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)

Status: Recruiting
Location: See all (276) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

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

• 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

Locations
United States
Alabama
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Mobile
Arizona
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Chandler
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Phoenix
California
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Anaheim
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Beverly Hills
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Loma Linda
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Redlands
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San Diego
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San Francisco
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Walnut Creek
Colorado
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Lone Tree
Connecticut
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Stamford
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Delaware
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Newark
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Bay Pines
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Fort Lauderdale
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Gainesville
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Jacksonville
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Miami
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Ocala
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St. Petersburg
Georgia
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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
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Rockford
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Lexington
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Lexington
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Louisville
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Alexandria
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Duluth
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Rochester
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Columbia
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Lincoln
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Buffalo
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Westbury
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Canton
Oregon
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Medford
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Portland
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Salem
Pennsylvania
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Pittsburgh
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York
Rhode Island
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Providence
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Pierre
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Chattanooga
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Palestine
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Norfolk
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Silverdale
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Spokane
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Tacoma
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Argentina
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Rosario
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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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Ijuí
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Londrina
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Passo Fundo
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Porto Alegre
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Salvador
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São Paulo
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Taubaté
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Vitória
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Hamilton
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Kingston
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Montreal
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Montreal
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Saint John
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Saint-jérôme
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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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Changsha
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Hangzhou
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Hangzhou
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Hangzhou
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Harbin
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Jingzhou
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Kunming
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Ningbo
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Wenzhou
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Nîmes
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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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Fukuoka
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Kobe
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Kōtoku
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Osaka
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Sendai
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Yokohama
Malaysia
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Petaling Jaya
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Alkmaar
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Ede
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Groningen
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Leidschendam
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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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Bialystok
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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
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Gyeonggi-do
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Seoul
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Seoul
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Seoul
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Seoul
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Seoul
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Songpa-gu
Spain
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Barcelona
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Castellon
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Las Palmas De Gran Canaria
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Madrid
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Madrid
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Majadahonda
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Seville
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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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Ankara
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Antalya
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Antalya
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Edirne
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Izmir
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Seyhan
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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Torquay
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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: 2024-11-27
Estimated Completion Date: 2030-03-25
Participants
Target number of participants: 878
Treatments
Experimental: Arm A
Rilvegostomig in combination with platinum-based doublet chemotherapy followed by rilvegostomig monotherapy plus pemetrexed in maintenance.
Active_comparator: Arm B
Pembrolizumab in combination with platinum-based doublet chemotherapy followed by pembrolizumab monotherapy plus pemetrexed in maintenance.
Sponsors
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov