A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Metastatic Squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung02)
Status: Recruiting
Location: See all (290) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of ARTEMIDE-Lung02 is to assess the efficacy and safety of rilvegostomig in combination with platinum-based chemotherapy for the first-line (1L) treatment of patients with metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Histologically or cytologically documented squamous NSCLC.
• Stage IV mNSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.
• Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any actionable driver oncogenes for which there are locally approved targeted 1L therapies.
• Provision of acceptable tumor sample to confirm tumor PD-L1 expression TC ≥ 1%.
• At least one lesion not previously irradiated that qualifies as a RECIST 1.1 TL at baseline and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with CT or MRI and is suitable for accurate repeated measurements.
• Adequate organ and bone marrow function.
Locations
United States
Arkansas
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Springdale
Arizona
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Tucson
California
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Beverly Hills
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Glendale
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Los Alamitos
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Redlands
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San Francisco
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Walnut Creek
Connecticut
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West Haven
Delaware
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Newark
Florida
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Bay Pines
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Fort Lauderdale
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Gainesville
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Gainesville
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Jacksonville
Georgia
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Athens
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Atlanta
Iowa
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Waterloo
Idaho
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Boise
Illinois
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Chicago
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Decatur
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Hinsdale
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Quincy
Kentucky
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Lexington
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Lexington
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Louisville
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Louisville
Louisiana
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Alexandria
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Baton Rouge
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Covington
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Shreveport
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Shreveport
Maryland
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Baltimore
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Bethesda
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South Portland
Michigan
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Detroit
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Grand Rapids
Minnesota
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Duluth
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Rochester
Missouri
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Bridgeton
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Columbia
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Kansas City
Nebraska
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Lincoln
New Jersey
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Camden
New York
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Buffalo
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East Syracuse
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Westbury
Ohio
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Cincinnati
Oregon
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Bend
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Medford
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Salem
Pennsylvania
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Hershey
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York
South Dakota
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Sioux Falls
Tennessee
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Chattanooga
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Nashville
Texas
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Fort Worth
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Houston
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Kingwood
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Lubbock
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Round Rock
Virginia
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Fairfax
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Fredericksburg
Washington
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Olympia
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Seattle
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Silverdale
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Spokane
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Tacoma
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Wenatchee
Other Locations
Argentina
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Buenos Aires
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Caba
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La Plata
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Pilar
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Rosario
Australia
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Darlinghurst
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Hyde Park
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Southport
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Wollongong
Austria
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Innsbruck
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Krems
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Rankweil
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Vienna
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Vienna
Belgium
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Anderlecht
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Brussels
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Charleroi
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Kortrijk
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Ottignies
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Sint-niklaas
Brazil
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Barretos
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Florianópolis
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Ijuí
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Londrina
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Porto Alegre
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Salvador
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São Paulo
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São Paulo
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Taubaté
Canada
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Hamilton
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Montreal
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Montreal
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Saint John
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Sault Ste. Marie
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Sydney
China
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Beijing
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Beijing
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Beijing
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Beijing
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Beijing
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Changchun
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Changde
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Changsha
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Chengdu
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Chengdu
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Chongqing
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Dalian
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Guangzhou
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Guangzhou
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Hangzhou
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Hangzhou
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Hangzhou
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Harbin
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Hefei
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Hefei
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Jinan
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Kunming
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Linhai
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Linyi
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Nanchang
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Ningbo
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Shanghai
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Shanghai
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Shanghai
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Shenyang
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Shenzhen
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Taiyuan
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Tianjin
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Wenzhou
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Wuhan
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Xi'an
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Yangzhou
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Yueyang
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Zhengzhou
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Zhengzhou
France
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Avignon
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La Rochelle
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Lyon
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Nîmes
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Rennes
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Strasbourg
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Suresnes
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Toulon
Germany
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Bad Berka
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Berlin
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Berlin
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Cologne
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Esslingen Am Neckar
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Frankfurt
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Gauting
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Giessen
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Großhansdorf
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Hamburg
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Hanover
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Hanover
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Heidelberg
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Hemer
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Homburg
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Kassel
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Kiel
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Krefeld
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Minden
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Moers
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München
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Regensburg
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Würzburg
Hungary
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Budapest
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Budapest
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Budapest
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Debrecen
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Gyöngyös
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Győr
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Pécs
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Székesfehérvár
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Törökbálint
India
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Calicut
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Delhi
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Kolkata
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Madurai
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Mumbai
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Nashik
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New Delhi
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Puducherry
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Surat
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Varanasi
Italy
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Florence
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Monza
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Orbassano
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Padua
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Peschiera Del Garda
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Roma
Japan
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Amagasaki-shi
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Bunkyō City
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Chūōku
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Fukuoka
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Fukuoka
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Hiroshima
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Kawagoe-shi
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Kitaadachi-gun
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Kitakyushu-shi
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Kobe
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Kōtoku
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Kumamoto
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Matsusaka-shi
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Osaka
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Ota-shi
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Saitama-shi
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Sayama
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Sendai
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Shinjuku-ku
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Yokohama
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Yokohama
Malaysia
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George Town
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Johor Bahru
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Kuala Lumpur
Netherlands
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Alkmaar
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Ede
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Groningen
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Leidschendam
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Veldhoven
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Zwolle
Peru
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Lima
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Lima
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Lima
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Lima
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Lima
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Lima
Poland
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SUSPENDED
Biała Podlaska
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Bialystok
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SUSPENDED
Bydgoszcz
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Bystra
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Lodz
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Poznan
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Warsaw
Puerto Rico
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San Juan
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San Juan
Republic of Korea
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Cheongju-si
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Incheon
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Seoul
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Seoul
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Seoul
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Seoul
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Suwon
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Suwon
Spain
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Barcelona
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Las Palmas De Gran Canaria
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Lleida
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Madrid
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Madrid
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Majadahonda
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Seville
Taiwan
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Kaohsiung City
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Kaohsiung City
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New Taipei City
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New Taipei City
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Taichung
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Taichung
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Tainan City
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Taoyuan District
Thailand
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Bangkok
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Chiang Mai
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Dusit
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Nakhon Ratchasima
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Songkhla
Turkey
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Antalya
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Istanbul
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Yenimahalle
United Kingdom
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Aberdeen
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Cambridge
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Edinburgh
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Exeter
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Greater London
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London
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London
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Manchester
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Newcastle Upon Tyne
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Preston
Viet Nam
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Can Tho
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Hanoi
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Ho Chi Minh City
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Vinh
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date:2024-11-18
Estimated Completion Date:2029-10-08
Participants
Target number of participants:880
Treatments
Experimental: Arm A
Rilvegostomig in combination with carboplatin and paclitaxel or nab-paclitaxel followed by rilvegostomig
Active_comparator: Arm B
Pembrolizumab in combination with carboplatin and paclitaxel or nab-paclitaxel followed by pembrolizumab