Volrustomig Priming Regimens Exploratory Phase II Platform Study (eVOLVE-01)

June 10, 2026 updated by: AstraZeneca

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Withdrawn
        • Research Site
  • China
      • Beijing, China, 100730
        • Recruiting
        • Research Site
      • Hangzhou, China, 310014
        • Recruiting
        • Research Site
      • Jinan, China, 250013
        • Recruiting
        • Research Site
      • Yantai, China, 264000
        • Recruiting
        • Research Site
      • Zhengzhou, China, 450000
        • Recruiting
        • Research Site
  • France
      • Bois-Guillaume, France, 76031
        • Recruiting
        • Research Site
      • Caen, France, 14076
        • Recruiting
        • Research Site
      • Créteil, France, 94000
        • Withdrawn
        • Research Site
      • Dijon, France, 21079
        • Recruiting
        • Research Site
      • Montpellier, France, 34070
        • Recruiting
        • Research Site
  • Georgia
      • Batumi, Georgia, 6010
        • Recruiting
        • Research Site
      • Tbilisi, Georgia, 0114
        • Recruiting
        • Research Site
      • Tbilisi, Georgia, 0144
        • Recruiting
        • Research Site
      • Tbilisi, Georgia, 0112
        • Recruiting
        • Research Site
      • Tbilisi, Georgia, 186
        • Recruiting
        • Research Site
      • Tbilisi, Georgia, '0159
        • Recruiting
        • Research Site
  • Greece
      • Athens, Greece, 12462
        • Recruiting
        • Research Site
      • Athens, Greece, 115 27
        • Not yet recruiting
        • Research Site
      • Elaiones, Greece, 546 23
        • Recruiting
        • Research Site
      • Piraeus, Greece, 185 47
        • Recruiting
        • Research Site
      • Thessaloniki, Greece, 57001
        • Recruiting
        • Research Site
  • Italy
      • Genoa, Italy, 16132
        • Recruiting
        • Research Site
      • Meldola, Italy, 47014
        • Recruiting
        • Research Site
      • Milan, Italy, 20133
        • Recruiting
        • Research Site
      • Naples, Italy, 80131
        • Recruiting
        • Research Site
      • Orbassano, Italy, 10043
        • Recruiting
        • Research Site
      • Perugia, Italy, 06132
        • Recruiting
        • Research Site
      • Rozzano, Italy, 20089
        • Recruiting
        • Research Site
      • Udine, Italy, 33100
        • Recruiting
        • Research Site
      • Verona, Italy, 37134
        • Recruiting
        • Research Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Recruiting
        • Research Site
      • Kuching, Malaysia, 93586
        • Recruiting
        • Research Site
      • Perai, Malaysia, 13700
        • Recruiting
        • Research Site
  • Portugal
      • Lisbon, Portugal, 1169-050
        • Recruiting
        • Research Site
      • Lisbon, Portugal, 1649-035
        • Recruiting
        • Research Site
      • Lisbon, Portugal, 1400-038
        • Recruiting
        • Research Site
      • Lisbon, Portugal, 1500-458
        • Withdrawn
        • Research Site
      • Porto, Portugal, 4099-001
        • Recruiting
        • Research Site
      • Porto, Portugal, 4100-180
        • Withdrawn
        • Research Site
  • Romania
      • Cluj-Napoca, Romania, 400641
        • Recruiting
        • Research Site
      • Craiova, Romania, 200542
        • Recruiting
        • Research Site
      • Floreşti, Romania, 407280
        • Recruiting
        • Research Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Withdrawn
        • Research Site
      • Belgrade, Serbia, 11000
        • Recruiting
        • Research Site
      • Kamenitz, Serbia, 21204
        • Withdrawn
        • Research Site
      • Kragujevac, Serbia, 34000
        • Withdrawn
        • Research Site
  • South Korea
      • Seongnam, South Korea, 13620
        • Completed
        • Research Site
      • Seoul, South Korea, 03722
        • Recruiting
        • Research Site
      • Seoul, South Korea, 06591
        • Withdrawn
        • Research Site
      • Suwon, South Korea, 16247
        • Recruiting
        • Research Site
  • Spain
      • A Coruña, Spain, 15009
        • Recruiting
        • Research Site
      • Alcorcón, Spain, 28922
        • Recruiting
        • Research Site
      • Barcelona, Spain, 08041
        • Recruiting
        • Research Site
      • Madrid, Spain, 28041
        • Recruiting
        • Research Site
      • Málaga, Spain, 29004
        • Recruiting
        • Research Site
      • Pamplona, Spain, 31008
        • Recruiting
        • Research Site
      • Santander, Spain, 39008
        • Recruiting
        • Research Site
      • Santiago de Compostela, Spain, 15706
        • Recruiting
        • Research Site
      • Valencia, Spain, 46026
        • Recruiting
        • Research Site
      • Valencia, Spain, 46015
        • Recruiting
        • Research Site
  • Switzerland
      • Basel, Switzerland, 4031
        • Withdrawn
        • Research Site
      • Geneva, Switzerland, 1205
        • Recruiting
        • Research Site
      • Lausanne, Switzerland, 1011
        • Recruiting
        • Research Site
      • Winterthur, Switzerland, 8401
        • Recruiting
        • Research Site
      • Zurich, Switzerland, 8091
        • Recruiting
        • Research Site
  • Taiwan
      • Changhua, Taiwan, 50006
        • Recruiting
        • Research Site
      • New Taipei City, Taiwan, 23561
        • Recruiting
        • Research Site
      • Taipei, Taiwan, 106
        • Recruiting
        • Research Site
      • Taipei, Taiwan, 110
        • Recruiting
        • Research Site
  • United States
    • California
      • Los Angeles, California, United States, 90067
        • Completed
        • Research Site
    • Colorado
      • Grand Junction, Colorado, United States, 81501
        • Withdrawn
        • Research Site
      • Wheat Ridge, Colorado, United States, 80033
        • Withdrawn
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Withdrawn
        • Research Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Withdrawn
        • Research Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Active, not recruiting
        • Research Site
    • Washington
      • Tacoma, Washington, United States, 98405
        • Withdrawn
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: Volrustomig
Participants will receive volrustomig via intravenous (IV) infusion.
Other Names:
  • MEDI5752
Drug: Carboplatin
Participants will receive carboplatin via IV infusion.
Drug: Pemetrexed
Participants will receive pemetrexed via IV infusion.
Experimental: 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.
Drug: Volrustomig
Participants will receive volrustomig via intravenous (IV) infusion.
Other Names:
  • MEDI5752
Drug: Carboplatin
Participants will receive carboplatin via IV infusion.
Drug: Pemetrexed
Participants will receive pemetrexed via IV infusion.
Experimental: 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).
Drug: Volrustomig
Participants will receive volrustomig via intravenous (IV) infusion.
Other Names:
  • MEDI5752
Drug: Carboplatin
Participants will receive carboplatin via IV infusion.
Drug: Pemetrexed
Participants will receive pemetrexed via IV infusion.
Drug: Ramucirumab
Participants will receive ramucirumab via IV infusion.
Drug: Paclitaxel
Participants will receive paclitaxel via IV infusion.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: From screening (Days -28 to Day -1) up to 2 year 10 months
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)
Time Frame: Up to 2 year 10 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Disease Control Rate (DCR)
Time Frame: Up to 2 year 10 months
DCR is defined as the percentage of participants who have a CR or PR or who have stable disease (SD) after the date of randomization or first dose.
Up to 2 year 10 months
Duration of Response (DOR)
Time Frame: Up to 2 year 10 months
DOR is defined as the time from the date of first documented response until the date of documented progression or death due to any cause (in the absence of progression).
Up to 2 year 10 months
Progression Free Survival (PFS)
Time Frame: Up to 2 year 10 months
PFS is defined as the time from randomization or first dose until radiological progression or death due to any cause (in the absence of progression).
Up to 2 year 10 months
Overall Survival (OS)
Time Frame: Up to 2 year 10 months
OS is defined as the time from randomization or first dose until the date of death due to any cause.
Up to 2 year 10 months
Serum Concentration of Volrustomig
Time Frame: Up to 2 year 10 months
The serum concentrations volrustomig alone and when used in combination with other anticancer agents in participants with pre-specified solid tumors will be assessed.
Up to 2 year 10 months
Trough concentration (Ctrough)
Time Frame: Up to 2 year 10 months
The trough concentrations volrustomig alone and when used in combination with other anticancer agents in participants with pre-specified solid tumors will be assessed.
Up to 2 year 10 months
Maximum Observed Concentration (Cmax)
Time Frame: Up to 2 year 10 months
The serum concentrations volrustomig alone and when used in combination with other anticancer agents in participants with pre-specified solid tumors will be assessed.
Up to 2 year 10 months
Area Under the Curve (AUC)
Time Frame: Up to 2 year 10 months
The AUC concentrations of volrustomig alone and when used in combination with other anticancer agents in participants with pre-specified solid tumors will be assessed.
Up to 2 year 10 months
Number of Participants with Positive Antidrug Antibodies (ADAs)
Time Frame: Up to 2 year 10 months
The incidence of ADAs against volrustomig or other anticancer agents in serum will be assessed.
Up to 2 year 10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 27, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D798KC00001
  • 2023-509482-20-00 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-small Cell Lung Cancer

Clinical Trials on Volrustomig

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings