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

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 Metastatic Squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung02)

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).

Study Overview

• Status: Recruiting
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Rilvegostomig; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Pembrolizumab

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

• Study Type: Interventional
• Enrollment (Estimated): 880
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1431FWO
    • Recruiting
    • Research Site
  • CABA, Argentina, 1425
    • Recruiting
    • Research Site
  • La Plata, Argentina, 1900
    • Withdrawn
    • Research Site
  • Pilar, Argentina, B1629ODT
    • Recruiting
    • Research Site
  • Rosario, Argentina, S2000DEJ
    • Recruiting
    • Research Site
• Australia
  • Darlinghurst, Australia, 2010
    • Recruiting
    • Research Site
  • Hyde Park, Australia, 4812
    • Recruiting
    • Research Site
  • Southport, Australia, 4215
    • Recruiting
    • Research Site
  • Wollongong, Australia, 2500
    • Recruiting
    • Research Site
• Austria
  • Innsbruck, Austria, 6020
    • Recruiting
    • Research Site
  • Krems, Austria, 3500
    • Recruiting
    • Research Site
  • Rankweil, Austria, 6830
    • Recruiting
    • Research Site
  • Vienna, Austria, 1210
    • Recruiting
    • Research Site
  • Vienna, Austria, 1160
    • Recruiting
    • Research Site
• Belgium
  • Anderlecht, Belgium, 1070
    • Withdrawn
    • Research Site
  • Brussels, Belgium, 1160
    • Recruiting
    • Research Site
  • Charleroi, Belgium, 6060
    • Recruiting
    • Research Site
  • Kortrijk, Belgium, 8500
    • Recruiting
    • Research Site
  • Ottignies, Belgium, 1340
    • Recruiting
    • Research Site
  • Sint-Niklaas, Belgium, 9100
    • Withdrawn
    • Research Site
• Brazil
  • Barretos, Brazil, 14784-400
    • Recruiting
    • Research Site
  • Florianópolis, Brazil, 88034-000
    • Recruiting
    • Research Site
  • Ijuí, Brazil, 98700-000
    • Recruiting
    • Research Site
  • Londrina, Brazil, 86015-520
    • Recruiting
    • Research Site
  • Porto Alegre, Brazil, 91350-200
    • Recruiting
    • Research Site
  • Salvador, Brazil, 40050 410
    • Recruiting
    • Research Site
  • São Paulo, Brazil, 01246-000
    • Recruiting
    • Research Site
  • São Paulo, Brazil, 05652-900
    • Recruiting
    • Research Site
  • Taubaté, Brazil, 12030-200
    • Withdrawn
    • Research Site
• Canada
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L 4L2
      • Recruiting
      • Research Site
  • Nova Scotia
    • Sydney, Nova Scotia, Canada, B1P 1P3
      • Recruiting
      • Research Site
  • Ontario
    • Hamilton, Ontario, Canada, L8V 1C3
      • Recruiting
      • Research Site
    • Sault Ste. Marie, Ontario, Canada, P6A 0A8
      • Recruiting
      • Research Site
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • Recruiting
      • Research Site
    • Montreal, Quebec, Canada, H2X 0A9
      • Recruiting
      • Research Site
• China
  • Beijing, China, 100029
    • Withdrawn
    • Research Site
  • Beijing, China, CN-100730
    • Recruiting
    • Research Site
  • Beijing, China, 100142
    • Recruiting
    • Research Site
  • Beijing, China, 100021
    • Recruiting
    • Research Site
  • Beijing, China, 101149
    • Not yet recruiting
    • Research Site
  • Changchun, China, 130012
    • Recruiting
    • Research Site
  • Changde, China, 415000
    • Recruiting
    • Research Site
  • Changsha, China, 410013
    • Recruiting
    • Research Site
  • Chengdu, China, 610041
    • Recruiting
    • Research Site
  • Chengdu, China, 610072
    • Recruiting
    • Research Site
  • Chongqing, China, 400030
    • Recruiting
    • Research Site
  • Dalian, China, 116001
    • Recruiting
    • Research Site
  • Guangzhou, China, 510062
    • Recruiting
    • Research Site
  • Guangzhou, China, 510100
    • Recruiting
    • Research Site
  • Hangzhou, China, 310003
    • Recruiting
    • Research Site
  • Hangzhou, China, 310022
    • Recruiting
    • Research Site
  • Hangzhou, China, 310016
    • Recruiting
    • Research Site
  • Harbin, China, 150081
    • Recruiting
    • Research Site
  • Hefei, China, 230601
    • Recruiting
    • Research Site
  • Hefei, China, 230001
    • Recruiting
    • Research Site
  • Jinan, China, 250117
    • Recruiting
    • Research Site
  • Kunming, China, 650118
    • Recruiting
    • Research Site
  • Linhai, China, 317000
    • Recruiting
    • Research Site
  • Linyi, China, 276001
    • Recruiting
    • Research Site
  • Nanchang, China, 330008
    • Recruiting
    • Research Site
  • Ningbo, China, 315010
    • Recruiting
    • Research Site
  • Shanghai, China, 200032
    • Recruiting
    • Research Site
  • Shanghai, China, 200030
    • Recruiting
    • Research Site
  • Shanghai, China, 200433
    • Recruiting
    • Research Site
  • Shenyang, China, 110004
    • Withdrawn
    • Research Site
  • Shenzhen, China, 518020
    • Recruiting
    • Research Site
  • Taiyuan, China, 030000
    • Recruiting
    • Research Site
  • Tianjin, China, 300050
    • Recruiting
    • Research Site
  • Wenzhou, China, CN-325000
    • Recruiting
    • Research Site
  • Wuhan, China, 430030
    • Suspended
    • Research Site
  • Xi'an, China, 710061
    • Recruiting
    • Research Site
  • Yangzhou, China, 225001
    • Recruiting
    • Research Site
  • Yueyang, China, 414000
    • Recruiting
    • Research Site
  • Zhengzhou, China, 450008
    • Recruiting
    • Research Site
  • Zhengzhou, China, 450052
    • Recruiting
    • Research Site
• France
  • Avignon, France, 84902
    • Recruiting
    • Research Site
  • La Rochelle, France, 17019
    • Recruiting
    • Research Site
  • Lyon, France, 69008
    • Recruiting
    • Research Site
  • Nîmes, France, 30029
    • Recruiting
    • Research Site
  • Rennes, France, 35033
    • Recruiting
    • Research Site
  • Strasbourg, France, 67091
    • Recruiting
    • Research Site
  • Suresnes, France, 92150
    • Recruiting
    • Research Site
  • Toulon, France, 83800
    • Recruiting
    • Research Site
• Germany
  • Bad Berka, Germany, 99437
    • Recruiting
    • Research Site
  • Berlin, Germany, 13125
    • Recruiting
    • Research Site
  • Berlin, Germany, 13585
    • Recruiting
    • Research Site
  • Bielefeld, Germany, 33611
    • Not yet recruiting
    • Research Site
  • Cologne, Germany, 51109
    • Recruiting
    • Research Site
  • Esslingen am Neckar, Germany, 73730
    • Recruiting
    • Research Site
  • Frankfurt, Germany, 60488
    • Recruiting
    • Research Site
  • Gauting, Germany, 82131
    • Recruiting
    • Research Site
  • Giessen, Germany, 35392
    • Recruiting
    • Research Site
  • Großhansdorf, Germany, 22927
    • Recruiting
    • Research Site
  • Hamburg, Germany, 20251
    • Recruiting
    • Research Site
  • Hanover, Germany, 30625
    • Recruiting
    • Research Site
  • Hanover, Germany, 30459
    • Recruiting
    • Research Site
  • Heidelberg, Germany, 69126
    • Recruiting
    • Research Site
  • Hemer, Germany, 58675
    • Recruiting
    • Research Site
  • Homburg, Germany, 66424
    • Recruiting
    • Research Site
  • Kassel, Germany, 34125
    • Recruiting
    • Research Site
  • Kiel, Germany, 24105
    • Recruiting
    • Research Site
  • Krefeld, Germany, 47805
    • Recruiting
    • Research Site
  • Minden, Germany, 32429
    • Recruiting
    • Research Site
  • Moers, Germany, 47441
    • Recruiting
    • Research Site
  • München, Germany, 81925
    • Not yet recruiting
    • Research Site
  • Regensburg, Germany, 93053
    • Recruiting
    • Research Site
  • Würzburg, Germany, 97067
    • Recruiting
    • Research Site
• Hungary
  • Budapest, Hungary, 1121
    • Recruiting
    • Research Site
  • Budapest, Hungary, 1122
    • Recruiting
    • Research Site
  • Budapest, Hungary, 1083
    • Not yet recruiting
    • Research Site
  • Debrecen, Hungary, 4032
    • Recruiting
    • Research Site
  • Gyöngyös, Hungary, 3200
    • Withdrawn
    • Research Site
  • Gyöngyös - Mátraháza, Hungary, 3200
    • Not yet recruiting
    • Research Site
  • Győr, Hungary, 9024
    • Recruiting
    • Research Site
  • Pécs, Hungary, 7624
    • Recruiting
    • Research Site
  • Székesfehérvár, Hungary, 8000
    • Not yet recruiting
    • Research Site
  • Törökbálint, Hungary, 2045
    • Recruiting
    • Research Site
• India
  • Calicut, India, 673601
    • Recruiting
    • Research Site
  • Delhi, India, 110029
    • Recruiting
    • Research Site
  • Kolkata, India, 700054
    • Withdrawn
    • Research Site
  • Madurai, India, 625107
    • Recruiting
    • Research Site
  • Mumbai, India, 400012
    • Not yet recruiting
    • Research Site
  • Nashik, India, 422002
    • Recruiting
    • Research Site
  • New Delhi, India, 110075
    • Withdrawn
    • Research Site
  • Puducherry, India, 605006
    • Withdrawn
    • Research Site
  • Surat, India, 395017
    • Recruiting
    • Research Site
  • Varanasi, India, 221005
    • Recruiting
    • Research Site
• Italy
  • Florence, Italy, 50134
    • Recruiting
    • Research Site
  • Monza, Italy, 20900
    • Recruiting
    • Research Site
  • Orbassano, Italy, 10043
    • Recruiting
    • Research Site
  • Padova, Italy, 35128
    • Recruiting
    • Research Site
  • Peschiera del Garda, Italy, 37019
    • Recruiting
    • Research Site
  • Roma, Italy, 00168
    • Recruiting
    • Research Site
• Japan
  • Amagasaki-shi, Japan, 660-8550
    • Recruiting
    • Research Site
  • Bunkyō City, Japan, 113-8603
    • Recruiting
    • Research Site
  • Chūōku, Japan, 104-0045
    • Recruiting
    • Research Site
  • Fukuoka, Japan, 812-8582
    • Recruiting
    • Research Site
  • Fukuoka, Japan, 814-0180
    • Recruiting
    • Research Site
  • Hiroshima, Japan, 734-8551
    • Recruiting
    • Research Site
  • Kawagoe-shi, Japan, 350-8550
    • Recruiting
    • Research Site
  • Kawasaki-shi, Japan, 216-8511
    • Recruiting
    • Research Site
  • Kitaadachi-gun, Japan, 362-0806
    • Recruiting
    • Research Site
  • Kitakyushu-shi, Japan, 807-8555
    • Recruiting
    • Research Site
  • Kobe, Japan, 650-0017
    • Recruiting
    • Research Site
  • Kumamoto, Japan, 861-4193
    • Recruiting
    • Research Site
  • Kumamoto, Japan, 860-8556
    • Recruiting
    • Research Site
  • Kyoto, Japan, 612-8555
    • Not yet recruiting
    • Research Site
  • Kōtoku, Japan, 135-8550
    • Recruiting
    • Research Site
  • Matsusaka-shi, Japan, 515-8544
    • Recruiting
    • Research Site
  • Osaka, Japan, 541-8567
    • Recruiting
    • Research Site
  • Ota-shi, Japan, 373-8550
    • Recruiting
    • Research Site
  • Saitama-shi, Japan, 338-0001
    • Recruiting
    • Research Site
  • Sakai, Japan, 590-0197
    • Recruiting
    • Research Site
  • Sendai, Japan, 981-0914
    • Recruiting
    • Research Site
  • Shinjuku-ku, Japan, 160-0023
    • Recruiting
    • Research Site
  • Takaoka-shi, Japan, 933-8555
    • Recruiting
    • Research Site
  • Yokohama, Japan, 241-8515
    • Recruiting
    • Research Site
  • Yokohama, Japan, 232-0024
    • Recruiting
    • Research Site
• Malaysia
  • George Town, Malaysia, 10450
    • Recruiting
    • Research Site
  • Johor Bahru, Malaysia, 81100
    • Recruiting
    • Research Site
  • Kuala Lumpur, Malaysia, 59100
    • Recruiting
    • Research Site
• Netherlands
  • Alkmaar, Netherlands, 1815 JD
    • Recruiting
    • Research Site
  • Ede, Netherlands, 6716 RP
    • Recruiting
    • Research Site
  • Groningen, Netherlands, 9713 GZ
    • Withdrawn
    • Research Site
  • Leidschendam, Netherlands, 2262 BA
    • Recruiting
    • Research Site
  • Veldhoven, Netherlands, 5504 DB
    • Recruiting
    • Research Site
  • Zwolle, Netherlands, 8025 AB
    • Recruiting
    • Research Site
• Peru
  • Lima, Peru, L27
    • Withdrawn
    • Research Site
  • Lima, Peru, 15036
    • Withdrawn
    • Research Site
  • Lima, Peru, LIMA 29
    • Withdrawn
    • Research Site
  • Lima, Peru, 15102
    • Withdrawn
    • Research Site
  • Lima, Peru, 34
    • Withdrawn
    • Research Site
  • Lima, Peru, Lima39
    • Withdrawn
    • Research Site
• Poland
  • Bialystok, Poland, 15-027
    • Withdrawn
    • Research Site
  • Biała Podlaska, Poland, 21-500
    • Suspended
    • Research Site
  • Bydgoszcz, Poland, 85-796
    • Suspended
    • Research Site
  • Bystra, Poland, 43-360
    • Recruiting
    • Research Site
  • Lodz, Poland, 93-338
    • Recruiting
    • Research Site
  • Poznan, Poland, 60-569
    • Recruiting
    • Research Site
  • Warsaw, Poland, 04-141
    • Recruiting
    • Research Site
• Puerto Rico
  • San Juan, Puerto Rico, 00918
    • Recruiting
    • Research Site
  • San Juan, Puerto Rico, 00909
    • Recruiting
    • Research Site
• South Korea
  • Cheongju-si, South Korea, 28644
    • Recruiting
    • Research Site
  • Incheon, South Korea, 21565
    • Recruiting
    • Research Site
  • Seoul, South Korea, 03080
    • Recruiting
    • Research Site
  • Seoul, South Korea, 06351
    • Recruiting
    • Research Site
  • Seoul, South Korea, 05505
    • Recruiting
    • Research Site
  • Seoul, South Korea, 03722
    • Recruiting
    • Research Site
  • Suwon, South Korea, 16247
    • Recruiting
    • Research Site
  • Suwon, South Korea, 16499
    • Recruiting
    • Research Site
• Spain
  • Barcelona, Spain, 8035
    • Recruiting
    • Research Site
  • Las Palmas de Gran Canaria, Spain, 35016
    • Recruiting
    • Research Site
  • Lleida, Spain, 25198
    • Recruiting
    • Research Site
  • Madrid, Spain, 28007
    • Recruiting
    • Research Site
  • Madrid, Spain, 28034
    • Recruiting
    • Research Site
  • Majadahonda, Spain, 28222
    • Recruiting
    • Research Site
  • Seville, Spain, 41013
    • Recruiting
    • Research Site
• Taiwan
  • Kaohsiung City, Taiwan, 80756
    • Recruiting
    • Research Site
  • Kaohsiung City, Taiwan, 824
    • Recruiting
    • Research Site
  • New Taipei City, Taiwan, 220
    • Recruiting
    • Research Site
  • New Taipei City, Taiwan, 23561
    • Recruiting
    • Research Site
  • Taichung, Taiwan, 40705
    • Recruiting
    • Research Site
  • Taichung, Taiwan, 402
    • Recruiting
    • Research Site
  • Tainan, Taiwan, 73657
    • Recruiting
    • Research Site
  • Taoyuan, Taiwan, 333
    • Recruiting
    • Research Site
• Thailand
  • Bangkok, Thailand, 10700
    • Recruiting
    • Research Site
  • Chiang Mai, Thailand, 50200
    • Recruiting
    • Research Site
  • Dusit, Thailand, 10300
    • Recruiting
    • Research Site
  • Nakhon Ratchasima, Thailand, 30000
    • Recruiting
    • Research Site
  • Songkhla, Thailand, 90110
    • Recruiting
    • Research Site
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 6500
    • Recruiting
    • Research Site
  • Antalya, Turkey (Türkiye), 07059
    • Recruiting
    • Research Site
  • Istanbul, Turkey (Türkiye), 34098
    • Recruiting
    • Research Site
  • Yenimahalle, Turkey (Türkiye), 06170
    • Recruiting
    • Research Site
• United Kingdom
  • Aberdeen, United Kingdom, AB25 2ZN
    • Recruiting
    • Research Site
  • Cambridge, United Kingdom, CB2 0QQ
    • Recruiting
    • Research Site
  • Edinburgh, United Kingdom, EH4 2XU
    • Recruiting
    • Research Site
  • Exeter, United Kingdom, EX2 5DW
    • Withdrawn
    • Research Site
  • Greater London, United Kingdom, SW3 6JJ
    • Recruiting
    • Research Site
  • London, United Kingdom, EC1A 7BE
    • Recruiting
    • Research Site
  • London, United Kingdom, SE1 9RT
    • Recruiting
    • Research Site
  • Manchester, United Kingdom, M20 4BX
    • Recruiting
    • Research Site
  • Newcastle upon Tyne, United Kingdom, NE7 7AF
    • Recruiting
    • Research Site
  • Preston, United Kingdom, PR2 9HT
    • Recruiting
    • Research Site
• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • Recruiting
      • Research Site
  • Arkansas
    • Springdale, Arkansas, United States, 72762
      • Recruiting
      • Research Site
  • California
    • Anaheim, California, United States, 92801
      • Recruiting
      • Research Site
    • Beverly Hills, California, United States, 90211
      • Recruiting
      • Research Site
    • Loma Linda, California, United States, 92354
      • Recruiting
      • Research Site
    • Los Alamitos, California, United States, 90720
      • Recruiting
      • Research Site
    • Redlands, California, United States, 92373
      • Recruiting
      • Research Site
    • San Francisco, California, United States, 94121
      • Recruiting
      • Research Site
    • Walnut Creek, California, United States, 94598
      • Recruiting
      • Research Site
  • Connecticut
    • West Haven, Connecticut, United States, 06516
      • Recruiting
      • Research Site
  • Delaware
    • Newark, Delaware, United States, 19713
      • Recruiting
      • Research Site
  • Florida
    • Bay Pines, Florida, United States, 33744
      • Recruiting
      • Research Site
    • Fort Lauderdale, Florida, United States, 33308
      • Recruiting
      • Research Site
    • Gainesville, Florida, United States, 32610
      • Withdrawn
      • Research Site
    • Gainesville, Florida, United States, 32608
      • Recruiting
      • Research Site
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Research Site
  • Georgia
    • Athens, Georgia, United States, 30607
      • Recruiting
      • Research Site
    • Atlanta, Georgia, United States, 30341
      • Withdrawn
      • Research Site
  • Idaho
    • Boise, Idaho, United States, 83712
      • Recruiting
      • Research Site
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • Research Site
    • Decatur, Illinois, United States, 62526
      • Recruiting
      • Research Site
    • Hinsdale, Illinois, United States, 60521
      • Recruiting
      • Research Site
    • Quincy, Illinois, United States, 62301
      • Recruiting
      • Research Site
    • Rockford, Illinois, United States, 61114
      • Not yet recruiting
      • Research Site
  • Iowa
    • Waterloo, Iowa, United States, 50702
      • Recruiting
      • Research Site
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Recruiting
      • Research Site
    • Lexington, Kentucky, United States, 40536
      • Withdrawn
      • Research Site
    • Louisville, Kentucky, United States, 40207
      • Recruiting
      • Research Site
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • Research Site
  • Louisiana
    • Alexandria, Louisiana, United States, 71301
      • Withdrawn
      • Research Site
    • Baton Rouge, Louisiana, United States, 70808
      • Recruiting
      • Research Site
    • Covington, Louisiana, United States, 70433
      • Withdrawn
      • Research Site
    • Shreveport, Louisiana, United States, 71105
      • Recruiting
      • Research Site
    • Shreveport, Louisiana, United States, 71103
      • Recruiting
      • Research Site
  • Maine
    • South Portland, Maine, United States, 04106
      • Recruiting
      • Research Site
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Recruiting
      • Research Site
    • Bethesda, Maryland, United States, 20817
      • Recruiting
      • Research Site
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Research Site
    • Grand Rapids, Michigan, United States, 49503
      • Recruiting
      • Research Site
  • Minnesota
    • Duluth, Minnesota, United States, 55802
      • Recruiting
      • Research Site
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Research Site
  • Missouri
    • Bridgeton, Missouri, United States, 63044
      • Recruiting
      • Research Site
    • Columbia, Missouri, United States, 65212
      • Withdrawn
      • Research Site
    • Kansas City, Missouri, United States, 64108
      • Recruiting
      • Research Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Recruiting
      • Research Site
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Recruiting
      • Research Site
  • New York
    • Buffalo, New York, United States, 14221
      • Recruiting
      • Research Site
    • East Syracuse, New York, United States, 13057
      • Recruiting
      • Research Site
    • Westbury, New York, United States, 11590
      • Recruiting
      • Research Site
  • North Dakota
    • Grand Forks, North Dakota, United States, 58201
      • Recruiting
      • Research Site
  • Ohio
    • Canton, Ohio, United States, 44718
      • Not yet recruiting
      • Research Site
    • Cincinnati, Ohio, United States, 45267
      • Recruiting
      • Research Site
  • Oregon
    • Bend, Oregon, United States, 97701
      • Withdrawn
      • Research Site
    • Medford, Oregon, United States, 97504
      • Recruiting
      • Research Site
    • Salem, Oregon, United States, 97301
      • Recruiting
      • Research Site
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Recruiting
      • Research Site
    • York, Pennsylvania, United States, 17403
      • Recruiting
      • Research Site
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Recruiting
      • Research Site
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Recruiting
      • Research Site
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Research Site
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Recruiting
      • Research Site
    • Houston, Texas, United States, 77090
      • Completed
      • Research Site
    • Kingwood, Texas, United States, 77339
      • Recruiting
      • Research Site
    • Lubbock, Texas, United States, 79410
      • Recruiting
      • Research Site
    • Round Rock, Texas, United States, 78665
      • Recruiting
      • Research Site
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • Research Site
    • Fredericksburg, Virginia, United States, 22408
      • Recruiting
      • Research Site
  • Washington
    • Olympia, Washington, United States, 98506
      • Recruiting
      • Research Site
    • Seattle, Washington, United States, 98101
      • Recruiting
      • Research Site
    • Silverdale, Washington, United States, 98383
      • Withdrawn
      • Research Site
    • Spokane, Washington, United States, 99208
      • Recruiting
      • Research Site
    • Tacoma, Washington, United States, 98405
      • Recruiting
      • Research Site
    • Wenatchee, Washington, United States, 98801
      • Withdrawn
      • Research Site
• Vietnam
  • Can Tho, Vietnam, 900000
    • Recruiting
    • Research Site
  • Hanoi, Vietnam, 100000
    • Recruiting
    • Research Site
  • Ho Chi Minh City, Vietnam, 700000
    • Recruiting
    • Research Site
  • Vinh, Vietnam, 460000
    • Recruiting
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically or cytologically documented squamous NSCLC.
• Stage 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 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.

Exclusion Criteria:

• 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 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 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.
• Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
• Active primary immunodeficiency/active infectious disease(s).
• Active tuberculosis infection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; Rilvegostomig in combination with carboplatin and paclitaxel or nab-paclitaxel followed by rilvegostomig	Drug: Rilvegostomig; Administered intravenously (IV) on Day 1 of each 21-day cycle; Other Names: AZD2936; Drug: Carboplatin; Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles; Drug: Paclitaxel; Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles; Drug: Nab-paclitaxel; Administered intravenously (IV) on Days 1, 8, and 15 of each 21-day cycle up to 4 cycles
Active Comparator: Arm B; Pembrolizumab in combination with carboplatin and paclitaxel or nab-paclitaxel followed by pembrolizumab	Drug: Carboplatin; Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles; Drug: Paclitaxel; Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles; Drug: Nab-paclitaxel; Administered intravenously (IV) on Days 1, 8, and 15 of each 21-day cycle up to 4 cycles; Drug: Pembrolizumab; Administered intravenously (IV) on Day 1 of each 21-day cycle; Other Names: Keytruda

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	OS is defined as the time from randomization until the date of death due to any cause.	Up to approximately 5 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).	Up to approximately 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Landmark overall survival (OS) rates	OS is defined as the time from randomization until the date of death due to any cause.	Up to approximately 5 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).	Up to approximately 5 years
Time to second progression or death (PFS2)	PFS2 is defined as the time from randomization until the earliest of the progression event (following the initial 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.	Up to approximately 5 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).	Up to approximately 5 years
Duration of response (DoR)	DoR is defined as the time from the date of first documented response until the date of documented progression using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) or death due to any cause (in the absence of progression).	Up to approximately 5 years
Pharmacokinetic (PK) of rilvegostomig	Concentration of rilvegostomig in serum.	Up to approximately 5 years
Immunogenicity of rilvegostomig	Presence of antidrug antibodies (ADAs), titer, and neutralizing antibodies for rilvegostomig.	Up to approximately 5 years
Patient-reported physical functioning	Proportion of participants with maintained or improved physical functioning as measured by Patient-Reported Outcomes Measurement Information System Physical Function - Short Form 8c - 7 day (PROMIS PF-SF 8c - 7 day) at each time point.	Up to approximately 5 years
Patient-reported lung cancer symptoms of non-small cell lung cancer (NSCLC)	Time to deterioration (TTD) in pulmonary symptoms as measured by the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ). TTD is defined as time from randomization to the date of first deterioration.	Up to approximately 5 years
Patient-reported global health status (GHS)/quality of life (QoL)	Time to deterioration (TTD) of GHS/QoL as measured by the European Organization for Research and Treatment of Cancer Item Library 172 (EORTC IL172). TTD is defined as time from randomization to the date of first deterioration. Deterioration is defined as a worsening change from baseline that reaches a clinically meaningful change threshold.	Up to approximately 5 years

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2024
• Primary Completion (Estimated): February 5, 2029
• Study Completion (Estimated): October 8, 2029

Study Registration Dates

• First Submitted: October 4, 2024
• First Submitted That Met QC Criteria: November 14, 2024
• First Posted (Actual): November 18, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Pembrolizumab; Carboplatin; Non-small cell lung cancer (NSCLC); Paclitaxel; Nab-paclitaxel; Bi-specific antibody; Programmed death-ligand 1 (PD-L1); Rilvegostomig (AZD2936); T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domain (TIGIT); ARTEMIDE-Lung02
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Organic Chemicals; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Coordination Complexes; Taxoids; Cyclodecanes; Diterpenes; Carboplatin; Paclitaxel; pembrolizumab; 130-nm albumin-bound paclitaxel
• Other Study ID Numbers: D702BC00001; 2024-514281-39-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the European Federation of Pharmaceutical Industries and Associations (EFPIA)/Pharmaceutical Research and Manufacturers of America (PhRMA) Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No