Rilvegostomig: Administered intravenously (IV) on Day 1 of each 21-day cycle
Pembrolizumab: Administered intravenously (IV) on Day 1 of each 21-day cycle
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)
Overall Survival (OS) — Up to approximately 5 years OS is defined as the time from randomization until the date of death due to any cause.
Progression-Free Survival (PFS) — Up to approximately 5 years PFS is defined as the time from randomization until radiological progression per RECIST 1.1 or death due to any cause (in the absence of progression).
Trial sites (304)
Facility
City
Region
Status
Research Site
La Mesa
California
Not Yet Recruiting
Research Site
Los Alamitos
California
Not Yet Recruiting
Research Site
Newark
Delaware
Recruiting
Research Site
Bay Pines
Florida
Recruiting
Research Site
Clearwater
Florida
Recruiting
Research Site
Gainesville
Florida
Recruiting
Research Site
St. Petersburg
Florida
Recruiting
Research Site
Marietta
Georgia
Recruiting
Research Site
Chicago
Illinois
Recruiting
Research Site
Decatur
Illinois
Recruiting
Research Site
Des Moines
Iowa
Recruiting
Research Site
Waterloo
Iowa
Not Yet Recruiting
Research Site
Leawood
Kansas
Recruiting
Research Site
Lexington
Kentucky
Not Yet Recruiting
Research Site
Owensboro
Kentucky
Recruiting
Research Site
Bethesda
Maryland
Recruiting
Research Site
Frederick
Maryland
Recruiting
Research Site
Silver Spring
Maryland
Recruiting
Research Site
Towson
Maryland
Recruiting
Research Site
Saginaw
Michigan
Not Yet Recruiting
Research Site
Bridgeton
Missouri
Recruiting
Research Site
Lincoln
Nebraska
Recruiting
Research Site
Reno
Nevada
Recruiting
Research Site
Paramus
New Jersey
Not Yet Recruiting
Research Site
Buffalo
New York
Recruiting
Research Site
East Syracuse
New York
Recruiting
Research Site
Fresh Meadows
New York
Recruiting
Research Site
Rochester
New York
Not Yet Recruiting
Research Site
Westbury
New York
Recruiting
Research Site
Canton
Ohio
Not Yet Recruiting
Research Site
Fountain Hill
Pennsylvania
Recruiting
Research Site
Kittanning
Pennsylvania
Not Yet Recruiting
Research Site
Philadelphia
Pennsylvania
Recruiting
Research Site
Round Rock
Texas
Not Yet Recruiting
Research Site
Aberdeen
Washington
Recruiting
Research Site
Renton
Washington
Not Yet Recruiting
Research Site
Charleston
West Virginia
Recruiting
Research Site
Morgantown
West Virginia
Recruiting
Research Site
Schofield
Wisconsin
Not Yet Recruiting
Research Site
CABA
Argentina
Recruiting
+ 264 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.