A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rilvegostomig, Pembrolizumab.
- Who it may be relevant to
- Registry conditions: Carcinoma, Non-Small Cell Lung. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Australia, Belgium, Brazil +22
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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.
Interventions
- Biological Rilvegostomig
Administered intravenously (IV) on Day 1 of each 21-day cycle - Biological Pembrolizumab
Administered intravenously (IV) on Day 1 of each 21-day cycle
Primary outcome measures
- Overall Survival (OS) [Time frame: Up to approximately 5 years]
- Progression-Free Survival (PFS) [Time frame: Up to approximately 5 years]
Secondary outcome measures (10)
- Landmark Overall Survival (OS) rates [Time frame: Up to approximately 5 years]
- Landmark Progression-Free Survival (PFS) rates [Time frame: Up to approximately 5 years]
- Objective Response Rate (ORR) [Time frame: Up to approximately 5 years]
- Duration of Response (DoR) [Time frame: Up to approximately 5 years]
- Time to second progression or death (PFS2) [Time frame: Up to approximately 5 years]
- Pharmakokinetics (PK) of rilvegostomig [Time frame: Up to approximately 5 years]
- Immunogenicity of rilvegostomig [Time frame: Up to approximately 5 years]
- Patient-reported physical functioning [Time frame: Up to approximately 5 years]
- Patient-reported global health status (GHS)/quality of life (QoL) [Time frame: Up to approximately 5 years]
- Patient-reported lung cancer symptoms of non-small cell lung cancer (NSCLC) [Time frame: Up to approximately 5 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 42 centers
Center list to be confirmed — check the primary protocol.
United States · 39 centers
- Research Site — La Mesa
- Research Site — Los Alamitos
- Research Site — Newark
- Research Site — Bay Pines
- Research Site — Clearwater
- Research Site — Gainesville
- Research Site — St. Petersburg
- Research Site — Marietta
- … and 31 more centers
Germany · 28 centers
Center list to be confirmed — check the primary protocol.
Japan · 25 centers
Center list to be confirmed — check the primary protocol.
Spain · 16 centers
Center list to be confirmed — check the primary protocol.
Brazil · 15 centers
- Research Site — Blumenau
- Research Site — Fortaleza
- Research Site — Ijuí
- Research Site — Itajaí
- Research Site — Londrina
- Research Site — Passo Fundo
- Research Site — Porto Alegre
- Research Site — Porto Alegre
- … and 7 more centers
France · 14 centers
Center list to be confirmed — check the primary protocol.
Italy · 13 centers
Center list to be confirmed — check the primary protocol.
Portugal · 11 centers
Center list to be confirmed — check the primary protocol.
Romania · 11 centers
Center list to be confirmed — check the primary protocol.
Israel · 10 centers
Center list to be confirmed — check the primary protocol.
Greece · 9 centers
Center list to be confirmed — check the primary protocol.
Canada · 7 centers
- Research Site — Edmonton
- Research Site — Kelowna
- Research Site — Cambridge
- Research Site — Newmarket
- Research Site — Toronto
- Research Site — Québec
- … and 1 more center
Ireland · 7 centers
Center list to be confirmed — check the primary protocol.
Argentina · 6 centers
- Research Site — CABA
- Research Site — Córdoba
- Research Site — Pilar
- Research Site — Rosario
- Research Site — Rosario
- Research Site — Viedma
Belgium · 6 centers
- Research Site — Edegem
- Research Site — Jette
- Research Site — Libramont-Chevigny
- Research Site — Liège
- Research Site — Mechelen
- Research Site — Roeselaere
Bulgaria · 6 centers
- Research Site — Burgas
- Research Site — Panagyurishte
- Research Site — Sofia
- Research Site — Sofia
- Research Site — Sofia
- Research Site — Varna
Turkey (Türkiye) · 6 centers
Center list to be confirmed — check the primary protocol.
United Kingdom · 6 centers
Center list to be confirmed — check the primary protocol.
Malaysia · 5 centers
Center list to be confirmed — check the primary protocol.
Chile · 4 centers
Center list to be confirmed — check the primary protocol.
Colombia · 4 centers
Center list to be confirmed — check the primary protocol.
Costa Rica · 4 centers
Center list to be confirmed — check the primary protocol.
Georgia · 4 centers
Center list to be confirmed — check the primary protocol.
South Korea · 3 centers
Center list to be confirmed — check the primary protocol.
Australia · 2 centers
- Research Site — Hobart
- Research Site — Woolloongabba
Switzerland · 1 center
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06868277 · D702GC00001 · 2024-517780-24-00