A Global Study of Volrustomig (MEDI5752) for Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma Following Definitive Concurrent Chemoradiotherapy

NCT06129864 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: D798EC00001
• Study Type: interventional
• Target: 1,145
• Locations: 23 countries
• Sites: 305

Brief Summary

The main purpose of this study is to assess the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not progressed after receiving definitive concurrent chemoradiotherapy (cCRT).

Conditions

Locally Advanced Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors

  PFS is defined as time from randomization until first objective radiological progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause (in the absence of progression). The analysis will include all randomized participants with PD-L1 expressing tumors.

  Up to approximately 8 years

Secondary Outcomes (13)

• Progression-Free Survival (PFS) in the unresected LA-HNSCC intent-to-treat (ITT) population

  Up to approximately 8 years

• Landmark Progression-Free Survival (PFS) Rates

  Up to approximately 8 years

• Overall Survival (OS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors

  Up to approximately 8 years

• Landmark Overall Survival (OS) Rates

  Up to approximately 8 years

• Overall Survival (OS) in the unresected LA-HNSCC ITT population

  Up to approximately 8 years

Study Arms (2)

Study Arm

EXPERIMENTAL

Participants in this arm will receive volrustomig.

Drug: volrustomig

Observation Arm

NO INTERVENTION

Patients in this arm will undergo observation.

Interventions

volrustomig DRUG

volrustomig

Also known as: MEDI5752

Study Arm

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically documented locally advanced squamous cell carcinoma of the oropharynx, hypopharynx, oral cavity, or larynx with no evidence of metastatic disease (i.e. M0).
• Confirmed unresected Stage III, Stage IVA or IVB according to the eighth edition of the American Joint Committee on Cancer (AJCC) staging manual (tumor, node, metastasis (TNM) staging system).
• Participants will have completed definitive concurrent chemoradiotherapy (cCRT) with curative intent prior to randomization.

You may not qualify if:

• Participants with any of the following:
• LA-HNSCC that was resected before definitive cCRT
• LA-HNSCC that was treated and is recurrent at the time of screening
• Participants who have received radiotherapy (RT) alone as definitive local therapy for LA-HNSCC.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (305)

Research Site

Birmingham, Alabama, 35233, United States

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Phoenix, Arizona, 85028, United States

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Prescott Valley, Arizona, 86314, United States

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Springdale, Arkansas, 72762, United States

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Fountain Valley, California, 92708, United States

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Los Angeles, California, 90024, United States

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Orange, California, 92868, United States

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San Francisco, California, 94143, United States

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Santa Rosa, California, 95403, United States

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Whittier, California, 90602, United States

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Aurora, Colorado, 80045, United States

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Colorado Springs, Colorado, 80909, United States

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Lone Tree, Colorado, 80124, United States

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Washington D.C., District of Columbia, 20037, United States

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Fort Myers, Florida, 33901, United States

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Gainesville, Florida, 32610, United States

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Miami, Florida, 33125, United States

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Palm Bay, Florida, 32909, United States

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West Palm Beach, Florida, 33401, United States

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Niles, Illinois, 60714, United States

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Des Moines, Iowa, 50309, United States

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Kansas City, Kansas, 66160, United States

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Louisville, Kentucky, 40202, United States

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Baton Rouge, Louisiana, 70817, United States

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Shreveport, Louisiana, 71101, United States

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Baltimore, Maryland, 21231, United States

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Bethesda, Maryland, 20817, United States

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Hyattsville, Maryland, 20782, United States

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Towson, Maryland, 21204, United States

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Upper Marlboro, Maryland, 20774, United States

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Boston, Massachusetts, 02215, United States

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Fairhaven, Massachusetts, 02719, United States

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Ann Arbor, Michigan, 48105, United States

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Ann Arbor, Michigan, 48109, United States

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Minneapolis, Minnesota, 55417, United States

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Columbia, Missouri, 65211, United States

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St Louis, Missouri, 63110, United States

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St Louis, Missouri, 63110, United States

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East Brunswick, New Jersey, 08816, United States

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Hackensack, New Jersey, 07601, United States

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New Brunswick, New Jersey, 08901, United States

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Albuquerque, New Mexico, 87108, United States

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New York, New York, 10065, United States

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New York, New York, 10075, United States

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Stony Brook, New York, 11794, United States

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Charlotte, North Carolina, 28204, United States

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Winston-Salem, North Carolina, 27157, United States

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Cleveland, Ohio, 44106, United States

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Portland, Oregon, 97213, United States

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Portland, Oregon, 97239, United States

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Philadelphia, Pennsylvania, 19107, United States

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Pittsburgh, Pennsylvania, 15261, United States

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York, Pennsylvania, 17403, United States

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Sioux Falls, South Dakota, 57104, United States

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Sioux Falls, South Dakota, 57105, United States

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Nashville, Tennessee, 37212, United States

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Austin, Texas, 78745, United States

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Dallas, Texas, 75251, United States

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Flower Mound, Texas, 75028, United States

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Houston, Texas, 77030, United States

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Odessa, Texas, 79761, United States

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Tyler, Texas, 75702, United States

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Salt Lake City, Utah, 84112, United States

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West Jordan, Utah, 84088, United States

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Fairfax, Virginia, 22031, United States

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Norfolk, Virginia, 23502, United States

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Richmond, Virginia, 23230, United States

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Spokane, Washington, 99204, United States

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Tacoma, Washington, 98405, United States

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Tacoma, Washington, 98415, United States

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Graz, 8036, Austria

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Innsbruck, 6020, Austria

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Linz, 4010, Austria

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Salzburg, 5020, Austria

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Vienna, 1080, Austria

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Charleroi, 6060, Belgium

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Edegem, 2650, Belgium

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Jette, 1090, Belgium

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La Louvière, 7100, Belgium

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Namur, 5000, Belgium

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Barretos, 14784-400, Brazil

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Florianópolis, 88034-000, Brazil

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Fortaleza, 60336-045, Brazil

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Ijuí, 98700-000, Brazil

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Ipatinga, 35162-189, Brazil

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Londrina, 86015-520, Brazil

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Natal, 59075-740, Brazil

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Porto Alegre, 91350200, Brazil

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Ribeirão Preto, 14051-140, Brazil

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Rio de Janeiro, 20231-050, Brazil

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São Paulo, 01509-900, Brazil

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São Paulo, 04538-132, Brazil

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Teresina, 64049-200, Brazil

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Calgary, Alberta, T2N 5G2, Canada

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Edmonton, Alberta, T6G 1Z2, Canada

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Kelowna, British Columbia, V1Y 5L3, Canada

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Kingston, Ontario, K7L 2V7, Canada

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London, Ontario, N6A 5W9, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Chicoutimi, Quebec, G7H 5H6, Canada

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Montreal, Quebec, H2X 0C1, Canada

COMPLETED

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Montreal, Quebec, H3T 1E2, Canada

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Montreal, Quebec, H4A 3J1, Canada

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Regina, S4T 7T1, Canada

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Beijing, 100142, China

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Beijing, 100210, China

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Bengbu, 233004, China

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Changchun, 130000, China

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Changsha, 410008, China

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Changsha, 410013, China

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Chengdu, 610000, China

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Chengdu, 610042, China

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Chengdu, 610072, China

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Chongqing, 400016, China

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Chongqing, 400030, China

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Dongwan, 523058, China

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Fuzhou, 350014, China

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Guangzhou, 510060, China

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Guangzhou, 510080, China

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Guangzhou, 510095, China

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Guangzhou, 510700, China

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Guiyang, 550002, China

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Hangzhou, 310022, China

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Harbin, 150049, China

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Hefei, 230001, China

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Huizhou, 516001, China

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Jinan, 250117, China

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Kunming, 650118, China

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Lanzhou, 730000, China

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Nanchang, 330029, China

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Nanning, 530021, China

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Shanghai, 20032, China

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Shenyang, 110004, China

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Shijiazhuang, 050000, China

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Tianjin, 300060, China

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Tianjin, 300060, China

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Ürümqi, 830000, China

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Wuhan, 430030, China

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Wuhan, 430060, China

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Wuxi, 214122, China

SUSPENDED

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Xi'an, 710061, China

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Xiamen, 361003, China

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Zhengzhou, 450008, China

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Zhuhai, 519000, China

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Avignon, 84918, France

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Bordeaux, 33075, France

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Le Mans, 72000, France

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Lyon, 69373, France

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Nice, 06100, France

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Saint-Herblain, 44805, France

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Toulouse, 31059, France

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Villejuif, 94805, France

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Berlin, 12200, Germany

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Erlangen, 91054, Germany

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Essen, 45122, Germany

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Freiburg im Breisgau, 79106, Germany

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Greifswald, 17475, Germany

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Hamburg, 20246, Germany

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Hanover, 30625, Germany

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Leipzig, 04103, Germany

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Lübeck, 23538, Germany

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München, 81675, Germany

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Rostock, 18059, Germany

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Tübingen, 72076, Germany

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Ulm, 89075, Germany

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Würzburg, 97070, Germany

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Budapest, 1062, Hungary

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Budapest, 1083, Hungary

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Budapest, 1122, Hungary

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Budapest, 1145, Hungary

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Győr, 9024, Hungary

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Gyula, 5700, Hungary

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Kecskemét, 6000, Hungary

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Miskolc, 3526, Hungary

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Nyíregyháza, 4400, Hungary

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Pécs, 7624, Hungary

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Szekszárd, 7100, Hungary

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Bengaluru, 560027, India

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Hyderabad, 500032, India

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Jaipur, 302022, India

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Kanpur, 208005, India

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Kochi, 682027, India

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Kolkata, 700099, India

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Lucknow, 226003, India

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Madurai, 625107, India

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Mohali, 160055, India

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Nashik, 422002, India

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New Delhi, 110076, India

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Thiruvananthapuram, 695011, India

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Vadodara, 391760, India

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Varanasi, 221005, India

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Aviano, 33081, Italy

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Florence, 50139, Italy

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Milan, 20133, Italy

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Modena, 41124, Italy

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Naples, 80131, Italy

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Padua, 35128, Italy

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Pavia, 27100, Italy

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Rozzano, 20089, Italy

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Bunkyō City, 113-8431, Japan

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Bunkyō City, 113-8519, Japan

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Chiba, 260-8677, Japan

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Chiba, 260-8717, Japan

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Chūōku, 104-0045, Japan

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Fukuoka, 811-1395, Japan

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Hidaka-shi, 350-1298, Japan

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Hiroshima, 734-8551, Japan

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Kashiwa, 277-8577, Japan

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Kobe, 650-0017, Japan

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Kōtoku, 135-8550, Japan

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Nagoya, 464-8681, Japan

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Nagoya, 466-8560, Japan

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Niigata, 951-8520, Japan

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Okayama, 700-8558, Japan

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Osaka, 541-8567, Japan

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Osakasayama-shi, 589-8511, Japan

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Sagamihara-shi, 252-0375, Japan

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Sapporo, 060-8638, Japan

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Sendai, 980-8574, Japan

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Shinjuku-ku, 160-0023, Japan

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Shiwa-gun, 028-3695, Japan

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Sunto-gun, 411-8777, Japan

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Yokohama, 236-0004, Japan

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Yokohama, 241-8515, Japan

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George Town, 10450, Malaysia

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Johor Bahru, 81100, Malaysia

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Kuala Lumpur, 50586, Malaysia

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Kuala Lumpur, 59100, Malaysia

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Kuala Selangor, 62250, Malaysia

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Kuching, 93586, Malaysia

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Cebu City, 6000, Philippines

NOT YET RECRUITING

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General Santos, 9500, Philippines

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Iloilo City, 5000, Philippines

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Manila, 1008, Philippines

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Pasig, 1605, Philippines

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Quezon City, 1112, Philippines

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West San Juan City, 1502, Philippines

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Bialystok, 15-027, Poland

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Bielsko-Biala, 43-300, Poland

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Bydgoszcz, 85-796, Poland

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Gliwice, 44-102, Poland

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Olsztyn, 10-228, Poland

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Piotrkow Trybunalski, 97-300, Poland

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Siedlce, 08-110, Poland

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Tomaszów Mazowiecki, 97-200, Poland

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Warsaw, 02-781, Poland

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San Juan, 00927, Puerto Rico

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Goyang-si, 410-769, South Korea

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Gyeonggi-do, 13620, South Korea

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Incheon, 21565, South Korea

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Seoul, 06351, South Korea

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Seoul, 3722, South Korea

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Seoul, 5505, South Korea

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Suwon, 16247, South Korea

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Badalona, 08916, Spain

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Barcelona, 08035, Spain

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Barcelona, 08036, Spain

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Jaén, 23007, Spain

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Madrid, 28007, Spain

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Madrid, 28034, Spain

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Madrid, 28040, Spain

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Valencia, 46014, Spain

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Valencia, 46026, Spain

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Changhua, 500, Taiwan

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Kaohsiung City, 80756, Taiwan

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Kaohsiung City, 833401, Taiwan

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Taichung, 404, Taiwan

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Taichung, 40705, Taiwan

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Taipei, 10002, Taiwan

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Taipei, 11217, Taiwan

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Taoyuan District, 333, Taiwan

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Bangkok, 10300, Thailand

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Bangkok, 10400, Thailand

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Bangkok, 10700, Thailand

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Chaing Mai, 50200, Thailand

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Hat Yai, 90110, Thailand

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Khon Kaen, 40002, Thailand

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Lampang, 52000, Thailand

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Muang, 22000, Thailand

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Mueang, 20000, Thailand

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Ankara, 06230, Turkey (Türkiye)

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Ankara, 6200, Turkey (Türkiye)

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Antalya, 07059, Turkey (Türkiye)

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Cordaleo, 35575, Turkey (Türkiye)

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Eskişehir, 26040, Turkey (Türkiye)

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Istanbul, 34722, Turkey (Türkiye)

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Yenimahalle, 06170, Turkey (Türkiye)

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Aberdeen, AB25 2ZN, United Kingdom

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Cambridge, CB2 0XY, United Kingdom

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Hampshire, SO16 6YD, United Kingdom

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Leeds, LS9 7TF, United Kingdom

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London, EC1A 7BE, United Kingdom

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London, SE1 9RT, United Kingdom

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London, SW3 6JJ, United Kingdom

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Manchester, M20 4BX, United Kingdom

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Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

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Northwood, HA6 2RN, United Kingdom

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Sutton, SM2 5PT, United Kingdom

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Taunton, TA1 5DA, United Kingdom

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Da Nang, 550000, Vietnam

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Hanoi, 100000, Vietnam

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Hà Nội, 100000, Vietnam

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Ho Chi Minh City, 700000, Vietnam

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Huế, 530000, Vietnam

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Vinh, 460000, Vietnam

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Study Officials

• Robert Haddad, MD

  Dana Farber Cancer Institute Massachusetts, USA

  STUDY CHAIR

• Lisa Licitra, MD

  Fondazione IRCCS Istituto Nazionale dei Tumori and University of Milan Milan, Italy

  STUDY CHAIR

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 13, 2023
• Study Start: December 14, 2023
• Primary Completion (Estimated): April 18, 2028
• Study Completion (Estimated): September 12, 2030
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

US (70); PR (1); JP (25); IT (8); AU (5); IN (14); PH (7); FR (8); KR (7); HU (11); CA (11); TU (7); PL (9); TW (8); GB (12); CN (40); MY (6); BE (5); BR (13); ES (9); VN (6); TH (9); DE (14)