A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer (ARTEMIDELung04)

May 13, 2026 updated by: AstraZeneca

A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab Monotherapy for the First-line Treatment of Patients With PD-L1-high Metastatic Non-small Cell Lung Cancer (ARTEMIDE-Lung04)

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.

Study Overview

Status

Recruiting

Conditions

Carcinoma, Non-Small Cell Lung

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

830

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Study Locations

Argentina
- - CABA, Argentina, 1425
    - Recruiting
    - Research Site
  - Córdoba, Argentina, 5000
    - Recruiting
    - Research Site
  - Pilar, Argentina, B1629AHJ
    - Not yet recruiting
    - Research Site
  - Rosario, Argentina, 2000
    - Recruiting
    - Research Site
  - Viedma, Argentina, R8500ACE
    - Recruiting
    - Research Site
Australia
- - Hobart, Australia, 7000
    - Withdrawn
    - Research Site
  - Woolloongabba, Australia, 4102
    - Withdrawn
    - Research Site
Belgium
- - Edegem, Belgium, 2650
    - Recruiting
    - Research Site
  - Jette, Belgium, 1090
    - Recruiting
    - Research Site
  - Libramont-Chevigny, Belgium, 6800
    - Recruiting
    - Research Site
  - Liège, Belgium, 4000
    - Recruiting
    - Research Site
  - Mechelen, Belgium, 2800
    - Recruiting
    - Research Site
  - Roeselaere, Belgium, 8800
    - Recruiting
    - Research Site
Brazil
- - Blumenau, Brazil, 89010-340
    - Recruiting
    - Research Site
  - Fortaleza, Brazil, 60336-550
    - Recruiting
    - Research Site
  - Ijuí, Brazil, 98700-000
    - Recruiting
    - Research Site
  - Itajaí, Brazil, 88301-220
    - Recruiting
    - Research Site
  - Londrina, Brazil, 86015-520
    - Recruiting
    - Research Site
  - Passo Fundo, Brazil, 99010-260
    - Recruiting
    - Research Site
  - Porto Alegre, Brazil, 90035-903
    - Recruiting
    - Research Site
  - Porto Alegre, Brazil, 90610-000
    - Recruiting
    - Research Site
  - Porto Velho, Brazil, 76834-899
    - Recruiting
    - Research Site
  - Salvador, Brazil, 41950-640
    - Recruiting
    - Research Site
  - Salvador, Brazil, 41253-190
    - Recruiting
    - Research Site
  - Santo André, Brazil, 09060-650
    - Recruiting
    - Research Site
  - São Paulo, Brazil, 01246-000
    - Recruiting
    - Research Site
  - São Paulo, Brazil, 04501-000
    - Recruiting
    - Research Site
  - Teresina, Brazil, 64049-200
    - Recruiting
    - Research Site
Bulgaria
- - Burgas, Bulgaria, 8000
    - Recruiting
    - Research Site
  - Panagyurishte, Bulgaria, 4500
    - Not yet recruiting
    - Research Site
  - Sofia, Bulgaria, 1407
    - Recruiting
    - Research Site
  - Sofia, Bulgaria, 1618
    - Recruiting
    - Research Site
  - Sofia, Bulgaria, 1756
    - Not yet recruiting
    - Research Site
  - Varna, Bulgaria, 9010
    - Not yet recruiting
    - Research Site
Canada
- Alberta
  - Edmonton, Alberta, Canada, T6G 1Z2
    - Recruiting
    - Research Site
- British Columbia
  - Kelowna, British Columbia, Canada, V1Y 5L3
    - Not yet recruiting
    - Research Site
- Ontario
  - Cambridge, Ontario, Canada, N1R 3G2
    - Not yet recruiting
    - Research Site
  - Newmarket, Ontario, Canada, L3Y 2P9
    - Not yet recruiting
    - Research Site
  - Toronto, Ontario, Canada, M4N 3M5
    - Recruiting
    - Research Site
- Quebec
  - Québec, Quebec, Canada, G1V 4G5
    - Not yet recruiting
    - Research Site
  - Saint-Jérôme, Quebec, Canada, J7Z 5T3
    - Not yet recruiting
    - Research Site
Chile
- - Conception, Chile, 4070196
    - Recruiting
    - Research Site
  - Santiago, Chile, 7500653
    - Recruiting
    - Research Site
  - Santiago, Chile, 8420383
    - Recruiting
    - Research Site
  - Santiago, Chile, 7500713
    - Recruiting
    - Research Site
China
- - Baoding, China, 071000
    - Not yet recruiting
    - Research Site
  - Beijing, China, 100142
    - Not yet recruiting
    - Research Site
  - Beijing, China, 100021
    - Recruiting
    - Research Site
  - Beijing, China, 101149
    - Not yet recruiting
    - Research Site
  - Bengbu, China, 233004
    - Recruiting
    - Research Site
  - Changchun, China, 130000
    - Not yet recruiting
    - Research Site
  - Changchun, China, 130033
    - Recruiting
    - Research Site
  - Changsha, China, 410013
    - Not yet recruiting
    - Research Site
  - Changsha, China, 410008
    - Not yet recruiting
    - Research Site
  - Chengdu, China, 610041
    - Recruiting
    - Research Site
  - Chongqing, China, 400042
    - Not yet recruiting
    - Research Site
  - Chongqing, China, 400030
    - Not yet recruiting
    - Research Site
  - Fuzhou, China, 350001
    - Recruiting
    - Research Site
  - Fuzhou, China, 350014
    - Not yet recruiting
    - Research Site
  - Guangzhou, China, 510080
    - Recruiting
    - Research Site
  - Haerbin, China, 150081
    - Recruiting
    - Research Site
  - Hangzhou, China, 310022
    - Not yet recruiting
    - Research Site
  - Hefei, China, 133500
    - Recruiting
    - Research Site
  - Hefei, China, 230022
    - Recruiting
    - Research Site
  - Jiamusi, China, 154007
    - Recruiting
    - Research Site
  - Jinan, China, 250117
    - Recruiting
    - Research Site
  - Lanzhou, China, 730050
    - Recruiting
    - Research Site
  - Linyi, China, 276001
    - Recruiting
    - Research Site
  - Liuzhou, China, 545007
    - Recruiting
    - Research Site
  - Nanchang, China, 330006
    - Not yet recruiting
    - Research Site
  - Nanchang, China, 330029
    - Recruiting
    - Research Site
  - Nanjing, China, 210008
    - Recruiting
    - Research Site
  - Nanjing, China, 210006
    - Recruiting
    - Research Site
  - Nanning, China, 530021
    - Not yet recruiting
    - Research Site
  - Ningbo, China, 315010
    - Recruiting
    - Research Site
  - Qingdao, China, 266071
    - Recruiting
    - Research Site
  - Shanghai, China, 200092
    - Not yet recruiting
    - Research Site
  - Shenyang, China, 110042
    - Not yet recruiting
    - Research Site
  - Suzhou, China, 215004
    - Recruiting
    - Research Site
  - Taiyuan, China, 030000
    - Recruiting
    - Research Site
  - Wuhan, China, 430060
    - Not yet recruiting
    - Research Site
  - Wuhan, China, 430030
    - Not yet recruiting
    - Research Site
  - Xuzhou, China, 221002
    - Recruiting
    - Research Site
  - Yantai, China, 264000
    - Recruiting
    - Research Site
  - Zhengzhou, China, 450008
    - Not yet recruiting
    - Research Site
Colombia
- - Cali, Colombia, 760032
    - Not yet recruiting
    - Research Site
  - Floridablanca, Colombia, 680001
    - Not yet recruiting
    - Research Site
  - Medellín, Colombia, 050034
    - Not yet recruiting
    - Research Site
  - Valledupar, Colombia, 200001
    - Not yet recruiting
    - Research Site
Costa Rica
- - San José, Costa Rica, 1000
    - Recruiting
    - Research Site
  - San José, Costa Rica, 10108
    - Recruiting
    - Research Site
  - San José Capital, Costa Rica, 1000
    - Recruiting
    - Research Site
  - Santa Ana, Costa Rica, 10903
    - Recruiting
    - Research Site
France
- - Angers, France, 49100
    - Not yet recruiting
    - Research Site
  - Avignon, France, 84000
    - Recruiting
    - Research Site
  - Boulogne-Billancourt, France, 92100
    - Recruiting
    - Research Site
  - Caen, France, 14000
    - Recruiting
    - Research Site
  - Chambéry, France, 73011
    - Recruiting
    - Research Site
  - Dijon, France, 21000
    - Not yet recruiting
    - Research Site
  - La Tronche, France, 38700
    - Recruiting
    - Research Site
  - Limoges, France, 87042
    - Recruiting
    - Research Site
  - Nantes, France, 44093
    - Recruiting
    - Research Site
  - Paris, France, 75020
    - Recruiting
    - Research Site
  - Pau, France, 64046
    - Recruiting
    - Research Site
  - St-Malo, France, 35403
    - Recruiting
    - Research Site
  - Toulouse, France, 31300
    - Not yet recruiting
    - Research Site
  - Tours, France, 37000
    - Recruiting
    - Research Site
Georgia
- - Tbilisi, Georgia, 0159
    - Recruiting
    - Research Site
  - Tbilisi, Georgia, 0112
    - Recruiting
    - Research Site
  - Tbilisi, Georgia, 160
    - Recruiting
    - Research Site
  - Tbilisi, Georgia, 177
    - Recruiting
    - Research Site
Germany
- - Amberg, Germany, 92224
    - Recruiting
    - Research Site
  - Augsburg, by, Germany, 86156
    - Not yet recruiting
    - Research Site
  - Bad Saarow, Germany, 15526
    - Recruiting
    - Research Site
  - Berlin, Germany, 12351
    - Not yet recruiting
    - Research Site
  - Berlin, Germany, 13359
    - Recruiting
    - Research Site
  - Bonn, Germany, 53127
    - Not yet recruiting
    - Research Site
  - Braunschweig, Germany, 38114
    - Recruiting
    - Research Site
  - Essen, Germany, 45147
    - Not yet recruiting
    - Research Site
  - Flensburg, Germany, 24939
    - Recruiting
    - Research Site
  - Frankfurt am Main, Germany, 60431
    - Not yet recruiting
    - Research Site
  - Hamburg, Germany, 21075
    - Recruiting
    - Research Site
  - Heidelberg, Germany, 69126
    - Recruiting
    - Research Site
  - Heilbronn, Germany, 74078
    - Not yet recruiting
    - Research Site
  - Immenhausen, Germany, 34376
    - Recruiting
    - Research Site
  - Koblenz, Germany, 56073
    - Recruiting
    - Research Site
  - Leipzig, Germany, 04103
    - Not yet recruiting
    - Research Site
  - München, Germany, 80336
    - Not yet recruiting
    - Research Site
  - Offenbach, Germany, 63069
    - Not yet recruiting
    - Research Site
  - Oldenburg, Germany, 26121
    - Recruiting
    - Research Site
  - Remscheid, Germany, 42859
    - Not yet recruiting
    - Research Site
  - Rotenburg (Wümme), Germany, 27356
    - Not yet recruiting
    - Research Site
  - Schweinfurt, Germany, 97421
    - Recruiting
    - Research Site
  - Trier, Germany, 54292
    - Not yet recruiting
    - Research Site
  - Velbert, Germany, 42551
    - Recruiting
    - Research Site
  - Wuppertal, Germany, 42283
    - Recruiting
    - Research Site
  - Würselen, Germany, 52146
    - Not yet recruiting
    - Research Site
  - Würzburg, Germany, 97080
    - Recruiting
    - Research Site
Greece
- - Athens, Greece, 12462
    - Not yet recruiting
    - Research Site
  - Athens, Greece, 11527
    - Recruiting
    - Research Site
  - Athens, Greece, 115 27
    - Recruiting
    - Research Site
  - Piraeus, Greece, 185 37
    - Recruiting
    - Research Site
  - Piraeus, Greece, 185 47
    - Recruiting
    - Research Site
  - Thessaloniki, Greece, 56429
    - Not yet recruiting
    - Research Site
  - Thessaloniki, Greece, 55236
    - Not yet recruiting
    - Research Site
  - Thessaloniki, Greece, 57001
    - Not yet recruiting
    - Research Site
  - Thessaloniki, Greece, 55236
    - Recruiting
    - Research Site
Ireland
- - Dublin, Ireland, D08 NHY1
    - Recruiting
    - Research Site
  - Dublin, Ireland, D24 NR0A
    - Recruiting
    - Research Site
  - Dublin, Ireland, D07 R2WY
    - Recruiting
    - Research Site
  - Dublin, Ireland, D09 V2N0
    - Recruiting
    - Research Site
  - Dublin, Ireland, DO4YN63
    - Recruiting
    - Research Site
  - Galway, Ireland, H91 YR71
    - Not yet recruiting
    - Research Site
Israel
- - Afula, Israel, 1834111
    - Recruiting
    - Research Site
  - Beersheba, Israel, 8410101
    - Recruiting
    - Research Site
  - Hadera, Israel, 38100
    - Recruiting
    - Research Site
  - Haifa, Israel, 34362
    - Recruiting
    - Research Site
  - Haifa, Israel, 91096
    - Recruiting
    - Research Site
  - Jerusalem, Israel, 91031
    - Recruiting
    - Research Site
  - Jerusalem, Israel, 91120
    - Recruiting
    - Research Site
  - Ramat Gan, Israel, 52621
    - Recruiting
    - Research Site
  - Tel Aviv, Israel, 64239
    - Recruiting
    - Research Site
  - Tel Aviv, Israel, 69710
    - Recruiting
    - Research Site
Italy
- - Candiolo, Italy, 10060
    - Recruiting
    - Research Site
  - Lecco, Italy, 23900
    - Recruiting
    - Research Site
  - Lucca, Italy, 55100
    - Recruiting
    - Research Site
  - Meldola, Italy, 47014
    - Recruiting
    - Research Site
  - Milan, Italy, 20133
    - Not yet recruiting
    - Research Site
  - Naples, Italy, 80131
    - Recruiting
    - Research Site
  - Peschiera del Garda, Italy, 37019
    - Recruiting
    - Research Site
  - Pisa, Italy, 56126
    - Recruiting
    - Research Site
  - Roma, Italy, 00144
    - Recruiting
    - Research Site
  - Torrette Di Ancona, Italy, 60126
    - Recruiting
    - Research Site
  - Udine, Italy, 33100
    - Recruiting
    - Research Site
  - Verona, Italy, 37126
    - Recruiting
    - Research Site
Japan
- - Akashi, Japan, 673-8558
    - Recruiting
    - Research Site
  - Bunkyō City, Japan, 113-8603
    - Recruiting
    - Research Site
  - Bunkyō City, Japan, 113-8677
    - Recruiting
    - Research Site
  - Fukuoka, Japan, 812-8582
    - Recruiting
    - Research Site
  - Fukuoka, Japan, 811-1395
    - Recruiting
    - Research Site
  - Hamamatsu, Japan, 431-3192
    - Recruiting
    - Research Site
  - Iwakuni-shi, Japan, 740-8510
    - Recruiting
    - Research Site
  - Izumi-shi, Japan, 594-0073
    - Recruiting
    - Research Site
  - Kashihara-shi, Japan, 634-8522
    - Recruiting
    - Research Site
  - Kobe, Japan, 650-0046
    - Recruiting
    - Research Site
  - Kurume-shi, Japan, 830-0011
    - Recruiting
    - Research Site
  - Kyoto, Japan, 602-8566
    - Recruiting
    - Research Site
  - Kōtoku, Japan, 135-8550
    - Recruiting
    - Research Site
  - Matsuyama, Japan, 791-0280
    - Recruiting
    - Research Site
  - Nankoku-shi, Japan, 783-8505
    - Recruiting
    - Research Site
  - Niigata, Japan, 951-8566
    - Recruiting
    - Research Site
  - Osaka, Japan, 534-0021
    - Recruiting
    - Research Site
  - Sakaishi, Japan, 591-8555
    - Recruiting
    - Research Site
  - Sayama, Japan, 589-8511
    - Recruiting
    - Research Site
  - Sendai, Japan, 980-0873
    - Recruiting
    - Research Site
  - Shinagawa-ku, Japan, 142-8666
    - Recruiting
    - Research Site
  - Takarazuka-shi, Japan, 665-0827
    - Recruiting
    - Research Site
  - Toon-Shi, Japan, 791-0295
    - Recruiting
    - Research Site
  - Toyoake-shi, Japan, 470-1192
    - Recruiting
    - Research Site
  - Toyonaka-shi, Japan, 560-8552
    - Recruiting
    - Research Site
Malaysia
- - George Town, Malaysia, 10350
    - Recruiting
    - Research Site
  - Kota Bharu, Malaysia, 15586
    - Recruiting
    - Research Site
  - Kuala Lumpur, Malaysia, 50586
    - Recruiting
    - Research Site
  - Kuala Selangor, Malaysia, 62250
    - Recruiting
    - Research Site
  - Perai, Malaysia, 13700
    - Recruiting
    - Research Site
Portugal
- - Alcabideche, Portugal, 2755-009
    - Recruiting
    - Research Site
  - Braga, Portugal, 4710-243
    - Recruiting
    - Research Site
  - Coimbra, Portugal, 3000-075
    - Recruiting
    - Research Site
  - Lisbon, Portugal, 1400-038
    - Recruiting
    - Research Site
  - Lisbon, Portugal, 1500-650
    - Recruiting
    - Research Site
  - Lisbon, Portugal, 1769-001
    - Recruiting
    - Research Site
  - Loures, Portugal, 2674-514
    - Recruiting
    - Research Site
  - Matosinhos Municipality, Portugal, 4454-509
    - Recruiting
    - Research Site
  - Porto, Portugal, 4200-319
    - Recruiting
    - Research Site
  - Porto, Portugal, 4200-072
    - Recruiting
    - Research Site
  - Porto, Portugal, 4100-180
    - Recruiting
    - Research Site
Romania
- - Bucharest, Romania, 022328
    - Recruiting
    - Research Site
  - Bucharest, Romania, 013812
    - Recruiting
    - Research Site
  - Bucharest, Romania, 30167
    - Recruiting
    - Research Site
  - Bucharest, Romania, 010626
    - Recruiting
    - Research Site
  - Craiova, Romania, 200385
    - Recruiting
    - Research Site
  - Craiova, Romania, 200542
    - Recruiting
    - Research Site
  - Iași, Romania, 700106
    - Not yet recruiting
    - Research Site
  - Otopeni, Romania, 075100
    - Recruiting
    - Research Site
  - Piteşti, Romania, 110283
    - Recruiting
    - Research Site
  - Sibiu, Romania, 550253
    - Recruiting
    - Research Site
  - Timișoara, Romania, 300239
    - Recruiting
    - Research Site
South Korea
- - Jinju, South Korea, 52727
    - Recruiting
    - Research Site
  - Seoul, South Korea, 5505
    - Recruiting
    - Research Site
  - Seoul, South Korea, 135-710
    - Recruiting
    - Research Site
Spain
- - Badajoz, Spain, 06080
    - Not yet recruiting
    - Research Site
  - Badalona, Spain, 8916
    - Not yet recruiting
    - Research Site
  - Barcelona, Spain, 08028
    - Not yet recruiting
    - Research Site
  - Castellon, Spain, 12002
    - Not yet recruiting
    - Research Site
  - Granada, Spain, 18016
    - Not yet recruiting
    - Research Site
  - Jaén, Spain, 23007
    - Not yet recruiting
    - Research Site
  - Lugo, Spain, 27003
    - Not yet recruiting
    - Research Site
  - Madrid, Spain, 28040
    - Not yet recruiting
    - Research Site
  - Madrid, Spain, 28050
    - Not yet recruiting
    - Research Site
  - Madrid, Spain, 28041
    - Not yet recruiting
    - Research Site
  - Málaga, Spain, 29010
    - Not yet recruiting
    - Research Site
  - Oviedo, Spain, 33006
    - Not yet recruiting
    - Research Site
  - Palma de Mallorca, Spain, 07198
    - Not yet recruiting
    - Research Site
  - Valencia, Spain, 46015
    - Not yet recruiting
    - Research Site
  - Vigo (Pontevedra), Spain, 36312
    - Not yet recruiting
    - Research Site
  - Zaragoza, Spain, 50009
    - Not yet recruiting
    - Research Site
Switzerland
- - Lausanne, Switzerland, 1011
    - Recruiting
    - Research Site
Turkey (Türkiye)
- - Ankara, Turkey (Türkiye), 06010
    - Recruiting
    - Research Site
  - Bakırköy, Turkey (Türkiye), 34147
    - Recruiting
    - Research Site
  - Küçükçekmece, Turkey (Türkiye), 34295
    - Recruiting
    - Research Site
  - Yüreğir, Turkey (Türkiye), 01240
    - Recruiting
    - Research Site
  - Çankaya, Turkey (Türkiye), 06680
    - Recruiting
    - Research Site
  - İzmit, Turkey (Türkiye), 41380
    - Recruiting
    - Research Site
United Kingdom
- - Blackpool, United Kingdom, FY3 8NR
    - Recruiting
    - Research Site
  - Glasgow, United Kingdom, G12 0YN
    - Recruiting
    - Research Site
  - Guildford, United Kingdom, GU2 7XX
    - Not yet recruiting
    - Research Site
  - Hull, United Kingdom, HU16 5JQ
    - Recruiting
    - Research Site
  - Oxford, United Kingdom, OX4 6LB
    - Recruiting
    - Research Site
  - Stevenage, United Kingdom, SG1 4AB
    - Recruiting
    - Research Site
United States
- California
  - La Mesa, California, United States, 91942
    - Not yet recruiting
    - Research Site
  - Los Alamitos, California, United States, 90720
    - Not yet recruiting
    - Research Site
- Connecticut
  - Farmington, Connecticut, United States, 06030
    - Recruiting
    - Research Site
- Delaware
  - Newark, Delaware, United States, 19713
    - Recruiting
    - Research Site
- Florida
  - Bay Pines, Florida, United States, 33744
    - Recruiting
    - Research Site
  - Clearwater, Florida, United States, 33756
    - Recruiting
    - Research Site
  - St. Petersburg, Florida, United States, 33705
    - Recruiting
    - Research Site
- Georgia
  - Marietta, Georgia, United States, 30060
    - Recruiting
    - Research Site
- Illinois
  - Chicago, Illinois, United States, 60612
    - Recruiting
    - Research Site
  - Decatur, Illinois, United States, 62526
    - Recruiting
    - Research Site
- Iowa
  - Des Moines, Iowa, United States, 50309
    - Recruiting
    - Research Site
  - Waterloo, Iowa, United States, 50702
    - Not yet recruiting
    - Research Site
- Kansas
  - Leawood, Kansas, United States, 66209
    - Recruiting
    - Research Site
- Kentucky
  - Lexington, Kentucky, United States, 40536
    - Not yet recruiting
    - Research Site
  - Owensboro, Kentucky, United States, 42303
    - Recruiting
    - Research Site
- Maryland
  - Bethesda, Maryland, United States, 20817
    - Recruiting
    - Research Site
  - Frederick, Maryland, United States, 21702
    - Recruiting
    - Research Site
  - Silver Spring, Maryland, United States, 20910
    - Recruiting
    - Research Site
  - Towson, Maryland, United States, 21204
    - Recruiting
    - Research Site
- Michigan
  - Saginaw, Michigan, United States, 48602
    - Not yet recruiting
    - Research Site
- Missouri
  - Bridgeton, Missouri, United States, 63044
    - Recruiting
    - Research Site
- Nebraska
  - Lincoln, Nebraska, United States, 68506
    - Recruiting
    - Research Site
- New Jersey
  - Paramus, New Jersey, United States, 07652
    - Not yet recruiting
    - Research Site
- New York
  - Buffalo, New York, United States, 14215
    - Recruiting
    - Research Site
  - East Syracuse, New York, United States, 13057
    - Recruiting
    - Research Site
  - Fresh Meadows, New York, United States, 11366
    - Not yet recruiting
    - Research Site
  - Rochester, New York, United States, 14642
    - Not yet recruiting
    - Research Site
  - Westbury, New York, United States, 11590
    - Recruiting
    - Research Site
- Ohio
  - Canton, Ohio, United States, 44718
    - Not yet recruiting
    - Research Site
- Pennsylvania
  - Fountain Hill, Pennsylvania, United States, 18015
    - Recruiting
    - Research Site
  - Kittanning, Pennsylvania, United States, 16201
    - Not yet recruiting
    - Research Site
  - Philadelphia, Pennsylvania, United States, 19104
    - Recruiting
    - Research Site
- Texas
  - Round Rock, Texas, United States, 78665
    - Not yet recruiting
    - Research Site
- Washington
  - Aberdeen, Washington, United States, 98520
    - Not yet recruiting
    - Research Site
  - Renton, Washington, United States, 98055
    - Not yet recruiting
    - Research Site
- West Virginia
  - Charleston, West Virginia, United States, 25304
    - Recruiting
    - Research Site
  - Morgantown, West Virginia, United States, 26506
    - Recruiting
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A Drug: rilvegostomig	Biological: Rilvegostomig Administered intravenously (IV) on Day 1 of each 21-day cycle Other Names: AZD2936
Active Comparator: Arm B Drug: Pembrolizumab	Biological: Pembrolizumab Administered intravenously (IV) on Day 1 of each 21-day cycle Other Names: KEYTRUDA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) Time Frame: Up to approximately 5 years	OS is defined as the time from randomization until the date of death due to any cause.	Up to approximately 5 years
Progression-Free Survival (PFS) Time Frame: Up to approximately 5 years	PFS is defined as the time from randomization until radiological progression per RECIST 1.1 or death due to any cause (in the absence of progression).	Up to approximately 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity of rilvegostomig Time Frame: Up to approximately 5 years	Presence of antidrug antibodies (ADAs), titer, and neutralizing antibodies for rilvegostomig.	Up to approximately 5 years
Patient-reported physical functioning Time Frame: Up to approximately 5 years	Proportion of participants with maintained or improved physical functioning as measured by Patient-Reported Outcomes Measurement Information System Physical Function - Short Form 8c - 7 day (PROMIS PF-SF 8c - 7 day) at each time point.	Up to approximately 5 years
Patient-reported global health status (GHS)/quality of life (QoL) Time Frame: Up to approximately 5 years	Time to deterioration (TTD) of GHS/QoL as measured by the European Organization for Research and Treatment of Cancer Item Library 172 (EORTC IL172). TTD is defined as time from randomization to the date of first deterioration.	Up to approximately 5 years
Patient-reported lung cancer symptoms of non-small cell lung cancer (NSCLC) Time Frame: Up to approximately 5 years	Time to deterioration (TTD) in pulmonary symptoms as measured by the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ). TTD is defined as time from randomization to the date of first deterioration.	Up to approximately 5 years
Landmark Overall Survival (OS) rates Time Frame: Up to approximately 5 years	OS is defined as the time from randomization until the date of death due to any cause.	Up to approximately 5 years
Landmark Progression-Free Survival (PFS) rates Time Frame: Up to approximately 5 years	PFS is defined as the time from randomization until radiological progression per RECIST 1.1 or death due to any cause (in the absence of progression).	Up to approximately 5 years
Objective Response Rate (ORR) Time Frame: Up to approximately 5 years	ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, using RECIST 1.1.	Up to approximately 5 years
Duration of Response (DoR) Time Frame: Up to approximately 5 years	DoR is defined as the time from the date of first documented response until the date of documented progression using RECIST 1.1 or death due to any cause (in the absence of progression).	Up to approximately 5 years
Time to second progression or death (PFS2) Time Frame: Up to approximately 5 years	PFS2 is defined as the time from randomization until the earliest of the progression event (following the initial investigator-assessed progression event), after the start of the first subsequent therapy, or death from any cause, whichever occurs first.	Up to approximately 5 years
Pharmakokinetics (PK) of rilvegostomig Time Frame: Up to approximately 5 years	Concentration of rilvegostomig in serum	Up to approximately 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2025

Primary Completion (Estimated)

January 17, 2030

Study Completion (Estimated)

December 2, 2030

Study Registration Dates

First Submitted

March 7, 2025

First Submitted That Met QC Criteria

March 7, 2025

First Posted (Actual)

March 10, 2025

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

D702GC00001
2024-517780-24-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual participant-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing 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 refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Carcinoma, Non-Small Cell Lung

Clinical Trials on Rilvegostomig

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