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

RecruitingPhase 3

A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung03)

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: AstraZeneca · Participants: 1,160 · Started: Nov 27, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06627647

Locations in the U.S.

AlabamaResearch Site, Mobile
ArizonaResearch Site, Phoenix
CaliforniaResearch Site, Anaheim
Research Site, Beverly Hills
Research Site, Loma Linda
Research Site, Redlands
Research Site, San Diego
Research Site, San Francisco
Research Site, Santa Rosa
Research Site, Walnut Creek
ColoradoResearch Site, Lone Tree
ConnecticutResearch Site, Stamford
Research Site, West Haven
DelawareResearch Site, Newark
FloridaResearch Site, Bay Pines
Research Site, Fort Lauderdale
Research Site, Jacksonville
Research Site, Miami
Research Site, Ocala
Research Site, St. Petersburg
IdahoResearch Site, Boise
IllinoisResearch Site, Chicago
Research Site, Decatur
Research Site, Hinsdale
Research Site, Quincy
IowaResearch Site, Waterloo
KentuckyResearch Site, Lexington
Research Site, Louisville
LouisianaResearch Site, Baton Rouge
Research Site, Shreveport
Research Site, Shreveport
MaineResearch Site, South Portland
MarylandResearch Site, Baltimore
Research Site, Bethesda (Not yet recruiting)
MichiganResearch Site, Grand Rapids
MinnesotaResearch Site, Rochester
Research Site, Saint Paul
MissouriResearch Site, Bridgeton
NebraskaResearch Site, Lincoln
New JerseyResearch Site, Camden
New YorkResearch Site, Buffalo
Research Site, Westbury
OhioResearch Site, Canton
OregonResearch Site, Medford
Research Site, Salem
PennsylvaniaResearch Site, York
South DakotaResearch Site, Pierre
Research Site, Sioux Falls
TennesseeResearch Site, Chattanooga
Research Site, Nashville
TexasResearch Site, Fort Worth
Research Site, Irving
Research Site, Kingwood
Research Site, Palestine
Research Site, Round Rock
VirginiaResearch Site, Fairfax
Research Site, Norfolk
Research Site, Roanoke
WashingtonResearch Site, Seattle
Research Site, Silverdale
Research Site, Spokane
Research Site, Tacoma

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.