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

October 28, 2026 updated by: AstraZeneca

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

The purpose of ARTEMIDE-Lung02 is to assess the efficacy and safety of rilvegostomig in combination with platinum-based chemotherapy for the first-line (1L) treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous locally advanced or metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
      • Greater Sudbury, Ontario, Canada, P3E 5J1
        • Not yet recruiting
        • Research Site
      • 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
        • 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
        • Withdrawn
        • Research Site
      • Taiyuan, China, 030000
        • Recruiting
        • Research Site
      • Tianjin, China, 300050
        • Recruiting
        • Research Site
      • Wenzhou, China, CN-325000
        • Recruiting
        • Research Site
      • Wuhan, China, 430030
        • Recruiting
        • 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
        • Withdrawn
        • Research Site
      • Berlin, Germany, 13585
        • Withdrawn
        • Research Site
      • Bielefeld, Germany, 33611
        • Not yet recruiting
        • Research Site
      • Bochum, Germany, 44791
        • Not yet recruiting
        • Research Site
      • Chemnitz, Germany, 09116
        • Not yet recruiting
        • Research Site
      • Cologne, Germany, 51109
        • Recruiting
        • Research Site
      • Cologne, Germany, 50677
        • Not yet recruiting
        • Research Site
      • Essen, Germany, 45136
        • Not yet recruiting
        • Research Site
      • Esslingen am Neckar, Germany, 73730
        • Recruiting
        • Research Site
      • Frankfurt, Germany, 60488
        • Recruiting
        • Research Site
      • Frankfurt am Main, Germany, 60431
        • Recruiting
        • Research Site
      • Gauting, Germany, 82131
        • Recruiting
        • Research Site
      • Giessen, Germany, 35392
        • Recruiting
        • Research Site
      • Großhansdorf, Germany, 22927
        • Recruiting
        • Research Site
      • Halle, Germany, 06120
        • Not yet recruiting
        • Research Site
      • Hamburg, Germany, 20251
        • Recruiting
        • Research Site
      • Hamburg, Germany, 22087
        • Not yet 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
      • Magdeburg, Germany, 39120
        • Not yet recruiting
        • Research Site
      • Minden, Germany, 32429
        • Recruiting
        • Research Site
      • Moers, Germany, 47441
        • Recruiting
        • Research Site
      • München, Germany, 81925
        • Recruiting
        • Research Site
      • Oldenburg i.H., Germany, 23758
        • Not yet recruiting
        • Research Site
      • Regensburg, Germany, 93053
        • Recruiting
        • Research Site
      • Schwerin, Germany, 19049
        • Not yet recruiting
        • Research Site
      • Velbert, Germany, 42551
        • Not yet recruiting
        • Research Site
      • Würzburg, Germany, 97067
        • Recruiting
        • Research Site
  • Hungary
      • Budapest, Hungary, 1121
        • Recruiting
        • Research Site
      • Budapest, Hungary, 1083
        • Recruiting
        • Research Site
      • Budapest, Hungary, 1122
        • Recruiting
        • Research Site
      • Debrecen, Hungary, 4032
        • Recruiting
        • Research Site
      • Edelény, Hungary, 3780
        • Not yet recruiting
        • Research Site
      • Gyöngyös, Hungary, 3200
        • Withdrawn
        • Research Site
      • Gyöngyös - Mátraháza, Hungary, 3200
        • Recruiting
        • Research Site
      • Győr, Hungary, 9024
        • Recruiting
        • Research Site
      • Pécs, Hungary, 7624
        • Recruiting
        • Research Site
      • Székesfehérvár, Hungary, 8000
        • Suspended
        • Research Site
      • Törökbálint, Hungary, 2045
        • Recruiting
        • Research Site
  • India
      • Calicut, India, 673601
        • Recruiting
        • Research Site
      • Delhi, India, 110029
        • Recruiting
        • Research Site
      • Gūrgaon, India, 122001
        • Recruiting
        • Research Site
      • Kolkata, India, 700054
        • Withdrawn
        • Research Site
      • Madurai, India, 625107
        • Recruiting
        • Research Site
      • Mumbai, India, 400012
        • Not yet recruiting
        • Research Site
      • Nagpur, India, 440001
        • 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
      • Legnano, Italy, 20025
        • Not yet recruiting
        • Research Site
      • Livorno, Italy, 57126
        • Not yet 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
      • Hirakata-shi, Japan, 573-1191
        • Not yet recruiting
        • Research Site
      • Hiroshima, Japan, 734-8551
        • Recruiting
        • Research Site
      • Kakogawa-shi, Japan, 675-8611
        • Not yet recruiting
        • Research Site
      • Kanazawa, Japan, 920-8530
        • 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
      • Kiyose-shi, Japan, 204-8522
        • Not yet 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
        • Recruiting
        • Research Site
      • Kōtoku, Japan, 135-8550
        • Recruiting
        • Research Site
      • Matsusaka-shi, Japan, 515-8544
        • Recruiting
        • Research Site
      • Obihiro-shi, Japan, 080-0024
        • Not yet 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
      • Sapporo, Japan, 006-8555
        • 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
        • Withdrawn
        • Research Site
      • Bydgoszcz, Poland, 85-796
        • Withdrawn
        • Research Site
      • Bystra, Poland, 43-360
        • Recruiting
        • Research Site
      • Lodz, Poland, 93-338
        • Recruiting
        • Research Site
      • Lublin, Poland, 20-090
        • Not yet recruiting
        • Research Site
      • Poznan, Poland, 60-569
        • Recruiting
        • Research Site
      • Warsaw, Poland, 04-141
        • Recruiting
        • Research Site
      • Wroclaw, Poland, 53-413
        • Recruiting
        • Research Site
  • Puerto Rico
      • San Juan, Puerto Rico, 00918
        • Recruiting
        • Research Site
      • San Juan, Puerto Rico, 00909
        • Recruiting
        • Research Site
  • South Korea
      • Changwon-si, South Korea, 51353
        • Recruiting
        • Research Site
      • Cheongju-si, South Korea, 28644
        • Recruiting
        • Research Site
      • Incheon, South Korea, 21565
        • Recruiting
        • Research Site
      • JinJoo, South Korea, 52727
        • 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
      • Almería, Spain, 04009
        • Not yet recruiting
        • Research Site
      • 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
      • Savannah, Georgia, United States, 31404
        • Not yet recruiting
        • 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
        • Withdrawn
        • Research Site
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • 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
      • Scarborough, Maine, United States, 04074
        • Recruiting
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Completed
        • Research Site
      • Bethesda, Maryland, United States, 20817
        • Recruiting
        • Research Site
      • Bethesda, Maryland, United States, 20889
        • Not yet recruiting
        • Research Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Research Site
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Research Site
      • Saginaw, Michigan, United States, 48602
        • Not yet 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 Carolina
      • Wilson, North Carolina, United States, 27893
        • Recruiting
        • Research Site
    • North Dakota
      • Grand Forks, North Dakota, United States, 58201
        • Recruiting
        • Research Site
    • Ohio
      • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically or cytologically documented squamous NSCLC.
  • Stage III B/C or IV mNSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.
  • Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any actionable driver oncogenes for which there are locally approved and available targeted 1L therapies.
  • Provision of acceptable tumor sample to confirm tumor PD-L1 expression TC ≥ 1%.
  • At least one lesion not previously irradiated that qualifies as a RECIST 1.1 TL at baseline and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with CT or MRI and is suitable for accurate repeated measurements.
  • Adequate organ and bone marrow function.

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, non-curative therapy received for NSCLC.
  • Any prior treatment with an anti-PD-1 or anti-PD-L1 agent.
  • Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.
  • History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence.
  • Active or prior documented autoimmune or inflammatory disorders requiring chronic systemic treatment with the use of disease-modifying agents or other immunosuppressive drugs.
  • Active primary immunodeficiency/active infectious disease(s).
  • Active tuberculosis infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to approximately 6 years
Progression-free survival (PFS)
Time Frame: Up to approximately 6 years

PFS is defined as the time from randomization until radiological progression per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) or death due to any cause (in the absence of progression).
Up to approximately 6 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Landmark overall survival (OS) rates
Time Frame: Up to approximately 6 years

OS is defined as the time from randomization until the date of death due to any cause.
Up to approximately 6 years
Landmark progression-free survival (PFS) rates
Time Frame: Up to approximately 6 years

PFS is defined as the time from randomization until radiological progression per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) or death due to any cause (in the absence of progression).
Up to approximately 6 years
Time to second progression or death (PFS2)
Time Frame: Up to approximately 6 years

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 6 years
Overall response rate (ORR)
Time Frame: Up to approximately 6 years

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 6 years
Duration of response (DoR)
Time Frame: Up to approximately 6 years

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 6 years
Pharmacokinetic (PK) of rilvegostomig
Time Frame: Up to approximately 6 years

Concentration of rilvegostomig in serum.
Up to approximately 6 years
Immunogenicity of rilvegostomig
Time Frame: Up to approximately 6 years

Presence of antidrug antibodies (ADAs), titer, and neutralizing antibodies for rilvegostomig.
Up to approximately 6 years
Patient-reported physical functioning
Time Frame: Up to approximately 6 years

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 6 years
Patient-reported global health status (GHS)/quality of life (QoL)
Time Frame: Up to approximately 6 years

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 6 years
Patient-reported lung cancer symptoms of non-small cell lung cancer (NSCLC)
Time Frame: Up to approximately 6 years

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 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 18, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings