Recruiting
Phase 3

Rilvegostomig & Pembrolizumab

Sponsor:

AstraZeneca

Code:

NCT06692738

Conditions

Non-small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rilvegostomig

Pembrolizumab

Carboplatin

Paclitaxel

Nab-paclitaxel

Study Details

Brief summary:

The purpose of ARTEMIDE-Lung02 is to assess the efficacy and safety of rilvegostomig in combination with platinum-based chemotherapy for the first-line (1L) treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1).

Conditions

Non-small Cell Lung Cancer

Study ID

NCT06692738

Start date

Nov 18, 2024

Status verified date

Aug, 2026

Completion date

Jul 1, 2030

Anticipated

Primary completion date

Jul 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Histologically or cytologically documented squamous NSCLC.
  • Stage III B/C or IV mNSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.
  • Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any 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, non-curative therapy received for NSCLC.
  • Any prior treatment with an anti-PD-1 or anti-PD-L1 agent.
  • Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.
  • 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 or other 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 carboplatin and paclitaxel or nab-paclitaxel followed by rilvegostomig

active comparator: Arm B

Pembrolizumab in combination with carboplatin and paclitaxel or nab-paclitaxel followed by pembrolizumab

Interventions

Rilvegostomig

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

Pembrolizumab

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

Carboplatin

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

Paclitaxel

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

Nab-paclitaxel

Administered intravenously (IV) on Days 1, 8, and 15 of each 21-day cycle up to 4 cycles

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

Tucson, Arizona, United States, 85724

Research Site

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Springdale, Arkansas, United States, 72762

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, 92354

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Los Alamitos, California, United States, 90720

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Redlands, California, United States, 92373

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San Francisco, California, United States, 94121

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Walnut Creek, California, United States, 94598

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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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Gainesville, Florida, United States, 32608

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Jacksonville, Florida, United States, 32224

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Athens, Georgia, United States, 30607

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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, 62301

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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, 40202

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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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Scarborough, Maine, United States, 04074

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Bethesda, Maryland, United States, 20817

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Detroit, Michigan, United States, 48202

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Grand Rapids, Michigan, United States, 49503

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Duluth, Minnesota, United States, 55802

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Rochester, Minnesota, United States, 55905

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Bridgeton, Missouri, United States, 63044

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Kansas City, Missouri, United States, 64108

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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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East Syracuse, New York, United States, 13057

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Westbury, New York, United States, 11590

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Wilson, North Carolina, United States, 27893

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Grand Forks, North Dakota, United States, 58201

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Cincinnati, Ohio, United States, 45267

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Medford, Oregon, United States, 97504

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Salem, Oregon, United States, 97301

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Hershey, Pennsylvania, United States, 17033

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York, Pennsylvania, United States, 17403

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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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Kingwood, Texas, United States, 77339

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Lubbock, Texas, United States, 79410

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Round Rock, Texas, United States, 78665

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Fairfax, Virginia, United States, 22031

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Fredericksburg, Virginia, United States, 22408

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Olympia, Washington, United States, 98506

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Seattle, Washington, United States, 98101

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Spokane, Washington, United States, 99208

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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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Sydney, Nova Scotia, Canada, B1P 1P3

Research Site

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Hamilton, Ontario, Canada, L8V 1C3

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

More Information

Sponsor

AstraZeneca

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Keywords

  • ARTEMIDE-Lung02
  • Rilvegostomig (AZD2936)
  • Non-small cell lung cancer (NSCLC)
  • Bi-specific antibody
  • T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domain (TIGIT)
  • Programmed death-ligand 1 (PD-L1)
  • Pembrolizumab
  • Carboplatin
  • Paclitaxel
  • Nab-paclitaxel

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-08-13.