A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)

Recruiting now · Phase 3

Conditions studied: Non-small Cell Lung Cancer

In brief

The purpose of ARTEMIDE-Lung02 is to assess the efficacy and safety of rilvegostomig in combination with platinum-based chemotherapy for the first-line (1L) treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1).

Key facts

Study ID

NCT06692738

Run by

AstraZeneca

People needed

1160

Starts

2024-11-18

Expected to finish

2030-07-01

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 squamous NSCLC.
• Stage III B/C or 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 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, non-curative therapy received for NSCLC.
• 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 systemic treatment with the use of disease-modifying agents or other immunosuppressive drugs.
• Active primary immunodeficiency/active infectious disease(s).
• Active tuberculosis infection.

Where it is running

• Research Site — Waterloo, Iowa, United States (enrolling)
• Research Site — Louisville, Kentucky, United States (enrolling)
• Research Site — Springdale, Arkansas, United States (enrolling)
• Research Site — Loma Linda, California, United States (enrolling)
• Research Site — Lexington, Kentucky, United States (enrolling)
• Research Site — Anaheim, California, United States (enrolling)
• Research Site — San Francisco, California, United States (enrolling)
• Research Site — Beverly Hills, California, United States (enrolling)
• Research Site — West Haven, Connecticut, United States (enrolling)
• Research Site — Newark, Delaware, United States (enrolling)
• Research Site — Tucson, Arizona, United States (enrolling)
• Research Site — Fort Lauderdale, Florida, United States (enrolling)
• Research Site — Gainesville, Florida, United States (enrolling)
• Research Site — Redlands, California, United States (enrolling)
• Research Site — Jacksonville, Florida, United States (enrolling)
• Research Site — Athens, Georgia, 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 — Decatur, Illinois, United States (enrolling)
• Research Site — Hinsdale, Illinois, United States (enrolling)
• Research Site — Quincy, Illinois, United States (enrolling)
• Research Site — Bay Pines, Florida, United States (enrolling)
• Research Site — Los Alamitos, California, United States (enrolling)
• Research Site — Louisville, Kentucky, United States (enrolling)

Full record on ClinicalTrials.gov

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