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)
Rilvegostomig: Administered intravenously (IV) on Day 1 of each 21-day cycle
Pembrolizumab: Administered intravenously (IV) on Day 1 of each 21-day cycle
Carboplatin: Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
Paclitaxel: Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
Nab-paclitaxel: Administered intravenously (IV) on Days 1, 8, and 15 of each 21-day cycle up to 4 cycles
Study summary
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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Overall survival (OS) — Up to approximately 6 years OS is defined as the time from randomization until the date of death due to any cause.
Progression-free survival (PFS) — Up to approximately 6 years PFS is defined as the time from randomization until radiological progression per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) or death due to any cause (in the absence of progression).
Trial sites (328)
Facility
City
Region
Status
Research Site
Tucson
Arizona
Recruiting
Research Site
Springdale
Arkansas
Recruiting
Research Site
Anaheim
California
Recruiting
Research Site
Beverly Hills
California
Recruiting
Research Site
Loma Linda
California
Recruiting
Research Site
Los Alamitos
California
Recruiting
Research Site
Redlands
California
Recruiting
Research Site
San Francisco
California
Recruiting
Research Site
Walnut Creek
California
Recruiting
Research Site
West Haven
Connecticut
Recruiting
Research Site
Newark
Delaware
Recruiting
Research Site
Bay Pines
Florida
Recruiting
Research Site
Fort Lauderdale
Florida
Recruiting
Research Site
Gainesville
Florida
Recruiting
Research Site
Gainesville
Florida
Withdrawn
Research Site
Jacksonville
Florida
Recruiting
Research Site
Athens
Georgia
Recruiting
Research Site
Atlanta
Georgia
Withdrawn
Research Site
Savannah
Georgia
Not Yet Recruiting
Research Site
Boise
Idaho
Recruiting
Research Site
Chicago
Illinois
Recruiting
Research Site
Decatur
Illinois
Recruiting
Research Site
Hinsdale
Illinois
Recruiting
Research Site
Quincy
Illinois
Recruiting
Research Site
Rockford
Illinois
Withdrawn
Research Site
Fort Wayne
Indiana
Not Yet Recruiting
Research Site
Waterloo
Iowa
Recruiting
Research Site
Lexington
Kentucky
Recruiting
Research Site
Lexington
Kentucky
Withdrawn
Research Site
Louisville
Kentucky
Recruiting
Research Site
Louisville
Kentucky
Recruiting
Research Site
Alexandria
Louisiana
Withdrawn
Research Site
Baton Rouge
Louisiana
Recruiting
Research Site
Covington
Louisiana
Withdrawn
Research Site
Shreveport
Louisiana
Recruiting
Research Site
Shreveport
Louisiana
Recruiting
Research Site
Scarborough
Maine
Recruiting
Research Site
Baltimore
Maryland
Completed
Research Site
Bethesda
Maryland
Recruiting
Research Site
Bethesda
Maryland
Not Yet Recruiting
+ 288 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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