Carcinoma, Non-Small Cell LungPhase 3ARTEMIDELung04NCT06868277
A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer
A Phase 3 study testing Rilvegostomig and Pembrolizumab in people with Carcinoma, Non-Small Cell Lung, run by AstraZeneca at 304 sites in 27 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small Cell Lung
- What is being tested?
- Rilvegostomig and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 830 participants
- Where
- 304 sitesin 27 countries
- Study dates
- 10 Apr 2025to 2 Dec 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
304 sites in 27 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
304 sites in 27 countries
China42 sites, 42 recruiting
- Not yet recruiting
Research Site
Baoding, 071000
- Recruiting
Research Site
Beijing, 100021
- Not yet recruiting
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Beijing, 100142
- Not yet recruiting
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Beijing, 101149
- Recruiting
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Bengbu, 233004
- Not yet recruiting
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Changchun, 130000
- Recruiting
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Changchun, 130033
- Not yet recruiting
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Changsha, 410008
- Not yet recruiting
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Changsha, 410013
- Recruiting
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Chengdu, 610041
- Not yet recruiting
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Chongqing, 400030
- Not yet recruiting
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Chongqing, 400042
- Recruiting
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Fuzhou, 350001
- Not yet recruiting
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Fuzhou, 350014
- Recruiting
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Guangzhou, 510080
- Recruiting
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Haerbin, 150081
- Not yet recruiting
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Hangzhou, 310022
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Hefei, 133500
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Hefei, 230022
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Jiamusi, 154007
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Jinan, 250117
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Langfang, 65699
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Lanzhou, 730050
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Linyi, 276001
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Liuzhou, 545007
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Nanchang, 330006
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Nanchang, 330029
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Nanjing, 210006
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Nanjing, 210008
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Nanning, 530021
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Ningbo, 315010
- Recruiting
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Qingdao, 266071
- Not yet recruiting
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Shanghai, 200092
- Not yet recruiting
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Shenyang, 110042
- Not yet recruiting
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Shenzhen, 518116
- Recruiting
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Suzhou, 215004
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Taiyuan, 030000
- Not yet recruiting
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Wuhan, 430030
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Wuhan, 430060
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Xuzhou, 221002
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Yantai, 264000
- Not yet recruiting
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Zhengzhou, 450008
United States39 sites, 39 recruiting
- Recruiting
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Aberdeen, Washington, 98520
- Recruiting
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Bay Pines, Florida, 33744
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Bethesda, Maryland, 20817
- Recruiting
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Bridgeton, Missouri, 63044
- Recruiting
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Buffalo, New York, 14215
- Not yet recruiting
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Canton, Ohio, 44718
- Recruiting
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Charleston, West Virginia, 25304
- Recruiting
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Chicago, Illinois, 60612
- Recruiting
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Clearwater, Florida, 33756
- Recruiting
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Decatur, Illinois, 62526
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Des Moines, Iowa, 50309
- Recruiting
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East Syracuse, New York, 13057
- Recruiting
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Fountain Hill, Pennsylvania, 18015
- Recruiting
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Frederick, Maryland, 21702
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Fresh Meadows, New York, 11366
- Recruiting
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Gainesville, Florida, 32610
- Not yet recruiting
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Kittanning, Pennsylvania, 16201
- Not yet recruiting
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La Mesa, California, 91942
- Recruiting
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Leawood, Kansas, 66209
- Not yet recruiting
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Lexington, Kentucky, 40536
- Recruiting
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Lincoln, Nebraska, 68506
- Not yet recruiting
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Los Alamitos, California, 90720
- Recruiting
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Marietta, Georgia, 30060
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Morgantown, West Virginia, 26506
- Recruiting
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Newark, Delaware, 19713
- Recruiting
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Owensboro, Kentucky, 42303
- Not yet recruiting
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Paramus, New Jersey, 07652
- Recruiting
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Philadelphia, Pennsylvania, 19104
- Recruiting
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Reno, Nevada, 89511
- Not yet recruiting
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Renton, Washington, 98055
- Not yet recruiting
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Rochester, New York, 14642
- Not yet recruiting
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Round Rock, Texas, 78665
- Not yet recruiting
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Saginaw, Michigan, 48602
- Not yet recruiting
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Schofield, Wisconsin, 54476
- Recruiting
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Silver Spring, Maryland, 20910
- Recruiting
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St. Petersburg, Florida, 33705
- Recruiting
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Towson, Maryland, 21204
- Not yet recruiting
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Waterloo, Iowa, 50702
- Recruiting
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Westbury, New York, 11590
Germany28 sites, 28 recruiting
- Recruiting
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Amberg, 92224
- Not yet recruiting
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Augsburg, by, 86156
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Bad Saarow, 15526
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Berlin, 12351
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Berlin, 13359
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Bonn, 53127
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Braunschweig, 38114
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Essen, 45147
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Flensburg, 24939
- Not yet recruiting
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Frankfurt am Main, 60431
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Hamburg, 21075
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Heidelberg, 69126
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Heilbronn, 74078
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Immenhausen, 34376
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Koblenz, 56073
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Leipzig, 04103
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München, 80336
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Neuss, 41462
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Offenbach, 63069
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Oldenburg, 26121
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Remscheid, 42859
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Rotenburg (Wümme), 27356
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Schweinfurt, 97421
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Trier, 54292
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Velbert, 42551
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Wuppertal, 42283
- Not yet recruiting
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Würselen, 52146
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Würzburg, 97080
Japan25 sites, 25 recruiting
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Akashi, 673-8558
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Bunkyō City, 113-8603
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Bunkyō City, 113-8677
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Fukuoka, 811-1395
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Fukuoka, 812-8582
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Hamamatsu, 431-3192
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Iwakuni-shi, 740-8510
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Izumi-shi, 594-0073
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Kashihara-shi, 634-8522
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Kobe, 650-0046
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Kōtoku, 135-8550
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Kurume-shi, 830-0011
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Kyoto, 602-8566
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Matsuyama, 791-0280
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Nankoku-shi, 783-8505
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Niigata, 951-8566
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Osaka, 534-0021
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Sakaishi, 591-8555
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Sayama, 589-8511
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Sendai, 980-0873
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Shinagawa-ku, 142-8666
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Takarazuka-shi, 665-0827
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Toon-Shi, 791-0295
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Toyoake-shi, 470-1192
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Toyonaka-shi, 560-8552
Spain16 sites, 16 recruiting
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Badajoz, 06080
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Badalona, 8916
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Barcelona, 08028
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Castellon, 12002
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Granada, 18016
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Jaén, 23007
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Lugo, 27003
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Madrid, 28040
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Madrid, 28041
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Madrid, 28050
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Málaga, 29010
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Oviedo, 33006
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Palma de Mallorca, 07198
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Valencia, 46015
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Vigo (Pontevedra), 36312
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Zaragoza, 50009
Brazil15 sites, 15 recruiting
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Blumenau, 89010-340
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Fortaleza, 60336-550
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Ijuí, 98700-000
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Itajaí, 88301-220
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Londrina, 86015-520
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Passo Fundo, 99010-260
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Porto Alegre, 90035-903
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Porto Alegre, 90610-000
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Porto Velho, 76834-899
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Salvador, 41253-190
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Salvador, 41950-640
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Santo André, 09060-650
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São Paulo, 01246-000
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São Paulo, 04501-000
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Teresina, 64049-200
France14 sites, 14 recruiting
- Not yet recruiting
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Angers, 49100
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Avignon, 84000
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Boulogne-Billancourt, 92100
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Caen, 14000
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Chambéry, 73011
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Dijon, 21000
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La Tronche, 38700
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Limoges, 87042
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Nantes, 44093
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Paris, 75020
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Pau, 64046
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St-Malo, 35403
- Not yet recruiting
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Toulouse, 31300
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Tours, 37000
Italy13 sites, 13 recruiting
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Candiolo, 10060
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Lecco, 23900
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Lucca, 55100
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Meldola, 47014
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Milan, 20132
- Not yet recruiting
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Milan, 20133
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Naples, 80131
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Peschiera del Garda, 37019
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Pisa, 56126
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Roma, 00144
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Torrette Di Ancona, 60126
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Udine, 33100
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Verona, 37126
Portugal11 sites, 11 recruiting
- Recruiting
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Alcabideche, 2755-009
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Braga, 4710-243
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Coimbra, 3000-075
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Lisbon, 1400-038
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Lisbon, 1500-650
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Lisbon, 1769-001
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Loures, 2674-514
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Matosinhos Municipality, 4454-509
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Porto, 4100-180
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Porto, 4200-072
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Porto, 4200-319
Romania11 sites, 11 recruiting
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Bucharest, 010626
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Bucharest, 013812
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Bucharest, 022328
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Bucharest, 30167
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Craiova, 200385
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Craiova, 200542
- Not yet recruiting
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Iași, 700106
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Otopeni, 075100
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Piteşti, 110283
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Sibiu, 550253
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Timișoara, 300239
Israel10 sites, 10 recruiting
- Recruiting
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Afula, 1834111
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Beersheba, 8410101
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Hadera, 38100
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Haifa, 34362
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Haifa, 91096
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Jerusalem, 91031
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Jerusalem, 91120
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Ramat Gan, 52621
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Tel Aviv, 64239
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Tel Aviv, 69710
Greece9 sites, 9 recruiting
- Recruiting
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Athens, 115 27
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Athens, 11527
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Athens, 12462
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Larissa, 411 10
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Piraeus, 185 37
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Piraeus, 185 47
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Thessaloniki, 55236
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Thessaloniki, 56429
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Thessaloniki, 57001
Canada7 sites, 7 recruiting
- Not yet recruiting
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Cambridge, Ontario, N1R 3G2
- Recruiting
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Edmonton, Alberta, T6G 1Z2
- Not yet recruiting
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Kelowna, British Columbia, V1Y 5L3
- Not yet recruiting
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Newmarket, Ontario, L3Y 2P9
- Not yet recruiting
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Québec, Quebec, G1V 4G5
- Not yet recruiting
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Saint-Jérôme, Quebec, J7Z 5T3
- Recruiting
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Toronto, Ontario, M4N 3M5
Ireland7 sites, 7 recruiting
- Not yet recruiting
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Cork, T12 DFK4
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Dublin, D07 R2WY
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Dublin, D08 NHY1
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Dublin, D09 V2N0
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Dublin, D24 NR0A
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Dublin, DO4YN63
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Galway, H91 YR71
Argentina6 sites, 6 recruiting
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CABA, 1425
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Córdoba, 5000
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Pilar, B1629AHJ
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Rosario, 2000
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Rosario, S2000CVB
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Viedma, R8500ACE
Belgium6 sites, 6 recruiting
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Edegem, 2650
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Jette, 1090
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Libramont-Chevigny, 6800
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Liège, 4000
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Mechelen, 2800
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Roeselaere, 8800
Bulgaria6 sites, 6 recruiting
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Burgas, 8000
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Panagyurishte, 4500
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Sofia, 1407
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Sofia, 1618
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Sofia, 1756
- Not yet recruiting
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Varna, 9010
Turkey (Türkiye)6 sites, 6 recruiting
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Ankara, 06010
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Bakırköy, 34147
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Çankaya, 06680
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İzmit, 41380
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Küçükçekmece, 34295
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Yüreğir, 01240
United Kingdom6 sites, 6 recruiting
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Blackpool, FY3 8NR
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Glasgow, G12 0YN
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Guildford, GU2 7XX
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Hull, HU16 5JQ
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Northwood, HA6 2RN
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Oxford, OX4 6LB
Malaysia5 sites, 5 recruiting
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George Town, 10350
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Kota Bharu, 15586
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Kuala Lumpur, 50586
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Kuala Selangor, 62250
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Perai, 13700
Chile4 sites, 4 recruiting
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Conception, 4070196
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Santiago, 7500653
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Santiago, 7500713
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Santiago, 8420383
Colombia4 sites, 4 recruiting
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Cali, 760032
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Floridablanca, 680001
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Medellín, 050034
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Valledupar, 200001
Costa Rica4 sites, 4 recruiting
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San José, 1000
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San José, 10108
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San José Capital, 1000
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Santa Ana, 10903
Georgia4 sites, 4 recruiting
- Recruiting
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Tbilisi, 0112
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Tbilisi, 0159
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Tbilisi, 160
- Recruiting
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Tbilisi, 177
South Korea3 sites, 3 recruiting
- Recruiting
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Jinju, 52727
- Recruiting
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Seoul, 135-710
- Recruiting
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Seoul, 5505
Australia2 sites
- Withdrawn
Research Site
Hobart, 7000
- Withdrawn
Research Site
Woolloongabba, 4102
About this study
Official title: 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.
Read the 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.
- Conditions
- Carcinoma, Non-Small Cell Lung
- Being tested
- Rilvegostomig, Pembrolizumab
- Keywords
- ARTEMIDE-Lung04, Rilvegostomig (AZD2936), Non-small cell lung cancer (NSCLC), Bi-specific antibody, T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domain (TIGIT), EGFR, ALK and ROS1 testing, Programmed cell death protein (PD-L1), Pembrolizumab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RilvegostomigBiological
Also called AZD2936
Administered intravenously (IV) on Day 1 of each 21-day cycle
PembrolizumabBiological
Also called KEYTRUDA
Administered intravenously (IV) on Day 1 of each 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Drug: rilvegostomig Receives: Biological: Rilvegostomig |
| Arm B | Active comparator | Drug: Pembrolizumab Receives: Biological: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS is defined as the time from randomization until the date of death due to any cause.
Measured: Up to approximately 5 years
Progression-Free Survival (PFS)
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).
Measured: Up to approximately 5 years
Secondary outcomes (10)
Landmark Overall Survival (OS) rates
OS is defined as the time from randomization until the date of death due to any cause.
Measured: Up to approximately 5 years
Landmark Progression-Free Survival (PFS) rates
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).
Measured: Up to approximately 5 years
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, using RECIST 1.1.
Measured: Up to approximately 5 years
Duration of Response (DoR)
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).
Measured: Up to approximately 5 years
Time to second progression or death (PFS2)
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.
Measured: Up to approximately 5 years
Pharmakokinetics (PK) of rilvegostomig
Concentration of rilvegostomig in serum
Measured: Up to approximately 5 years
Immunogenicity of rilvegostomig
Presence of antidrug antibodies (ADAs), titer, and neutralizing antibodies for rilvegostomig.
Measured: Up to approximately 5 years
Patient-reported physical functioning
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.
Measured: Up to approximately 5 years
Patient-reported global health status (GHS)/quality of life (QoL)
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.
Measured: Up to approximately 5 years
Patient-reported lung cancer symptoms of non-small cell lung cancer (NSCLC)
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.
Measured: Up to approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start10 Apr 2025
- Primary completion17 Jan 2030 (estimated)
- Study completion2 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small Cell LungStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to one of the following intervention arms: Arm A : Rilvegostomig Arm B : Pembrolizumab
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 830 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868277
- Sponsor's protocol ID
- D702GC00001
- Other IDs
- 2024-517780-24-00
- Acronym
- ARTEMIDELung04
- Status last verified
- Sep 2026
- First submitted
- 7 Mar 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.