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

Last updated: April 29, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

3

Condition

Non-small Cell Lung Cancer

Treatment

Pembrolizumab

Carboplatin

Nab-paclitaxel

Clinical Study ID

NCT06692738
D702BC00001
2024-514281-39-00
  • Ages > 18
  • All Genders

Study 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 metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically or cytologically documented squamous NSCLC.

  • Stage IV mNSCLC (based on the American Joint Committee on Cancer Edition 8) notamenable to curative treatment.

  • Absence of documented tumor genomic mutation results from tests conducted as part ofstandard local practice in any actionable driver oncogenes for which there arelocally approved 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 atbaseline and can be accurately measured at baseline as ≥ 10 mm in the longestdiameter (except lymph nodes, which must have short axis ≥ 15 mm) with CT or MRI andis suitable for accurate repeated measurements.

  • Adequate organ and bone marrow function.

Exclusion

Exclusion Criteria:

  • Presence of small cell and neuroendocrine histology components.

  • Brain metastases unless asymptomatic, stable, and not requiring steroids oranticonvulsants for at least 7 days prior to randomization. A minimum of 2 weeksmust have elapsed between the end of local therapy (brain radiotherapy or surgery)and randomization. Participants must have recovered from the acute toxic effect ofradiotherapy (eg, dizziness and signs of increased intracranial pressure) or surgeryprior to randomization.

  • Any prior systemic therapy received for advanced or mNSCLC.

  • 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 therapytargeting immune-regulatory receptors or mechanisms.

  • History of another primary malignancy except for malignancy treated with curativeintent with no known active disease ≥ 2 years before the first dose of studyintervention and of low potential risk for recurrence.

  • Active or prior documented autoimmune or inflammatory disorders requiring chronictreatment with steroids or other immunosuppressive treatment.

  • Active primary immunodeficiency/active infectious disease(s).

  • Active tuberculosis infection.

Study Design

Total Participants: 880
Treatment Group(s): 5
Primary Treatment: Pembrolizumab
Phase: 3
Study Start date:
November 18, 2024
Estimated Completion Date:
October 08, 2029

Study 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 metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

Connect with a study center

  • Research Site

    Buenos Aires, C1431FWO
    Argentina

    Active - Recruiting

  • Research Site

    Caba, 1425
    Argentina

    Site Not Available

  • Research Site

    La Plata, 1900
    Argentina

    Site Not Available

  • Research Site

    Pilar, B1629ODT
    Argentina

    Active - Recruiting

  • Research Site

    Rosario, S2000DEJ
    Argentina

    Active - Recruiting

  • Research Site

    Darlinghurst, 2010
    Australia

    Site Not Available

  • Research Site

    Hyde Park, 4812
    Australia

    Site Not Available

  • Research Site

    Southport, 4215
    Australia

    Site Not Available

  • Research Site

    Wollongong, 2500
    Australia

    Site Not Available

  • Research Site

    Innsbruck, 6020
    Austria

    Site Not Available

  • Research Site

    Krems, 3500
    Austria

    Active - Recruiting

  • Research Site

    Rankweil, 6830
    Austria

    Active - Recruiting

  • Research Site

    Wien, 1210
    Austria

    Active - Recruiting

  • Research Site

    Anderlecht, 1070
    Belgium

    Site Not Available

  • Research Site

    Brussels, 1160
    Belgium

    Site Not Available

  • Research Site

    Charleroi, 6060
    Belgium

    Site Not Available

  • Research Site

    Kortrijk, 8500
    Belgium

    Site Not Available

  • Research Site

    Sint-Niklaas, 9100
    Belgium

    Site Not Available

  • Research Site

    Barretos, 14784-400
    Brazil

    Active - Recruiting

  • Research Site

    Florianópolis, 88034-000
    Brazil

    Active - Recruiting

  • Research Site

    Ijuí, 98700-000
    Brazil

    Active - Recruiting

  • Research Site

    Londrina, 86015-520
    Brazil

    Site Not Available

  • Research Site

    Porto Alegre, 91350-200
    Brazil

    Site Not Available

  • Research Site

    Salvador, 40050 410
    Brazil

    Active - Recruiting

  • Research Site

    Sao Paulo, 01246-000
    Brazil

    Active - Recruiting

  • Research Site

    Taubaté, 12030-200
    Brazil

    Site Not Available

  • Research Site

    Saint John, New Brunswick E2L 4L2
    Canada

    Active - Recruiting

  • Research Site

    Sydney, Nova Scotia B1P 1P3
    Canada

    Site Not Available

  • Research Site

    Hamilton, Ontario L8V 1C3
    Canada

    Site Not Available

  • Research Site

    Montreal, Quebec H4A 3J1
    Canada

    Active - Recruiting

  • Research Site

    Montréal, Quebec H2X 0A9
    Canada

    Site Not Available

  • Research Site

    Beijing, CN-100730
    China

    Active - Recruiting

  • Research Site

    Changchun, 130012
    China

    Site Not Available

  • Research Site

    Changde, 415003
    China

    Active - Recruiting

  • Research Site

    Changsha, 410013
    China

    Active - Recruiting

  • Research Site

    Chengdu, 610041
    China

    Active - Recruiting

  • Research Site

    Chongqing, 400030
    China

    Active - Recruiting

  • Research Site

    Dalian, 116001
    China

    Site Not Available

  • Research Site

    Guangzhou, 510062
    China

    Site Not Available

  • Research Site

    Hangzhou, 310022
    China

    Site Not Available

  • Research Site

    Harbin, 150081
    China

    Site Not Available

  • Research Site

    Hefei, 230001
    China

    Site Not Available

  • Research Site

    Jinan, 250117
    China

    Active - Recruiting

  • Research Site

    Kunming, 650118
    China

    Active - Recruiting

  • Research Site

    Linhai, 317000
    China

    Active - Recruiting

  • Research Site

    Linyi, 276001
    China

    Active - Recruiting

  • Research Site

    Nanchang, 330008
    China

    Site Not Available

  • Research Site

    Ningbo, 315010
    China

    Active - Recruiting

  • Research Site

    Shanghai, 200030
    China

    Site Not Available

  • Research Site

    Shenyang, 110004
    China

    Site Not Available

  • Research Site

    Shenzhen, 518020
    China

    Active - Recruiting

  • Research Site

    Taiyuan, 030000
    China

    Site Not Available

  • Research Site

    Tianjin, 300050
    China

    Active - Recruiting

  • Research Site

    Wenzhou, CN-325000
    China

    Active - Recruiting

  • Research Site

    Wuhan, 430030
    China

    Site Not Available

  • Research Site

    Xi'an, 710061
    China

    Site Not Available

  • Research Site

    Yangzhou, 225001
    China

    Active - Recruiting

  • Research Site

    Yueyang, 414000
    China

    Active - Recruiting

  • Research Site

    Zhengzhou, 450052
    China

    Site Not Available

  • Research Site

    Avignon, 84902
    France

    Active - Recruiting

  • Research Site

    La Rochelle Cedex, 17019
    France

    Site Not Available

  • Research Site

    Lyon, 69008
    France

    Site Not Available

  • Research Site

    Nimes, 30029
    France

    Active - Recruiting

  • Research Site

    Rennes, 35033
    France

    Site Not Available

  • Research Site

    Strasbourg Cedex, 67091
    France

    Active - Recruiting

  • Research Site

    Suresnes, 92150
    France

    Site Not Available

  • Research Site

    Toulon Cedex 9, 83800
    France

    Active - Recruiting

  • Research Site

    Bad Berka, 99437
    Germany

    Suspended

  • Research Site

    Berlin, 13585
    Germany

    Site Not Available

  • Research Site

    Esslingen, 73730
    Germany

    Site Not Available

  • Research Site

    Frankfurt, 60488
    Germany

    Site Not Available

  • Research Site

    Gauting, 82131
    Germany

    Site Not Available

  • Research Site

    Giessen, 35392
    Germany

    Site Not Available

  • Research Site

    Großhansdorf, 22927
    Germany

    Site Not Available

  • Research Site

    Hamburg, 20251
    Germany

    Site Not Available

  • Research Site

    Hannover, 30459
    Germany

    Suspended

  • Research Site

    Heidelberg, 69126
    Germany

    Site Not Available

  • Research Site

    Hemer, 58675
    Germany

    Suspended

  • Research Site

    Homburg, 66424
    Germany

    Site Not Available

  • Research Site

    Kassel, 34125
    Germany

    Suspended

  • Research Site

    Kiel, 24105
    Germany

    Site Not Available

  • Research Site

    Krefeld, 47805
    Germany

    Suspended

  • Research Site

    Köln, 51109
    Germany

    Site Not Available

  • Research Site

    Minden, 32429
    Germany

    Site Not Available

  • Research Site

    Moers, 47441
    Germany

    Suspended

  • Research Site

    München, 81925
    Germany

    Site Not Available

  • Research Site

    Regensburg, 93053
    Germany

    Site Not Available

  • Research Site

    Würzburg, 97067
    Germany

    Site Not Available

  • Research Site

    Budapest, 1083
    Hungary

    Site Not Available

  • Research Site

    Debrecen, 4032
    Hungary

    Site Not Available

  • Research Site

    Gyöngyös, 3200
    Hungary

    Site Not Available

  • Research Site

    Győr, 9024
    Hungary

    Site Not Available

  • Research Site

    Pécs, 7624
    Hungary

    Site Not Available

  • Research Site

    Székesfehérvár, 8000
    Hungary

    Site Not Available

  • Research Site

    Törökbálint, 2045
    Hungary

    Site Not Available

  • Research Site

    Calicut, 673601
    India

    Site Not Available

  • Research Site

    Delhi, 110029
    India

    Site Not Available

  • Research Site

    Kolkata, 700054
    India

    Site Not Available

  • Research Site

    Madurai, 625107
    India

    Site Not Available

  • Research Site

    Mumbai, 400012
    India

    Site Not Available

  • Research Site

    Nashik, 422002
    India

    Site Not Available

  • Research Site

    New Delhi, 110075
    India

    Site Not Available

  • Research Site

    Pondicherry, 605006
    India

    Site Not Available

  • Research Site

    Surat, 395017
    India

    Site Not Available

  • Research Site

    Varanasi, 221005
    India

    Site Not Available

  • Research Site

    Firenze, 50134
    Italy

    Site Not Available

  • Research Site

    Monza, 20900
    Italy

    Site Not Available

  • Research Site

    Orbassano, 10043
    Italy

    Site Not Available

  • Research Site

    Padova, 35128
    Italy

    Site Not Available

  • Research Site

    Peschiera Del Garda, 37019
    Italy

    Site Not Available

  • Research Site

    Roma, 00168
    Italy

    Site Not Available

  • Research Site

    Amagasaki-shi, 660-8550
    Japan

    Active - Recruiting

  • Research Site

    Bunkyo-ku, 113-8603
    Japan

    Active - Recruiting

  • Research Site

    Chuo-ku, 104-0045
    Japan

    Active - Recruiting

  • Research Site

    Fukuoka-shi, 814-0180
    Japan

    Active - Recruiting

  • Research Site

    Hiroshima-shi, 734-8551
    Japan

    Active - Recruiting

  • Research Site

    Kawagoe-shi, 350-8550
    Japan

    Active - Recruiting

  • Research Site

    Kitaadachi-gun, 362-0806
    Japan

    Active - Recruiting

  • Research Site

    Kitakyushu-shi, 807-8555
    Japan

    Active - Recruiting

  • Research Site

    Kobe-shi, 650-0017
    Japan

    Active - Recruiting

  • Research Site

    Koto-ku, 135-8550
    Japan

    Active - Recruiting

  • Research Site

    Kumamoto-shi, 860-8556
    Japan

    Active - Recruiting

  • Research Site

    Matsusaka-shi, 515-8544
    Japan

    Active - Recruiting

  • Research Site

    Osaka-shi, 541-8567
    Japan

    Active - Recruiting

  • Research Site

    Osakasayama, 589-8511
    Japan

    Active - Recruiting

  • Research Site

    Ota-shi, 373-8550
    Japan

    Active - Recruiting

  • Research Site

    Saitama-shi, 338-0001
    Japan

    Active - Recruiting

  • Research Site

    Sendai-shi, 981-0914
    Japan

    Active - Recruiting

  • Research Site

    Shinjuku-ku, 160-0023
    Japan

    Active - Recruiting

  • Research Site

    Yokohama-shi, 241-8515
    Japan

    Active - Recruiting

  • Research Site

    Cheongju-si, 28644
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Incheon, 21565
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Suwon-si, 16499
    Korea, Republic of

    Active - Recruiting

  • Research Site

    George Town, 10450
    Malaysia

    Active - Recruiting

  • Research Site

    Johor Bahru, 81100
    Malaysia

    Active - Recruiting

  • Research Site

    Kuala Lumpur, 59100
    Malaysia

    Site Not Available

  • Research Site

    Alkmaar, 1815 JD
    Netherlands

    Site Not Available

  • Research Site

    Groningen, 9713 GZ
    Netherlands

    Site Not Available

  • Research Site

    Leidschendam, 2262 BA
    Netherlands

    Active - Recruiting

  • Research Site

    Utrecht, 2512 VA
    Netherlands

    Site Not Available

  • Research Site

    Veldhoven, 5504 DB
    Netherlands

    Site Not Available

  • Research Site

    Zwolle, 8025 AB
    Netherlands

    Site Not Available

  • Research Site

    Lima, 15036
    Peru

    Site Not Available

  • Research Site

    Biała Podlaska, 21-500
    Poland

    Suspended

  • Research Site

    Białystok, 15-027
    Poland

    Site Not Available

  • Research Site

    Bydgoszcz, 85-796
    Poland

    Suspended

  • Research Site

    Bystra, 43-360
    Poland

    Site Not Available

  • Research Site

    Poznań, 60-569
    Poland

    Active - Recruiting

  • Research Site

    Warszawa, 04-141
    Poland

    Site Not Available

  • Research Site

    Łódź, 93-338
    Poland

    Active - Recruiting

  • Research Site

    San Juan, 00909
    Puerto Rico

    Site Not Available

  • Research Site

    Barcelona, 8035
    Spain

    Site Not Available

  • Research Site

    Las Palmas de Gran Canaria, 35016
    Spain

    Site Not Available

  • Research Site

    Lérida, 25198
    Spain

    Site Not Available

  • Research Site

    Madrid, 28007
    Spain

    Site Not Available

  • Research Site

    Majadahonda, 28222
    Spain

    Site Not Available

  • Research Site

    Sevilla, 41013
    Spain

    Site Not Available

  • Research Site

    Kaohsiung, 80756
    Taiwan

    Active - Recruiting

  • Research Site

    New Taipei, 220
    Taiwan

    Active - Recruiting

  • Research Site

    New Taipei City, 23561
    Taiwan

    Active - Recruiting

  • Research Site

    Taichung, 402
    Taiwan

    Active - Recruiting

  • Research Site

    Tainan City, 73657
    Taiwan

    Active - Recruiting

  • Research Site

    Taipei, 23561
    Taiwan

    Site Not Available

  • Research Site

    Taoyuan, 333
    Taiwan

    Active - Recruiting

  • Research Site

    Bangkok, 10700
    Thailand

    Active - Recruiting

  • Research Site

    Chiang Mai, 50200
    Thailand

    Active - Recruiting

  • Research Site

    Dusit, 10300
    Thailand

    Active - Recruiting

  • Research Site

    Nakhon Ratchasima, 30000
    Thailand

    Active - Recruiting

  • Research Site

    Songkla, 90110
    Thailand

    Active - Recruiting

  • Research Site

    Antalya, 07058
    Turkey

    Site Not Available

  • Research Site

    Istanbul, 34098
    Turkey

    Site Not Available

  • Research Site

    Yenimahalle, 06170
    Turkey

    Site Not Available

  • Research Site

    Aberdeen, AB25 2ZN
    United Kingdom

    Site Not Available

  • Research Site

    Cambridge, CB2 0QQ
    United Kingdom

    Active - Recruiting

  • Research Site

    Edinburgh, EH4 2XU
    United Kingdom

    Site Not Available

  • Research Site

    Exeter, EX2 5DW
    United Kingdom

    Site Not Available

  • Research Site

    Greater London, SW3 6JJ
    United Kingdom

    Active - Recruiting

  • Research Site

    London, EC1A 7BE
    United Kingdom

    Active - Recruiting

  • Research Site

    Manchester, M20 4BX
    United Kingdom

    Active - Recruiting

  • Research Site

    Newcastle upon Tyne, NE7 7AF
    United Kingdom

    Site Not Available

  • Research Site

    Preston, PR2 9HT
    United Kingdom

    Site Not Available

  • Research Site

    Springdale, Arkansas 72762
    United States

    Active - Recruiting

  • Research Site

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Research Site

    Glendale, California 91204
    United States

    Active - Recruiting

  • Research Site

    Los Alamitos, California 90720
    United States

    Site Not Available

  • Research Site

    Redlands, California 92373
    United States

    Site Not Available

  • Research Site

    San Francisco, California 94121
    United States

    Site Not Available

  • Research Site

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Research Site

    West Haven, Connecticut 06516
    United States

    Site Not Available

  • Research Site

    Newark, Delaware 19713
    United States

    Active - Recruiting

  • Research Site

    Bay Pines, Florida 33744
    United States

    Site Not Available

  • Research Site

    Gainesville, Florida 32608
    United States

    Site Not Available

  • Research Site

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Research Site

    Athens, Georgia 30607
    United States

    Active - Recruiting

  • Research Site

    Atlanta, Georgia 30341
    United States

    Site Not Available

  • Research Site

    Boise, Idaho 83712
    United States

    Active - Recruiting

  • Research Site

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Research Site

    Decatur, Illinois 62526
    United States

    Active - Recruiting

  • Research Site

    Quincy, Illinois 62301
    United States

    Site Not Available

  • Research Site

    Waterloo, Iowa 50702
    United States

    Site Not Available

  • Research Site

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • Research Site

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • Research Site

    Alexandria, Louisiana 71301
    United States

    Site Not Available

  • Research Site

    Baton Rouge, Louisiana 70808
    United States

    Site Not Available

  • Research Site

    Covington, Louisiana 70433
    United States

    Active - Recruiting

  • Research Site

    Shreveport, Louisiana 71103
    United States

    Site Not Available

  • Research Site

    Baltimore, Maryland 21202
    United States

    Active - Recruiting

  • Research Site

    Bethesda, Maryland 20817
    United States

    Site Not Available

  • Research Site

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Research Site

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • Research Site

    Duluth, Minnesota 55802
    United States

    Active - Recruiting

  • Research Site

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Research Site

    Bridgeton, Missouri 63044
    United States

    Site Not Available

  • Research Site

    Columbia, Missouri 65212
    United States

    Site Not Available

  • Research Site

    Kansas City, Missouri 64108
    United States

    Site Not Available

  • Research Site

    Omaha, Nebraska 68130
    United States

    Active - Recruiting

  • Research Site

    Camden, New Jersey 08103
    United States

    Site Not Available

  • Research Site

    Buffalo, New York 14221
    United States

    Site Not Available

  • Research Site

    East Syracuse, New York 13057
    United States

    Active - Recruiting

  • Research Site

    Westbury, New York 11590
    United States

    Active - Recruiting

  • Research Site

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • Research Site

    Bend, Oregon 97701
    United States

    Site Not Available

  • Research Site

    Medford, Oregon 97504
    United States

    Active - Recruiting

  • Research Site

    Salem, Oregon 97301
    United States

    Active - Recruiting

  • Research Site

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Research Site

    York, Pennsylvania 17403
    United States

    Active - Recruiting

  • Research Site

    Sioux Falls, South Dakota 57105
    United States

    Active - Recruiting

  • Research Site

    Chattanooga, Tennessee 37404
    United States

    Active - Recruiting

  • Research Site

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Research Site

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Research Site

    Houston, Texas 77090
    United States

    Active - Recruiting

  • Research Site

    Kingwood, Texas 77339
    United States

    Site Not Available

  • Research Site

    Lubbock, Texas 79410
    United States

    Site Not Available

  • Research Site

    Round Rock, Texas 78665
    United States

    Site Not Available

  • Research Site

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • Research Site

    Fredericksburg, Virginia 22408
    United States

    Site Not Available

  • Research Site

    Olympia, Washington 98506
    United States

    Active - Recruiting

  • Research Site

    Seattle, Washington 98101
    United States

    Site Not Available

  • Research Site

    Silverdale, Washington 98383
    United States

    Site Not Available

  • Research Site

    Spokane, Washington 99208
    United States

    Site Not Available

  • Research Site

    Tacoma, Washington 98405
    United States

    Active - Recruiting

  • Research Site

    Wenatchee, Washington 98801
    United States

    Site Not Available

  • Research Site

    Can Tho, 900000
    Vietnam

    Site Not Available

  • Research Site

    Hanoi, 100000
    Vietnam

    Site Not Available

  • Research Site

    Ho Chi Minh, 700000
    Vietnam

    Site Not Available

  • Research Site

    Ho Chi Minh City, 700000
    Vietnam

    Active - Recruiting

  • Research Site

    Vinh, 460000
    Vietnam

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.