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Comparing rilvegostomig and pembrolizumab for treating advanced lung cancer

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)

Phase 3 Interventional AstraZeneca · NCT06868277

This study is testing whether a new drug called rilvegostomig works better than pembrolizumab for treating advanced lung cancer in patients whose tumors have a specific marker.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment830 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionspembrolizumab
Locations294 sites (La Mesa, California and 293 other locations)
Trial IDNCT06868277 on ClinicalTrials.gov

What this trial studies

This global Phase III study aims to evaluate the efficacy and safety of rilvegostomig compared to pembrolizumab as a first-line treatment for patients with metastatic non-small cell lung cancer (mNSCLC) that expresses PD-L1. The study is designed as a randomized, double-blind, multicenter trial, meaning neither the participants nor the researchers know which treatment is being administered to ensure unbiased results. Participants must have stage IV mNSCLC and meet specific eligibility criteria, including the absence of certain genetic mutations. The study will assess how well each treatment works and their safety profiles.

Who should consider this trial

Good fit: Ideal candidates are adults with stage IV metastatic non-small cell lung cancer whose tumors express PD-L1 and do not have specific genetic mutations.

Not a fit: Patients with actionable driver oncogenes for which there are locally approved targeted therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with advanced lung cancer.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

La Mesa, California and 293 other locations

+244 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Carcinoma, Non-Small Cell LungARTEMIDE-Lung04RilvegostomigNon-small cell lung cancerBi-specific antibodyT-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domainEGFR, ALK and ROS1 testingProgrammed cell death protein
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.