A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Non-squamous 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 Non-squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung03)
2 other identifiers
interventional
878
25 countries
282
Brief Summary
The purpose of ARTEMIDE-Lung03 is to evaluate the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line treatment of patients with non-squamous mNSCLC whose tumors express PD-L1.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2024
Longer than P75 for phase_3
282 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2024
CompletedFirst Posted
Study publicly available on registry
October 4, 2024
CompletedStudy Start
First participant enrolled
November 27, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 25, 2030
March 27, 2026
March 1, 2026
4.5 years
October 3, 2024
March 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 RECIST 1.1, or death due to any cause (in the absence of progression).
Up to approximately 5 years
Secondary Outcomes (10)
Landmark overall survival (OS) rates
Up to approximately 5 years
Landmark progression-free survival (PFS) rates
Up to approximately 5 years
Time to second progression or death (PFS2)
Up to approximately 5 years
Overall response rate (ORR)
Up to approximately 5 years
Duration of response (DoR)
Up to approximately 5 years
- +5 more secondary outcomes
Study Arms (2)
Arm A
EXPERIMENTALRilvegostomig in combination with platinum-based doublet chemotherapy followed by rilvegostomig monotherapy plus pemetrexed in maintenance.
Arm B
ACTIVE COMPARATORPembrolizumab in combination with platinum-based doublet chemotherapy followed by pembrolizumab monotherapy plus pemetrexed in maintenance.
Interventions
Administered as one intravenously (IV) on Day 1 of each 21-day cycle
Administered as one intravenously (IV) on Day 1 of each 21-day cycle
Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (282)
Research Site
Mobile, Alabama, 36608, United States
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Chandler, Arizona, 85224, United States
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Phoenix, Arizona, 85054, United States
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Anaheim, California, 92801, United States
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Beverly Hills, California, 90211, United States
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Loma Linda, California, 92350, United States
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Redlands, California, 92373, United States
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San Diego, California, 92123, United States
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San Francisco, California, 94121, United States
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Santa Rosa, California, 95403, United States
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Walnut Creek, California, 94598, United States
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Lone Tree, Colorado, 80124, United States
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Stamford, Connecticut, 06902, United States
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West Haven, Connecticut, 06516, United States
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Newark, Delaware, 19713, United States
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Bay Pines, Florida, 33744, United States
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Fort Lauderdale, Florida, 33308, United States
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Gainesville, Florida, 32610, United States
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Jacksonville, Florida, 32224, United States
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Miami, Florida, 33125, United States
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Ocala, Florida, 34474, United States
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St. Petersburg, Florida, 33709, United States
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Atlanta, Georgia, 30342, United States
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Boise, Idaho, 83712, United States
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Chicago, Illinois, 60637, United States
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Decatur, Illinois, 62526, United States
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Hinsdale, Illinois, 60521, United States
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Quincy, Illinois, 62305, United States
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Rockford, Illinois, 61114, United States
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Waterloo, Iowa, 50702, United States
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Lexington, Kentucky, 40509, United States
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Lexington, Kentucky, 40536, United States
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Louisville, Kentucky, 40207, United States
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Alexandria, Louisiana, 71301, United States
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Baton Rouge, Louisiana, 70808, United States
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Shreveport, Louisiana, 71103, United States
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Shreveport, Louisiana, 71105, United States
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South Portland, Maine, 04106, United States
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Baltimore, Maryland, 21202, United States
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Grand Rapids, Michigan, 49503, United States
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Duluth, Minnesota, 55805, United States
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Rochester, Minnesota, 55905, United States
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Saint Paul, Minnesota, 55102, United States
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Bridgeton, Missouri, 63044, United States
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Columbia, Missouri, 65212, United States
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Lincoln, Nebraska, 68506, United States
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Camden, New Jersey, 08103, United States
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Buffalo, New York, 14221, United States
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Westbury, New York, 11590, United States
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Canton, Ohio, 44710, United States
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Medford, Oregon, 97504, United States
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Portland, Oregon, 97239, United States
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Salem, Oregon, 97301, United States
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Pittsburgh, Pennsylvania, 15212, United States
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York, Pennsylvania, 17403, United States
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Providence, Rhode Island, 02903, United States
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Pierre, South Dakota, 57501, United States
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Sioux Falls, South Dakota, 57105, United States
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Chattanooga, Tennessee, 37404, United States
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Nashville, Tennessee, 37203, United States
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Fort Worth, Texas, 76104, United States
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Houston, Texas, 77090, United States
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Irving, Texas, 75063, United States
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Kingwood, Texas, 77339, United States
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Lubbock, Texas, 79410, United States
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Palestine, Texas, 75801, United States
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Round Rock, Texas, 78665, United States
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Fairfax, Virginia, 22031, United States
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Norfolk, Virginia, 23502, United States
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Roanoke, Virginia, 24014, United States
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Seattle, Washington, 98101, United States
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Seattle, Washington, 98104, United States
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Silverdale, Washington, 98383, United States
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Spokane, Washington, 99208, United States
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Tacoma, Washington, 98405, United States
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Wenatchee, Washington, 98801, United States
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La Crosse, Wisconsin, 54601, United States
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Buenos Aires, C1431FWO, Argentina
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CABA, 1425, Argentina
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La Plata, 1900, Argentina
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Pilar, B1629ODT, Argentina
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Rosario, S2000DEJ, Argentina
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Darlinghurst, 2010, Australia
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Hyde Park, 4812, Australia
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Southport, 4215, Australia
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Wollongong, 2500, Australia
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Brussels, 1160, Belgium
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Charleroi, 6060, Belgium
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Kortrijk, 8500, Belgium
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Ottignies, 1340, Belgium
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Sint-Niklaas, 9100, Belgium
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Ijuí, 98700-000, Brazil
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Londrina, 86015-520, Brazil
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Passo Fundo, 99010-260, Brazil
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Porto Alegre, 91350-200, Brazil
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Salvador, 40050 410, Brazil
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São Paulo, 01246-000, Brazil
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São Paulo, 01327-001, Brazil
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São Paulo, 05652000, Brazil
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Taubaté, 12030-200, Brazil
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Vitória, 29043-260, Brazil
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Saint John, New Brunswick, E2L 4L2, Canada
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Sydney, Nova Scotia, B1P 1P3, Canada
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Hamilton, Ontario, L8V 1C3, Canada
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Kingston, Ontario, K7L 2V7, Canada
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Sault Ste. Marie, Ontario, P6A 0A8, Canada
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Montreal, Quebec, H2X 0A9, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Saint-Jérôme, Quebec, J7Z 2V4, Canada
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Beijing, 100021, China
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Beijing, 100029, China
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Beijing, CN-100730, China
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Changchun, 130012, China
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Changsha, 410013, China
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Chengdu, 610041, China
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Chongqing, 400030, China
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Fuzhou, 350007, China
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Guangzhou, 510062, China
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Guangzhou, 510180, China
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Hangzhou, 310003, China
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Hangzhou, 310016, China
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Hangzhou, 310022, China
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Harbin, 150081, China
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Hefei, 230601, China
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Jinan, 250117, China
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Jingzhou, 434000, China
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Kunming, 650118, China
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Linhai, 317000, China
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Nanchang, 330008, China
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Ningbo, 315010, China
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Shanghai, 200030, China
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Shanghai, 200433, China
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Wenzhou, CN-325000, China
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Wuhan, 430000, China
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Xi'an, 710061, China
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Xiangyang, 441000, China
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Zhengzhou, 450008, China
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Zhengzhou, 450052, China
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Avignon, 84902, France
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La Rochelle, 17019, France
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Lyon, 69373, France
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Nîmes, 30029, France
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Rennes, 35033, France
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Strasbourg, 67091, France
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Suresnes, 92150, France
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Toulon, 83800, France
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Bad Berka, 99437, Germany
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Berlin, 13585, Germany
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Cologne, 51109, Germany
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Esslingen am Neckar, 73730, Germany
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Frankfurt, 60488, Germany
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Gauting, 82131, Germany
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Giessen, 35392, Germany
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Großhansdorf, 22927, Germany
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Hamburg, 20251, Germany
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Hanover, 30459, Germany
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Hanover, 30625, Germany
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Hemer, 58675, Germany
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Homburg, 66424, Germany
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Kassel, 34125, Germany
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Kiel, 24105, Germany
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Krefeld, 47805, Germany
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Minden, 32429, Germany
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Moers, 47441, Germany
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München, 81925, Germany
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Regensburg, 93053, Germany
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Würzburg, 97067, Germany
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Budapest, 1083, Hungary
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Budapest, 1121, Hungary
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Budapest, 1122, Hungary
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Debrecen, 4032, Hungary
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Gyöngyös, 3200, Hungary
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Gyöngyös - Mátraháza, 3200, Hungary
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Győr, 9024, Hungary
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Pécs, 7624, Hungary
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Székesfehérvár, 8000, Hungary
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Törökbálint, 2045, Hungary
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Calicut, 673601, India
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Delhi, 110029, India
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Kolkata, 700054, India
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Madurai, 625107, India
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Mumbai, 400012, India
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Nashik, 422002, India
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New Delhi, 110075, India
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Varanasi, 221005, India
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Florence, 50134, Italy
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Monza, 20052, Italy
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Peschiera del Garda, 37019, Italy
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Rome, 00168, Italy
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Amagasaki-shi, 660-8550, Japan
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Bunkyō City, 113-8603, Japan
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Chūōku, 104-0045, Japan
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Fukuoka, 812-8582, Japan
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Fukuoka, 814-0180, Japan
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Hiroshima, 734-8551, Japan
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Kawagoe-shi, 350-8550, Japan
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Kawasaki-shi, 216-8511, Japan
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Kitaadachi-gun, 362-0806, Japan
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Kitakyushu-shi, 807-8555, Japan
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Kobe, 650-0017, Japan
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Kōtoku, 135-8550, Japan
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Kumamoto, 860-8556, Japan
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Kumamoto, 861-4193, Japan
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Kyoto, 612-8555, Japan
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Matsusaka-shi, 515-8544, Japan
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Osaka, 541-8567, Japan
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Ota-shi, 373-8550, Japan
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Saitama-shi, 338-0001, Japan
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Sendai, 981-0914, Japan
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Shinjuku-ku, 160-0023, Japan
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Sunto-gun, 411-8777, Japan
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Takaoka-shi, 933-8555, Japan
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Yokohama, 232-0024, Japan
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Yokohama, 241-8515, Japan
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Kuala Lumpur, 59100, Malaysia
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Kuching, 93586, Malaysia
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Petaling Jaya, 47500, Malaysia
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Alkmaar, 1815 JD, Netherlands
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Ede, 6716 RP, Netherlands
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Groningen, 9713 GZ, Netherlands
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Leidschendam, 2262 BA, Netherlands
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Veldhoven, 5504 DB, Netherlands
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Lima, 15036, Peru
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Lima, 15102, Peru
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Lima, LIMA 29, Peru
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Lima, Lima 34, Peru
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Bialystok, 15-027, Poland
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Biała Podlaska, 21-500, Poland
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Bydgoszcz, 85-796, Poland
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Bystra, 43-360, Poland
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Lodz, 93-338, Poland
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Poznan, 60-569, Poland
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Warsaw, 04-141, Poland
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San Juan, 00918, Puerto Rico
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San Juan, 00935, Puerto Rico
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Gyeonggi-do, 13620, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 06351, South Korea
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Seoul, 06591, South Korea
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Seoul, 07061, South Korea
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Songpa-gu, 05505, South Korea
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Barcelona, 8035, Spain
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Castellon, 12002, Spain
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Las Palmas de Gran Canaria, 35016, Spain
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Madrid, 28034, Spain
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Madrid, 28046, Spain
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Majadahonda, 28222, Spain
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Seville, 41013, Spain
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Kaohsiung City, 80756, Taiwan
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Kaohsiung City, 824, Taiwan
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New Taipei City, 220, Taiwan
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New Taipei City, 23561, Taiwan
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Taichung, 40201, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 736, Taiwan
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Taoyuan District, 333423, Taiwan
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Bangkok, 10700, Thailand
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Chiang Mai, 50200, Thailand
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Dusit, 10300, Thailand
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Nakhon Ratchasima, 30000, Thailand
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Songkhla, 90110, Thailand
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Ankara, 06010, Turkey (Türkiye)
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Antalya, 07070, Turkey (Türkiye)
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Antalya, 07100, Turkey (Türkiye)
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Edirne, 22030, Turkey (Türkiye)
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Izmir, 35965, Turkey (Türkiye)
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Seyhan, 1060, Turkey (Türkiye)
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Aberdeen, AB25 2ZN, United Kingdom
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Cambridge, CB2 0QQ, United Kingdom
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Edinburgh, EH4 2XU, United Kingdom
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Exeter, EX2 5DW, United Kingdom
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Greater London, SW3 6JJ, United Kingdom
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London, EC1A 7BE, United Kingdom
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London, SE1 9RT, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Newcastle upon Tyne, NE7 7AF, United Kingdom
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Torquay, TQ2 7AA, United Kingdom
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Can Tho, 900000, Vietnam
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Hanoi, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Vinh, 460000, Vietnam
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-blind masking
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2024
First Posted
October 4, 2024
Study Start
November 27, 2024
Primary Completion (Estimated)
May 10, 2029
Study Completion (Estimated)
March 25, 2030
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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
- 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.
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.