RecruitingInterventionalPhase 3

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)

NCT ID: NCT06627647Sponsor: AstraZenecaLast updated: 2026-05-22

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.

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, both in combination with platinum-based doublet chemotherapy, as a 1L treatment for patients with non-squamous mNSCLC whose tumors express PD-L1 (TC ≥ 1%).

Arms & interventions

DrugRilvegostomig
Administered as one intravenously (IV) on Day 1 of each 21-day cycle
DrugPembrolizumab
Administered as one intravenously (IV) on Day 1 of each 21-day cycle
DrugCarboplatin
Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
DrugCisplatin
Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
DrugPemetrexed
Administered as one 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
Time to second progression or death (PFS2)
Time frame: Up to approximately 5 years
Overall response rate (ORR)
Time frame: Up to approximately 5 years
Duration of response (DoR)
Time frame: Up to approximately 5 years
Pharmacokinetic (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 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 Exclusion Criteria: * Presence of small cell and neuroendocrine histology components. * Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 7 days prior to randomization. A minimum of 2 weeks must have elapsed between the end of local therapy (brain radiotherapy or surgery) and randomization. Participants must have recovered from the acute toxic effect of radiotherapy (eg, dizziness and signs of increased intracranial pressure) or surgery prior to randomization. * Any prior systemic therapy received for advanced or mNSCLC. Prior systemic therapy in the neoadjuvant or adjuvant setting and/or definitive radio- or chemoradiotherapy for early-stage disease are allowed, provided that recurrence or progression has occurred \> 12 months after the end of treatment. * Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms. * Any prior treatment with an anti-PD-1 or anti-PD-L1 agent. * 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. * Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment. * Active primary immunodeficiency/active infectious disease(s). * Active tuberculosis infection.

Study locations (77)

Research Site

Mobile, Alabama, 36608

Recruiting

Research Site

Chandler, Arizona, 85224

Withdrawn

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Phoenix, Arizona, 85054

Recruiting

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Anaheim, California, 92801

Recruiting

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Beverly Hills, California, 90211

Recruiting

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Loma Linda, California, 92350

Not Yet Recruiting

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Redlands, California, 92373

Recruiting

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San Diego, California, 92123

Recruiting

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San Francisco, California, 94121

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Santa Rosa, California, 95403

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Walnut Creek, California, 94598

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Lone Tree, Colorado, 80124

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Stamford, Connecticut, 06902

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West Haven, Connecticut, 06516

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Newark, Delaware, 19713

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Bay Pines, Florida, 33744

Recruiting

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Fort Lauderdale, Florida, 33308

Recruiting

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Gainesville, Florida, 32610

Withdrawn

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Jacksonville, Florida, 32224

Recruiting

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Miami, Florida, 33125

Recruiting

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Ocala, Florida, 34474

Recruiting

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St. Petersburg, Florida, 33709

Recruiting

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Atlanta, Georgia, 30342

Withdrawn

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Boise, Idaho, 83712

Recruiting

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Chicago, Illinois, 60637

Recruiting

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Decatur, Illinois, 62526

Recruiting

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Hinsdale, Illinois, 60521

Recruiting

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Quincy, Illinois, 62305

Recruiting

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Rockford, Illinois, 61114

Withdrawn

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Waterloo, Iowa, 50702

Recruiting

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Lexington, Kentucky, 40509

Recruiting

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Lexington, Kentucky, 40536

Withdrawn

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Louisville, Kentucky, 40207

Recruiting

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Alexandria, Louisiana, 71301

Withdrawn

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Baton Rouge, Louisiana, 70808

Not Yet Recruiting

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Shreveport, Louisiana, 71103

Recruiting

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Shreveport, Louisiana, 71105

Recruiting

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South Portland, Maine, 04106

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Baltimore, Maryland, 21202

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Grand Rapids, Michigan, 49503

Recruiting

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Duluth, Minnesota, 55805

Withdrawn

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Rochester, Minnesota, 55905

Recruiting

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Saint Paul, Minnesota, 55102

Recruiting

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Bridgeton, Missouri, 63044

Recruiting

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Columbia, Missouri, 65212

Withdrawn

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Lincoln, Nebraska, 68506

Recruiting

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Camden, New Jersey, 08103

Recruiting

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Buffalo, New York, 14221

Recruiting

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Westbury, New York, 11590

Recruiting

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Canton, Ohio, 44710

Recruiting

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Medford, Oregon, 97504

Recruiting

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Portland, Oregon, 97239

Withdrawn

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Salem, Oregon, 97301

Recruiting

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Pittsburgh, Pennsylvania, 15212

Withdrawn

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York, Pennsylvania, 17403

Recruiting

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Providence, Rhode Island, 02903

Withdrawn

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Pierre, South Dakota, 57501

Recruiting

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Sioux Falls, South Dakota, 57105

Recruiting

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Chattanooga, Tennessee, 37404

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Nashville, Tennessee, 37203

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Fort Worth, Texas, 76104

Recruiting

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Houston, Texas, 77090

Withdrawn

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Irving, Texas, 75063

Recruiting

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Kingwood, Texas, 77339

Recruiting

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Lubbock, Texas, 79410

Withdrawn

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Palestine, Texas, 75801

Recruiting

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Round Rock, Texas, 78665

Recruiting

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Fairfax, Virginia, 22031

Recruiting

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Norfolk, Virginia, 23502

Recruiting

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Roanoke, Virginia, 24014

Recruiting

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Seattle, Washington, 98101

Recruiting

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Seattle, Washington, 98104

Withdrawn

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Silverdale, Washington, 98383

Recruiting

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Spokane, Washington, 99208

Recruiting

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Tacoma, Washington, 98405

Recruiting

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Wenatchee, Washington, 98801

Withdrawn

Research Site

La Crosse, Wisconsin, 54601

Withdrawn