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

Last updated: February 20, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Rilvegostomig

Carboplatin

Pemetrexed

Clinical Study ID

NCT06627647
D702FC00001
2024-515008-38-00
  • Ages > 18
  • All Genders

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 non-squamous mNSCLC whose tumors express PD-L1.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically or cytologically documented non-squamous NSCLC.

  • Stage IV mNSCLC (based on the American Joint Committee on Cancer Edition 8) notamenable to curative treatment.

  • Absence of sensitizing EGFR mutations (including, but not limited to, exon 19deletion and exon 21 L858R, exon 21 L861Q, exon 18 G719X, and exon 20 S768Imutations) and ALK and ROS1 rearrangements.

  • Absence of documented tumor genomic mutation results from tests conducted as part ofstandard local practice in any other actionable driver oncogenes for which there arelocally approved 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 atbaseline and can be accurately measured at baseline as ≥ 10 mm in the longestdiameter (except lymph nodes, which must have short axis ≥ 15 mm) with CT or MRI andis suitable for accurate repeated measurements.

  • Adequate organ and bone marrow function

Exclusion

Exclusion Criteria:

  • Presence of small cell and neuroendocrine histology components.

  • Brain metastases unless asymptomatic, stable, and not requiring steroids oranticonvulsants for at least 4 weeks prior to start of study intervention. A minimumof 2 weeks must have elapsed between the end of brain radiotherapy and studyenrollment. Participants must have recovered from the acute toxic effect ofradiotherapy (eg, dizziness and signs of increased intracranial pressure).

  • Any prior systemic therapy received for advanced or mNSCLC. Prior systemic therapyin the neoadjuvant or adjuvant setting and/or definitive radio- or chemoradiotherapyfor early-stage disease are allowed, provided that recurrence or progression hasoccurred > 12 months after the end of treatment.

  • Any prior exposure to an anti-TIGIT therapy or any other anticancer therapytargeting 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 curativeintent with no known active disease ≥ 2 years before the first dose of studyintervention and of low potential risk for recurrence.

  • Active or prior documented autoimmune or inflammatory disorders requiring chronictreatment with steroids or other immunosuppressive treatment.

  • Active primary immunodeficiency/active infectious disease(s).

  • Active tuberculosis infection.

Study Design

Total Participants: 878
Treatment Group(s): 5
Primary Treatment: Rilvegostomig
Phase: 3
Study Start date:
November 27, 2024
Estimated Completion Date:
March 25, 2030

Study 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 non-squamous mNSCLC whose tumors express PD-L1 (TC ≥ 1%).

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    Buenos Aires, C1431FWO
    Argentina

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    La Plata, 1900
    Argentina

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    Pilar, B1629ODT
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    Rosario, S2000DEJ
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    Brussels, 1160
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    Charleroi, 6060
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    Kortrijk, 8500
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    Sint-Niklaas, 9100
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    Ijuí, 98700-000
    Brazil

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    Londrina, 86015-520
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    Passo Fundo, 99010-260
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    Porto Alegre, 91350-200
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    Salvador, 40050 410
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    Sao Paulo, 01327-001
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    São Paulo, 01246-000
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    Taubaté, 12030-200
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    Vitoria, 29043-260
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    Kingston, Ontario K7L 2V7
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    Changchun, 130012
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    Changsha, 410013
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    Chongqing, 400030
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    Phoenix, Arizona 85054
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    Saint Petersburg, Florida 33709
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    Chicago, Illinois 60637
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    Omaha, Nebraska 68130
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    Westbury, New York 11590
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    Canton, Ohio 44710
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    Medford, Oregon 97504
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    Salem, Oregon 97301
    United States

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    Pittsburgh, Pennsylvania 15212
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    York, Pennsylvania 17403
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    Providence, Rhode Island 02903
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    Sioux Falls, South Dakota 57105
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    Chattanooga, Tennessee 37404
    United States

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    Nashville, Tennessee 37203
    United States

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    Fort Worth, Texas 76104
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    Houston, Texas 77090
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    Kingwood, Texas 77339
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    Lubbock, Texas 79410
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    Round Rock, Texas 78665
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    Fairfax, Virginia 22031
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    Norfolk, Virginia 23502
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    Seattle, Washington 98101
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    La Crosse, Wisconsin 54601
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    Hanoi, 100000
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    Ho Chi Minh, 700000
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