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 · NCT06692738 · Interventional (participants receive a specific treatment) · Lead sponsor: AstraZeneca

View the official record on ClinicalTrials.gov →

Interventions studied

Carboplatin Nab-paclitaxel Paclitaxel Pembrolizumab Rilvegostomig

What this trial is about

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).

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

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.

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, 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

60 locations listed across 31 US states.

Research Site - Tucson, Arizona, United States
Research Site - Springdale, Arkansas, United States
Research Site - Anaheim, California, United States
Research Site - Beverly Hills, California, United States
Research Site - Loma Linda, California, United States
Research Site - Los Alamitos, California, United States
Research Site - Redlands, California, United States
Research Site - San Francisco, California, United States
Research Site - Walnut Creek, California, United States
Research Site - West Haven, Connecticut, United States
Research Site - Newark, Delaware, United States
Research Site - Bay Pines, Florida, United States
Research Site - Fort Lauderdale, Florida, United States
Research Site - Gainesville, Florida, United States
Research Site - Gainesville, Florida, United States
Research Site - Jacksonville, Florida, United States
Research Site - Athens, Georgia, United States
Research Site - Atlanta, Georgia, United States
Research Site - Savannah, Georgia, United States
Research Site - Boise, Idaho, United States
Research Site - Chicago, Illinois, United States
Research Site - Decatur, Illinois, United States
Research Site - Hinsdale, Illinois, United States
Research Site - Quincy, Illinois, United States
Research Site - Rockford, Illinois, United States
Research Site - Fort Wayne, Indiana, United States
Research Site - Waterloo, Iowa, United States
Research Site - Lexington, Kentucky, United States
Research Site - Lexington, Kentucky, United States
Research Site - Louisville, Kentucky, United States
Research Site - Louisville, Kentucky, United States
Research Site - Alexandria, Louisiana, United States
Research Site - Baton Rouge, Louisiana, United States
Research Site - Covington, Louisiana, United States
Research Site - Shreveport, Louisiana, United States
Research Site - Shreveport, Louisiana, United States
Research Site - Scarborough, Maine, United States
Research Site - Baltimore, Maryland, United States
Research Site - Bethesda, Maryland, United States
Research Site - Bethesda, Maryland, United States
Research Site - Detroit, Michigan, United States
Research Site - Grand Rapids, Michigan, United States
Research Site - Saginaw, Michigan, United States
Research Site - Duluth, Minnesota, United States
Research Site - Rochester, Minnesota, United States
Research Site - Bridgeton, Missouri, United States
Research Site - Columbia, Missouri, United States
Research Site - Kansas City, Missouri, United States
Research Site - Lincoln, Nebraska, United States
Research Site - Camden, New Jersey, United States
Research Site - Buffalo, New York, United States
Research Site - East Syracuse, New York, United States
Research Site - Westbury, New York, United States
Research Site - Wilson, North Carolina, United States
Research Site - Grand Forks, North Dakota, United States
Research Site - Cincinnati, Ohio, United States
Research Site - Bend, Oregon, United States
Research Site - Medford, Oregon, United States
Research Site - Salem, Oregon, United States
Research Site - Hershey, Pennsylvania, United States

Showing 60 of 325 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →