A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Locally Advanced or Metastatic Non-Squamous NSCLC

Recruiting now · Phase 3

Conditions studied: Non-squamous Non-small Cell Lung Cancer

In brief

The purpose of ARTEMIDE-Lung03 is to evaluate the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line treatment of patients with locally advanced or metastatic non-squamous NSCLC whose tumors express PD-L1.

Key facts

Study ID

NCT06627647

Run by

AstraZeneca

People needed

1160

Starts

2024-11-27

Expected to finish

2030-11-18

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically documented non-squamous NSCLC.
• Stage III B/C or IV NSCLC (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 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

You may not qualify if…

• 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 NSCLC except in the neoadjuvant or adjuvant setting or definitive chemoradiotherapy with the intent to cure, provided that progression has occurred > 12 months after the end of systemic therapy 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 systemic treatment with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs.
• Active primary immunodeficiency/active infectious disease(s).
• Active tuberculosis infection.

Where it is running

• Research Site — Hinsdale, Illinois, United States (enrolling)
• Research Site — Quincy, Illinois, United States (enrolling)
• Research Site — Mobile, Alabama, United States (enrolling)
• Research Site — Decatur, Illinois, United States (enrolling)
• Research Site — Phoenix, Arizona, United States (enrolling)
• Research Site — Redlands, California, United States (enrolling)
• Research Site — San Diego, California, United States (enrolling)
• Research Site — Anaheim, California, United States (enrolling)
• Research Site — Santa Rosa, California, United States (enrolling)
• Research Site — Beverly Hills, California, United States (enrolling)
• Research Site — Lone Tree, Colorado, United States (enrolling)
• Research Site — Stamford, Connecticut, United States (enrolling)
• Research Site — West Haven, Connecticut, United States (enrolling)
• Research Site — Newark, Delaware, United States (enrolling)
• Research Site — Bay Pines, Florida, United States (enrolling)
• Research Site — Fort Lauderdale, Florida, United States (enrolling)
• Research Site — San Francisco, California, United States (enrolling)
• Research Site — Jacksonville, Florida, United States (enrolling)
• Research Site — Miami, Florida, United States (enrolling)
• Research Site — Ocala, Florida, United States (enrolling)
• Research Site — St. Petersburg, Florida, United States (enrolling)
• Research Site — Walnut Creek, California, United States (enrolling)
• Research Site — Boise, Idaho, United States (enrolling)
• Research Site — Chicago, Illinois, United States (enrolling)
• Research Site — Waterloo, Iowa, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.