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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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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
Are there results?: Not yet: the study is under way

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.

Show all 11Show fewer

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

1-877-240-9479

information.center@astrazeneca.com

Country

City, postcode or hospital

Sites recruiting now only

304 sites in 27 countries

China42 sites, 42 recruiting

Research Site
Baoding, 071000
Not yet recruiting
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Beijing, 100021
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Beijing, 100142
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Beijing, 101149
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Bengbu, 233004
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Changchun, 130000
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Changchun, 130033
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Changsha, 410008
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Changsha, 410013
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Chengdu, 610041
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Chongqing, 400030
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Chongqing, 400042
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Fuzhou, 350001
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Fuzhou, 350014
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Guangzhou, 510080
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Haerbin, 150081
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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
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Qingdao, 266071
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Shanghai, 200092
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Shenyang, 110042
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Shenzhen, 518116
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Suzhou, 215004
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Taiyuan, 030000
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Wuhan, 430030
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Wuhan, 430060
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Xuzhou, 221002
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Yantai, 264000
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Zhengzhou, 450008
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Other trials in China

United States39 sites, 39 recruiting

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Aberdeen, Washington, 98520
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Bay Pines, Florida, 33744
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Bethesda, Maryland, 20817
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Bridgeton, Missouri, 63044
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Buffalo, New York, 14215
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Canton, Ohio, 44718
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Charleston, West Virginia, 25304
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Chicago, Illinois, 60612
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Clearwater, Florida, 33756
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Decatur, Illinois, 62526
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Des Moines, Iowa, 50309
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East Syracuse, New York, 13057
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Fountain Hill, Pennsylvania, 18015
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Frederick, Maryland, 21702
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Fresh Meadows, New York, 11366
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Gainesville, Florida, 32610
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Kittanning, Pennsylvania, 16201
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La Mesa, California, 91942
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Leawood, Kansas, 66209
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Lexington, Kentucky, 40536
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Lincoln, Nebraska, 68506
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Los Alamitos, California, 90720
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Marietta, Georgia, 30060
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Morgantown, West Virginia, 26506
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Newark, Delaware, 19713
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Owensboro, Kentucky, 42303
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Paramus, New Jersey, 07652
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Philadelphia, Pennsylvania, 19104
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Reno, Nevada, 89511
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Renton, Washington, 98055
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Rochester, New York, 14642
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Round Rock, Texas, 78665
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Saginaw, Michigan, 48602
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Schofield, Wisconsin, 54476
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Silver Spring, Maryland, 20910
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St. Petersburg, Florida, 33705
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Towson, Maryland, 21204
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Waterloo, Iowa, 50702
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Westbury, New York, 11590
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Other trials in United States

Germany28 sites, 28 recruiting

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Amberg, 92224
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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
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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
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Würselen, 52146
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Würzburg, 97080
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Japan25 sites, 25 recruiting

Research Site
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
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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
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Other trials in Spain

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
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Other trials in Brazil

France14 sites, 14 recruiting

Research Site
Angers, 49100
Not yet recruiting
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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
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Toulouse, 31300
Not yet recruiting
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Tours, 37000
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Other trials in France

Italy13 sites, 13 recruiting

Research Site
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
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Milan, 20133
Not yet recruiting
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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
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Other trials in Italy

Portugal11 sites, 11 recruiting

Research Site
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
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Other trials in Portugal

Romania11 sites, 11 recruiting

Research Site
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
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Iași, 700106
Not yet recruiting
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Otopeni, 075100
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Piteşti, 110283
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Sibiu, 550253
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Timișoara, 300239
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Other trials in Romania

Israel10 sites, 10 recruiting

Research Site
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
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Other trials in Israel

Greece9 sites, 9 recruiting

Research Site
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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Research Site
Thessaloniki, 56429
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Research Site
Thessaloniki, 57001
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Other trials in Greece

Canada7 sites, 7 recruiting

Research Site
Cambridge, Ontario, N1R 3G2
Not yet recruiting
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Edmonton, Alberta, T6G 1Z2
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
Not yet recruiting
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Toronto, Ontario, M4N 3M5
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Other trials in Canada

Ireland7 sites, 7 recruiting

Research Site
Cork, T12 DFK4
Not yet recruiting
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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
Not yet recruiting

Other trials in Ireland

Argentina6 sites, 6 recruiting

Research Site
CABA, 1425
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Córdoba, 5000
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Research Site
Pilar, B1629AHJ
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Rosario, 2000
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Rosario, S2000CVB
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Viedma, R8500ACE
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Other trials in Argentina

Belgium6 sites, 6 recruiting

Research Site
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
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Other trials in Belgium

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
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Varna, 9010
Not yet recruiting

Other trials in Bulgaria

Turkey (Türkiye)6 sites, 6 recruiting

Research Site
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
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Other trials in Turkey (Türkiye)

United Kingdom6 sites, 6 recruiting

Research Site
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
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Other trials in United Kingdom

Malaysia5 sites, 5 recruiting

Research Site
George Town, 10350
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Kota Bharu, 15586
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Kuala Lumpur, 50586
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Research Site
Kuala Selangor, 62250
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Research Site
Perai, 13700
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Other trials in Malaysia

Chile4 sites, 4 recruiting

Research Site
Conception, 4070196
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Research Site
Santiago, 7500653
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Research Site
Santiago, 7500713
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Santiago, 8420383
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Colombia4 sites, 4 recruiting

Research Site
Cali, 760032
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Floridablanca, 680001
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Medellín, 050034
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Valledupar, 200001
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Other trials in Colombia

Costa Rica4 sites, 4 recruiting

Research Site
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
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Other trials in Costa Rica

Georgia4 sites, 4 recruiting

Research Site
Tbilisi, 0112
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Tbilisi, 0159
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Tbilisi, 160
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Research Site
Tbilisi, 177
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Other trials in Georgia

South Korea3 sites, 3 recruiting

Research Site
Jinju, 52727
Recruiting
Research Site
Seoul, 135-710
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Research Site
Seoul, 5505
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Other trials in South Korea

Australia2 sites

Research Site
Hobart, 7000
Withdrawn
Research Site
Woolloongabba, 4102
Withdrawn

Other trials in Australia

Switzerland1 site, 1 recruiting

Research Site
Lausanne, 1011
Recruiting

Other trials in Switzerland

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)

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 groups in NCT06868277
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.

10 Apr 20252 Dec 2030

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)

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.

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT06868277
Acronym / sponsor ID: ARTEMIDELung04 / D702GC00001
Conditions: Carcinoma, Non-Small Cell Lung
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
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 830 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 10 Apr 2025 (actual)
Primary completion: 17 Jan 2030 (estimated)
Study completion: 2 Dec 2030 (estimated)
First posted: 10 Mar 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Participants will be randomized in a 1:1 ratio to one of the following intervention arms: Arm A : Rilvegostomig Arm B : Pembrolizumab

Arm	Type	Receives
Arm A	Experimental	Biological: RilvegostomigDrug: rilvegostomig
Arm B	Active comparator	Biological: PembrolizumabDrug: Pembrolizumab

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (11 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RilvegostomigAlso: AZD2936Administered intravenously (IV) on Day 1 of each 21-day cycle	Biological	Arm A
PembrolizumabAlso: KEYTRUDAAdministered intravenously (IV) on Day 1 of each 21-day cycle	Biological	Arm B

Primary outcome

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.
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).

10 secondary outcomes

Landmark Overall Survival (OS) rates
Time frame: Up to approximately 5 years
Landmark Progression-Free Survival (PFS) rates
Time frame: Up to approximately 5 years
Objective Response Rate (ORR)
Time frame: Up to approximately 5 years
Duration of Response (DoR)
Time frame: Up to approximately 5 years
Time to second progression or death (PFS2)
Time frame: Up to approximately 5 years
Pharmakokinetics (PK) of rilvegostomig
Time frame: Up to approximately 5 years
Immunogenicity of rilvegostomig
Time frame: Up to approximately 5 years
Patient-reported physical functioning
Time frame: Up to approximately 5 years
Patient-reported global health status (GHS)/quality of life (QoL)
Time frame: Up to approximately 5 years
Patient-reported lung cancer symptoms of non-small cell lung cancer (NSCLC)
Time frame: Up to approximately 5 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

304 sites in 27 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 304 sites in China, United States, Germany, Japan, Spain and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Up to approximately 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06868277.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.