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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)

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 Squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung02)

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

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).

What is being tested

Sponsor: AstraZeneca · Participants: 1,160 · Started: Nov 18, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06692738

Locations in the U.S.

ArizonaResearch Site, Tucson
ArkansasResearch Site, Springdale
CaliforniaResearch Site, Anaheim
Research Site, Beverly Hills
Research Site, Loma Linda
Research Site, Los Alamitos
Research Site, Redlands
Research Site, San Francisco
Research Site, Walnut Creek
ConnecticutResearch Site, West Haven
DelawareResearch Site, Newark
FloridaResearch Site, Bay Pines
Research Site, Fort Lauderdale
Research Site, Gainesville
Research Site, Jacksonville
GeorgiaResearch Site, Athens
Research Site, Savannah (Not yet recruiting)
IdahoResearch Site, Boise
IllinoisResearch Site, Chicago
Research Site, Decatur
Research Site, Hinsdale
Research Site, Quincy
IndianaResearch Site, Fort Wayne (Not yet recruiting)
IowaResearch Site, Waterloo
KentuckyResearch Site, Lexington
Research Site, Louisville
Research Site, Louisville
LouisianaResearch Site, Baton Rouge
Research Site, Shreveport
Research Site, Shreveport
MaineResearch Site, Scarborough
MarylandResearch Site, Bethesda
Research Site, Bethesda (Not yet recruiting)
MichiganResearch Site, Detroit
Research Site, Grand Rapids
Research Site, Saginaw (Not yet recruiting)
MinnesotaResearch Site, Duluth
Research Site, Rochester
MissouriResearch Site, Bridgeton
Research Site, Kansas City
NebraskaResearch Site, Lincoln
New JerseyResearch Site, Camden
New YorkResearch Site, Buffalo
Research Site, East Syracuse
Research Site, Westbury
North CarolinaResearch Site, Wilson
North DakotaResearch Site, Grand Forks
OhioResearch Site, Cincinnati
OregonResearch Site, Medford
Research Site, Salem
PennsylvaniaResearch Site, Hershey
Research Site, York
South DakotaResearch Site, Sioux Falls
TennesseeResearch Site, Chattanooga
Research Site, Nashville
TexasResearch Site, Fort Worth
Research Site, Kingwood
Research Site, Lubbock
Research Site, Round Rock
VirginiaResearch Site, Fairfax
Research Site, Fredericksburg
WashingtonResearch Site, Olympia
Research Site, Seattle
Research Site, Spokane
Research Site, Tacoma

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.