Löwenstein, 74245
Research Site
Moers, 47441
Research Site
Regensburg, 93049
Research Site
Regensburg, 93053
Research Site
Tübingen, 72076

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India15 sites

Research Site
Ahmedabad, 380054
Research Site
Bangalore, 560027
Research Site
Bangalore, 560064
Research Site
Delhi, 110085
Research Site
Howrah, 711103
Research Site
Hyderabad, 500032
Research Site
Jaipur, 302004
Research Site
Jaipur, 302022
Research Site
Kolkata, 700160
Research Site
Marg Jaipur, 302004
Research Site
Mohali, 160055
Research Site
Namakkal, 637001
Research Site
New Delhi, 110005
Research Site
New Delhi, 110029
Research Site
Varanasi, 221005

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France11 sites

Research Site
Aix-en-Provence, 13616
Research Site
Angers, 49055
Research Site
Bobigny, 93000
Research Site
Lille, 59000
Research Site
Paris, 75014
Research Site
Pau, 6400
Research Site
Quimper, 29000
Research Site
Saint-Grégoire, 35760
Research Site
Saint-Quentin, 02321
Research Site
Vantoux, 57070
Research Site
Villeurbanne, 69100

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South Korea10 sites

Research Site
Daegu, 42415
Research Site
Goyang-si, 10408
Research Site
Incheon, 21431
Research Site
Incheon, 21565
Research Site
Jinju, 52727
Research Site
Seoul, 03722
Research Site
Seoul, 06273
Research Site
Seoul, 06351
Research Site
Seoul, 07061
Research Site
Suwon, 16247

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Turkey (Türkiye)10 sites

Research Site
Adapazarı, 54290
Research Site
Ankara, 06340
Research Site
Ankara, 6100
Research Site
Antalya, 07058
Research Site
Çankaya, 06680
Research Site
Edirne, 22030
Research Site
Istanbul, 34098
Research Site
Istanbul, 34662
Research Site
Izmir, 35360
Research Site
Konya, 42080

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United Kingdom10 sites

Research Site
Birmingham, B9 5SS
Research Site
Brighton, BN2 5BE
Research Site
Cardiff, CF14 2TL
Research Site
Cheltenham, GL53 7AN
Research Site
Edinburgh, EH4 2XR
Research Site
High Heaton/Newcastle Upon Tyn, NE7 7DN
Research Site
Leeds, LS 9 7TF
Research Site
London, SE1 9RT
Research Site
Nottingham, NG5 1PB
Research Site
Truro, TR1 3LJ

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Taiwan9 sites

Research Site
Hsinchu, 300
Research Site
New Taipei City, 220216
Research Site
Taichung, 40447
Research Site
Taichung, 40705
Research Site
Tainan, 704
Research Site
Taipei, 10002
Research Site
Taipei, 10449
Research Site
Taipei, 11217
Research Site
Taoyuan, 333

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Brazil8 sites

Research Site
Barretos, 14784-400
Research Site
Londrina, 86015-520
Research Site
Porto Alegre, 91350200
Research Site
Porto Velho, 76834-899
Research Site
Rio de Janeiro, 20231-050
Research Site
Santo André, 09060-650
Research Site
São Paulo, 01221-900
Research Site
Taubaté, 12030-200

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Greece8 sites

Research Site
Athens, 11526
Research Site
Athens, 11527
Research Site
Athens, 12462
Research Site
Athens, 18547
Research Site
Holargos, Athens, 155 62
Research Site
Thessaloniki, 55236
Research Site
Thessaloniki, 56 429
Research Site
Thessaloniki, 57001

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Romania8 sites

Research Site
Bucharest, 022328
Research Site
Bucharest, 050098
Research Site
Craiova, 200542
Research Site
Floreşti
Research Site
Iași, 700483
Research Site
Oradea, 410001
Research Site
Sibiu, 550245
Research Site
Suceava, 720214

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Chile7 sites

Research Site
Las Condes, 7560908
Research Site
Port Montt, 5500243
Research Site
Santiago, 7500713
Research Site
Santiago, 7520426
Research Site
Santiago, 7630370
Research Site
Santiago, 8241479
Research Site
Temuco, 4810218

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Hungary7 sites

Research Site
Budapest, 1121
Research Site
Budapest, 1122
Research Site
Deszk, 6772
Research Site
Győr, 9024
Research Site
Salgótarján, 3100
Research Site
Székesfehérvár, 8000
Research Site
Törökbálint, 2045

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Belgium6 sites

Research Site
Brussels, 1160
Research Site
Edegem, 2650
Research Site
Haine-Saint-Paul, 7100
Research Site
Leuven, 3000
Research Site
Liège, 4000
Research Site
Sint-Niklaas, 9100

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Poland6 sites

Research Site
Bialystok, 15-027
Research Site
Gliwice, 44-102
Research Site
Katowice, 40-074
Research Site
Lodz, 93-513
Research Site
Warsaw, 02-781
Research Site
Wroclaw, 53-413

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Spain6 sites

Research Site
Bilbao (Vizcaya), 48013
Research Site
Castellon, 12002
Research Site
Córdoba, 14004
Research Site
El Palmar, 30120
Research Site
Palma de Mallorca, 07010
Research Site
Sabadell (Barcelona), 08208

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Canada4 sites

Research Site
Calgary, Alberta, T2N 5G2
Research Site
Kelowna, British Columbia, V1Y 5L3
Research Site
Laval, Quebec, H7M 3L9
Research Site
Montreal, Quebec, H4A 3J1

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Malaysia4 sites

Research Site
Johor Bahru, 81100
Research Site
Kuala Lumpur, 59100
Research Site
Kuala Selangor, 46050
Research Site
Kuching, 93586

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Mexico4 sites

Research Site
Chihuahua City, 31207
Research Site
Guadalajara, 44638
Research Site
Mexico City, 03810
Research Site
Oaxaca City, 68020

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Norway4 sites

Research Site
Bodø, 8092
Research Site
Gjøvik, 2819
Research Site
Oslo, 0379
Research Site
Trondheim, 0730

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Philippines4 sites

Research Site
City of Muntinlupa, 1780
Research Site
Iloilo City, 5000
Research Site
Quezon City, 1100
Research Site
Quezon City, 1112

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Thailand4 sites

Research Site
Bangkok, 10300
Research Site
Bangkok, 10400
Research Site
Bangkok, 10700
Research Site
Hat Yai, 90110

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Italy3 sites

Research Site
Bergamo, 24127
Research Site
Roma, 00144
Research Site
Rozzano, 20089

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South Africa3 sites

Research Site
eManzimtoti, 4126
Research Site
Parktown, 2193
Research Site
Pretoria, 0084

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Switzerland3 sites

Research Site
Basel, 4031
Research Site
Bern, CH-3010
Research Site
Lausanne, 1011

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Vietnam3 sites

Research Site
Hanoi, 100000
Research Site
Hanoi, 10000
Research Site
Ho Chi Minh City, 700000

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Hong Kong1 site

Research Site
Hong Kong, 150001

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About this study

Official title: 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

Conditions: Non-Small Cell Lung Cancer
Being tested: Durvalumab, Domvanalimab, Placebo
Keywords: non-small cell lung cancer, locally advanced, NSCLC
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DurvalumabDrug
Durvalumab IV (Intravenous infusion)
DomvanalimabDrug
Domvanalimab IV (Intravenous infusion)
PlaceboOther
Placebo IV (Intravenous infusion)

Study groups in NCT05211895
Study group	Role	What they receive
Arm A: Durvalumab + Domvanalimab	Experimental	Durvalumab and domvanalimab as an IV infusion q4w, starting on Day 1 for up to a maximum of 12 months Receives: Drug: Durvalumab; Drug: Domvanalimab
Arm B: Durvalumab + Placebo	Active comparator	Durvalumab + placebo as an IV infusion q4w starting on Day 1 for up to a maximum of 12 months Receives: Drug: Durvalumab; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression Free Survival (PFS)
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.
Measured: Up to 5 years after randomization

Secondary outcomes (13)

Progression Free Survival (PFS)
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.
Measured: Up to 5 years after randomization
Overall Survival (OS)
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.
Measured: Approximately 5 years after randomization
Objective Response Rate (ORR)
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.
Measured: Approximately 5 years after randomization
Duration of Response (DoR)
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.
Measured: Approximately 5 years after randomization
Time from randomization to second progression (PFS2)
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.
Measured: Approximately 5 years after randomization
Time from randomization to first date of distant metastasis or death (TTDM)
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.
Measured: Approximately 5 years after randomization
Time to first subsequent therapy (TFST)
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.
Measured: Approximately 5 years after randomization
Concentration of Durvalumab and Domvanalimab
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.
Measured: Approximately 12 weeks after last IP dose
PFS6, PFS12, PFS18, PFS24
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.
Measured: Approximately 6, 12, 18 and 24 months after randomization
Anti-Drug Antibodies (ADAs)
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.
Measured: Approximately 12 weeks after last IP dose.
Time to deterioration in pulmonary symptoms (TTFCD)
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.
Measured: Approximately 5 years after randomization
PFS investigator
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.
Measured: Up to 5 years after randomization
OS 24
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.
Measured: Approximately 24 months after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Feb 20228 Sep 2027

First posted27 Jan 2022
Study start18 Feb 2022
Primary completion10 Aug 2026
Study completion8 Sep 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 791 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05211895
Sponsor's protocol ID: D9075C00001
Other IDs: 2021-004327-32
Acronym: PACIFIC-8
Status last verified: Aug 2026
First submitted: 11 Jan 2022
Last updated: 28 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05211895
Acronym / sponsor ID: PACIFIC-8 / D9075C00001
Conditions: Non-Small Cell Lung Cancer
Keywords: non-small cell lung cancer, locally advanced, NSCLC
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 791 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Arcus Biosciences, Inc.
Study start: 18 Feb 2022 (actual)
Primary completion: 10 Aug 2026 (actual)
Study completion: 8 Sep 2027 (estimated)
First posted: 27 Jan 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Arm A: Durvalumab + Domvanalimab	Experimental	Drug: Durvalumab, Drug: DomvanalimabDurvalumab and domvanalimab as an IV infusion q4w, starting on Day 1 for up to a maximum of 12 months
Arm B: Durvalumab + Placebo	Active comparator	Drug: Durvalumab, Other: PlaceboDurvalumab + placebo as an IV infusion q4w starting on Day 1 for up to a maximum of 12 months

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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).

Key exclusion criteria (13 listed)

History of another primary malignancy, except for:
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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DurvalumabDurvalumab IV (Intravenous infusion)	Drug	Arm A: Durvalumab + Domvanalimab, Arm B: Durvalumab + Placebo
DomvanalimabDomvanalimab IV (Intravenous infusion)	Drug	Arm A: Durvalumab + Domvanalimab
PlaceboPlacebo IV (Intravenous infusion)	Other	Arm B: Durvalumab + Placebo

Primary outcome

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.

13 secondary outcomes

Progression Free Survival (PFS)
Time frame: Up to 5 years after randomization
Overall Survival (OS)
Time frame: Approximately 5 years after randomization
Objective Response Rate (ORR)
Time frame: Approximately 5 years after randomization
Duration of Response (DoR)
Time frame: Approximately 5 years after randomization
Time from randomization to second progression (PFS2)
Time frame: 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 to first subsequent therapy (TFST)
Time frame: Approximately 5 years after randomization
Concentration of Durvalumab and Domvanalimab
Time frame: Approximately 12 weeks after last IP dose
PFS6, PFS12, PFS18, PFS24
Time frame: Approximately 6, 12, 18 and 24 months after randomization
Anti-Drug Antibodies (ADAs)
Time frame: Approximately 12 weeks after last IP dose.
Time to deterioration in pulmonary symptoms (TTFCD)
Time frame: Approximately 5 years after randomization
PFS investigator
Time frame: Up to 5 years after randomization
OS 24
Time frame: Approximately 24 months after randomization

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
1-844-432-3892 Lung Cancer Study Locator details to CT.gov for the US sites onlyLink provided by the sponsor.

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A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hidehito Horinouchi, MD, PhD principal investigator

National Cancer Center Hospital

Alexander Spira, MD, PhD principal investigator

Virginia Cancer Specialists Research Institute

Jinming Yu, MD, PhD principal investigator

Shandong Cancer Hospital and Institute

226 sites in 28 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Durvalumab and Domvanalimab in people with Non-Small Cell Lung Cancer, run by AstraZeneca at 226 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 226 sites in United States, Japan, Germany, India, France and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: Up to 5 years after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05211895.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.