Volrustomig Priming Regimens Exploratory Phase II Platform Study
NCT ID: NCT06448754
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
180 participants
INTERVENTIONAL
2024-08-27
2027-07-30
Brief Summary
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Detailed Description
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This platform study currently includes 2 substudies:
Substudy 1: metastatic non-small cell lung cancer (mNSCLC) (non-squamous \[NSQ\]). Participants will be randomized in two treatment arms: Arm 1A and Arm 1B.
Substudy 2: mNSCLC (squamous \[SQ\] or NSQ). Participants will enroll to the Arm 2A only.
All arms will test a volrustomig dosing in combination with chemotherapy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Substudy 1 is randomized and Substudy 2 is non-randomized.
TREATMENT
NONE
Study Groups
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Substudy 1: Arm 1A: Volrustomig dose regimen 1 + Carboplatin and Pemetrexed
Volrustomig priming dose followed by volrustomig dosing regimen 1 in combination with carboplatin and pemetrexed.
Volrustomig
Participants will receive volrustomig via intravenous (IV) infusion.
Carboplatin
Participants will receive carboplatin via IV infusion.
Pemetrexed
Participants will receive pemetrexed via IV infusion.
Substudy 1: Arm 1B: Volrustomig dose regimen 2 + Carboplatin and Pemetrexed
Volrustomig priming dose followed by volrustomig dosing regimen 2 in combination with carboplatin and pemetrexed.
Volrustomig
Participants will receive volrustomig via intravenous (IV) infusion.
Carboplatin
Participants will receive carboplatin via IV infusion.
Pemetrexed
Participants will receive pemetrexed via IV infusion.
Substudy 2: Arm 2A: Volrustomig dose regimen 2 +Ramucirumab + Carboplatin + Pemetrexed or Paclitaxel
Volrustomig priming dose followed by volrustomig dosing regimen 2 in combination with ramucirumab and histology-specific chemotherapy (carboplatin+ either pemetrexed or paclitaxel).
Volrustomig
Participants will receive volrustomig via intravenous (IV) infusion.
Carboplatin
Participants will receive carboplatin via IV infusion.
Pemetrexed
Participants will receive pemetrexed via IV infusion.
Ramucirumab
Participants will receive ramucirumab via IV infusion.
Paclitaxel
Participants will receive paclitaxel via IV infusion.
Interventions
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Volrustomig
Participants will receive volrustomig via intravenous (IV) infusion.
Carboplatin
Participants will receive carboplatin via IV infusion.
Pemetrexed
Participants will receive pemetrexed via IV infusion.
Ramucirumab
Participants will receive ramucirumab via IV infusion.
Paclitaxel
Participants will receive paclitaxel via IV infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 in substudy 1 and SQ or NSQ mNSCLC in substudy 2.
* Absence of sensitizing epidermal growth factor receptor (EGFR) mutations.
* Absence of documented tumor genomic alteration 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.
* At least one measurable lesion not previously irradiated that can be accurately measured at baseline as \>= 10 millimeter (mm) in the longest diameter.
Exclusion Criteria
* 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 at least 14 days prior to start of study intervention. A minimum of 2 weeks must have elapsed between the end of radiation therapy and study enrollment.
* Prior chemotherapy or any other systemic therapy for Stage IV NSCLC. Participants who have received prior platinum-containing adjuvant, neoadjuvant, or definitive chemoradiation for local disease are eligible, provided that progression has occurred greater (\>) 12 months from end of last therapy.
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Los Angeles, California, United States
Research Site
Grand Junction, Colorado, United States
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Wheat Ridge, Colorado, United States
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Baltimore, Maryland, United States
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Detroit, Michigan, United States
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Chapel Hill, North Carolina, United States
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Tacoma, Washington, United States
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Montreal, Quebec, Canada
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Beijing, , China
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Hangzhou, , China
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Jinan, , China
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Yantai, , China
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Zhengzhou, , China
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Bois-Guillaume, , France
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Caen, , France
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Créteil, , France
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Dijon, , France
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Montpellier, , France
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Batumi, , Georgia
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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Athens, , Greece
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Athens, , Greece
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Elaiones, , Greece
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Piraeus, , Greece
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Thessaloniki, , Greece
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Genoa, , Italy
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Meldola, , Italy
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Milan, , Italy
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Napoli, , Italy
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Orbassano, , Italy
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Perugia, , Italy
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Rozzano, , Italy
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Udine, , Italy
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Verona, , Italy
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Kuala Lumpur, , Malaysia
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Kuching, , Malaysia
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Perai, , Malaysia
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Lisbon, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Porto, , Portugal
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Cluj-Napoca, , Romania
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Craiova, , Romania
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Floreşti, , Romania
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Belgrade, , Serbia
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Belgrade, , Serbia
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Kamenitz, , Serbia
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Kragujevac, , Serbia
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Seongnam, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Suwon, , South Korea
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A Coruña, , Spain
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Alcorcón, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Pamplona, , Spain
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Santander, , Spain
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Santiago de Compostela, , Spain
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Valencia, , Spain
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Valencia, , Spain
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Basel, , Switzerland
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Geneva, , Switzerland
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Lausanne, , Switzerland
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Winterthur, , Switzerland
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Zurich, , Switzerland
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Changhua, , Taiwan
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New Taipei City, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taipei, , Taiwan
Countries
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Central Contacts
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Other Identifiers
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2023-509482-20-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
D798KC00001
Identifier Type: -
Identifier Source: org_study_id
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