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A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab Monotherapy for the First-line Treatment of Patients With PD-L1-high Metastatic Non-small Cell Lung Cancer (ARTEMIDE-Lung04)

Status: Recruiting
Location: See all (295) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of ARTEMIDE-Lung04 is to assess the efficacy and safety of rilvegostomig compared with pembrolizumab monotherapy as 1L treatment in participants with mNSCLC and whose tumors express PD-L1.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically or cytologically documented NSCLC (non small lung cancer), including all histological subtypes.

• Stage IV mNSCLC (metastatic non-small cell lung cancer) (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.

• Absence of sensitizing EGFR (epidermal growth factor) mutations and ALK (anaplastic lymphoma kinase) and ROS1 (c-ros oncogene 1) rearrangements. Negative assay result is required for all non-squamous histology subtypes.

• 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 (first line) therapies.

• WHO (World Health Organization)/ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1, with no deterioration over the previous 2 weeks prior to baseline at screening and prior to randomization.

• Minimum life expectancy of 12 weeks.

• Provision of acceptable tumor sample for the central testing prior to randomization.

• At least one lesion not previously irradiated that qualifies as a RECIST 1.1 (Response Evaluation Criteria in Solid Tumors, Version 1.1) TL (target lesion) 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 (computed tomography) or MRI (magnetic resonance imaging) and is suitable for accurate repeated measurements.

• Adequate organ and bone marrow function

Locations
United States
California
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La Mesa
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Los Alamitos
Connecticut
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Farmington
Delaware
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Newark
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Clearwater
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St. Petersburg
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Marietta
Iowa
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Des Moines
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Chicago
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Lexington
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Frederick
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Silver Spring
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Towson
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Saginaw
Missouri
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Bridgeton
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Lincoln
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Paramus
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Buffalo
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East Syracuse
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Fresh Meadows
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Rochester
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Westbury
Ohio
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Canton
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Fountain Hill
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Kittanning
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Philadelphia
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Aberdeen
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Renton
West Virginia
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Charleston
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Pilar
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Viedma
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Hobart
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Edegem
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Blumenau
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Bulgaria
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Sofia
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Sofia
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Cambridge
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Edmonton
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Santiago
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Santiago
China
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Baoding
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Beijing
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Beijing
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Beijing
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Chengdu
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Liuzhou
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Nanjing
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Nanning
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Ningbo
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Qingdao
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Shanghai
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Berlin
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Berlin
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Bonn
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Braunschweig
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Velbert
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Athens
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Jerusalem
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Tel Aviv
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Roma
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Fukuoka
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Hamamatsu
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Kobe
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Kyoto
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Osaka
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Sayama
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Sendai
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Malaysia
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George Town
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Kuala Lumpur
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Kuala Selangor
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Perai
Portugal
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Braga
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Coimbra
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Lisbon
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Loures
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Matosinhos Municipality
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Porto
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Porto
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Porto
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Craiova
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Craiova
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Iași
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Otopeni
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Piteşti
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Sibiu
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Timișoara
Spain
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Badajoz
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Badalona
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Barcelona
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Castellon
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Granada
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Jaén
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Lugo
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Madrid
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Madrid
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Madrid
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Málaga
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Oviedo
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Palma De Mallorca
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Valencia
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Vigo (pontevedra)
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Zaragoza
Switzerland
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Lausanne
Turkey
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Ankara
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Bakırköy
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Çankaya
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İzmit
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Küçükçekmece
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Yüreğir
United Kingdom
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Blackpool
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Glasgow
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Guildford
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Hull
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Oxford
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Stevenage
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2025-04-10
Estimated Completion Date: 2030-12-02
Participants
Target number of participants: 830
Treatments
Experimental: Arm A
Drug: rilvegostomig
Active_comparator: Arm B
Drug: Pembrolizumab
Sponsors
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov