Clinical trial NCT06868277: A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Carcinoma, Non-Small Cell Lung
Keywords: ARTEMIDE-Lung04
Rilvegostomig (AZD2936)
Non-small cell lung cancer (NSCLC)
Bi-specific antibody
T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domain (TIGIT)
EGFR, ALK and ROS1 testing
Programmed cell death protein (PD-L1)
Pembrolizumab
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2025-03-10
Enrollment: 830
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized in a 1:1 ratio to one of the following intervention arms:

Arm A : Rilvegostomig Arm B : Pembrolizumab
Primary purpose: TREATMENT

Brief 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.

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 as a 1L treatment for patients with mNSCLC whose tumors express PD-L1.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* As judged by the investigator, any severe or uncontrolled systemic diseases, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.
* History of organ transplant.
* Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
* 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.
* Presence of small cell and neuroendocrine histology components.
* Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 4 weeks prior to start of study intervention.
* Active primary immunodeficiency/active infectious disease(s)
* Active tuberculosis infection
* Any prior systemic therapy received for advanced or mNSCLC (metastatic non-small cell lung cancer).
* Any prior exposure to an anti-TIGIT (T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domain) therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.
* Any prior treatment with an anti-PD-1 (programmed cell death protein 1) or anti-PD-L1 (anti-programmed death-ligand 1) agent.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 5 years
measure: Progression-Free Survival (PFS)
timeFrame: Up to approximately 5 years
Secondary outcomes:
measure: Landmark Overall Survival (OS) rates
timeFrame: Up to approximately 5 years
measure: Landmark Progression-Free Survival (PFS) rates
timeFrame: Up to approximately 5 years
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 5 years
measure: Duration of Response (DoR)
timeFrame: Up to approximately 5 years
measure: Time to second progression or death (PFS2)
timeFrame: Up to approximately 5 years
measure: Pharmakokinetics (PK) of rilvegostomig
timeFrame: Up to approximately 5 years
measure: Immunogenicity of rilvegostomig
timeFrame: Up to approximately 5 years
measure: Patient-reported physical functioning
timeFrame: Up to approximately 5 years
measure: Patient-reported global health status (GHS)/quality of life (QoL)
timeFrame: Up to approximately 5 years
measure: Patient-reported lung cancer symptoms of non-small cell lung cancer (NSCLC)
timeFrame: Up to approximately 5 years
Other outcomes:
Locations:
city: Bay Pines
country: United States
facility: Research Site
state: Florida
city: Clearwater
country: United States
facility: Research Site
state: Florida
city: Saint Petersburg
country: United States
facility: Research Site
state: Florida
city: Marietta
country: United States
facility: Research Site
state: Georgia
city: Decatur
country: United States
facility: Research Site
state: Illinois
city: Des Moines
country: United States
facility: Research Site
state: Iowa
city: Leawood
country: United States
facility: Research Site
state: Kansas
city: Frederick
country: United States
facility: Research Site
state: Maryland
city: Silver Spring
country: United States
facility: Research Site
state: Maryland
city: Towson
country: United States
facility: Research Site
state: Maryland
city: Lincoln
country: United States
facility: Research Site
state: Nebraska
city: Paramus
country: United States
facility: Research Site
state: New Jersey
city: Westbury
country: United States
facility: Research Site
state: New York
city: Canton
country: United States
facility: Research Site
state: Ohio
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Aberdeen
country: United States
facility: Research Site
state: Washington
city: Cordoba
country: Argentina
facility: Research Site
city: Rosario
country: Argentina
facility: Research Site
city: Hobart
country: Australia
facility: Research Site
city: Woolloongabba
country: Australia
facility: Research Site
city: Edegem
country: Belgium
facility: Research Site
city: Liège
country: Belgium
facility: Research Site
city: Mechelen
country: Belgium
facility: Research Site
city: Roeselaere
country: Belgium
facility: Research Site
city: Blumenau
country: Brazil
facility: Research Site
city: Fortaleza
country: Brazil
facility: Research Site
city: Ijui
country: Brazil
facility: Research Site
city: Itajai
country: Brazil
facility: Research Site
city: Passo Fundo
country: Brazil
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
city: Porto Velho
country: Brazil
facility: Research Site
city: São Paulo
country: Brazil
facility: Research Site
city: Burgas
country: Bulgaria
facility: Research Site
city: Panagyurishte
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Kelowna
country: Canada
facility: Research Site
state: British Columbia
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Baoding
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Changchun
country: China
facility: Research Site
city: Changchun
country: China
facility: Research Site
city: Changsha
country: China
facility: Research Site
city: Changsha
country: China
facility: Research Site
city: Chongqing
country: China
facility: Research Site
city: Fuzhou
country: China
facility: Research Site
city: Fuzhou
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Jiamusi
country: China
facility: Research Site
city: Jinan
country: China
facility: Research Site
city: Lanzhou
country: China
facility: Research Site
city: Linyi
country: China
facility: Research Site
city: Nanchang
country: China
facility: Research Site
city: Nanchang
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Ningbo
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shenyang
country: China
facility: Research Site
city: Suzhou
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
city: Xuzhou
country: China
facility: Research Site
city: Yantai
country: China
facility: Research Site
city: Valledupar
country: Colombia
facility: Research Site
city: Angers
country: France
facility: Research Site
city: Avignon
country: France
facility: Research Site
city: Caen
country: France
facility: Research Site
city: Dijon
country: France
facility: Research Site
city: La Tronche
country: France
facility: Research Site
city: Limoges
country: France
facility: Research Site
city: Nantes CEDEX 1
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Pau Cedex
country: France
facility: Research Site
city: Toulouse
country: France
facility: Research Site
city: Tbilisi
country: Georgia
facility: Research Site
city: Tbilisi
country: Georgia
facility: Research Site
city: Amberg
country: Germany
facility: Research Site
city: Bad Saarow
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bonn
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Frankfurt am Main
country: Germany
facility: Research Site
city: Heilbronn
country: Germany
facility: Research Site
city: Immenhausen
country: Germany
facility: Research Site
city: Koblenz
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Oldenburg
country: Germany
facility: Research Site
city: Rotenburg
country: Germany
facility: Research Site
city: Schweinfurt
country: Germany
facility: Research Site
city: Velbert
country: Germany
facility: Research Site
city: Würselen
country: Germany
facility: Research Site
city: Würzburg
country: Germany
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Peiraias
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Afula
country: Israel
facility: Research Site
city: Beer-Sheva
country: Israel
facility: Research Site
city: Hadera
country: Israel
facility: Research Site
city: Jerusalem
country: Israel
facility: Research Site
city: Jerusalem
country: Israel
facility: Research Site
city: Ramat Gan
country: Israel
facility: Research Site
city: Candiolo
country: Italy
facility: Research Site
city: Lucca
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Peschiera Del Garda
country: Italy
facility: Research Site
city: Pisa
country: Italy
facility: Research Site
city: Udine
country: Italy
facility: Research Site
city: Verona
country: Italy
facility: Research Site
city: Akashi
country: Japan
facility: Research Site
city: Bunkyo-ku
country: Japan
facility: Research Site
city: Bunkyo-ku
country: Japan
facility: Research Site
city: Fukuoka-shi
country: Japan
facility: Research Site
city: Fukuoka-Shi
country: Japan
facility: Research Site
city: Hamamatsu-shi
country: Japan
facility: Research Site
city: Iwakuni-shi
country: Japan
facility: Research Site
city: Izumi-shi
country: Japan
facility: Research Site
city: Kashihara-shi
country: Japan
facility: Research Site
city: Kobe
country: Japan
facility: Research Site
city: Koto-ku
country: Japan
facility: Research Site
city: Kurume-shi
country: Japan
facility: Research Site
city: Kyoto-shi
country: Japan
facility: Research Site
city: Matsuyama-shi
country: Japan
facility: Research Site
city: Nankoku-shi
country: Japan
facility: Research Site
city: Niigata-shi
country: Japan
facility: Research Site
city: Osaka-shi
country: Japan
facility: Research Site
city: Osakasayama
country: Japan
facility: Research Site
city: Sakai-shi
country: Japan
facility: Research Site
city: Sendai-shi
country: Japan
facility: Research Site
city: Shinagawa-ku
country: Japan
facility: Research Site
city: Toyoake-shi
country: Japan
facility: Research Site
city: Toyonaka-shi
country: Japan
facility: Research Site
city: Jinju-si
country: Korea, Republic of
facility: Research Site
city: Kuala Lumpur
country: Malaysia
facility: Research Site
city: Perai
country: Malaysia
facility: Research Site
city: Selangor
country: Malaysia
facility: Research Site
city: Alcabideche
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Lisbon
country: Portugal
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Craiova
country: Romania
facility: Research Site
city: Craiova
country: Romania
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
city: Pitesti
country: Romania
facility: Research Site
city: Badalona
country: Spain
facility: Research Site
city: Castellón
country: Spain
facility: Research Site
city: Granada
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Málaga
country: Spain
facility: Research Site
city: Oviedo
country: Spain
facility: Research Site
city: Bakirkoy
country: Turkey
facility: Research Site
city: Izmit
country: Turkey
facility: Research Site
city: Yüreğir
country: Turkey
facility: Research Site
city: Blackpool
country: United Kingdom
facility: Research Site
city: Hull
country: United Kingdom
facility: Research Site
city: Stevenage
country: United Kingdom
facility: Research Site
Study officials:
References: