Non-squamous Non-small Cell Lung CancerPhase 3NCT06627647

A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Locally Advanced or Metastatic Non-Squamous NSCLC

A Phase 3 study testing Rilvegostomig, Pembrolizumab and Carboplatin in people with Non-squamous Non-small Cell Lung Cancer, run by AstraZeneca at 301 sites in 25 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-Lung03 is to evaluate the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line treatment of patients with locally advanced or metastatic non-squamous NSCLC whose tumors express PD-L1. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-squamous 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: 301 sitesin 25 countries
Study dates: 27 Nov 2024to 18 Nov 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 non-squamous NSCLC.
Stage III B/C or IV NSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.
Absence of sensitizing EGFR mutations (including, but not limited to, exon 19 deletion and exon 21 L858R, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations) and ALK and ROS1 rearrangements.
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 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 therapy received for NSCLC except in the neoadjuvant or adjuvant setting or definitive chemoradiotherapy with the intent to cure, provided that progression has occurred > 12 months after the end of systemic therapy treatment.
Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.
Any prior treatment with an anti-PD-1 or anti-PD-L1 agent.
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, corticosteroids, or immunosuppressive drugs.
Active primary immunodeficiency/active infectious disease(s).
Active tuberculosis infection.

Trial locations and contacts

301 sites in 25 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

301 sites in 25 countries

United States78 sites, 61 recruiting

Research Site
Alexandria, Louisiana, 71301
Withdrawn
Research Site
Anaheim, California, 92801
Recruiting
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Atlanta, Georgia, 30342
Withdrawn
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Baltimore, Maryland, 21202
Recruiting
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Baton Rouge, Louisiana, 70808
Recruiting
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Bay Pines, Florida, 33744
Recruiting
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Bethesda, Maryland, 20889
Not yet recruiting
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Beverly Hills, California, 90211
Recruiting
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Boise, Idaho, 83712
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Bridgeton, Missouri, 63044
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Buffalo, New York, 14221
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Camden, New Jersey, 08103
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Canton, Ohio, 44710
Recruiting
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Chandler, Arizona, 85224
Withdrawn
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Chattanooga, Tennessee, 37404
Recruiting
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Chicago, Illinois, 60637
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Columbia, Missouri, 65212
Withdrawn
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Decatur, Illinois, 62526
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Duluth, Minnesota, 55805
Withdrawn
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Fairfax, Virginia, 22031
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Fort Lauderdale, Florida, 33308
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Fort Worth, Texas, 76104
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Gainesville, Florida, 32610
Withdrawn
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Grand Rapids, Michigan, 49503
Recruiting
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Hinsdale, Illinois, 60521
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Houston, Texas, 77090
Withdrawn
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Irving, Texas, 75063
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Jacksonville, Florida, 32224
Recruiting
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Kingwood, Texas, 77339
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La Crosse, Wisconsin, 54601
Withdrawn
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Lexington, Kentucky, 40509
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Lexington, Kentucky, 40536
Withdrawn
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Lincoln, Nebraska, 68506
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Loma Linda, California, 92350
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Lone Tree, Colorado, 80124
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Louisville, Kentucky, 40207
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Lubbock, Texas, 79410
Withdrawn
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Medford, Oregon, 97504
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Miami, Florida, 33125
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Mobile, Alabama, 36608
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Nashville, Tennessee, 37203
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Newark, Delaware, 19713
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Norfolk, Virginia, 23502
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Ocala, Florida, 34474
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Palestine, Texas, 75801
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Phoenix, Arizona, 85054
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Pierre, South Dakota, 57501
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Pittsburgh, Pennsylvania, 15212
Withdrawn
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Portland, Oregon, 97239
Withdrawn
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Providence, Rhode Island, 02903
Withdrawn
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Quincy, Illinois, 62305
Recruiting
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Redlands, California, 92373
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Roanoke, Virginia, 24014
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Rochester, Minnesota, 55905
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Rockford, Illinois, 61114
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Round Rock, Texas, 78665
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Saint Paul, Minnesota, 55102
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Salem, Oregon, 97301
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San Diego, California, 92123
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San Francisco, California, 94121
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Santa Rosa, California, 95403
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Seattle, Washington, 98101
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Seattle, Washington, 98104
Withdrawn
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Shreveport, Louisiana, 71103
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Shreveport, Louisiana, 71105
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Silverdale, Washington, 98383
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Sioux Falls, South Dakota, 57105
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South Portland, Maine, 04106
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Spokane, Washington, 99208
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St. Petersburg, Florida, 33709
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Stamford, Connecticut, 06902
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Tacoma, Washington, 98405
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Walnut Creek, California, 94598
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Waterloo, Iowa, 50702
Recruiting
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Wenatchee, Washington, 98801
Withdrawn
Research Site
West Haven, Connecticut, 06516
Recruiting
Research Site
Westbury, New York, 11590
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Research Site
York, Pennsylvania, 17403
Recruiting

Other trials in United States

Germany31 sites, 30 recruiting

Research Site
Bad Berka, 99437
Recruiting
Research Site
Berlin, 13585
Withdrawn
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Bielefeld, 33611
Not yet recruiting
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Bochum, 44791
Not yet recruiting
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Chemnitz, 09116
Not yet recruiting
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Cologne, 51109
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Esslingen am Neckar, 73730
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Frankfurt, 60488
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Frankfurt am Main, 60431
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Gauting, 82131
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Giessen, 35392
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Großhansdorf, 22927
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Halle, 06120
Not yet recruiting
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Hamburg, 20251
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Hanover, 30459
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Hanover, 30625
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Hemer, 58675
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Homburg, 66424
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Karlsruhe, 76133
Not yet recruiting
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Kassel, 34125
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Kiel, 24105
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Krefeld, 47805
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Magdeburg, 39120
Not yet recruiting
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Minden, 32429
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Moers, 47441
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München, 81925
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Oldenburg i.H., 23758
Not yet recruiting
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Regensburg, 93053
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Schwerin, 19049
Not yet recruiting
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Velbert, 42551
Not yet recruiting
Research Site
Würzburg, 97067
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Other trials in Germany

China29 sites, 29 recruiting

Research Site
Beijing, 100021
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Beijing, 100029
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Beijing, CN-100730
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Changchun, 130012
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Changsha, 410013
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Chengdu, 610041
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Chongqing, 400030
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Fuzhou, 350007
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Guangzhou, 510062
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Guangzhou, 510180
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Hangzhou, 310003
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Hangzhou, 310016
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Hangzhou, 310022
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Harbin, 150081
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Hefei, 230601
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Jinan, 250117
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Jingzhou, 434000
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Kunming, 650118
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Linhai, 317000
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Nanchang, 330008
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Ningbo, 315010
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Shanghai, 200030
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Shanghai, 200433
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Wenzhou, CN-325000
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Wuhan, 430000
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Xi'an, 710061
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Xiangyang, 441000
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Research Site
Zhengzhou, 450008
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Research Site
Zhengzhou, 450052
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Other trials in China

Japan26 sites, 26 recruiting

Research Site
Amagasaki-shi, 660-8550
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Bunkyō City, 113-8603
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Research Site
Chūōku, 104-0045
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Research Site
Fukuoka, 812-8582
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Fukuoka, 814-0180
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Hiroshima, 734-8551
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Kawagoe-shi, 350-8550
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Research Site
Kawasaki-shi, 216-8511
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Research Site
Kitaadachi-gun, 362-0806
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Kitakyushu-shi, 807-8555
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Research Site
Kiyose-shi, 204-8522
Not yet recruiting
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Kobe, 650-0017
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Kōtoku, 135-8550
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Kumamoto, 860-8556
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Kumamoto, 861-4193
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Kyoto, 612-8555
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Matsusaka-shi, 515-8544
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Research Site
Obihiro-shi, 080-0024
Not yet recruiting
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Osaka, 541-8567
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Research Site
Ota-shi, 373-8550
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Research Site
Saitama-shi, 338-0001
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Research Site
Shinjuku-ku, 160-0023
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Research Site
Sunto-gun, 411-8777
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Takaoka-shi, 933-8555
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Research Site
Yokohama, 232-0024
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Research Site
Yokohama, 241-8515
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Other trials in Japan

Brazil10 sites, 8 recruiting

Research Site
Ijuí, 98700-000
Recruiting
Research Site
Londrina, 86015-520
Recruiting
Research Site
Passo Fundo, 99010-260
Recruiting
Research Site
Porto Alegre, 91350-200
Recruiting
Research Site
Salvador, 40050 410
Recruiting
Research Site
São Paulo, 01246-000
Withdrawn
Research Site
São Paulo, 01327-001
Recruiting
Research Site
São Paulo, 05652000
Recruiting
Research Site
Taubaté, 12030-200
Withdrawn
Research Site
Vitória, 29043-260
Recruiting

Other trials in Brazil

Canada10 sites, 9 recruiting

Research Site
Abbotsford British Columbia, British Columbia, V2S0C2
Withdrawn
Research Site
Greater Sudbury, Ontario, P3E 5J1
Not yet recruiting
Research Site
Hamilton, Ontario, L8V 1C3
Recruiting
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Kingston, Ontario, K7L 2V7
Recruiting
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Montreal, Quebec, H2X 0A9
Recruiting
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Montreal, Quebec, H4A 3J1
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Saint John, New Brunswick, E2L 4L2
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Saint-Jérôme, Quebec, J7Z 2V4
Recruiting
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Sault Ste. Marie, Ontario, P6A 0A8
Recruiting
Research Site
Sydney, Nova Scotia, B1P 1P3
Not yet recruiting

Other trials in Canada

Hungary10 sites, 8 recruiting

Research Site
Budapest, 1083
Recruiting
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Budapest, 1121
Recruiting
Research Site
Budapest, 1122
Recruiting
Research Site
Debrecen, 4032
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
Withdrawn
Research Site
Törökbálint, 2045
Recruiting

Other trials in Hungary

United Kingdom10 sites, 9 recruiting

Research Site
Aberdeen, AB25 2ZN
Recruiting
Research Site
Cambridge, CB2 0QQ
Recruiting
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Edinburgh, EH4 2XU
Recruiting
Research Site
Exeter, EX2 5DW
Withdrawn
Research Site
Greater London, SW3 6JJ
Recruiting
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London, EC1A 7BE
Recruiting
Research Site
London, SE1 9RT
Recruiting
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Manchester, M20 4BX
Recruiting
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Newcastle upon Tyne, NE7 7AF
Recruiting
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Torquay, TQ2 7AA
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Other trials in United Kingdom

India9 sites, 7 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
Recruiting
Research Site
Nashik, 422002
Recruiting
Research Site
New Delhi, 110075
Withdrawn
Research Site
Varanasi, 221005
Recruiting

Other trials in India

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
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La Rochelle, 17019
Recruiting
Research Site
Lyon, 69373
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

Taiwan8 sites, 7 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, 40201
Recruiting
Research Site
Taichung, 40705
Recruiting
Research Site
Tainan, 736
Withdrawn
Research Site
Taoyuan, 333423
Recruiting

Other trials in Taiwan

South Korea7 sites, 7 recruiting

Research Site
Gyeonggi-do, 13620
Recruiting
Research Site
Seoul, 03080
Recruiting
Research Site
Seoul, 03722
Recruiting
Research Site
Seoul, 06351
Recruiting
Research Site
Seoul, 06591
Recruiting
Research Site
Seoul, 07061
Recruiting
Research Site
Songpa-gu, 05505
Recruiting

Other trials in South Korea

Spain7 sites, 7 recruiting

Research Site
Barcelona, 8035
Recruiting
Research Site
Castellon, 12002
Recruiting
Research Site
Las Palmas de Gran Canaria, 35016
Recruiting
Research Site
Madrid, 28034
Recruiting
Research Site
Madrid, 28046
Recruiting
Research Site
Majadahonda, 28222
Recruiting
Research Site
Seville, 41013
Recruiting

Other trials in Spain

Italy6 sites, 6 recruiting

Research Site
Florence, 50134
Recruiting
Research Site
Legnano, 20025
Not yet recruiting
Research Site
Livorno, 57126
Not yet recruiting
Research Site
Monza, 20052
Recruiting
Research Site
Peschiera del Garda, 37019
Recruiting
Research Site
Rome, 00168
Recruiting

Other trials in Italy

Turkey (Türkiye)6 sites, 6 recruiting

Research Site
Ankara, 06010
Recruiting
Research Site
Antalya, 07070
Recruiting
Research Site
Antalya, 07100
Recruiting
Research Site
Edirne, 22030
Recruiting
Research Site
Izmir, 35965
Recruiting
Research Site
Seyhan, 1060
Recruiting

Other trials in Turkey (Türkiye)

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

Belgium5 sites, 4 recruiting

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

Netherlands5 sites, 4 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

Other trials in Netherlands

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

Peru4 sites

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

Other trials in Peru

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
Kuala Lumpur, 59100
Recruiting
Research Site
Kuching, 93586
Recruiting
Research Site
Petaling Jaya, 47500
Recruiting

Other trials in Malaysia

Puerto Rico2 sites, 1 recruiting

Research Site
San Juan, 00918
Suspended
Research Site
San Juan, 00935
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 Non-squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung03)

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 1L treatment for patients with locally advanced or metastatic non-squamous NSCLC whose tumors express PD-L1 (TC ≥ 1%).

Conditions: Non-squamous Non-small Cell Lung Cancer
Being tested: Rilvegostomig, Pembrolizumab, Carboplatin, Cisplatin, Pemetrexed
Keywords: ARTEMIDE-Lung03, Rilvegostomig (AZD2936), Non-squamous 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, Carboplatin, Cisplatin, Pemetrexed

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RilvegostomigDrug
Also called AZD2936
Administered as one intravenously (IV) on Day 1 of each 21-day cycle
PembrolizumabDrug
Also called Keytruda
Administered as one intravenously (IV) on Day 1 of each 21-day cycle
CarboplatinDrug
Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
CisplatinDrug
Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
PemetrexedDrug
Administered as one intravenously (IV) on Day 1 of each 21-day cycle

Study groups in NCT06627647
Study group	Role	What they receive
Arm A	Experimental	Rilvegostomig in combination with platinum-based doublet chemotherapy followed by rilvegostomig monotherapy plus pemetrexed in maintenance. Receives: Drug: Rilvegostomig; Drug: Carboplatin; Drug: Cisplatin; Drug: Pemetrexed
Arm B	Active comparator	Pembrolizumab in combination with platinum-based doublet chemotherapy followed by pembrolizumab monotherapy plus pemetrexed in maintenance. Receives: Drug: Pembrolizumab; Drug: Carboplatin; Drug: Cisplatin; Drug: Pemetrexed

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 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 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 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 CR or confirmed PR, using 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 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 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)
TTD of GHS/QoL as measured by the 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)
TTD in pulmonary symptoms as measured by the 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.

27 Nov 202418 Nov 2030

First posted4 Oct 2024
Study start27 Nov 2024
Primary completion18 Nov 2030 (estimated)
Study completion18 Nov 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non-squamous 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 platinum-based doublet chemotherapy followed by rilvegostomig monotherapy plus pemetrexed in maintenance. Arm B: Pembrolizumab in combination with platinum-based doublet chemotherapy followed by pembrolizumab monotherapy plus pemetrexed in maintenance.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,160 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06627647
Sponsor's protocol ID: D702FC00001
Other IDs: 2024-515008-38-00
Status last verified: Oct 2026
First submitted: 3 Oct 2024
Last updated: 28 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 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 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)
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Not yet recruitingPhase 2
Phase II Study to Evaluate Telisotuzumab Adizutecan in Combination With RC148(ABBV-1480) as First-Line Treatment for Patients With Non-Squamous Non-Small-Cell Lung Cancer
Patients With Locally Advanced or Metastatic Non-Squamous NSCLC Requiring First-Line Treatment and no Driver Gene Alterations Confirmed by Histology or Cytology
Active, not recruitingPhase 2
Carboplatin, Taxane And Ramucirumab for Patients With NSCLC After Pemetrexed or Pembrolizumab Maintenance
Non-small Cell Lung Cancer
RecruitingPhase 1
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Advanced/Metastatic Solid Tumors, Bladder Cancer

All Non-squamous Non-small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 28 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 Non-squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung03)
ClinicalTrials.gov ID: NCT06627647
Acronym / sponsor ID: D702FC00001
Conditions: Non-squamous Non-small Cell Lung Cancer
Keywords: ARTEMIDE-Lung03, Rilvegostomig (AZD2936), Non-squamous 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: 1,160 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 27 Nov 2024 (actual)
Primary completion: 18 Nov 2030 (estimated)
Study completion: 18 Nov 2030 (estimated)
First posted: 4 Oct 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 platinum-based doublet chemotherapy followed by rilvegostomig monotherapy plus pemetrexed in maintenance. Arm B: Pembrolizumab in combination with platinum-based doublet chemotherapy followed by pembrolizumab monotherapy plus pemetrexed in maintenance.

Arm	Type	Receives
Arm A	Experimental	Drug: Rilvegostomig, Drug: Carboplatin, Drug: Cisplatin, Drug: PemetrexedRilvegostomig in combination with platinum-based doublet chemotherapy followed by rilvegostomig monotherapy plus pemetrexed in maintenance.
Arm B	Active comparator	Drug: Pembrolizumab, Drug: Carboplatin, Drug: Cisplatin, Drug: PemetrexedPembrolizumab in combination with platinum-based doublet chemotherapy followed by pembrolizumab monotherapy plus pemetrexed in maintenance.

Who may qualify

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

Key inclusion criteria (7 listed)

Histologically or cytologically documented non-squamous NSCLC.
Stage III B/C or IV NSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.
Absence of sensitizing EGFR mutations (including, but not limited to, exon 19 deletion and exon 21 L858R, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations) and ALK and ROS1 rearrangements.
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 and available targeted 1L therapies.
Provision of acceptable tumor sample, to confirm tumor PD-L1 expression TC ≥ 1%.

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 therapy received for NSCLC except in the neoadjuvant or adjuvant setting or definitive chemoradiotherapy with the intent to cure, provided that progression has occurred > 12 months after the end of systemic therapy treatment.
Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.
Any prior treatment with an anti-PD-1 or anti-PD-L1 agent.

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 as one intravenously (IV) on Day 1 of each 21-day cycle	Drug	Arm A
PembrolizumabAlso: KeytrudaAdministered as one intravenously (IV) on Day 1 of each 21-day cycle	Drug	Arm B
CarboplatinAdministered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles	Drug	Arm A, Arm B
CisplatinAdministered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles	Drug	Arm A, Arm B
PemetrexedAdministered as one intravenously (IV) on Day 1 of each 21-day cycle	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 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 28 Oct 2026.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca 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 IPD, but this does not mean all requests will be approved.

Related trials for Non-squamous 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
Not yet recruitingPhase 2
Phase II Study to Evaluate Telisotuzumab Adizutecan in Combination With RC148(ABBV-1480) as First-Line Treatment for Patients With Non-Squamous Non-Small-Cell Lung Cancer
Patients With Locally Advanced or Metastatic Non-Squamous NSCLC Requiring First-Line Treatment and no Driver Gene Alterations Confirmed by Histology or Cytology
Active, not recruitingPhase 2
Carboplatin, Taxane And Ramucirumab for Patients With NSCLC After Pemetrexed or Pembrolizumab Maintenance
Non-small Cell Lung Cancer
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder 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

301 sites in 25 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-squamous Non-small Cell Lung Cancer, run by AstraZeneca at 301 sites in 25 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 7 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 28 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 301 sites in United States, Germany, China, Japan, Brazil and 20 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 NCT06627647.

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 28 Oct 2026.