A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Locally Advanced or Metastatic Non-Squamous NSCLC
Rilvegostomig: Administered as one intravenously (IV) on Day 1 of each 21-day cycle
Pembrolizumab: Administered as one intravenously (IV) on Day 1 of each 21-day cycle
Carboplatin: Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
Cisplatin: Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
Pemetrexed: Administered as one intravenously (IV) on Day 1 of each 21-day cycle
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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
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 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.
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 RECIST 1.1, or death due to any cause (in the absence of progression).
Trial sites (295)
Facility
City
Region
Status
Research Site
Mobile
Alabama
Recruiting
Research Site
Chandler
Arizona
Withdrawn
Research Site
Phoenix
Arizona
Recruiting
Research Site
Anaheim
California
Recruiting
Research Site
Beverly Hills
California
Recruiting
Research Site
Loma Linda
California
Recruiting
Research Site
Redlands
California
Recruiting
Research Site
San Diego
California
Recruiting
Research Site
San Francisco
California
Recruiting
Research Site
Santa Rosa
California
Recruiting
Research Site
Walnut Creek
California
Recruiting
Research Site
Lone Tree
Colorado
Recruiting
Research Site
Stamford
Connecticut
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
Withdrawn
Research Site
Jacksonville
Florida
Recruiting
Research Site
Miami
Florida
Recruiting
Research Site
Ocala
Florida
Recruiting
Research Site
St. Petersburg
Florida
Recruiting
Research Site
Atlanta
Georgia
Withdrawn
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
Waterloo
Iowa
Recruiting
Research Site
Lexington
Kentucky
Recruiting
Research Site
Lexington
Kentucky
Withdrawn
Research Site
Louisville
Kentucky
Recruiting
Research Site
Alexandria
Louisiana
Withdrawn
Research Site
Baton Rouge
Louisiana
Recruiting
Research Site
Shreveport
Louisiana
Recruiting
Research Site
Shreveport
Louisiana
Recruiting
Research Site
South Portland
Maine
Recruiting
Research Site
Baltimore
Maryland
Recruiting
Research Site
Grand Rapids
Michigan
Recruiting
+ 255 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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