Volrustomig Priming Regimens Exploratory Phase II Platform Study

Last updated: April 24, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

2

Condition

Non-small Cell Lung Cancer

Treatment

Carboplatin

Volrustomig

Pemetrexed

Clinical Study ID

NCT06448754
D798KC00001
2023-509482-20
2023-509482-20-00
  • Ages 18-130
  • All Genders

Study Summary

Purpose of this study is to assess the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of volrustomig in combination with other anticancer drugs in participants with specified solid tumors.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with nodeterioration.

  • Life expectancy greater than or equal to (>=) 12 weeks.

  • Adequate organ and bone marrow function.

  • Body weight greater than (>) 35 kilograms (kg) at screening and at randomization.

  • Histologically or cytologically documented NSQ NSCLC.

  • Absence of sensitizing epidermal growth factor receptor (EGFR) mutations.

  • Absence of documented tumor genomic alteration results from tests conducted as partof standard local practice in any other actionable driver oncogenes for which thereare locally approved targeted 1L therapies.

  • At least one measurable lesion not previously irradiated that can be accuratelymeasured at baseline as >= 10 millimeter (mm) in the longest diameter.

Exclusion

Key Exclusion Criteria:

  • Spinal cord compression.

  • History of primary active immunodeficiency.

  • Active or prior documented autoimmune or inflammatory disorders.

  • Mixed small-cell lung cancer and NSCLC histology or sarcomatoid variant.

  • Brain metastases unless asymptomatic, stable, and not requiring steroids for atleast 14 days prior to start of study intervention. A minimum of 2 weeks must haveelapsed between the end of radiation therapy and study enrollment.

  • Prior chemotherapy or any other systemic therapy for Stage IV NSCLC. Participantswho have received prior platinum-containing adjuvant, neoadjuvant, or definitivechemoradiation for advanced disease are eligible, provided that progression hasoccurred greater (>) 12 months from end of last therapy.

Study Design

Total Participants: 120
Treatment Group(s): 3
Primary Treatment: Carboplatin
Phase: 2
Study Start date:
August 27, 2024
Estimated Completion Date:
June 30, 2027

Study Description

This is a platform, randomized, open-label, multicenter, global study.

Enrolled participants with Stage IV non-squamous non-small cell lung cancer (NSQ NSCLC) who are treatment-naïve and have not received previous treatment for advanced or metastatic disease.

These participants will be randomized in a 1:1 ratio to one of the two treatment arms: Arm 1A and Arm 1B.

Both arms will test a volrustomig dosing in combination with chemotherapy.

Connect with a study center

  • Research Site

    Montreal, Quebec H4A 3J1
    Canada

    Site Not Available

  • Research Site

    Beijing, 100730
    China

    Active - Recruiting

  • Research Site

    Hangzhou, 310014
    China

    Active - Recruiting

  • Research Site

    Jinan, 250013
    China

    Active - Recruiting

  • Research Site

    Yantai, 264000
    China

    Active - Recruiting

  • Research Site

    Zhengzhou City, 450000
    China

    Active - Recruiting

  • Research Site

    Bois Guillaume, 76031
    France

    Site Not Available

  • Research Site

    Caen Cedex, 14076
    France

    Site Not Available

  • Research Site

    Créteil, 94000
    France

    Site Not Available

  • Research Site

    Dijon, 21079
    France

    Site Not Available

  • Research Site

    Montpellier, 34070
    France

    Active - Recruiting

  • Research Site

    Batumi, 6010
    Georgia

    Active - Recruiting

  • Research Site

    Tbilisi, 0114
    Georgia

    Active - Recruiting

  • Research Site

    Athens, 12462
    Greece

    Site Not Available

  • Research Site

    Elaiones, 546 23
    Greece

    Site Not Available

  • Research Site

    Peiraias, 185 47
    Greece

    Site Not Available

  • Research Site

    Thessaloniki, 57001
    Greece

    Site Not Available

  • Research Site

    Genoa, 16132
    Italy

    Active - Recruiting

  • Research Site

    Meldola, 47014
    Italy

    Active - Recruiting

  • Research Site

    Milano, 20133
    Italy

    Site Not Available

  • Research Site

    Napoli, 80131
    Italy

    Site Not Available

  • Research Site

    Orbassano, 10043
    Italy

    Active - Recruiting

  • Research Site

    Perugia, 06132
    Italy

    Site Not Available

  • Research Site

    Rozzano, 20089
    Italy

    Active - Recruiting

  • Research Site

    Udine, 33100
    Italy

    Active - Recruiting

  • Research Site

    Verona, 37134
    Italy

    Active - Recruiting

  • Research Site

    Seongnam, 13620
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Suwon, 16247
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Kuala Lumpur, 59100
    Malaysia

    Site Not Available

  • Research Site

    Kuching, 93586
    Malaysia

    Site Not Available

  • Research Site

    Perai, 13700
    Malaysia

    Site Not Available

  • Research Site

    Lisboa, 1500-458
    Portugal

    Site Not Available

  • Research Site

    Porto, 4099-001
    Portugal

    Site Not Available

  • Research Site

    Cluj-Napoca, 400641
    Romania

    Site Not Available

  • Research Site

    Craiova, 200542
    Romania

    Site Not Available

  • Research Site

    Floresti, 407280
    Romania

    Site Not Available

  • Research Site

    Belgrade, 11000
    Serbia

    Site Not Available

  • Research Site

    Kragujevac, 34000
    Serbia

    Site Not Available

  • Research Site

    Sremska Kamenica, 21204
    Serbia

    Site Not Available

  • Research Site

    Alcorcón, 28922
    Spain

    Active - Recruiting

  • Research Site

    Barcelona, 08041
    Spain

    Active - Recruiting

  • Research Site

    La Coruna, 15006
    Spain

    Active - Recruiting

  • Research Site

    Madrid, 28041
    Spain

    Active - Recruiting

  • Research Site

    Málaga, 29004
    Spain

    Active - Recruiting

  • Research Site

    Pamplona, 31008
    Spain

    Active - Recruiting

  • Research Site

    Santander, 39008
    Spain

    Active - Recruiting

  • Research Site

    Santiago de Compostela, 15706
    Spain

    Active - Recruiting

  • Research Site

    Valencia, 46015
    Spain

    Active - Recruiting

  • Research Site

    Basel, 4031
    Switzerland

    Site Not Available

  • Research Site

    Genève 14, 1205
    Switzerland

    Active - Recruiting

  • Research Site

    Lausanne, 1011
    Switzerland

    Site Not Available

  • Research Site

    Winterthur, 8401
    Switzerland

    Active - Recruiting

  • Research Site

    Zürich, 8091
    Switzerland

    Site Not Available

  • Research Site

    Changhua City, 50006
    Taiwan

    Active - Recruiting

  • Research Site

    New Taipei, 23561
    Taiwan

    Active - Recruiting

  • Research Site

    Taipei, 106
    Taiwan

    Site Not Available

  • Research Site

    Taipei City, 110
    Taiwan

    Active - Recruiting

  • Research Site

    Los Angeles, California 90067
    United States

    Active - Recruiting

  • Research Site

    Grand Junction, Colorado 81501
    United States

    Active - Recruiting

  • Research Site

    Wheat Ridge, Colorado 80033
    United States

    Active - Recruiting

  • Research Site

    Baltimore, Maryland 21231
    United States

    Suspended

  • Research Site

    Detroit, Michigan 48202
    United States

    Suspended

  • Research Site

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • Research Site

    Tacoma, Washington 98405
    United States

    Site Not Available

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