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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Arm A: Rilvegostomig in combination with platinum-based doublet chemotherapy followed by rilvegostomig monotherapy plus pemetrexed in maintenance. Arm B: Pembrolizumab in combination with platinum-based doublet chemotherapy followed by pembrolizumab monotherapy plus pemetrexed in maintenance.
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Double-blind masking

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A 		Rilvegostomig in combination with platinum-based doublet chemotherapy followed by rilvegostomig monotherapy plus pemetrexed in maintenance.
  • Drug: Rilvegostomig
    Administered as one intravenously (IV) on Day 1 of each 21-day cycle
    Other names:
    • AZD2936
  • Drug: Carboplatin
    Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
  • Drug: Cisplatin
    Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
  • Drug: Pemetrexed
    Administered as one intravenously (IV) on Day 1 of each 21-day cycle
Active Comparator
Arm B 		Pembrolizumab in combination with platinum-based doublet chemotherapy followed by pembrolizumab monotherapy plus pemetrexed in maintenance.
  • Drug: Pembrolizumab
    Administered as one intravenously (IV) on Day 1 of each 21-day cycle
    Other names:
    • Keytruda
  • Drug: Carboplatin
    Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
  • Drug: Cisplatin
    Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
  • Drug: Pemetrexed
    Administered as one intravenously (IV) on Day 1 of each 21-day cycle

Recruiting Locations

Research Site
Mobile, Alabama 36608

Research Site
Phoenix, Arizona 85054

Research Site
Anaheim, California 92801

Research Site
Beverly Hills, California 90211

Research Site
Redlands, California 92373

Research Site
San Diego, California 92123

Research Site
San Francisco, California 94121

Research Site
Santa Rosa, California 95403

Research Site
Walnut Creek, California 94598

Research Site
Lone Tree, Colorado 80124

Research Site
Stamford, Connecticut 06902

Research Site
West Haven, Connecticut 06516

Research Site
Newark, Delaware 19713

Research Site
Bay Pines, Florida 33744

Research Site
Fort Lauderdale, Florida 33308

Research Site
Jacksonville, Florida 32224

Research Site
Miami, Florida 33125

Research Site
Ocala, Florida 34474

Research Site
St. Petersburg, Florida 33709

Research Site
Boise, Idaho 83712

Research Site
Chicago, Illinois 60637

Research Site
Decatur, Illinois 62526

Research Site
Hinsdale, Illinois 60521

Research Site
Quincy, Illinois 62305

Research Site
Waterloo, Iowa 50702

Research Site
Lexington, Kentucky 40509

Research Site
Louisville, Kentucky 40207

Research Site
Baton Rouge, Louisiana 70808

Research Site
Shreveport, Louisiana 71103

Research Site
Shreveport, Louisiana 71105

Research Site
South Portland, Maine 04106

Research Site
Baltimore, Maryland 21202

Research Site
Grand Rapids, Michigan 49503

Research Site
Rochester, Minnesota 55905

Research Site
Saint Paul, Minnesota 55102

Research Site
Bridgeton, Missouri 63044

Research Site
Lincoln, Nebraska 68506

Research Site
Camden, New Jersey 08103

Research Site
Buffalo, New York 14221

Research Site
Westbury, New York 11590

Research Site
Canton, Ohio 44710

Research Site
Medford, Oregon 97504

Research Site
Salem, Oregon 97301

Research Site
York, Pennsylvania 17403

Research Site
Pierre, South Dakota 57501

Research Site
Sioux Falls, South Dakota 57105

Research Site
Chattanooga, Tennessee 37404

Research Site
Nashville, Tennessee 37203

Research Site
Fort Worth, Texas 76104

Research Site
Irving, Texas 75063

Research Site
Kingwood, Texas 77339

Research Site
Palestine, Texas 75801

Research Site
Round Rock, Texas 78665

Research Site
Fairfax, Virginia 22031

Research Site
Norfolk, Virginia 23502

Research Site
Roanoke, Virginia 24014

Research Site
Seattle, Washington 98101

Research Site
Silverdale, Washington 98383

Research Site
Spokane, Washington 99208

Research Site
Tacoma, Washington 98405

Research Site
San Juan, Puerto Rico 00935

More Details

Status
Recruiting
Sponsor
AstraZeneca

Study Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com

Detailed Description

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a 1L treatment for patients with locally advanced or metastatic non-squamous NSCLC whose tumors express PD-L1 (TC ≥ 1%).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.