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

NCT05211895 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: D9075C000012021-004327-32
• Study Type: interventional
• Target: 860
• Locations: 28 countries
• Sites: 264

Brief 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 following definitive platinum-based cCRT.

Conditions

Non-Small Cell Lung Cancer

Keywords

non-small cell lung cancer; locally advanced; NSCLC

Outcome Measures

Primary Outcomes (1)

• 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%.

  Up to 8 years after randomization

Secondary Outcomes (13)

• Progression Free Survival (PFS)

  Up to 8 years after randomization

• Overall Survival (OS)

  Approximately 8 years after randomization

• Objective Response Rate (ORR)

  Approximately 8 years after randomization

• Duration of Response (DoR)

  Approximately 8 years after randomization

• Time from randomization to second progression (PFS2)

  Approximately 8 years after randomization

Study Arms (2)

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

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

Drug: Durvalumab; Other: Placebo

Interventions

Durvalumab DRUG

Durvalumab IV (Intravenous infusion)

Arm A: Durvalumab + Domvanalimab; Arm B: Durvalumab + Placebo

Domvanalimab DRUG

Domvanalimab IV (Intravenous infusion)

Arm A: Durvalumab + Domvanalimab

Placebo OTHER

Placebo IV (Intravenous infusion)

Arm B: Durvalumab + Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• Arcus Biosciences, Inc.: collaborator

Study Sites (264)

Research Site

Chandler, Arizona, 85224, United States

RECRUITING

Research Site

Phoenix, Arizona, 85054, United States

SUSPENDED

Research Site

Fountain Valley, California, 92708, United States

RECRUITING

Research Site

Santa Rosa, California, 95403, United States

RECRUITING

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Washington D.C., District of Columbia, 20016, United States

RECRUITING

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Jacksonville, Florida, 32224, United States

SUSPENDED

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Orlando, Florida, 32804, United States

RECRUITING

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Saint Augustine, Florida, 32086, United States

RECRUITING

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Macon, Georgia, 31217, United States

SUSPENDED

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Elmhurst, Illinois, 60126, United States

SUSPENDED

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Maywood, Illinois, 60153, United States

WITHDRAWN

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Naperville, Illinois, 60540, United States

WITHDRAWN

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Louisville, Kentucky, 40202, United States

SUSPENDED

Research Site

Baltimore, Maryland, 21224, United States

RECRUITING

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Silver Spring, Maryland, 20910, United States

SUSPENDED

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Ann Arbor, Michigan, 48106-0995, United States

RECRUITING

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Detroit, Michigan, 48202, United States

COMPLETED

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Minneapolis, Minnesota, 55407, United States

RECRUITING

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Rochester, Minnesota, 55905, United States

SUSPENDED

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Reno, Nevada, 89511, United States

RECRUITING

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East Brunswick, New Jersey, 08816, United States

RECRUITING

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Florham Park, New Jersey, 07932, United States

WITHDRAWN

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Buffalo, New York, 14221, United States

WITHDRAWN

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Johnson City, New York, 13790, United States

WITHDRAWN

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Asheville, North Carolina, 28805, United States

WITHDRAWN

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Asheville, North Carolina, 28806, United States

WITHDRAWN

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Charlotte, North Carolina, 28204, United States

WITHDRAWN

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Winston-Salem, North Carolina, 27157, United States

WITHDRAWN

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Columbus, Ohio, 43214, United States

RECRUITING

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Columbus, Ohio, 43219, United States

WITHDRAWN

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Maumee, Ohio, 43537, United States

RECRUITING

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Oklahoma City, Oklahoma, 73102, United States

RECRUITING

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Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

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Charleston, South Carolina, 29401, United States

SUSPENDED

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Chattanooga, Tennessee, 37404, United States

RECRUITING

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Nashville, Tennessee, 37203, United States

RECRUITING

Research Site

Nashville, Tennessee, 37232, United States

SUSPENDED

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Fort Sam Houston, Texas, 78234, United States

RECRUITING

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Kingwood, Texas, 77339, United States

WITHDRAWN

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Arlington, Virginia, 22205, United States

RECRUITING

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Fort Belvoir, Virginia, 22060, United States

RECRUITING

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Spokane Valley, Washington, 99216, United States

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Appleton, Wisconsin, 54911, United States

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Brussels, 1160, Belgium

RECRUITING

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Edegem, 2650, Belgium

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Haine-Saint-Paul, 7100, Belgium

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Leuven, 3000, Belgium

RECRUITING

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Liège, 4000, Belgium

RECRUITING

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Sint-Niklaas, 9100, Belgium

RECRUITING

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Barretos, 14784-400, Brazil

ACTIVE NOT RECRUITING

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Londrina, 86015-520, Brazil

RECRUITING

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Porto Alegre, 91350200, Brazil

RECRUITING

Research Site

Porto Velho, 76834-899, Brazil

ACTIVE NOT RECRUITING

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Rio de Janeiro, 20231-050, Brazil

RECRUITING

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Santo André, 09060-650, Brazil

ACTIVE NOT RECRUITING

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São Paulo, 01221-900, Brazil

RECRUITING

Research Site

São Paulo, 01236-030, Brazil

WITHDRAWN

Research Site

São Paulo, 01310-000, Brazil

WITHDRAWN

Research Site

São Paulo, 04556-100, Brazil

WITHDRAWN

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Taubaté, 12030-200, Brazil

ACTIVE NOT RECRUITING

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Calgary, Alberta, T2N 5G2, Canada

RECRUITING

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Kelowna, British Columbia, V1Y 5L3, Canada

RECRUITING

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Laval, Quebec, H7M 3L9, Canada

RECRUITING

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Montreal, Quebec, H4A 3J1, Canada

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Las Condes, 7560908, Chile

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Port Montt, 5500243, Chile

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Santiago, 7500713, Chile

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Santiago, 7520426, Chile

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Santiago, 7630370, Chile

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Santiago, 8241479, Chile

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Temuco, 4810218, Chile

RECRUITING

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Aix-en-Provence, 13616, France

RECRUITING

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Angers, 49055, France

RECRUITING

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Bobigny, 93000, France

RECRUITING

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Clermont-Ferrand, 63000, France

WITHDRAWN

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Lille, 59000, France

RECRUITING

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Paris, 75014, France

RECRUITING

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Pau, 6400, France

RECRUITING

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Quimper, 29000, France

RECRUITING

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Saint-Grégoire, 35760, France

RECRUITING

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Saint-Quentin, 02321, France

RECRUITING

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Vantoux, 57070, France

RECRUITING

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Villeurbanne, 69100, France

RECRUITING

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Berlin, 12351, Germany

RECRUITING

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Berlin-Zehlendorf, 14165, Germany

RECRUITING

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Braunschweig, 38114, Germany

RECRUITING

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Chemnitz, 09116, Germany

RECRUITING

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Cologne, 51109, Germany

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Erlangen, 91054, Germany

RECRUITING

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Essen, 45147, Germany

RECRUITING

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Georgsmarienhütte, 49124, Germany

WITHDRAWN

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Giessen, 35392, Germany

RECRUITING

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Halle, 06120, Germany

RECRUITING

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Hamburg, 21075, Germany

WITHDRAWN

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Homburg, 66421, Germany

WITHDRAWN

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Koblenz, 56073, Germany

RECRUITING

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Krefeld, 47805, Germany

RECRUITING

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Löwenstein, 74245, Germany

RECRUITING

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Moers, 47441, Germany

TERMINATED

Research Site

München, 81675, Germany

WITHDRAWN

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Regensburg, 93049, Germany

RECRUITING

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Regensburg, 93053, Germany

RECRUITING

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Tübingen, 72076, Germany

RECRUITING

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Athens, 11526, Greece

RECRUITING

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Athens, 11527, Greece

RECRUITING

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Athens, 12462, Greece

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Athens, 18547, Greece

RECRUITING

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Holargos, Athens, 155 62, Greece

RECRUITING

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Thessaloniki, 55236, Greece

RECRUITING

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Thessaloniki, 56 429, Greece

RECRUITING

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Thessaloniki, 57001, Greece

RECRUITING

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Hong Kong, 150001, Hong Kong

RECRUITING

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Budapest, 1121, Hungary

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Budapest, 1122, Hungary

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Deszk, 6772, Hungary

RECRUITING

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Győr, 9024, Hungary

RECRUITING

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Salgótarján, 3100, Hungary

RECRUITING

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Székesfehérvár, 8000, Hungary

RECRUITING

Research Site

Törökbálint, 2045, Hungary

RECRUITING

Research Site

Ahmedabad, 380054, India

COMPLETED

Research Site

Bangalore, 560027, India

RECRUITING

Research Site

Bangalore, 560064, India

RECRUITING

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Delhi, 110085, India

RECRUITING

Research Site

Gurgaon, 122001, India

WITHDRAWN

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Howrah, 711103, India

RECRUITING

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Hyderabad, 500032, India

RECRUITING

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Jaipur, 302004, India

RECRUITING

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Jaipur, 302022, India

RECRUITING

Research Site

Kolkata, 700160, India

RECRUITING

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Marg Jaipur, 302004, India

RECRUITING

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Mohali, 160055, India

COMPLETED

Research Site

Namakkal, 637001, India

RECRUITING

Research Site

New Delhi, 110005, India

COMPLETED

Research Site

New Delhi, 110029, India

RECRUITING

Research Site

Varanasi, 221005, India

RECRUITING

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Bergamo, 24127, Italy

RECRUITING

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Roma, 00144, Italy

RECRUITING

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Rozzano, 20089, Italy

RECRUITING

Research Site

Udine, 33100, Italy

WITHDRAWN

Research Site

Bunkyō City, 113-8431, Japan

RECRUITING

Research Site

Bunkyō City, 113-8603, Japan

RECRUITING

Research Site

Bunkyō City, 113-8677, Japan

RECRUITING

Research Site

Chiba, 260-8717, Japan

RECRUITING

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Fukuoka, 812-8582, Japan

RECRUITING

Research Site

Hidaka-shi, 350-1298, Japan

RECRUITING

Research Site

Hirosaki-shi, 036-8563, Japan

RECRUITING

Research Site

Itabashi-ku, 173-0003, Japan

RECRUITING

Research Site

Kashihara-shi, 634-8522, Japan

RECRUITING

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Kōtoku, 135-8550, Japan

RECRUITING

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Kumamoto, 860-8556, Japan

RECRUITING

Research Site

Matsuyama, 791-0280, Japan

RECRUITING

Research Site

Nagoya, 464-8681, Japan

RECRUITING

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Osaka, 545-8586, Japan

RECRUITING

Research Site

Osakasayama-shi, 589-8511, Japan

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Research Site

Sapporo, 003-0804, Japan

RECRUITING

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Sunto-gun, 411-8777, Japan

RECRUITING

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Tokyo, 104-0045, Japan

RECRUITING

Research Site

Yokohama, 221-0855, Japan

RECRUITING

Research Site

Yokohama, 241-8515, Japan

RECRUITING

Research Site

Johor Bahru, 81100, Malaysia

RECRUITING

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Kuala Lumpur, 59100, Malaysia

RECRUITING

Research Site

Kuala Selangor, 46050, Malaysia

RECRUITING

Research Site

Kuching, 93586, Malaysia

RECRUITING

Research Site

Aguascalientes, 20230, Mexico

WITHDRAWN

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Chihuahua City, 31207, Mexico

RECRUITING

Research Site

Guadalajara, 44280, Mexico

WITHDRAWN

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Guadalajara, 44638, Mexico

RECRUITING

Research Site

Mexico City, 03810, Mexico

RECRUITING

Research Site

Monterrey, 64460, Mexico

WITHDRAWN

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Oaxaca City, 68020, Mexico

RECRUITING

Research Site

San Pedro Garza García, 66220, Mexico

WITHDRAWN

Research Site

Sonora, 83207, Mexico

WITHDRAWN

Research Site

Veracruz, 91900, Mexico

WITHDRAWN

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Bodø, 8092, Norway

RECRUITING

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Gjøvik, 2819, Norway

RECRUITING

Research Site

Oslo, 0379, Norway

RECRUITING

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Trondheim, 0730, Norway

RECRUITING

Research Site

Bacolod, 6100, Philippines

WITHDRAWN

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City of Muntinlupa, 1780, Philippines

RECRUITING

Research Site

Iloilo City, 5000, Philippines

RECRUITING

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Manila, 1000, Philippines

NOT YET RECRUITING

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Pasig, 1605, Philippines

WITHDRAWN

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Quezon City, 1100, Philippines

RECRUITING

Research Site

Quezon City, 1112, Philippines

RECRUITING

Research Site

Bialystok, 15-027, Poland

RECRUITING

Research Site

Gliwice, 44-102, Poland

WITHDRAWN

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Gliwice, 44-102, Poland

RECRUITING

Research Site

Katowice, 40-074, Poland

COMPLETED

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Lodz, 93-513, Poland

RECRUITING

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Warsaw, 02-781, Poland

RECRUITING

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Wroclaw, 53-413, Poland

RECRUITING

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Zielona Góra, 65-046, Poland

WITHDRAWN

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Bucharest, 022328, Romania

COMPLETED

Research Site

Bucharest, 050098, Romania

COMPLETED

Research Site

Craiova, 200542, Romania

RECRUITING

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Floreşti, Romania

RECRUITING

Research Site

Iași, 700483, Romania

RECRUITING

Research Site

Oradea, 410001, Romania

RECRUITING

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Sibiu, 550245, Romania

RECRUITING

Research Site

Suceava, 720214, Romania

COMPLETED

Research Site

Timișoara, 300166, Romania

WITHDRAWN

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Cape Town, 7570, South Africa

WITHDRAWN

Research Site

eManzimtoti, 4126, South Africa

WITHDRAWN

Research Site

eManzimtoti, 4126, South Africa

COMPLETED

Research Site

Johannesburg, 2196, South Africa

WITHDRAWN

Research Site

Parktown, 2193, South Africa

TERMINATED

Research Site

Pretoria, 0084, South Africa

ACTIVE NOT RECRUITING

Research Site

Daegu, 42415, South Korea

RECRUITING

Research Site

Goyang-si, 10408, South Korea

RECRUITING

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Incheon, 21431, South Korea

RECRUITING

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Incheon, 21565, South Korea

RECRUITING

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Jinju, 52727, South Korea

RECRUITING

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Seoul, 02841, South Korea

WITHDRAWN

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Seoul, 03722, South Korea

RECRUITING

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Seoul, 06273, South Korea

RECRUITING

Research Site

Seoul, 06351, South Korea

RECRUITING

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Seoul, 07061, South Korea

RECRUITING

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Suwon, 16247, South Korea

RECRUITING

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Bilbao (Vizcaya), 48013, Spain

RECRUITING

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Castellon, 12002, Spain

RECRUITING

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Córdoba, 14004, Spain

RECRUITING

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El Palmar, 30120, Spain

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Palma de Mallorca, 07010, Spain

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Sabadell (Barcelona), 08208, Spain

RECRUITING

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Basel, 4031, Switzerland

RECRUITING

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Bern, CH-3010, Switzerland

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Lausanne, 1011, Switzerland

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Hsinchu, 300, Taiwan

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New Taipei City, 220216, Taiwan

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Taichung, 40447, Taiwan

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Taichung, 40705, Taiwan

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Tainan, 704, Taiwan

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Taipei, 10002, Taiwan

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Taipei, 10449, Taiwan

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Taipei, 11217, Taiwan

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Taoyuan District, 333, Taiwan

RECRUITING

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Bangkok, 10300, Thailand

RECRUITING

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Bangkok, 10400, Thailand

RECRUITING

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Bangkok, 10700, Thailand

RECRUITING

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Hat Yai, 90110, Thailand

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Adapazarı, 54290, Turkey (Türkiye)

RECRUITING

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Ankara, 06340, Turkey (Türkiye)

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Ankara, 6100, Turkey (Türkiye)

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Antalya, 07058, Turkey (Türkiye)

RECRUITING

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Çankaya, 06680, Turkey (Türkiye)

RECRUITING

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Edirne, 22030, Turkey (Türkiye)

RECRUITING

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Istanbul, 34098, Turkey (Türkiye)

RECRUITING

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Istanbul, 34662, Turkey (Türkiye)

RECRUITING

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Izmir, 35360, Turkey (Türkiye)

RECRUITING

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Konya, 42080, Turkey (Türkiye)

RECRUITING

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Birmingham, B9 5SS, United Kingdom

RECRUITING

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Brighton, BN2 5BE, United Kingdom

RECRUITING

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Cambridge, CB2 0QQ, United Kingdom

WITHDRAWN

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Cardiff, CF14 2TL, United Kingdom

RECRUITING

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Cheltenham, GL53 7AN, United Kingdom

RECRUITING

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Edinburgh, EH4 2XR, United Kingdom

RECRUITING

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High Heaton/Newcastle Upon Tyn, NE7 7DN, United Kingdom

RECRUITING

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Leeds, LS 9 7TF, United Kingdom

RECRUITING

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London, SE1 9RT, United Kingdom

RECRUITING

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Nottingham, NG5 1PB, United Kingdom

RECRUITING

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Truro, TR1 3LJ, United Kingdom

RECRUITING

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Hanoi, 100000, Vietnam

RECRUITING

Research Site

Hanoi, 10000, Vietnam

RECRUITING

Research Site

Ho Chi Minh City, 700000, Vietnam

RECRUITING

Related Links

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

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

durvalumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

AstraZeneca Lung Cancer Study Locator Service

CONTACT

1-884-432-3892; az-lcsl@careboxhealth.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: January 27, 2022
• Study Start: February 18, 2022
• Primary Completion (Estimated): July 12, 2028
• Study Completion (Estimated): October 1, 2030
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

VN (3); RO (9); BE (6); MY (4); US (43); JP (20); PL (8); KR (11); ME (10); IT (4); ES (6); GR (8); HK (1); FR (12); TU (10); GB (11); TH (4); CL (7); BR (11); IN (16); DE (20); NO (4); ZA (6); CH (3); TW (9); CA (4); HU (7); PH (7)