Back to Trials
NCT06868277PHASE3Recruiting

A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer

AstraZeneca

Start Date

4/10/2025

Completion Date

12/2/2030

Summary

The purpose of ARTEMIDE-Lung04 is to assess the efficacy and safety of rilvegostomig compared with pembrolizumab monotherapy as 1L treatment in participants with mNSCLC and whose tumors express PD-L1.

Detailed Description

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab as a 1L treatment for patients with mNSCLC whose tumors express PD-L1.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Histologically or cytologically documented NSCLC (non small lung cancer), including all histological subtypes. * Stage IV mNSCLC (metastatic non-small cell lung cancer) (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment. * Absence of sensitizing EGFR (epidermal growth factor) mutations and ALK (anaplastic lymphoma kinase) and ROS1 (c-ros oncogene 1) rearrangements. Negative assay result is required for all non-squamous histology subtypes. * Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted 1L (first line) therapies. * WHO (World Health Organization)/ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1, with no deterioration over the previous 2 weeks prior to baseline at screening and prior to randomization. * Minimum life expectancy of 12 weeks. * Provision of acceptable tumor sample for the central testing prior to randomization. * At least one lesion not previously irradiated that qualifies as a RECIST 1.1 (Response Evaluation Criteria in Solid Tumors, Version 1.1) TL (target lesion) at baseline and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with CT (computed tomography) or MRI (magnetic resonance imaging) and is suitable for accurate repeated measurements. * Adequate organ and bone marrow function Exclusion Criteria: * As judged by the investigator, any severe or uncontrolled systemic diseases, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol. * History of organ transplant. * Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment. * History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence. * Presence of small cell and neuroendocrine histology components. * Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 4 weeks prior to start of study intervention. * Active primary immunodeficiency/active infectious disease(s) * Active tuberculosis infection * Any prior systemic therapy received for advanced or mNSCLC (metastatic non-small cell lung cancer). * Any prior exposure to an anti-TIGIT (T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domain) therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms. * Any prior treatment with an anti-PD-1 (programmed cell death protein 1) or anti-PD-L1 (anti-programmed death-ligand 1) agent.

Interventions

BIOLOGICAL

Rilvegostomig

BIOLOGICAL

Pembrolizumab

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Carcinoma, Non-Small Cell Lung

Locations

Research Site

La Mesa, California 91942

United States

Research Site

Los Alamitos, California 90720

United States

Research Site

Farmington, Connecticut 06030

United States

Research Site

Newark, Delaware 19713

United States

Research Site

Bay Pines, Florida 33744

United States

Research Site

Clearwater, Florida 33756

United States

Research Site

St. Petersburg, Florida 33705

United States

Research Site

Marietta, Georgia 30060

United States

Research Site

Chicago, Illinois 60612

United States

Research Site

Decatur, Illinois 62526

United States

Research Site

Des Moines, Iowa 50309

United States

Research Site

Waterloo, Iowa 50702

United States

Research Site

Leawood, Kansas 66209

United States

Research Site

Lexington, Kentucky 40536

United States

Research Site

Owensboro, Kentucky 42303

United States

Research Site

Bethesda, Maryland 20817

United States

Research Site

Frederick, Maryland 21702

United States

Research Site

Silver Spring, Maryland 20910

United States

Research Site

Towson, Maryland 21204

United States

Research Site

Saginaw, Michigan 48602

United States

Research Site

Bridgeton, Missouri 63044

United States

Research Site

Lincoln, Nebraska 68506

United States

Research Site

Paramus, New Jersey 07652

United States

Research Site

Buffalo, New York 14215

United States

Research Site

East Syracuse, New York 13057

United States

Research Site

Fresh Meadows, New York 11366

United States

Research Site

Rochester, New York 14642

United States

Research Site

Westbury, New York 11590

United States

Research Site

Canton, Ohio 44718

United States

Research Site

Fountain Hill, Pennsylvania 18015

United States

Research Site

Kittanning, Pennsylvania 16201

United States

Research Site

Philadelphia, Pennsylvania 19104

United States

Research Site

Round Rock, Texas 78665

United States

Research Site

Aberdeen, Washington 98520

United States

Research Site

Renton, Washington 98055

United States

Research Site

Charleston, West Virginia 25304

United States

Research Site

Morgantown, West Virginia 26506

United States

Research Site

CABA, 1425

Argentina

Research Site

Córdoba, 5000

Argentina

Research Site

Pilar, B1629AHJ

Argentina

Research Site

Rosario, 2000

Argentina

Research Site

Viedma, R8500ACE

Argentina

Research Site

Hobart, 7000

Australia

Research Site

Woolloongabba, 4102

Australia

Research Site

Edegem, 2650

Belgium

Research Site

Jette, 1090

Belgium

Research Site

Libramont-Chevigny, 6800

Belgium

Research Site

Liège, 4000

Belgium

Research Site

Mechelen, 2800

Belgium

Research Site

Roeselaere, 8800

Belgium

Research Site

Blumenau, 89010-340

Brazil

Research Site

Fortaleza, 60336-550

Brazil

Research Site

Ijuí, 98700-000

Brazil

Research Site

Itajaí, 88301-220

Brazil

Research Site

Londrina, 86015-520

Brazil

Research Site

Passo Fundo, 99010-260

Brazil

Research Site

Porto Alegre, 90035-903

Brazil

Research Site

Porto Alegre, 90610-000

Brazil

Research Site

Porto Velho, 76834-899

Brazil

Research Site

Salvador, 41253-190

Brazil

Research Site

Salvador, 41950-640

Brazil

Research Site

Santo André, 09060-650

Brazil

Research Site

São Paulo, 01246-000

Brazil

Research Site

São Paulo, 04501-000

Brazil

Research Site

Teresina, 64049-200

Brazil

Research Site

Burgas, 8000

Bulgaria

Research Site

Panagyurishte, 4500

Bulgaria

Research Site

Sofia, 1407

Bulgaria

Research Site

Sofia, 1618

Bulgaria

Research Site

Sofia, 1756

Bulgaria

Research Site

Varna, 9010

Bulgaria

Research Site

Edmonton, Alberta T6G 1Z2

Canada

Research Site

Kelowna, British Columbia V1Y 5L3

Canada

Research Site

Cambridge, Ontario N1R 3G2

Canada

Research Site

Newmarket, Ontario L3Y 2P9

Canada

Research Site

Toronto, Ontario M4N 3M5

Canada

Research Site

Québec, Quebec G1V 4G5

Canada

Research Site

Saint-Jérôme, Quebec J7Z 5T3

Canada

Research Site

Conception, 4070196

Chile

Research Site

Santiago, 7500653

Chile

Research Site

Santiago, 7500713

Chile

Research Site

Santiago, 8420383

Chile

Research Site

Baoding, 071000

China

Research Site

Beijing, 100021

China

Research Site

Beijing, 100142

China

Research Site

Beijing, 101149

China

Research Site

Bengbu, 233004

China

Research Site

Changchun, 130000

China

Research Site

Changchun, 130033

China

Research Site

Changsha, 410008

China

Research Site

Changsha, 410013

China

Research Site

Chengdu, 610041

China

Research Site

Chongqing, 400030

China

Research Site

Chongqing, 400042

China

Research Site

Fuzhou, 350001

China

Research Site

Fuzhou, 350014

China

Research Site

Guangzhou, 510080

China

Research Site

Haerbin, 150081

China

Research Site

Hangzhou, 310022

China

Research Site

Hefei, 133500

China

Research Site

Hefei, 230022

China

Research Site

Jiamusi, 154007

China

Research Site

Jinan, 250117

China

Research Site

Lanzhou, 730050

China

Research Site

Linyi, 276001

China

Research Site

Liuzhou, 545007

China

Research Site

Nanchang, 330006

China

Research Site

Nanchang, 330029

China

Research Site

Nanjing, 210006

China

Research Site

Nanjing, 210008

China

Research Site

Nanning, 530021

China

Research Site

Ningbo, 315010

China

Research Site

Qingdao, 266071

China

Research Site

Shanghai, 200092

China

Research Site

Shenyang, 110042

China

Research Site

Suzhou, 215004

China

Research Site

Taiyuan, 030000

China

Research Site

Wuhan, 430030

China

Research Site

Wuhan, 430060

China

Research Site

Xuzhou, 221002

China

Research Site

Yantai, 264000

China

Research Site

Zhengzhou, 450008

China

Research Site

Cali, 760032

Colombia

Research Site

Floridablanca, 680001

Colombia

Research Site

Medellín, 050034

Colombia

Research Site

Valledupar, 200001

Colombia

Research Site

San José, 1000

Costa Rica

Research Site

San José, 10108

Costa Rica

Research Site

San José Capital, 1000

Costa Rica

Research Site

Santa Ana, 10903

Costa Rica

Research Site

Angers, 49100

France

Research Site

Avignon, 84000

France

Research Site

Boulogne-Billancourt, 92100

France

Research Site

Caen, 14000

France

Research Site

Chambéry, 73011

France

Research Site

Dijon, 21000

France

Research Site

La Tronche, 38700

France

Research Site

Limoges, 87042

France

Research Site

Nantes, 44093

France

Research Site

Paris, 75020

France

Research Site

Pau, 64046

France

Research Site

St-Malo, 35403

France

Research Site

Toulouse, 31300

France

Research Site

Tours, 37000

France

Research Site

Tbilisi, 0112

Georgia

Research Site

Tbilisi, 0159

Georgia

Research Site

Tbilisi, 160

Georgia

Research Site

Tbilisi, 177

Georgia

Research Site

Amberg, 92224

Germany

Research Site

Augsburg, by, 86156

Germany

Research Site

Bad Saarow, 15526

Germany

Research Site

Berlin, 12351

Germany

Research Site

Berlin, 13359

Germany

Research Site

Bonn, 53127

Germany

Research Site

Braunschweig, 38114

Germany

Research Site

Essen, 45147

Germany

Research Site

Flensburg, 24939

Germany

Research Site

Frankfurt am Main, 60431

Germany

Research Site

Hamburg, 21075

Germany

Research Site

Heidelberg, 69126

Germany

Research Site

Heilbronn, 74078

Germany

Research Site

Immenhausen, 34376

Germany

Research Site

Koblenz, 56073

Germany

Research Site

Leipzig, 04103

Germany

Research Site

München, 80336

Germany

Research Site

Offenbach, 63069

Germany

Research Site

Oldenburg, 26121

Germany

Research Site

Remscheid, 42859

Germany

Research Site

Rotenburg (Wümme), 27356

Germany

Research Site

Schweinfurt, 97421

Germany

Research Site

Trier, 54292

Germany

Research Site

Velbert, 42551

Germany

Research Site

Wuppertal, 42283

Germany

Research Site

Würselen, 52146

Germany

Research Site

Würzburg, 97080

Germany

Research Site

Athens, 115 27

Greece

Research Site

Athens, 11527

Greece

Research Site

Athens, 12462

Greece

Research Site

Piraeus, 185 37

Greece

Research Site

Piraeus, 185 47

Greece

Research Site

Thessaloniki, 55236

Greece

Research Site

Thessaloniki, 55236

Greece

Research Site

Thessaloniki, 56429

Greece

Research Site

Thessaloniki, 57001

Greece

Research Site

Dublin, D07 R2WY

Ireland

Research Site

Dublin, D08 NHY1

Ireland

Research Site

Dublin, D09 V2N0

Ireland

Research Site

Dublin, D24 NR0A

Ireland

Research Site

Dublin, DO4YN63

Ireland

Research Site

Galway, H91 YR71

Ireland

Research Site

Afula, 1834111

Israel

Research Site

Beersheba, 8410101

Israel

Research Site

Hadera, 38100

Israel

Research Site

Haifa, 34362

Israel

Research Site

Haifa, 91096

Israel

Research Site

Jerusalem, 91031

Israel

Research Site

Jerusalem, 91120

Israel

Research Site

Ramat Gan, 52621

Israel

Research Site

Tel Aviv, 64239

Israel

Research Site

Tel Aviv, 69710

Israel

Research Site

Candiolo, 10060

Italy

Research Site

Lecco, 23900

Italy

Research Site

Lucca, 55100

Italy

Research Site

Meldola, 47014

Italy

Research Site

Milan, 20133

Italy

Research Site

Naples, 80131

Italy

Research Site

Peschiera del Garda, 37019

Italy

Research Site

Pisa, 56126

Italy

Research Site

Roma, 00144

Italy

Research Site

Torrette Di Ancona, 60126

Italy

Research Site

Udine, 33100

Italy

Research Site

Verona, 37126

Italy

Research Site

Akashi, 673-8558

Japan

Research Site

Bunkyō City, 113-8603

Japan

Research Site

Bunkyō City, 113-8677

Japan

Research Site

Fukuoka, 811-1395

Japan

Research Site

Fukuoka, 812-8582

Japan

Research Site

Hamamatsu, 431-3192

Japan

Research Site

Iwakuni-shi, 740-8510

Japan

Research Site

Izumi-shi, 594-0073

Japan

Research Site

Kashihara-shi, 634-8522

Japan

Research Site

Kobe, 650-0046

Japan

Research Site

Kōtoku, 135-8550

Japan

Research Site

Kurume-shi, 830-0011

Japan

Research Site

Kyoto, 602-8566

Japan

Research Site

Matsuyama, 791-0280

Japan

Research Site

Nankoku-shi, 783-8505

Japan

Research Site

Niigata, 951-8566

Japan

Research Site

Osaka, 534-0021

Japan

Research Site

Sakaishi, 591-8555

Japan

Research Site

Sayama, 589-8511

Japan

Research Site

Sendai, 980-0873

Japan

Research Site

Shinagawa-ku, 142-8666

Japan

Research Site

Takarazuka-shi, 665-0827

Japan

Research Site

Toon-Shi, 791-0295

Japan

Research Site

Toyoake-shi, 470-1192

Japan

Research Site

Toyonaka-shi, 560-8552

Japan

Research Site

George Town, 10350

Malaysia

Research Site

Kota Bharu, 15586

Malaysia

Research Site

Kuala Lumpur, 50586

Malaysia

Research Site

Kuala Selangor, 62250

Malaysia

Research Site

Perai, 13700

Malaysia

Research Site

Alcabideche, 2755-009

Portugal

Research Site

Braga, 4710-243

Portugal

Research Site

Coimbra, 3000-075

Portugal

Research Site

Lisbon, 1400-038

Portugal

Research Site

Lisbon, 1500-650

Portugal

Research Site

Lisbon, 1769-001

Portugal

Research Site

Loures, 2674-514

Portugal

Research Site

Matosinhos Municipality, 4454-509

Portugal

Research Site

Porto, 4100-180

Portugal

Research Site

Porto, 4200-072

Portugal

Research Site

Porto, 4200-319

Portugal

Research Site

Bucharest, 010626

Romania

Research Site

Bucharest, 013812

Romania

Research Site

Bucharest, 022328

Romania

Research Site

Bucharest, 30167

Romania

Research Site

Craiova, 200385

Romania

Research Site

Craiova, 200542

Romania

Research Site

Iași, 700106

Romania

Research Site

Otopeni, 075100

Romania

Research Site

Piteşti, 110283

Romania

Research Site

Sibiu, 550253

Romania

Research Site

Timișoara, 300239

Romania

Research Site

Jinju, 52727

South Korea

Research Site

Seoul, 135-710

South Korea

Research Site

Seoul, 5505

South Korea

Research Site

Badajoz, 06080

Spain

Research Site

Badalona, 8916

Spain

Research Site

Barcelona, 08028

Spain

Research Site

Castellon, 12002

Spain

Research Site

Granada, 18016

Spain

Research Site

Jaén, 23007

Spain

Research Site

Lugo, 27003

Spain

Research Site

Madrid, 28040

Spain

Research Site

Madrid, 28041

Spain

Research Site

Madrid, 28050

Spain

Research Site

Málaga, 29010

Spain

Research Site

Oviedo, 33006

Spain

Research Site

Palma de Mallorca, 07198

Spain

Research Site

Valencia, 46015

Spain

Research Site

Vigo (Pontevedra), 36312

Spain

Research Site

Zaragoza, 50009

Spain

Research Site

Lausanne, 1011

Switzerland

Research Site

Ankara, 06010

Turkey (Türkiye)

Research Site

Bakırköy, 34147

Turkey (Türkiye)

Research Site

Çankaya, 06680

Turkey (Türkiye)

Research Site

İzmit, 41380

Turkey (Türkiye)

Research Site

Küçükçekmece, 34295

Turkey (Türkiye)

Research Site

Yüreğir, 01240

Turkey (Türkiye)

Research Site

Blackpool, FY3 8NR

United Kingdom

Research Site

Glasgow, G12 0YN

United Kingdom

Research Site

Guildford, GU2 7XX

United Kingdom

Research Site

Hull, HU16 5JQ

United Kingdom

Research Site

Oxford, OX4 6LB

United Kingdom

Research Site

Stevenage, SG1 4AB

United Kingdom