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RecruitingInterventionalPhase 3

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)

NCT ID: NCT06868277Sponsor: AstraZenecaLast updated: 2026-05-14

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.

Arms & interventions

  • BiologicalRilvegostomig

    Administered intravenously (IV) on Day 1 of each 21-day cycle

  • BiologicalPembrolizumab

    Administered intravenously (IV) on Day 1 of each 21-day cycle

Outcome measures

Primary

  • Overall Survival (OS)

    OS is defined as the time from randomization until the date of death due to any cause.

    Time frame: Up to approximately 5 years

  • Progression-Free Survival (PFS)

    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).

    Time frame: Up to approximately 5 years

Secondary

  • 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

Sex: AllAge: 18 Years and olderHealthy 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.

Study locations (37)

Research Site

La Mesa, California, 91942

Not Yet Recruiting

Research Site

Los Alamitos, California, 90720

Not Yet Recruiting

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Farmington, Connecticut, 06030

Recruiting

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Newark, Delaware, 19713

Recruiting

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Bay Pines, Florida, 33744

Recruiting

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Clearwater, Florida, 33756

Recruiting

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St. Petersburg, Florida, 33705

Recruiting

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Marietta, Georgia, 30060

Recruiting

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Chicago, Illinois, 60612

Recruiting

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Decatur, Illinois, 62526

Recruiting

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Des Moines, Iowa, 50309

Recruiting

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Waterloo, Iowa, 50702

Not Yet Recruiting

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Leawood, Kansas, 66209

Recruiting

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Lexington, Kentucky, 40536

Not Yet Recruiting

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Owensboro, Kentucky, 42303

Recruiting

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Bethesda, Maryland, 20817

Recruiting

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Frederick, Maryland, 21702

Recruiting

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Silver Spring, Maryland, 20910

Recruiting

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Towson, Maryland, 21204

Recruiting

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Saginaw, Michigan, 48602

Not Yet Recruiting

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Bridgeton, Missouri, 63044

Recruiting

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Lincoln, Nebraska, 68506

Recruiting

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Paramus, New Jersey, 07652

Not Yet Recruiting

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Buffalo, New York, 14215

Recruiting

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East Syracuse, New York, 13057

Recruiting

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Fresh Meadows, New York, 11366

Not Yet Recruiting

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Rochester, New York, 14642

Not Yet Recruiting

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Westbury, New York, 11590

Recruiting

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Canton, Ohio, 44718

Not Yet Recruiting

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Fountain Hill, Pennsylvania, 18015

Recruiting

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Kittanning, Pennsylvania, 16201

Not Yet Recruiting

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Philadelphia, Pennsylvania, 19104

Recruiting

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Round Rock, Texas, 78665

Not Yet Recruiting

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Aberdeen, Washington, 98520

Not Yet Recruiting

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Renton, Washington, 98055

Not Yet Recruiting

Research Site

Charleston, West Virginia, 25304

Recruiting

Research Site

Morgantown, West Virginia, 26506

Recruiting