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NCT06448754PHASE2Recruiting

Volrustomig Priming Regimens Exploratory Phase II Platform Study

AstraZeneca

Start Date

8/27/2024

Completion Date

7/30/2027

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.

Detailed Description

This Phase II, platform, open-label, multicenter study will evaluate the efficacy, safety, and tolerability of volrustomig in combination with anticancer drugs in various solid tumor types. 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.

Eligibility Criteria

Age Range: 18 years to 130 years

Key Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration. * 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. 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 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.

Interventions

DRUG

Volrustomig

DRUG

Carboplatin

DRUG

Pemetrexed

DRUG

Ramucirumab

DRUG

Paclitaxel

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Conditions

Non-small Cell Lung Cancer

Locations

Research Site

Los Angeles, California 90067

United States

Research Site

Grand Junction, Colorado 81501

United States

Research Site

Wheat Ridge, Colorado 80033

United States

Research Site

Baltimore, Maryland 21231

United States

Research Site

Detroit, Michigan 48202

United States

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Chapel Hill, North Carolina 27514

United States

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Tacoma, Washington 98405

United States

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Montreal, Quebec H4A 3J1

Canada

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Beijing, 100730

China

Research Site

Hangzhou, 310014

China

Research Site

Jinan, 250013

China

Research Site

Yantai, 264000

China

Research Site

Zhengzhou, 450000

China

Research Site

Bois-Guillaume, 76031

France

Research Site

Caen, 14076

France

Research Site

Créteil, 94000

France

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Dijon, 21079

France

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Montpellier, 34070

France

Research Site

Batumi, 6010

Georgia

Research Site

Tbilisi, '0159

Georgia

Research Site

Tbilisi, 0112

Georgia

Research Site

Tbilisi, 0114

Georgia

Research Site

Tbilisi, 0144

Georgia

Research Site

Tbilisi, 186

Georgia

Research Site

Athens, 115 27

Greece

Research Site

Athens, 12462

Greece

Research Site

Elaiones, 546 23

Greece

Research Site

Piraeus, 185 47

Greece

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Thessaloniki, 57001

Greece

Research Site

Genoa, 16132

Italy

Research Site

Meldola, 47014

Italy

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Milan, 20133

Italy

Research Site

Naples, 80131

Italy

Research Site

Orbassano, 10043

Italy

Research Site

Perugia, 06132

Italy

Research Site

Rozzano, 20089

Italy

Research Site

Udine, 33100

Italy

Research Site

Verona, 37134

Italy

Research Site

Kuala Lumpur, 59100

Malaysia

Research Site

Kuching, 93586

Malaysia

Research Site

Perai, 13700

Malaysia

Research Site

Lisbon, 1169-050

Portugal

Research Site

Lisbon, 1400-038

Portugal

Research Site

Lisbon, 1500-458

Portugal

Research Site

Lisbon, 1649-035

Portugal

Research Site

Porto, 4099-001

Portugal

Research Site

Porto, 4100-180

Portugal

Research Site

Cluj-Napoca, 400641

Romania

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Craiova, 200542

Romania

Research Site

Floreşti, 407280

Romania

Research Site

Belgrade, 11000

Serbia

Research Site

Belgrade, 11000

Serbia

Research Site

Kamenitz, 21204

Serbia

Research Site

Kragujevac, 34000

Serbia

Research Site

Seongnam, 13620

South Korea

Research Site

Seoul, 03722

South Korea

Research Site

Seoul, 06591

South Korea

Research Site

Suwon, 16247

South Korea

Research Site

A Coruña, 15009

Spain

Research Site

Alcorcón, 28922

Spain

Research Site

Barcelona, 08041

Spain

Research Site

Madrid, 28041

Spain

Research Site

Málaga, 29004

Spain

Research Site

Pamplona, 31008

Spain

Research Site

Santander, 39008

Spain

Research Site

Santiago de Compostela, 15706

Spain

Research Site

Valencia, 46015

Spain

Research Site

Valencia, 46026

Spain

Research Site

Basel, 4031

Switzerland

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Geneva, 1205

Switzerland

Research Site

Lausanne, 1011

Switzerland

Research Site

Winterthur, 8401

Switzerland

Research Site

Zurich, 8091

Switzerland

Research Site

Changhua, 50006

Taiwan

Research Site

New Taipei City, 23561

Taiwan

Research Site

Taipei, 106

Taiwan

Research Site

Taipei, 110

Taiwan