RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 non-squamous mNSCLC whose tumors express PD-L1.

Official Title

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 Metastatic Non-squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung03)

Quick Facts

Study Start:2024-11-27
Study Completion:2030-03-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06627647

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically or cytologically documented non-squamous NSCLC.
  2. * Stage IV mNSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.
  3. * 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.
  4. * 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 targeted 1L therapies.
  5. * Provision of acceptable tumor sample, to confirm tumor PD-L1 expression TC ≥ 1%.
  6. * 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.
  7. * Adequate organ and bone marrow function
  1. * Presence of small cell and neuroendocrine histology components.
  2. * Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 4 weeks prior to start of study intervention. A minimum of 2 weeks must have elapsed between the end of brain radiotherapy and study enrollment. Participants must have recovered from the acute toxic effect of radiotherapy (eg, dizziness and signs of increased intracranial pressure).
  3. * Any prior systemic therapy received for advanced or mNSCLC. Prior systemic therapy in the neoadjuvant or adjuvant setting and/or definitive radio- or chemoradiotherapy for early-stage disease are allowed, provided that recurrence or progression has occurred \> 12 months after the end of treatment.
  4. * Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.
  5. * Any prior treatment with an anti-PD-1 or anti-PD-L1 agent.
  6. * 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.
  7. * Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
  8. * Active primary immunodeficiency/active infectious disease(s).
  9. * Active tuberculosis infection.

Contacts and Locations

Study Contact

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

Study Locations (Sites)

Research Site
Phoenix, Arizona, 85054
United States
Research Site
Anaheim, California, 92801
United States
Research Site
Beverly Hills, California, 90211
United States
Research Site
San Diego, California, 92123
United States
Research Site
San Francisco, California, 94121
United States
Research Site
Santa Rosa, California, 95403
United States
Research Site
Walnut Creek, California, 94598
United States
Research Site
Lone Tree, Colorado, 80124
United States
Research Site
West Haven, Connecticut, 06516
United States
Research Site
Newark, Delaware, 19713
United States
Research Site
Bay Pines, Florida, 33744
United States
Research Site
Jacksonville, Florida, 32224
United States
Research Site
Miami, Florida, 33125
United States
Research Site
Atlanta, Georgia, 30342
United States
Research Site
Chicago, Illinois, 60637
United States
Research Site
Decatur, Illinois, 62526
United States
Research Site
Waterloo, Iowa, 50702
United States
Research Site
Shreveport, Louisiana, 71103
United States
Research Site
Shreveport, Louisiana, 71105
United States
Research Site
Baltimore, Maryland, 21202
United States
Research Site
Grand Rapids, Michigan, 49503
United States
Research Site
Rochester, Minnesota, 55905
United States
Research Site
Saint Paul, Minnesota, 55102
United States
Research Site
Bridgeton, Missouri, 63044
United States
Research Site
Columbia, Missouri, 65212
United States
Research Site
Omaha, Nebraska, 68130
United States
Research Site
Westbury, New York, 11590
United States
Research Site
Canton, Ohio, 44710
United States
Research Site
Medford, Oregon, 97504
United States
Research Site
Salem, Oregon, 97301
United States
Research Site
Pittsburgh, Pennsylvania, 15212
United States
Research Site
York, Pennsylvania, 17403
United States
Research Site
Providence, Rhode Island, 02903
United States
Research Site
Sioux Falls, South Dakota, 57105
United States
Research Site
Chattanooga, Tennessee, 37404
United States
Research Site
Nashville, Tennessee, 37203
United States
Research Site
Fort Worth, Texas, 76104
United States
Research Site
Houston, Texas, 77090
United States
Research Site
Kingwood, Texas, 77339
United States
Research Site
Lubbock, Texas, 79410
United States
Research Site
Round Rock, Texas, 78665
United States
Research Site
Fairfax, Virginia, 22031
United States
Research Site
Norfolk, Virginia, 23502
United States
Research Site
Seattle, Washington, 98101
United States
Research Site
Seattle, Washington, 98104
United States
Research Site
Silverdale, Washington, 98383
United States
Research Site
Tacoma, Washington, 98405
United States
Research Site
Wenatchee, Washington, 98801
United States
Research Site
La Crosse, Wisconsin, 54601
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-27
Study Completion Date2030-03-20

Study Record Updates

Study Start Date2024-11-27
Study Completion Date2030-03-20

Terms related to this study

Keywords Provided by Researchers

  • ARTEMIDE-Lung03
  • Rilvegostomig (AZD2936)
  • Non-squamous non-small cell lung cancer (NSCLC)
  • Bi-specific antibody
  • T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domain (TIGIT)
  • EGFR, ALK and ROS1 testing
  • Programmed cell death protein (PD-L1)
  • Pembrolizumab
  • Carboplatin
  • Cisplatin
  • Pemetrexed

Additional Relevant MeSH Terms

  • Non-squamous Non-small Cell Lung Cancer