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Combining Rilvegostomig or Pembrolizumab with Chemotherapy for Lung Cancer Treatment

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 Squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung02)

Phase 3 Interventional AstraZeneca · NCT06692738

This study is testing whether a new drug called rilvegostomig combined with chemotherapy works better than pembrolizumab with chemotherapy for treating advanced lung cancer in patients with certain tumor markers.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment880 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionschemotherapy, pembrolizumab
Locations301 sites (Tucson, Arizona and 300 other locations)
Trial IDNCT06692738 on ClinicalTrials.gov

What this trial studies

This global Phase III study evaluates the effectiveness and safety of rilvegostomig in combination with platinum-based chemotherapy compared to pembrolizumab plus chemotherapy for first-line treatment of metastatic squamous non-small cell lung cancer (mNSCLC) with PD-L1 expression. The study is randomized, double-blind, and multicenter, involving patients whose tumors express programmed death-ligand 1 (PD-L1). Participants will receive either treatment regimen to determine which is more effective in managing their condition.

Who should consider this trial

Good fit: Ideal candidates include patients with stage IV metastatic squamous NSCLC whose tumors express PD-L1 and who have not received prior treatment.

Not a fit: Patients with small cell or neuroendocrine histology components or those with symptomatic brain metastases 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 squamous non-small cell lung cancer.

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

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Histologically or cytologically documented squamous NSCLC.
* Stage 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 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.
* 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 treatment with steroids or other immunosuppressive treatment.
* Active primary immunodeficiency/active infectious disease(s).
* Active tuberculosis infection.

Where this trial is running

Tucson, Arizona and 300 other locations

+251 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 Non-small Cell Lung CancerARTEMIDE-Lung02RilvegostomigNon-small cell lung cancerBi-specific antibodyT-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domainProgrammed death-ligand 1Pembrolizumab
Last reviewed 2026-06-10 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.