NCT06448754 · AstraZeneca
Volrustomig Priming Regimens Exploratory Phase II Platform Study
(eVOLVE-01)
What this study is about
Purpose of this study is to assess the safety, tolerability, how the drug moves through the body, immunogenicity, and antitumor activity of volrustomig in combination with other anticancer drugs in participants with specified solid tumors.
View original scientific description
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.
Interventions
DRUG
Volrustomig
Participants will receive volrustomig via intravenous (IV) infusion.
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.
Primary outcome measures
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.
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 i
Where
- Los Angeles, California
- Grand Junction, Colorado
- Wheat Ridge, Colorado
- Baltimore, Maryland
- Detroit, Michigan
- Chapel Hill, North Carolina
- Tacoma, Washington
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 9, 2026 · Source of record for eligibility and locations