Recruiting
Phase 3

Rilvegostomig & Pembrolizumab

Sponsor:

AstraZeneca

Code:

NCT06627647

Conditions

Non-squamous Non-small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rilvegostomig

Pembrolizumab

Carboplatin

Cisplatin

Pemetrexed

Study Details

Brief 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 locally advanced or metastatic non-squamous NSCLC whose tumors express PD-L1.

Conditions

Non-squamous Non-small Cell Lung Cancer

Study ID

NCT06627647

Start date

Nov 27, 2024

Status verified date

Aug, 2026

Completion date

Nov 18, 2030

Anticipated

Primary completion date

Nov 18, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Histologically or cytologically documented non-squamous NSCLC.
  • Stage III B/C or IV NSCLC (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 and available 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 NSCLC except in the neoadjuvant or adjuvant setting or definitive chemoradiotherapy with the intent to cure, provided that progression has occurred > 12 months after the end of systemic therapy 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 systemic treatment with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs.
  • Active primary immunodeficiency/active infectious disease(s).
  • Active tuberculosis infection.

Study Design

Enrollment

1160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A

Rilvegostomig in combination with platinum-based doublet chemotherapy followed by rilvegostomig monotherapy plus pemetrexed in maintenance.

active comparator: Arm B

Pembrolizumab in combination with platinum-based doublet chemotherapy followed by pembrolizumab monotherapy plus pemetrexed in maintenance.

Interventions

Rilvegostomig

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

Pembrolizumab

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

Carboplatin

Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles

Cisplatin

Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles

Pemetrexed

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

Primary outcome measure

  • Overall survival (OS) [ Time Frame: Up to approximately 6 years ]
  • Progression-free survival (PFS) [ Time Frame: Up to approximately 6 years ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Mobile, Alabama, United States, 36608

Research Site

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Phoenix, Arizona, United States, 85054

Research Site

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Anaheim, California, United States, 92801

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Beverly Hills, California, United States, 90211

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Loma Linda, California, United States, 92350

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Redlands, California, United States, 92373

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San Diego, California, United States, 92123

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San Francisco, California, United States, 94121

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Santa Rosa, California, United States, 95403

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Walnut Creek, California, United States, 94598

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Lone Tree, Colorado, United States, 80124

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Stamford, Connecticut, United States, 06902

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West Haven, Connecticut, United States, 06516

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Newark, Delaware, United States, 19713

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Bay Pines, Florida, United States, 33744

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Fort Lauderdale, Florida, United States, 33308

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Jacksonville, Florida, United States, 32224

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Miami, Florida, United States, 33125

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Ocala, Florida, United States, 34474

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St. Petersburg, Florida, United States, 33709

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Boise, Idaho, United States, 83712

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Chicago, Illinois, United States, 60637

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Decatur, Illinois, United States, 62526

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Hinsdale, Illinois, United States, 60521

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Quincy, Illinois, United States, 62305

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Waterloo, Iowa, United States, 50702

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Lexington, Kentucky, United States, 40509

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Louisville, Kentucky, United States, 40207

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Baton Rouge, Louisiana, United States, 70808

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Shreveport, Louisiana, United States, 71103

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Shreveport, Louisiana, United States, 71105

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South Portland, Maine, United States, 04106

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Baltimore, Maryland, United States, 21202

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Grand Rapids, Michigan, United States, 49503

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Rochester, Minnesota, United States, 55905

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Saint Paul, Minnesota, United States, 55102

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Bridgeton, Missouri, United States, 63044

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Lincoln, Nebraska, United States, 68506

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Camden, New Jersey, United States, 08103

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Buffalo, New York, United States, 14221

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Westbury, New York, United States, 11590

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Canton, Ohio, United States, 44710

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Medford, Oregon, United States, 97504

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Salem, Oregon, United States, 97301

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York, Pennsylvania, United States, 17403

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Pierre, South Dakota, United States, 57501

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Sioux Falls, South Dakota, United States, 57105

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Chattanooga, Tennessee, United States, 37404

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Nashville, Tennessee, United States, 37203

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Fort Worth, Texas, United States, 76104

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Irving, Texas, United States, 75063

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Kingwood, Texas, United States, 77339

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Palestine, Texas, United States, 75801

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Round Rock, Texas, United States, 78665

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Fairfax, Virginia, United States, 22031

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Norfolk, Virginia, United States, 23502

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Roanoke, Virginia, United States, 24014

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Seattle, Washington, United States, 98101

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Silverdale, Washington, United States, 98383

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Spokane, Washington, United States, 99208

Research Site

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Tacoma, Washington, United States, 98405

Research Site

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Saint John, New Brunswick, Canada, E2L 4L2

Research Site

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Hamilton, Ontario, Canada, L8V 1C3

Research Site

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Kingston, Ontario, Canada, K7L 2V7

Research Site

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Sault Ste. Marie, Ontario, Canada, P6A 0A8

Research Site

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Montreal, Quebec, Canada, H2X 0A9

Research Site

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Montreal, Quebec, Canada, H4A 3J1

Research Site

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Saint-Jérôme, Quebec, Canada, J7Z 2V4

More Information

Sponsor

AstraZeneca

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

  • ARTEMIDE-Lung03
  • Rilvegostomig (AZD2936)
  • Non-squamous 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
  • Carboplatin
  • Cisplatin
  • Pemetrexed

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-08-14.