Volrustomig Priming Regimens Exploratory Phase II Platform Study
eVOLVE-01
A Phase II, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Volrustomig Priming Regimens in Combination With Other Anticancer Agents in Participants With Solid Tumors (eVOLVE-01)
2 other identifiers
interventional
180
15 countries
77
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 nonsmall-cell-lung-cancer
Started Aug 2024
77 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2024
CompletedFirst Posted
Study publicly available on registry
June 7, 2024
CompletedStudy Start
First participant enrolled
August 27, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 30, 2027
April 13, 2026
April 1, 2026
2.9 years
June 4, 2024
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
The safety and tolerability of volrustomig in combination with other anticancer drugs in participants with specified solid tumors will be assessed.
From screening (Days -28 to Day -1) up to 2 year 10 months
Confirmed Objective Response rate (ORR)
ORR is defined as the percentage of participants who have a confirmed complete response (CR) or confirmed partial response (PR), as per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
Up to 2 year 10 months
Secondary Outcomes (9)
Disease Control Rate (DCR)
Up to 2 year 10 months
Duration of Response (DOR)
Up to 2 year 10 months
Progression Free Survival (PFS)
Up to 2 year 10 months
Overall Survival (OS)
Up to 2 year 10 months
Serum Concentration of Volrustomig
Up to 2 year 10 months
- +4 more secondary outcomes
Study Arms (3)
Substudy 1: Arm 1A: Volrustomig dose regimen 1 + Carboplatin and Pemetrexed
EXPERIMENTALVolrustomig priming dose followed by volrustomig dosing regimen 1 in combination with carboplatin and pemetrexed.
Substudy 1: Arm 1B: Volrustomig dose regimen 2 + Carboplatin and Pemetrexed
EXPERIMENTALVolrustomig priming dose followed by volrustomig dosing regimen 2 in combination with carboplatin and pemetrexed.
Substudy 2: Arm 2A: Volrustomig dose regimen 2 +Ramucirumab + Carboplatin + Pemetrexed or Paclitaxel
EXPERIMENTALVolrustomig priming dose followed by volrustomig dosing regimen 2 in combination with ramucirumab and histology-specific chemotherapy (carboplatin+ either pemetrexed or paclitaxel).
Interventions
Participants will receive pemetrexed via IV infusion.
Participants will receive ramucirumab via IV infusion.
Participants will receive paclitaxel via IV infusion.
Participants will receive volrustomig via intravenous (IV) infusion.
Participants will receive carboplatin via IV infusion.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (77)
Research Site
Los Angeles, California, 90067, United States
Research Site
Grand Junction, Colorado, 81501, United States
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Wheat Ridge, Colorado, 80033, United States
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Baltimore, Maryland, 21231, United States
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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
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Hangzhou, 310014, China
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Jinan, 250013, China
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Yantai, 264000, China
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Zhengzhou, 450000, China
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Bois-Guillaume, 76031, France
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Caen, 14076, France
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Créteil, 94000, France
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Dijon, 21079, France
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Montpellier, 34070, France
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Batumi, 6010, Georgia
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Tbilisi, '0159, Georgia
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Tbilisi, 0112, Georgia
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Tbilisi, 0114, Georgia
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Tbilisi, 0144, Georgia
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Tbilisi, 186, Georgia
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Athens, 115 27, Greece
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Athens, 12462, Greece
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Elaiones, 546 23, Greece
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Piraeus, 185 47, Greece
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Thessaloniki, 57001, Greece
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Genoa, 16132, Italy
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Meldola, 47014, Italy
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Milan, 20133, Italy
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Naples, 80131, Italy
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Orbassano, 10043, Italy
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Perugia, 06132, Italy
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Rozzano, 20089, Italy
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Udine, 33100, Italy
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Verona, 37134, Italy
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Kuala Lumpur, 59100, Malaysia
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Kuching, 93586, Malaysia
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Perai, 13700, Malaysia
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Lisbon, 1169-050, Portugal
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Lisbon, 1400-038, Portugal
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Lisbon, 1500-458, Portugal
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Lisbon, 1649-035, Portugal
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Porto, 4099-001, Portugal
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Porto, 4100-180, Portugal
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Cluj-Napoca, 400641, Romania
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Craiova, 200542, Romania
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Floreşti, 407280, Romania
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Belgrade, 11000, Serbia
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Belgrade, 11000, Serbia
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Kamenitz, 21204, Serbia
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Kragujevac, 34000, Serbia
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Seongnam, 13620, South Korea
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Seoul, 03722, South Korea
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Seoul, 06591, South Korea
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Suwon, 16247, South Korea
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A Coruña, 15009, Spain
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Alcorcón, 28922, Spain
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Barcelona, 08041, Spain
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Madrid, 28041, Spain
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Málaga, 29004, Spain
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Pamplona, 31008, Spain
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Santander, 39008, Spain
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Santiago de Compostela, 15706, Spain
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Valencia, 46015, Spain
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Valencia, 46026, Spain
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Basel, 4031, Switzerland
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Geneva, 1205, Switzerland
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Lausanne, 1011, Switzerland
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Winterthur, 8401, Switzerland
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Zurich, 8091, Switzerland
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Changhua, 50006, Taiwan
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New Taipei City, 23561, Taiwan
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Taipei, 106, Taiwan
Research Site
Taipei, 110, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2024
First Posted
June 7, 2024
Study Start
August 27, 2024
Primary Completion (Estimated)
July 30, 2027
Study Completion (Estimated)
July 30, 2027
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitment smade to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment athttps://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure researchenvironmentVivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-leveldata from AstraZeneca group of companies sponsored clinical trials via therequest portal Vivli.org. All requests will be evaluated as per the AZ disclosurecommitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure."Yes",indicates that AZ are accepting requests for IPD, but this does not mean allrequests will be approved.