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

May 21, 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 Metastatic Non-squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung03)

The purpose of ARTEMIDE-Lung03 is to evaluate the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line treatment of patients with non-squamous mNSCLC whose tumors express PD-L1.

Study Overview

Status

Recruiting

Conditions

Non-squamous Non-small Cell Lung Cancer

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

878

Phase

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

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    - Withdrawn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
Belgium
- - 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
- - Ijuí, Brazil, 98700-000
    - Recruiting
    - Research Site
  - Londrina, Brazil, 86015-520
    - Recruiting
    - Research Site
  - Passo Fundo, Brazil, 99010-260
    - Recruiting
    - Research Site
  - Porto Alegre, Brazil, 91350-200
    - Recruiting
    - Research Site
  - Salvador, Brazil, 40050 410
    - Recruiting
    - Research Site
  - São Paulo, Brazil, 05652000
    - Recruiting
    - Research Site
  - São Paulo, Brazil, 01246-000
    - Withdrawn
    - Research Site
  - São Paulo, Brazil, 01327-001
    - Recruiting
    - Research Site
  - Taubaté, Brazil, 12030-200
    - Withdrawn
    - Research Site
  - Vitória, Brazil, 29043-260
    - Recruiting
    - Research Site
Canada
- New Brunswick
  - Saint John, New Brunswick, Canada, E2L 4L2
    - Recruiting
    - Research Site
- Nova Scotia
  - Sydney, Nova Scotia, Canada, B1P 1P3
    - Withdrawn
    - Research Site
- Ontario
  - Hamilton, Ontario, Canada, L8V 1C3
    - Recruiting
    - Research Site
  - Kingston, Ontario, Canada, K7L 2V7
    - 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
  - Saint-Jérôme, Quebec, Canada, J7Z 2V4
    - Recruiting
    - Research Site
China
- - Beijing, China, 100029
    - Recruiting
    - Research Site
  - Beijing, China, CN-100730
    - Recruiting
    - Research Site
  - Beijing, China, 100021
    - Recruiting
    - Research Site
  - Changchun, China, 130012
    - Recruiting
    - Research Site
  - Changsha, China, 410013
    - Not yet recruiting
    - Research Site
  - Chengdu, China, 610041
    - Recruiting
    - Research Site
  - Chongqing, China, 400030
    - Recruiting
    - Research Site
  - Fuzhou, China, 350007
    - Recruiting
    - Research Site
  - Guangzhou, China, 510062
    - Recruiting
    - Research Site
  - Guangzhou, China, 510180
    - 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
  - Jinan, China, 250117
    - Active, not recruiting
    - Research Site
  - Jingzhou, China, 434000
    - Recruiting
    - Research Site
  - Kunming, China, 650118
    - Recruiting
    - Research Site
  - Linhai, China, 317000
    - Recruiting
    - Research Site
  - Nanchang, China, 330008
    - Recruiting
    - Research Site
  - Ningbo, China, 315010
    - Recruiting
    - Research Site
  - Shanghai, China, 200030
    - Recruiting
    - Research Site
  - Shanghai, China, 200433
    - Not yet recruiting
    - Research Site
  - Wenzhou, China, CN-325000
    - Recruiting
    - Research Site
  - Wuhan, China, 430000
    - Recruiting
    - Research Site
  - Xi'an, China, 710061
    - Recruiting
    - Research Site
  - Xiangyang, China, 441000
    - 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, 69373
    - 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, 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
  - 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
    - Recruiting
    - Research Site
  - Győr, Hungary, 9024
    - Recruiting
    - Research Site
  - Pécs, Hungary, 7624
    - Recruiting
    - Research Site
  - Székesfehérvár, Hungary, 8000
    - Withdrawn
    - 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
  - Varanasi, India, 221005
    - Recruiting
    - Research Site
Italy
- - Florence, Italy, 50134
    - Recruiting
    - Research Site
  - Monza, Italy, 20052
    - Recruiting
    - Research Site
  - Peschiera del Garda, Italy, 37019
    - Recruiting
    - Research Site
  - Rome, 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
  - Sendai, Japan, 981-0914
    - Recruiting
    - Research Site
  - Shinjuku-ku, Japan, 160-0023
    - Recruiting
    - Research Site
  - Sunto-gun, Japan, 411-8777
    - 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
- - Kuala Lumpur, Malaysia, 59100
    - Recruiting
    - Research Site
  - Kuching, Malaysia, 93586
    - Recruiting
    - Research Site
  - Petaling Jaya, Malaysia, 47500
    - 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
Peru
- - Lima, Peru, 15036
    - Withdrawn
    - Research Site
  - Lima, Peru, LIMA 29
    - Withdrawn
    - Research Site
  - Lima, Peru, Lima 34
    - Withdrawn
    - Research Site
  - Lima, Peru, 15102
    - 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
    - Not yet recruiting
    - Research Site
Puerto Rico
- - San Juan, Puerto Rico, 00935
    - Recruiting
    - Research Site
  - San Juan, Puerto Rico, 00918
    - Suspended
    - Research Site
South Korea
- - Gyeonggi-do, South Korea, 13620
    - Recruiting
    - Research Site
  - Seoul, South Korea, 03080
    - Recruiting
    - Research Site
  - Seoul, South Korea, 06351
    - Recruiting
    - Research Site
  - Seoul, South Korea, 03722
    - Recruiting
    - Research Site
  - Seoul, South Korea, 06591
    - Recruiting
    - Research Site
  - Seoul, South Korea, 07061
    - Recruiting
    - Research Site
  - Songpa-gu, South Korea, 05505
    - Recruiting
    - Research Site
Spain
- - Barcelona, Spain, 8035
    - Recruiting
    - Research Site
  - Castellon, Spain, 12002
    - Recruiting
    - Research Site
  - Las Palmas de Gran Canaria, Spain, 35016
    - Recruiting
    - Research Site
  - Madrid, Spain, 28034
    - Recruiting
    - Research Site
  - Madrid, Spain, 28046
    - 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, 40201
    - Recruiting
    - Research Site
  - Tainan, Taiwan, 736
    - Withdrawn
    - Research Site
  - Taoyuan, Taiwan, 333423
    - 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), 06010
    - Recruiting
    - Research Site
  - Antalya, Turkey (Türkiye), 07070
    - Recruiting
    - Research Site
  - Antalya, Turkey (Türkiye), 07100
    - Recruiting
    - Research Site
  - Edirne, Turkey (Türkiye), 22030
    - Recruiting
    - Research Site
  - Izmir, Turkey (Türkiye), 35965
    - Recruiting
    - Research Site
  - Seyhan, Turkey (Türkiye), 1060
    - 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
  - Torquay, United Kingdom, TQ2 7AA
    - Recruiting
    - Research Site
United States
- Alabama
  - Mobile, Alabama, United States, 36608
    - Recruiting
    - Research Site
- Arizona
  - Chandler, Arizona, United States, 85224
    - Withdrawn
    - Research Site
  - Phoenix, Arizona, United States, 85054
    - 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, 92350
    - Not yet recruiting
    - Research Site
  - Redlands, California, United States, 92373
    - Recruiting
    - Research Site
  - San Diego, California, United States, 92123
    - Recruiting
    - Research Site
  - San Francisco, California, United States, 94121
    - Recruiting
    - Research Site
  - Santa Rosa, California, United States, 95403
    - Recruiting
    - Research Site
  - Walnut Creek, California, United States, 94598
    - Recruiting
    - Research Site
- Colorado
  - Lone Tree, Colorado, United States, 80124
    - Recruiting
    - Research Site
- Connecticut
  - Stamford, Connecticut, United States, 06902
    - Recruiting
    - Research Site
  - 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
  - Jacksonville, Florida, United States, 32224
    - Recruiting
    - Research Site
  - Miami, Florida, United States, 33125
    - Recruiting
    - Research Site
  - Ocala, Florida, United States, 34474
    - Recruiting
    - Research Site
  - St. Petersburg, Florida, United States, 33709
    - Recruiting
    - Research Site
- Georgia
  - Atlanta, Georgia, United States, 30342
    - 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, 62305
    - Recruiting
    - Research Site
  - Rockford, Illinois, United States, 61114
    - Withdrawn
    - 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
- Louisiana
  - Alexandria, Louisiana, United States, 71301
    - Withdrawn
    - Research Site
  - Baton Rouge, Louisiana, United States, 70808
    - Not yet recruiting
    - 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
- Michigan
  - Grand Rapids, Michigan, United States, 49503
    - Recruiting
    - Research Site
- Minnesota
  - Duluth, Minnesota, United States, 55805
    - Withdrawn
    - Research Site
  - Rochester, Minnesota, United States, 55905
    - Recruiting
    - Research Site
  - Saint Paul, Minnesota, United States, 55102
    - Recruiting
    - Research Site
- Missouri
  - Bridgeton, Missouri, United States, 63044
    - Recruiting
    - Research Site
  - Columbia, Missouri, United States, 65212
    - Withdrawn
    - 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
  - Westbury, New York, United States, 11590
    - Recruiting
    - Research Site
- Ohio
  - Canton, Ohio, United States, 44710
    - Recruiting
    - Research Site
- Oregon
  - Medford, Oregon, United States, 97504
    - Recruiting
    - Research Site
  - Portland, Oregon, United States, 97239
    - Withdrawn
    - Research Site
  - Salem, Oregon, United States, 97301
    - Recruiting
    - Research Site
- Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15212
    - Withdrawn
    - Research Site
  - York, Pennsylvania, United States, 17403
    - Recruiting
    - Research Site
- Rhode Island
  - Providence, Rhode Island, United States, 02903
    - Withdrawn
    - Research Site
- South Dakota
  - Pierre, South Dakota, United States, 57501
    - Recruiting
    - Research Site
  - 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
    - Withdrawn
    - Research Site
  - Irving, Texas, United States, 75063
    - Recruiting
    - Research Site
  - Kingwood, Texas, United States, 77339
    - Recruiting
    - Research Site
  - Lubbock, Texas, United States, 79410
    - Withdrawn
    - Research Site
  - Palestine, Texas, United States, 75801
    - Recruiting
    - Research Site
  - Round Rock, Texas, United States, 78665
    - Recruiting
    - Research Site
- Virginia
  - Fairfax, Virginia, United States, 22031
    - Recruiting
    - Research Site
  - Norfolk, Virginia, United States, 23502
    - Recruiting
    - Research Site
  - Roanoke, Virginia, United States, 24014
    - Recruiting
    - Research Site
- Washington
  - Seattle, Washington, United States, 98104
    - Withdrawn
    - Research Site
  - Seattle, Washington, United States, 98101
    - Recruiting
    - Research Site
  - Silverdale, Washington, United States, 98383
    - Recruiting
    - 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
- Wisconsin
  - La Crosse, Wisconsin, United States, 54601
    - 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

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Histologically or cytologically documented non-squamous NSCLC.
Stage IV mNSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.
Absence of sensitizing EGFR mutations (including, but not limited to, exon 19 deletion and exon 21 L858R, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations) and ALK and ROS1 rearrangements.
Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved 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. Prior systemic therapy in the neoadjuvant or adjuvant setting and/or definitive radio- or chemoradiotherapy for early-stage disease are allowed, provided that recurrence or progression has occurred > 12 months after the end of treatment.
Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.
Any prior treatment with an anti-PD-1 or anti-PD-L1 agent.
History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence.
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

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

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A Rilvegostomig in combination with platinum-based doublet chemotherapy followed by rilvegostomig monotherapy plus pemetrexed in maintenance.	Drug: Rilvegostomig Administered as one intravenously (IV) on Day 1 of each 21-day cycle Other Names: AZD2936 Drug: Carboplatin Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles Drug: Cisplatin Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles Drug: Pemetrexed Administered as one intravenously (IV) on Day 1 of each 21-day cycle
Active Comparator: Arm B Pembrolizumab in combination with platinum-based doublet chemotherapy followed by pembrolizumab monotherapy plus pemetrexed in maintenance.	Drug: Carboplatin Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles Drug: Cisplatin Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles Drug: Pemetrexed Administered as one intravenously (IV) on Day 1 of each 21-day cycle Drug: Pembrolizumab Administered as one intravenously (IV) on Day 1 of each 21-day cycle Other Names: Keytruda

Participant Group / Arm

Intervention / Treatment

Experimental: Arm A

Rilvegostomig in combination with platinum-based doublet chemotherapy followed by rilvegostomig monotherapy plus pemetrexed in maintenance.

Drug: Rilvegostomig

Administered as one intravenously (IV) on Day 1 of each 21-day cycle

Other Names:

AZD2936

Drug: Carboplatin

Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles

Drug: Cisplatin

Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles

Drug: Pemetrexed

Administered as one intravenously (IV) on Day 1 of each 21-day cycle

Active Comparator: Arm B

Pembrolizumab in combination with platinum-based doublet chemotherapy followed by pembrolizumab monotherapy plus pemetrexed in maintenance.

Drug: Carboplatin

Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles

Drug: Cisplatin

Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles

Drug: Pemetrexed

Administered as one intravenously (IV) on Day 1 of each 21-day cycle

Drug: Pembrolizumab

Administered as one 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) Time Frame: Up to approximately 5 years	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) Time Frame: Up to approximately 5 years	PFS is defined as the time from randomization until radiological progression per RECIST 1.1, or death due to any cause (in the absence of progression).	Up to approximately 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Landmark overall survival (OS) rates Time Frame: Up to approximately 5 years	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 Time Frame: Up to approximately 5 years	PFS is defined as the time from randomization until radiological progression per RECIST 1.1, or death due to any cause (in the absence of progression).	Up to approximately 5 years
Time to second progression or death (PFS2) Time Frame: Up to approximately 5 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 eCRF and defined according to local standard clinical practice.	Up to approximately 5 years
Overall response rate (ORR) Time Frame: Up to approximately 5 years	ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, using RECIST 1.1.	Up to approximately 5 years
Duration of response (DoR) Time Frame: Up to approximately 5 years	DoR is defined as the time from the date of first documented response until the date of documented progression using RECIST 1.1 or death due to any cause (in the absence of progression).	Up to approximately 5 years
Pharmacokinetic (PK) of rilvegostomig Time Frame: Up to approximately 5 years	Concentration of rilvegostomig in serum	Up to approximately 5 years
Immunogenicity of rilvegostomig Time Frame: Up to approximately 5 years	Presence of antidrug antibodies (ADAs), titer, and neutralizing antibodies for rilvegostomig	Up to approximately 5 years
Patient-reported physical functioning Time Frame: Up to approximately 5 years	Proportion of participants with maintained or improved physical functioning as measured by 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 Frame: Up to approximately 5 years	TTD in pulmonary symptoms as measured by the 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 Frame: Up to approximately 5 years	TTD of GHS/QoL as measured by the EORTC IL172. TTD is defined as time from randomization to the date of first deterioration. Deterioration is defined as a worsening change from baseline that reaches a clinically meaningful change threshold.	Up to approximately 5 years

Collaborators and Investigators

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

Sponsor

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)

November 27, 2024

Primary Completion (Estimated)

May 10, 2029

Study Completion (Estimated)

March 25, 2030

Study Registration Dates

First Submitted

October 3, 2024

First Submitted That Met QC Criteria

October 3, 2024

First Posted (Actual)

October 4, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

D702FC00001
2024-515008-38-00 (Other Identifier: CTIS ID)

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 group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/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

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.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Non-squamous Non-small Cell Lung Cancer

Clinical Trials on Rilvegostomig

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