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Comparing Rilvegostomig and Pembrolizumab with Chemotherapy for Lung Cancer

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)

PHASE3 · AstraZeneca · NCT06627647

This study is testing whether a new drug called rilvegostomig or pembrolizumab, both used with chemotherapy, can help people with advanced lung cancer whose tumors have a specific marker.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment878 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca (industry)
Drugs / interventionspembrolizumab, chemotherapy
Locations282 sites (Mobile, Alabama and 281 other locations)
Trial IDNCT06627647 on ClinicalTrials.gov

What this trial studies

This global Phase III study evaluates the efficacy and safety of rilvegostomig versus pembrolizumab, both combined with platinum-based chemotherapy, as first-line treatments for patients with metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors express PD-L1. The study is randomized and double-blind, ensuring unbiased results. Participants will be monitored for treatment response and safety throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are patients with stage IV non-squamous NSCLC whose tumors express PD-L1 and do not have actionable mutations.

Not a fit: Patients with sensitizing EGFR mutations or ALK and ROS1 rearrangements 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 metastatic non-squamous NSCLC.

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

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Mobile, Alabama and 281 other locations

+232 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 →

Conditions: Non-squamous Non-small Cell Lung Cancer, ARTEMIDE-Lung03, Rilvegostomig, Non-squamous non-small cell lung cancer, Bi-specific antibody, T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domain, EGFR, ALK and ROS1 testing, Programmed cell death protein

Last reviewed 2026-05-15 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.