Recruiting
Phase 3

Rilvegostomig vs. Pembrolizumab

Sponsor:

AstraZeneca

Code:

NCT06868277

Conditions

Carcinoma, Non-Small Cell Lung

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rilvegostomig

Pembrolizumab

Study Details

Brief 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.

Conditions

Carcinoma, Non-Small Cell Lung

Study ID

NCT06868277

Start date

Apr 10, 2025

Status verified date

Jul, 2026

Completion date

Dec 2, 2030

Anticipated

Primary completion date

Jan 17, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

830 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A

Drug: rilvegostomig

active comparator: Arm B

Drug: 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

Primary outcome measure

  • Overall Survival (OS) [ Time Frame: Up to approximately 5 years ]
  • Progression-Free Survival (PFS) [ Time Frame: Up to approximately 5 years ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

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

Locations

Research Site

Recruiting

Newark, Delaware, United States, 19713

Research Site

Recruiting

Bay Pines, Florida, United States, 33744

Research Site

Recruiting

Clearwater, Florida, United States, 33756

Research Site

Recruiting

Gainesville, Florida, United States, 32610

Research Site

Recruiting

St. Petersburg, Florida, United States, 33705

Research Site

Recruiting

Marietta, Georgia, United States, 30060

Research Site

Recruiting

Chicago, Illinois, United States, 60612

Research Site

Recruiting

Decatur, Illinois, United States, 62526

Research Site

Recruiting

Des Moines, Iowa, United States, 50309

Research Site

Recruiting

Leawood, Kansas, United States, 66209

Research Site

Recruiting

Owensboro, Kentucky, United States, 42303

Research Site

Recruiting

Bethesda, Maryland, United States, 20817

Research Site

Recruiting

Frederick, Maryland, United States, 21702

Research Site

Recruiting

Silver Spring, Maryland, United States, 20910

Research Site

Recruiting

Towson, Maryland, United States, 21204

Research Site

Recruiting

Bridgeton, Missouri, United States, 63044

Research Site

Recruiting

Lincoln, Nebraska, United States, 68506

Research Site

Recruiting

Reno, Nevada, United States, 89511

Research Site

Recruiting

Buffalo, New York, United States, 14215

Research Site

Recruiting

East Syracuse, New York, United States, 13057

Research Site

Recruiting

Fresh Meadows, New York, United States, 11366

Research Site

Recruiting

Westbury, New York, United States, 11590

Research Site

Recruiting

Fountain Hill, Pennsylvania, United States, 18015

Research Site

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Research Site

Recruiting

Aberdeen, Washington, United States, 98520

Research Site

Recruiting

Charleston, West Virginia, United States, 25304

Research Site

Recruiting

Morgantown, West Virginia, United States, 26506

Research Site

Recruiting

Edmonton, Alberta, Canada, T6G 1Z2

Research Site

Recruiting

Toronto, Ontario, Canada, M4N 3M5

More Information

Sponsor

AstraZeneca

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Keywords

  • ARTEMIDE-Lung04
  • Rilvegostomig (AZD2936)
  • 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

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 2026-08-03.