Non-small Cell Lung CancerPhase 2eVOLVE-01NCT06448754
Volrustomig Priming Regimens Exploratory Phase II Platform Study
A Phase 2 study testing Volrustomig, Carboplatin and Pemetrexed in people with Non-small Cell Lung Cancer, run by AstraZeneca at 63 sites in 14 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Volrustomig, Carboplatin and Pemetrexed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 63 sitesin 14 countries
- Study dates
- 27 Aug 2024to 30 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
63 sites in 14 countries.
63 sites in 14 countries
Spain10 sites
Research Site
A Coruña, 15009
Research Site
Alcorcón, 28922
Research Site
Barcelona, 08041
Research Site
Madrid, 28041
Research Site
Málaga, 29004
Research Site
Pamplona, 31008
Research Site
Santander, 39008
Research Site
Santiago de Compostela, 15706
Research Site
Valencia, 46015
Research Site
Valencia, 46026
Italy9 sites
Research Site
Genoa, 16132
Research Site
Meldola, 47014
Research Site
Milan, 20133
Research Site
Naples, 80131
Research Site
Orbassano, 10043
Research Site
Perugia, 06132
Research Site
Rozzano, 20089
Research Site
Udine, 33100
Research Site
Verona, 37134
Georgia6 sites
Research Site
Batumi, 6010
Research Site
Tbilisi, '0159
Research Site
Tbilisi, 0112
Research Site
Tbilisi, 0114
Research Site
Tbilisi, 0144
Research Site
Tbilisi, 186
China5 sites
Research Site
Beijing, 100730
Research Site
Hangzhou, 310014
Research Site
Jinan, 250013
Research Site
Yantai, 264000
Research Site
Zhengzhou, 450000
Greece5 sites
Research Site
Athens, 115 27
Research Site
Athens, 12462
Research Site
Elaiones, 546 23
Research Site
Piraeus, 185 47
Research Site
Thessaloniki, 57001
France4 sites
Research Site
Bois-Guillaume, 76031
Research Site
Caen, 14076
Research Site
Dijon, 21079
Research Site
Montpellier, 34070
Portugal4 sites
Research Site
Lisbon, 1169-050
Research Site
Lisbon, 1400-038
Research Site
Lisbon, 1649-035
Research Site
Porto, 4099-001
Switzerland4 sites
Research Site
Geneva, 1205
Research Site
Lausanne, 1011
Research Site
Winterthur, 8401
Research Site
Zurich, 8091
Taiwan4 sites
Research Site
Changhua, 50006
Research Site
New Taipei City, 23561
Research Site
Taipei, 106
Research Site
Taipei, 110
Malaysia3 sites
Research Site
Kuala Lumpur, 59100
Research Site
Kuching, 93586
Research Site
Perai, 13700
Romania3 sites
Research Site
Cluj-Napoca, 400641
Research Site
Craiova, 200542
Research Site
Floreşti, 407280
South Korea3 sites
Research Site
Seongnam, 13620
Research Site
Seoul, 03722
Research Site
Suwon, 16247
United States2 sites
Research Site
Chapel Hill, North Carolina, 27514
Research Site
Los Angeles, California, 90067
About this study
Official title: 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.
Read the 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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Volrustomig, Carboplatin, Pemetrexed, Ramucirumab, Paclitaxel
- Keywords
- Solid Tumor, Programmed cell death-ligand-1, Tumor proportion score
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VolrustomigDrug
Also called MEDI5752
Participants will receive volrustomig via intravenous (IV) infusion.
CarboplatinDrug
Participants will receive carboplatin via IV infusion.
PemetrexedDrug
Participants will receive pemetrexed via IV infusion.
RamucirumabDrug
Participants will receive ramucirumab via IV infusion.
PaclitaxelDrug
Participants will receive paclitaxel via IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Substudy 1: Arm 1A: Volrustomig dose regimen 1 + Carboplatin and Pemetrexed | Experimental | Volrustomig priming dose followed by volrustomig dosing regimen 1 in combination with carboplatin and pemetrexed. Receives: Drug: Volrustomig; Drug: Carboplatin; Drug: Pemetrexed |
| Substudy 1: Arm 1B: Volrustomig dose regimen 2 + Carboplatin and Pemetrexed | Experimental | Volrustomig priming dose followed by volrustomig dosing regimen 2 in combination with carboplatin and pemetrexed. Receives: Drug: Volrustomig; Drug: Carboplatin; Drug: Pemetrexed |
| Substudy 2: Arm 2A: Volrustomig dose regimen 2 +Ramucirumab + Carboplatin + Pemetrexed or Paclitaxel | Experimental | Volrustomig priming dose followed by volrustomig dosing regimen 2 in combination with ramucirumab and histology-specific chemotherapy (carboplatin+ either pemetrexed or paclitaxel). Receives: Drug: Volrustomig; Drug: Carboplatin; Drug: Pemetrexed; Drug: Ramucirumab; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Up to 2 year 10 months
Secondary outcomes (9)
Disease Control Rate (DCR)
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.
Measured: Up to 2 year 10 months
Duration of Response (DOR)
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).
Measured: Up to 2 year 10 months
Progression Free Survival (PFS)
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).
Measured: Up to 2 year 10 months
Overall Survival (OS)
OS is defined as the time from randomization or first dose until the date of death due to any cause.
Measured: Up to 2 year 10 months
Serum Concentration of Volrustomig
The serum concentrations volrustomig alone and when used in combination with other anticancer agents in participants with pre-specified solid tumors will be assessed.
Measured: Up to 2 year 10 months
Trough concentration (Ctrough)
The trough concentrations volrustomig alone and when used in combination with other anticancer agents in participants with pre-specified solid tumors will be assessed.
Measured: Up to 2 year 10 months
Maximum Observed Concentration (Cmax)
The serum concentrations volrustomig alone and when used in combination with other anticancer agents in participants with pre-specified solid tumors will be assessed.
Measured: Up to 2 year 10 months
Area Under the Curve (AUC)
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.
Measured: Up to 2 year 10 months
Number of Participants with Positive Antidrug Antibodies (ADAs)
The incidence of ADAs against volrustomig or other anticancer agents in serum will be assessed.
Measured: Up to 2 year 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start27 Aug 2024
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This platform study includes 2 substudies: Substudy 1 is randomized and Substudy 2 is non-randomized.
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448754
- Sponsor's protocol ID
- D798KC00001
- Other IDs
- 2023-509482-20-00, 2023
- Acronym
- eVOLVE-01
- Status last verified
- Sep 2026
- First submitted
- 4 Jun 2024
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06448754
- Acronym / sponsor ID
- eVOLVE-01 / D798KC00001
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Solid Tumor, Programmed cell death-ligand-1, Tumor proportion score
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 194 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This platform study includes 2 substudies: Substudy 1 is randomized and Substudy 2 is non-randomized.
| Arm | Type | Receives |
|---|---|---|
| Substudy 1: Arm 1A: Volrustomig dose regimen 1 + Carboplatin and Pemetrexed | Experimental | Drug: Volrustomig, Drug: Carboplatin, Drug: PemetrexedVolrustomig 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 | Experimental | Drug: Volrustomig, Drug: Carboplatin, Drug: PemetrexedVolrustomig 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 | Experimental | Drug: Volrustomig, Drug: Carboplatin, Drug: Pemetrexed, Drug: Ramucirumab, Drug: PaclitaxelVolrustomig priming dose followed by volrustomig dosing regimen 2 in combination with ramucirumab and histology-specific chemotherapy (carboplatin+ either pemetrexed or paclitaxel). |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VolrustomigAlso: MEDI5752Participants will receive volrustomig via intravenous (IV) infusion. | Drug | Substudy 1: Arm 1A: Volrustomig dose regimen 1 + Carboplatin and Pemetrexed, Substudy 1: Arm 1B: Volrustomig dose regimen 2 + Carboplatin and Pemetrexed, Substudy 2: Arm 2A: Volrustomig dose regimen 2 +Ramucirumab + Carboplatin + Pemetrexed or Paclitaxel |
| CarboplatinParticipants will receive carboplatin via IV infusion. | Drug | Substudy 1: Arm 1A: Volrustomig dose regimen 1 + Carboplatin and Pemetrexed, Substudy 1: Arm 1B: Volrustomig dose regimen 2 + Carboplatin and Pemetrexed, Substudy 2: Arm 2A: Volrustomig dose regimen 2 +Ramucirumab + Carboplatin + Pemetrexed or Paclitaxel |
| PemetrexedParticipants will receive pemetrexed via IV infusion. | Drug | Substudy 1: Arm 1A: Volrustomig dose regimen 1 + Carboplatin and Pemetrexed, Substudy 1: Arm 1B: Volrustomig dose regimen 2 + Carboplatin and Pemetrexed, Substudy 2: Arm 2A: Volrustomig dose regimen 2 +Ramucirumab + Carboplatin + Pemetrexed or Paclitaxel |
| RamucirumabParticipants will receive ramucirumab via IV infusion. | Drug | Substudy 2: Arm 2A: Volrustomig dose regimen 2 +Ramucirumab + Carboplatin + Pemetrexed or Paclitaxel |
| PaclitaxelParticipants will receive paclitaxel via IV infusion. | Drug | Substudy 2: Arm 2A: Volrustomig dose regimen 2 +Ramucirumab + Carboplatin + Pemetrexed or Paclitaxel |
Primary outcome
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).
9 secondary outcomes
Disease Control Rate (DCR)
Time frame: Up to 2 year 10 months
Duration of Response (DOR)
Time frame: Up to 2 year 10 months
Progression Free Survival (PFS)
Time frame: Up to 2 year 10 months
Overall Survival (OS)
Time frame: Up to 2 year 10 months
Serum Concentration of Volrustomig
Time frame: Up to 2 year 10 months
Trough concentration (Ctrough)
Time frame: Up to 2 year 10 months
Maximum Observed Concentration (Cmax)
Time frame: Up to 2 year 10 months
Area Under the Curve (AUC)
Time frame: Up to 2 year 10 months
Number of Participants with Positive Antidrug Antibodies (ADAs)
Time frame: Up to 2 year 10 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
63 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Volrustomig, Carboplatin and Pemetrexed in people with Non-small Cell Lung Cancer, run by AstraZeneca at 63 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in Spain, Italy, Georgia, China, Greece and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.