Non-small Cell Lung CancerPhase 3NCT06692738

A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)

A Phase 3 study testing Rilvegostomig, Pembrolizumab and Carboplatin in people with Non-small Cell Lung Cancer, run by AstraZeneca at 333 sites in 26 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-Lung02 is to assess the efficacy and safety of rilvegostomig in combination with platinum-based chemotherapy for the first-line (1L) treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-small Cell Lung Cancer
What is being tested?: Rilvegostomig, Pembrolizumab and Carboplatin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,160 participants
Where: 333 sitesin 26 countries
Study dates: 18 Nov 2024to 1 Jul 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 squamous NSCLC.
Stage III B/C or IV mNSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.
Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any actionable driver oncogenes for which there are locally approved and available targeted 1L therapies.
Provision of acceptable tumor sample to confirm tumor PD-L1 expression TC ≥ 1%.
At least one lesion not previously irradiated that qualifies as a RECIST 1.1 TL 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 or MRI and is suitable for accurate repeated measurements.
Adequate organ and bone marrow function.

Who cannot join

Presence of small cell and neuroendocrine histology components.
Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 7 days prior to randomization. A minimum of 2 weeks must have elapsed between the end of local therapy (brain radiotherapy or surgery) and randomization. Participants must have recovered from the acute toxic effect of radiotherapy (eg, dizziness and signs of increased intracranial pressure) or surgery prior to randomization.
Any prior systemic, non-curative therapy received for NSCLC.
Any prior treatment with an anti-PD-1 or anti-PD-L1 agent.
Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.
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.

Show all 9Show fewer

Active or prior documented autoimmune or inflammatory disorders requiring chronic systemic treatment with the use of disease-modifying agents or other immunosuppressive drugs.
Active primary immunodeficiency/active infectious disease(s).
Active tuberculosis infection.

Trial locations and contacts

333 sites in 26 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

333 sites in 26 countries

United States77 sites, 65 recruiting

Research Site
Alexandria, Louisiana, 71301
Withdrawn
Research Site
Anaheim, California, 92801
Recruiting
Research Site
Athens, Georgia, 30607
Recruiting
Research Site
Atlanta, Georgia, 30341
Withdrawn
Research Site
Baltimore, Maryland, 21202
Completed
Research Site
Baton Rouge, Louisiana, 70808
Recruiting
Research Site
Bay Pines, Florida, 33744
Recruiting
Research Site
Bend, Oregon, 97701
Withdrawn
Research Site
Bethesda, Maryland, 20817
Recruiting
Research Site
Bethesda, Maryland, 20889
Not yet recruiting
Research Site
Beverly Hills, California, 90211
Recruiting
Research Site
Boise, Idaho, 83712
Recruiting
Research Site
Bridgeton, Missouri, 63044
Recruiting
Research Site
Buffalo, New York, 14221
Recruiting
Research Site
Camden, New Jersey, 08103
Recruiting
Research Site
Chattanooga, Tennessee, 37404
Recruiting
Research Site
Chicago, Illinois, 60637
Recruiting
Research Site
Cincinnati, Ohio, 45267
Recruiting
Research Site
Columbia, Missouri, 65212
Withdrawn
Research Site
Covington, Louisiana, 70433
Withdrawn
Research Site
Decatur, Illinois, 62526
Recruiting
Research Site
Detroit, Michigan, 48202
Recruiting
Research Site
Duluth, Minnesota, 55802
Recruiting
Research Site
East Syracuse, New York, 13057
Recruiting
Research Site
Fairfax, Virginia, 22031
Recruiting
Research Site
Fort Lauderdale, Florida, 33308
Recruiting
Research Site
Fort Wayne, Indiana, 46845
Not yet recruiting
Research Site
Fort Worth, Texas, 76104
Recruiting
Research Site
Fredericksburg, Virginia, 22408
Recruiting
Research Site
Gainesville, Florida, 32608
Recruiting
Research Site
Gainesville, Florida, 32610
Withdrawn
Research Site
Grand Forks, North Dakota, 58201
Recruiting
Research Site
Grand Rapids, Michigan, 49503
Recruiting
Research Site
Hershey, Pennsylvania, 17033
Recruiting
Research Site
Hinsdale, Illinois, 60521
Recruiting
Research Site
Houston, Texas, 77090
Completed
Research Site
Jacksonville, Florida, 32224
Recruiting
Research Site
Kansas City, Missouri, 64108
Recruiting
Research Site
Kingwood, Texas, 77339
Recruiting
Research Site
Lexington, Kentucky, 40509
Recruiting
Research Site
Lexington, Kentucky, 40536
Withdrawn
Research Site
Lincoln, Nebraska, 68506
Recruiting
Research Site
Loma Linda, California, 92354
Recruiting
Research Site
Los Alamitos, California, 90720
Recruiting
Research Site
Louisville, Kentucky, 40202
Recruiting
Research Site
Louisville, Kentucky, 40207
Recruiting
Research Site
Lubbock, Texas, 79410
Recruiting
Research Site
Medford, Oregon, 97504
Recruiting
Research Site
Nashville, Tennessee, 37203
Recruiting
Research Site
Newark, Delaware, 19713
Recruiting
Research Site
Olympia, Washington, 98506
Recruiting
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Quincy, Illinois, 62301
Recruiting
Research Site
Redlands, California, 92373
Recruiting
Research Site
Rochester, Minnesota, 55905
Recruiting
Research Site
Rockford, Illinois, 61114
Withdrawn
Research Site
Round Rock, Texas, 78665
Recruiting
Research Site
Saginaw, Michigan, 48602
Not yet recruiting
Research Site
Salem, Oregon, 97301
Recruiting
Research Site
San Francisco, California, 94121
Recruiting
Research Site
Savannah, Georgia, 31404
Not yet recruiting
Research Site
Scarborough, Maine, 04074
Recruiting
Research Site
Seattle, Washington, 98101
Recruiting
Research Site
Shreveport, Louisiana, 71103
Recruiting
Research Site
Shreveport, Louisiana, 71105
Recruiting
Research Site
Silverdale, Washington, 98383
Withdrawn
Research Site
Sioux Falls, South Dakota, 57105
Recruiting
Research Site
Spokane, Washington, 99208
Recruiting
Research Site
Springdale, Arkansas, 72762
Recruiting
Research Site
Tacoma, Washington, 98405
Recruiting
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Tucson, Arizona, 85724
Recruiting
Research Site
Walnut Creek, California, 94598
Recruiting
Research Site
Waterloo, Iowa, 50702
Recruiting
Research Site
Wenatchee, Washington, 98801
Withdrawn
Research Site
West Haven, Connecticut, 06516
Recruiting
Research Site
Westbury, New York, 11590
Recruiting
Research Site
Wilson, North Carolina, 27893
Recruiting
Research Site
York, Pennsylvania, 17403
Recruiting

Other trials in United States

China40 sites, 37 recruiting

Research Site
Beijing, 100021
Recruiting
Research Site
Beijing, 100029
Withdrawn
Research Site
Beijing, 100142
Recruiting
Research Site
Beijing, 101149
Recruiting
Research Site
Beijing, CN-100730
Recruiting
Research Site
Changchun, 130012
Recruiting
Research Site
Changde, 415000
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Research Site
Changsha, 410013
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Research Site
Chengdu, 610041
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Research Site
Chengdu, 610072
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Research Site
Chongqing, 400030
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Dalian, 116001
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Research Site
Guangzhou, 510062
Recruiting
Research Site
Guangzhou, 510100
Recruiting
Research Site
Hangzhou, 310003
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Research Site
Hangzhou, 310016
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Research Site
Hangzhou, 310022
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Harbin, 150081
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Research Site
Hefei, 230001
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Hefei, 230601
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Research Site
Jinan, 250117
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Kunming, 650118
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Research Site
Linhai, 317000
Recruiting
Research Site
Linyi, 276001
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Research Site
Nanchang, 330008
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Research Site
Ningbo, 315010
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Shanghai, 200030
Recruiting
Research Site
Shanghai, 200032
Recruiting
Research Site
Shanghai, 200433
Recruiting
Research Site
Shenyang, 110004
Withdrawn
Research Site
Shenzhen, 518020
Withdrawn
Research Site
Taiyuan, 030000
Recruiting
Research Site
Tianjin, 300050
Recruiting
Research Site
Wenzhou, CN-325000
Recruiting
Research Site
Wuhan, 430030
Recruiting
Research Site
Xi'an, 710061
Recruiting
Research Site
Yangzhou, 225001
Recruiting
Research Site
Yueyang, 414000
Recruiting
Research Site
Zhengzhou, 450008
Recruiting
Research Site
Zhengzhou, 450052
Recruiting

Other trials in China

Germany35 sites, 33 recruiting

Research Site
Bad Berka, 99437
Recruiting
Research Site
Berlin, 13125
Withdrawn
Research Site
Berlin, 13585
Withdrawn
Research Site
Bielefeld, 33611
Not yet recruiting
Research Site
Bochum, 44791
Not yet recruiting
Research Site
Chemnitz, 09116
Not yet recruiting
Research Site
Cologne, 50677
Not yet recruiting
Research Site
Cologne, 51109
Recruiting
Research Site
Essen, 45136
Not yet recruiting
Research Site
Esslingen am Neckar, 73730
Recruiting
Research Site
Frankfurt, 60488
Recruiting
Research Site
Frankfurt am Main, 60431
Recruiting
Research Site
Gauting, 82131
Recruiting
Research Site
Giessen, 35392
Recruiting
Research Site
Großhansdorf, 22927
Recruiting
Research Site
Halle, 06120
Not yet recruiting
Research Site
Hamburg, 20251
Recruiting
Research Site
Hamburg, 22087
Not yet recruiting
Research Site
Hanover, 30459
Recruiting
Research Site
Hanover, 30625
Recruiting
Research Site
Heidelberg, 69126
Recruiting
Research Site
Hemer, 58675
Recruiting
Research Site
Homburg, 66424
Recruiting
Research Site
Kassel, 34125
Recruiting
Research Site
Kiel, 24105
Recruiting
Research Site
Krefeld, 47805
Recruiting
Research Site
Magdeburg, 39120
Not yet recruiting
Research Site
Minden, 32429
Recruiting
Research Site
Moers, 47441
Recruiting
Research Site
München, 81925
Recruiting
Research Site
Oldenburg i.H., 23758
Not yet recruiting
Research Site
Regensburg, 93053
Recruiting
Research Site
Schwerin, 19049
Not yet recruiting
Research Site
Velbert, 42551
Not yet recruiting
Research Site
Würzburg, 97067
Recruiting

Other trials in Germany

Japan31 sites, 31 recruiting

Research Site
Amagasaki-shi, 660-8550
Recruiting
Research Site
Bunkyō City, 113-8603
Recruiting
Research Site
Chūōku, 104-0045
Recruiting
Research Site
Fukuoka, 812-8582
Recruiting
Research Site
Fukuoka, 814-0180
Recruiting
Research Site
Hirakata-shi, 573-1191
Not yet recruiting
Research Site
Hiroshima, 734-8551
Recruiting
Research Site
Kakogawa-shi, 675-8611
Not yet recruiting
Research Site
Kanazawa, 920-8530
Recruiting
Research Site
Kawagoe-shi, 350-8550
Recruiting
Research Site
Kawasaki-shi, 216-8511
Recruiting
Research Site
Kitaadachi-gun, 362-0806
Recruiting
Research Site
Kitakyushu-shi, 807-8555
Recruiting
Research Site
Kiyose-shi, 204-8522
Not yet recruiting
Research Site
Kobe, 650-0017
Recruiting
Research Site
Kōtoku, 135-8550
Recruiting
Research Site
Kumamoto, 860-8556
Recruiting
Research Site
Kumamoto, 861-4193
Recruiting
Research Site
Kyoto, 612-8555
Recruiting
Research Site
Matsusaka-shi, 515-8544
Recruiting
Research Site
Obihiro-shi, 080-0024
Not yet recruiting
Research Site
Osaka, 541-8567
Recruiting
Research Site
Ota-shi, 373-8550
Recruiting
Research Site
Saitama-shi, 338-0001
Recruiting
Research Site
Sakai, 590-0197
Recruiting
Research Site
Sapporo, 006-8555
Recruiting
Research Site
Sendai, 981-0914
Recruiting
Research Site
Shinjuku-ku, 160-0023
Recruiting
Research Site
Takaoka-shi, 933-8555
Recruiting
Research Site
Yokohama, 232-0024
Recruiting
Research Site
Yokohama, 241-8515
Recruiting

Other trials in Japan

India12 sites, 9 recruiting

Research Site
Calicut, 673601
Recruiting
Research Site
Delhi, 110029
Recruiting
Research Site
Gūrgaon, 122001
Recruiting
Research Site
Kolkata, 700054
Withdrawn
Research Site
Madurai, 625107
Recruiting
Research Site
Mumbai, 400012
Not yet recruiting
Research Site
Nagpur, 440001
Not yet recruiting
Research Site
Nashik, 422002
Recruiting
Research Site
New Delhi, 110075
Withdrawn
Research Site
Puducherry, 605006
Withdrawn
Research Site
Surat, 395017
Recruiting
Research Site
Varanasi, 221005
Recruiting

Other trials in India

Hungary11 sites, 9 recruiting

Research Site
Budapest, 1083
Recruiting
Research Site
Budapest, 1121
Recruiting
Research Site
Budapest, 1122
Recruiting
Research Site
Debrecen, 4032
Recruiting
Research Site
Edelény, 3780
Not yet recruiting
Research Site
Gyöngyös, 3200
Withdrawn
Research Site
Gyöngyös - Mátraháza, 3200
Recruiting
Research Site
Győr, 9024
Recruiting
Research Site
Pécs, 7624
Recruiting
Research Site
Székesfehérvár, 8000
Suspended
Research Site
Törökbálint, 2045
Recruiting

Other trials in Hungary

South Korea10 sites, 10 recruiting

Research Site
Changwon-si, 51353
Recruiting
Research Site
Cheongju-si, 28644
Recruiting
Research Site
Incheon, 21565
Recruiting
Research Site
JinJoo, 52727
Recruiting
Research Site
Seoul, 03080
Recruiting
Research Site
Seoul, 03722
Recruiting
Research Site
Seoul, 05505
Recruiting
Research Site
Seoul, 06351
Recruiting
Research Site
Suwon, 16247
Recruiting
Research Site
Suwon, 16499
Recruiting

Other trials in South Korea

United Kingdom10 sites, 9 recruiting

Research Site
Aberdeen, AB25 2ZN
Recruiting
Research Site
Cambridge, CB2 0QQ
Recruiting
Research Site
Edinburgh, EH4 2XU
Recruiting
Research Site
Exeter, EX2 5DW
Withdrawn
Research Site
Greater London, SW3 6JJ
Recruiting
Research Site
London, EC1A 7BE
Recruiting
Research Site
London, SE1 9RT
Recruiting
Research Site
Manchester, M20 4BX
Recruiting
Research Site
Newcastle upon Tyne, NE7 7AF
Recruiting
Research Site
Preston, PR2 9HT
Recruiting

Other trials in United Kingdom

Brazil9 sites, 8 recruiting

Research Site
Barretos, 14784-400
Recruiting
Research Site
Florianópolis, 88034-000
Recruiting
Research Site
Ijuí, 98700-000
Recruiting
Research Site
Londrina, 86015-520
Recruiting
Research Site
Porto Alegre, 91350-200
Recruiting
Research Site
Salvador, 40050 410
Recruiting
Research Site
São Paulo, 01246-000
Recruiting
Research Site
São Paulo, 05652-900
Recruiting
Research Site
Taubaté, 12030-200
Withdrawn

Other trials in Brazil

Poland9 sites, 6 recruiting

Research Site
Biała Podlaska, 21-500
Withdrawn
Research Site
Bialystok, 15-027
Withdrawn
Research Site
Bydgoszcz, 85-796
Withdrawn
Research Site
Bystra, 43-360
Recruiting
Research Site
Lodz, 93-338
Recruiting
Research Site
Lublin, 20-090
Not yet recruiting
Research Site
Poznan, 60-569
Recruiting
Research Site
Warsaw, 04-141
Recruiting
Research Site
Wroclaw, 53-413
Recruiting

Other trials in Poland

France8 sites, 8 recruiting

Research Site
Avignon, 84902
Recruiting
Research Site
La Rochelle, 17019
Recruiting
Research Site
Lyon, 69008
Recruiting
Research Site
Nîmes, 30029
Recruiting
Research Site
Rennes, 35033
Recruiting
Research Site
Strasbourg, 67091
Recruiting
Research Site
Suresnes, 92150
Recruiting
Research Site
Toulon, 83800
Recruiting

Other trials in France

Italy8 sites, 8 recruiting

Research Site
Florence, 50134
Recruiting
Research Site
Legnano, 20025
Not yet recruiting
Research Site
Livorno, 57126
Not yet recruiting
Research Site
Monza, 20900
Recruiting
Research Site
Orbassano, 10043
Recruiting
Research Site
Padova, 35128
Recruiting
Research Site
Peschiera del Garda, 37019
Recruiting
Research Site
Roma, 00168
Recruiting

Other trials in Italy

Spain8 sites, 8 recruiting

Research Site
Almería, 04009
Not yet recruiting
Research Site
Barcelona, 8035
Recruiting
Research Site
Las Palmas de Gran Canaria, 35016
Recruiting
Research Site
Lleida, 25198
Recruiting
Research Site
Madrid, 28007
Recruiting
Research Site
Madrid, 28034
Recruiting
Research Site
Majadahonda, 28222
Recruiting
Research Site
Seville, 41013
Recruiting

Other trials in Spain

Taiwan8 sites, 8 recruiting

Research Site
Kaohsiung City, 80756
Recruiting
Research Site
Kaohsiung City, 824
Recruiting
Research Site
New Taipei City, 220
Recruiting
Research Site
New Taipei City, 23561
Recruiting
Research Site
Taichung, 402
Recruiting
Research Site
Taichung, 40705
Recruiting
Research Site
Tainan, 73657
Recruiting
Research Site
Taoyuan, 333
Recruiting

Other trials in Taiwan

Canada7 sites, 7 recruiting

Research Site
Greater Sudbury, Ontario, P3E 5J1
Not yet recruiting
Research Site
Hamilton, Ontario, L8V 1C3
Recruiting
Research Site
Montreal, Quebec, H2X 0A9
Recruiting
Research Site
Montreal, Quebec, H4A 3J1
Recruiting
Research Site
Saint John, New Brunswick, E2L 4L2
Recruiting
Research Site
Sault Ste. Marie, Ontario, P6A 0A8
Recruiting
Research Site
Sydney, Nova Scotia, B1P 1P3
Recruiting

Other trials in Canada

Belgium6 sites, 4 recruiting

Research Site
Anderlecht, 1070
Withdrawn
Research Site
Brussels, 1160
Recruiting
Research Site
Charleroi, 6060
Recruiting
Research Site
Kortrijk, 8500
Recruiting
Research Site
Ottignies, 1340
Recruiting
Research Site
Sint-Niklaas, 9100
Withdrawn

Other trials in Belgium

Netherlands6 sites, 5 recruiting

Research Site
Alkmaar, 1815 JD
Recruiting
Research Site
Ede, 6716 RP
Recruiting
Research Site
Groningen, 9713 GZ
Withdrawn
Research Site
Leidschendam, 2262 BA
Recruiting
Research Site
Veldhoven, 5504 DB
Recruiting
Research Site
Zwolle, 8025 AB
Recruiting

Other trials in Netherlands

Peru6 sites

Research Site
Lima, 15036
Withdrawn
Research Site
Lima, 15102
Withdrawn
Research Site
Lima, 34
Withdrawn
Research Site
Lima, L27
Withdrawn
Research Site
Lima, LIMA 29
Withdrawn
Research Site
Lima, Lima39
Withdrawn

Other trials in Peru

Argentina5 sites, 4 recruiting

Research Site
Buenos Aires, C1431FWO
Recruiting
Research Site
CABA, 1425
Recruiting
Research Site
La Plata, 1900
Withdrawn
Research Site
Pilar, B1629ODT
Recruiting
Research Site
Rosario, S2000DEJ
Recruiting

Other trials in Argentina

Austria5 sites, 5 recruiting

Research Site
Innsbruck, 6020
Recruiting
Research Site
Krems, 3500
Recruiting
Research Site
Rankweil, 6830
Recruiting
Research Site
Vienna, 1160
Recruiting
Research Site
Vienna, 1210
Recruiting

Other trials in Austria

Thailand5 sites, 5 recruiting

Research Site
Bangkok, 10700
Recruiting
Research Site
Chiang Mai, 50200
Recruiting
Research Site
Dusit, 10300
Recruiting
Research Site
Nakhon Ratchasima, 30000
Recruiting
Research Site
Songkhla, 90110
Recruiting

Other trials in Thailand

Australia4 sites, 4 recruiting

Research Site
Darlinghurst, 2010
Recruiting
Research Site
Hyde Park, 4812
Recruiting
Research Site
Southport, 4215
Recruiting
Research Site
Wollongong, 2500
Recruiting

Other trials in Australia

Turkey (Türkiye)4 sites, 4 recruiting

Research Site
Ankara, 6500
Recruiting
Research Site
Antalya, 07059
Recruiting
Research Site
Istanbul, 34098
Recruiting
Research Site
Yenimahalle, 06170
Recruiting

Other trials in Turkey (Türkiye)

Vietnam4 sites, 4 recruiting

Research Site
Can Tho, 900000
Recruiting
Research Site
Hanoi, 100000
Recruiting
Research Site
Ho Chi Minh City, 700000
Recruiting
Research Site
Vinh, 460000
Recruiting

Other trials in Vietnam

Malaysia3 sites, 3 recruiting

Research Site
George Town, 10450
Recruiting
Research Site
Johor Bahru, 81100
Recruiting
Research Site
Kuala Lumpur, 59100
Recruiting

Other trials in Malaysia

Puerto Rico2 sites, 2 recruiting

Research Site
San Juan, 00909
Recruiting
Research Site
San Juan, 00918
Recruiting

Other trials in Puerto Rico

About this study

Official title: A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung02)

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, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous locally advanced or metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

Conditions: Non-small Cell Lung Cancer
Being tested: Rilvegostomig, Pembrolizumab, Carboplatin, Paclitaxel, Nab-paclitaxel
Keywords: ARTEMIDE-Lung02, Rilvegostomig (AZD2936), Non-small cell lung cancer (NSCLC), Bi-specific antibody, T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domain (TIGIT), Programmed death-ligand 1 (PD-L1), Pembrolizumab, Carboplatin, Paclitaxel, Nab-paclitaxel
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.

RilvegostomigDrug
Also called AZD2936
Administered intravenously (IV) on Day 1 of each 21-day cycle
PembrolizumabDrug
Also called Keytruda
Administered intravenously (IV) on Day 1 of each 21-day cycle
CarboplatinDrug
Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
PaclitaxelDrug
Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
Nab-paclitaxelDrug
Administered intravenously (IV) on Days 1, 8, and 15 of each 21-day cycle up to 4 cycles

Study groups in NCT06692738
Study group	Role	What they receive
Arm A	Experimental	Rilvegostomig in combination with carboplatin and paclitaxel or nab-paclitaxel followed by rilvegostomig Receives: Drug: Rilvegostomig; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab-paclitaxel
Arm B	Active comparator	Pembrolizumab in combination with carboplatin and paclitaxel or nab-paclitaxel followed by pembrolizumab Receives: Drug: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab-paclitaxel

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 6 years
Progression-free survival (PFS)
PFS is defined as the time from randomization until radiological progression per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) or death due to any cause (in the absence of progression).
Measured: Up to approximately 6 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 6 years
Landmark progression-free survival (PFS) rates
PFS is defined as the time from randomization until radiological progression per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) or death due to any cause (in the absence of progression).
Measured: Up to approximately 6 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 progression event), after the start of the first subsequent therapy, or death from any cause, whichever occurs first. The date of the second progression will be recorded by the investigator in the electronic Case Report Form (eCRF) and defined according to local standard clinical practice.
Measured: Up to approximately 6 years
Overall response rate (ORR)
ORR is defined as the proportion of participants who have a confirmed complete response (CR) or confirmed partial response (PR), by using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
Measured: Up to approximately 6 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 Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) or death due to any cause (in the absence of progression).
Measured: Up to approximately 6 years
Pharmacokinetic (PK) of rilvegostomig
Concentration of rilvegostomig in serum.
Measured: Up to approximately 6 years
Immunogenicity of rilvegostomig
Presence of antidrug antibodies (ADAs), titer, and neutralizing antibodies for rilvegostomig.
Measured: Up to approximately 6 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 6 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. Deterioration is defined as a worsening change from baseline that reaches a clinically meaningful change threshold.
Measured: Up to approximately 6 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 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Nov 20241 Jul 2030

First posted18 Nov 2024
Study start18 Nov 2024
Primary completion1 Jul 2030 (estimated)
Study completion1 Jul 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non-small Cell Lung CancerStudies 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: Arm A: Rilvegostomig in combination with carboplatin and paclitaxel or nab-paclitaxel followed by rilvegostomig Arm B: Pembrolizumab in combination with carboplatin and paclitaxel or nab-paclitaxel followed by pembrolizumab
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,160 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06692738
Sponsor's protocol ID: D702BC00001
Other IDs: 2024-514281-39-00
Status last verified: Oct 2026
First submitted: 4 Oct 2024
Last updated: 29 Oct 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 patient-level data from AstraZeneca (AZ) group of companies sponsored clinical trials via the request portal Vivli.org. 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 Important Protocol Deviation (IPD), but this does not mean all requests will be approved.

Interested in taking part?

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer

All Non-small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 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 in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung02)
ClinicalTrials.gov ID: NCT06692738
Acronym / sponsor ID: D702BC00001
Conditions: Non-small Cell Lung Cancer
Keywords: ARTEMIDE-Lung02, Rilvegostomig (AZD2936), Non-small cell lung cancer (NSCLC), Bi-specific antibody, T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domain (TIGIT), Programmed death-ligand 1 (PD-L1), Pembrolizumab, Carboplatin
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 1,160 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 18 Nov 2024 (actual)
Primary completion: 1 Jul 2030 (estimated)
Study completion: 1 Jul 2030 (estimated)
First posted: 18 Nov 2024 (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: Arm A: Rilvegostomig in combination with carboplatin and paclitaxel or nab-paclitaxel followed by rilvegostomig Arm B: Pembrolizumab in combination with carboplatin and paclitaxel or nab-paclitaxel followed by pembrolizumab

Arm	Type	Receives
Arm A	Experimental	Drug: Rilvegostomig, Drug: Carboplatin, Drug: Paclitaxel, Drug: Nab-paclitaxelRilvegostomig in combination with carboplatin and paclitaxel or nab-paclitaxel followed by rilvegostomig
Arm B	Active comparator	Drug: Pembrolizumab, Drug: Carboplatin, Drug: Paclitaxel, Drug: Nab-paclitaxelPembrolizumab in combination with carboplatin and paclitaxel or nab-paclitaxel followed by pembrolizumab

Who may qualify

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

Key inclusion criteria (6 listed)

Histologically or cytologically documented squamous NSCLC.
Stage III B/C or IV mNSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.
Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any actionable driver oncogenes for which there are locally approved and available targeted 1L therapies.
Provision of acceptable tumor sample to confirm tumor PD-L1 expression TC ≥ 1%.
At least one lesion not previously irradiated that qualifies as a RECIST 1.1 TL 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 or MRI and is suitable for accurate repeated measurements.

Key exclusion criteria (9 listed)

Presence of small cell and neuroendocrine histology components.
Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 7 days prior to randomization. A minimum of 2 weeks must have elapsed between the end of local therapy (brain radiotherapy or surgery) and randomization. Participants must have recovered from the acute toxic effect of radiotherapy (eg, dizziness and signs of increased intracranial pressure) or surgery prior to randomization.
Any prior systemic, non-curative therapy received for NSCLC.
Any prior treatment with an anti-PD-1 or anti-PD-L1 agent.
Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.

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	Drug	Arm A
PembrolizumabAlso: KeytrudaAdministered intravenously (IV) on Day 1 of each 21-day cycle	Drug	Arm B
CarboplatinAdministered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles	Drug	Arm A, Arm B
PaclitaxelAdministered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles	Drug	Arm A, Arm B
Nab-paclitaxelAdministered intravenously (IV) on Days 1, 8, and 15 of each 21-day cycle up to 4 cycles	Drug	Arm A, Arm B

Primary outcome

Overall survival (OS)
Time frame: Up to approximately 6 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 6 years
PFS is defined as the time from randomization until radiological progression per Response Evaluation Criteria in Solid Tumors, Version 1.1 (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 6 years
Landmark progression-free survival (PFS) rates
Time frame: Up to approximately 6 years
Time to second progression or death (PFS2)
Time frame: Up to approximately 6 years
Overall response rate (ORR)
Time frame: Up to approximately 6 years
Duration of response (DoR)
Time frame: Up to approximately 6 years
Pharmacokinetic (PK) of rilvegostomig
Time frame: Up to approximately 6 years
Immunogenicity of rilvegostomig
Time frame: Up to approximately 6 years
Patient-reported physical functioning
Time frame: Up to approximately 6 years
Patient-reported global health status (GHS)/quality of life (QoL)
Time frame: Up to approximately 6 years
Patient-reported lung cancer symptoms of non-small cell lung cancer (NSCLC)
Time frame: Up to approximately 6 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 29 Oct 2026.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca (AZ) group of companies sponsored clinical trials via the request portal Vivli.org. 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 Important Protocol Deviation (IPD), but this does not mean all requests will be approved.

Related trials for Non-small Cell Lung Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer

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

333 sites in 26 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rilvegostomig, Pembrolizumab and Carboplatin in people with Non-small Cell Lung Cancer, run by AstraZeneca at 333 sites in 26 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 6 inclusion and 9 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 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 333 sites in United States, China, Germany, Japan, India and 21 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 6 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 NCT06692738.

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 29 Oct 2026.