A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)

Last updated: February 27, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

3

Condition

Non-small Cell Lung Cancer

Treatment

Pembrolizumab

Carboplatin

Nab-paclitaxel

Clinical Study ID

NCT06692738
D702BC00001
2024-514281-39-00
  • Ages > 18
  • All Genders

Study Summary

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 metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically or cytologically documented squamous non-small cell lung cancer (NSCLC).

  • Stage IV metastatic non-small cell lung cancer (mNSCLC) (based on the American JointCommittee on Cancer Edition 8) not amenable to curative treatment.

  • Absence of documented tumor genomic mutation results from tests conducted as part ofstandard local practice in any actionable driver oncogenes for which there arelocally approved targeted first-line (1L) therapies.

  • Provision of acceptable tumor sample to confirm tumor programmed death-ligand 1 (PD-L1) expression tumor cells (TC) ≥ 1%.

  • At least one lesion not previously irradiated that qualifies as a ResponseEvaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) target lesion (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 computedtomography (CT) or magnetic resonance imaging (MRI) and is suitable for accuraterepeated 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 metastatic non-small cell lungcancer (mNSCLC).

  • Prior treatment with an anti-programmed cell death protein 1 (anti-PD-1) oranti-programmed death-ligand 1 (anti-PD-L1) agent.

  • Any prior exposure to an anti-T-cell immunoglobulin and immunoreceptortyrosine-based inhibitory motif domain (anti-TIGIT) therapy or any other anticancertherapy targeting immune-regulatory receptors or mechanisms.

  • 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: 880
Treatment Group(s): 5
Primary Treatment: Pembrolizumab
Phase: 3
Study Start date:
November 18, 2024
Estimated Completion Date:
October 08, 2029

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 first-line (1L) treatment for patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

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    Buenos Aires, C1431FWO
    Argentina

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    La Plata, 1900
    Argentina

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    Pilar, B1629ODT
    Argentina

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    Rosario, S2000DEJ
    Argentina

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    Innsbruck, 6020
    Austria

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    Krems, 3500
    Austria

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    Rankweil, 6830
    Austria

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    Wien, 1210
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    Anderlecht, 1070
    Belgium

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    Brussels, 1160
    Belgium

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    Charleroi, 6060
    Belgium

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    Kortrijk, 8500
    Belgium

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    Sint-Niklaas, 9100
    Belgium

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    Barretos, 14784-400
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    Florianópolis, 88034-000
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    Ijuí, 98700-000
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    Londrina, 86015-520
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    Porto Alegre, 91350-200
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    Salvador, 40050 410
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    Taubaté, 12030-200
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    Hamilton, Ontario L8V 1C3
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    Dalian, 116001
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    Linhai, 318000
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    Linyi, 276001
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    Avignon, 84902
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    La Rochelle Cedex, 17019
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    Toulon Cedex 9, 83800
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    Bad Berka, 99437
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    Hamburg, 20251
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    Germany

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    Kobe-shi, 650-0017
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    Kumamoto-shi, 860-8556
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    Matsusaka-shi, 515-8544
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    Osaka-shi, 541-8567
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    Osakasayama, 589-8511
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    Ota-shi, 373-8550
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    Utrecht, 2512 VA
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    Veldhoven, 5504 DB
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    Zwolle, 8025 AB
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    Lima, Lima39
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    Biała Podlaska, 21-500
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    Bydgoszcz, 85-796
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    Warszawa, 04-141
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    Łódź, 93-338
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    Madrid, 28007
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    Majadahonda, 28222
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    Kaohsiung, 80756
    Taiwan

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    New Taipei, 220
    Taiwan

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    New Taipei City, 23561
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    Taichung, 402
    Taiwan

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    Tainan City, 73657
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    Taipei, 23561
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    Taoyuan, 333
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    Bangkok, 10700
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    Chiang Mai, 50200
    Thailand

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    Dusit, 10300
    Thailand

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    Nakhon Ratchasima, 30000
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    Songkla, 90110
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    Antalya, 07058
    Turkey

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    Istanbul, 34098
    Turkey

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    Yenimahalle, 06170
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    Aberdeen, AB25 2ZN
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    Cambridge, CB2 0QQ
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    London, EC1A 7BE
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    Springdale, Arkansas 72762
    United States

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    Glendale, California 91204
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    San Francisco, California 94121
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    West Haven, Connecticut 06516
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    Newark, Delaware 19713
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    Bay Pines, Florida 33744
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    Gainesville, Florida 32608
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    Jacksonville, Florida 32224
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    Athens, Georgia 30607
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    United States

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    Louisville, Kentucky 40202
    United States

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    Covington, Louisiana 70433
    United States

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    Baltimore, Maryland 21202
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    Detroit, Michigan 48202
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    Grand Rapids, Michigan 49503
    United States

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    Duluth, Minnesota 55802
    United States

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    Rochester, Minnesota 55905
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    Bridgeton, Missouri 63044
    United States

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    Columbia, Missouri 65212
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    Omaha, Nebraska 68130
    United States

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    Camden, New Jersey 08103
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    East Syracuse, New York 13057
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    Westbury, New York 11590
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    Cincinnati, Ohio 45267
    United States

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    Bend, Oregon 97701
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    Medford, Oregon 97504
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    Salem, Oregon 97301
    United States

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    York, Pennsylvania 17403
    United States

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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
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    Fort Worth, Texas 76104
    United States

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    Houston, Texas 77090
    United States

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    Kingwood, Texas 77339
    United States

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    Lubbock, Texas 79410
    United States

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    Round Rock, Texas 78665
    United States

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    Fairfax, Virginia 22031
    United States

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    Fredericksburg, Virginia 22408
    United States

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    Olympia, Washington 98506
    United States

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    Seattle, Washington 98101
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    Silverdale, Washington 98383
    United States

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    Tacoma, Washington 98405
    United States

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    Wenatchee, Washington 98801
    United States

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    Can Tho, 900000
    Vietnam

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    Hanoi, 100000
    Vietnam

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    Ho Chi Minh, 700000
    Vietnam

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    Ho Chi Minh city, 700000
    Vietnam

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    Vinh, 460000
    Vietnam

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