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AzTrials

Metastatic Non-small Cell Lung CancerPhase 3eVOLVE-Lung02NCT05984277

A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer.

A Phase 3 study testing Volrustomig, Pembrolizumab and Carboplatin in people with Metastatic Non-small Cell Lung Cancer, run by AstraZeneca at 231 sites in 25 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of eVOLVE-Lung02 is to test the effectiveness (efficacy) and measure the safety of volrustomig in combination with chemotherapy compared with pembrolizumab in combination with chemotherapy as 1L treatment in participants with mNSCLC in PD-L1 < 50%. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Non-small Cell Lung Cancer
What is being tested?
Volrustomig, Pembrolizumab and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
895 participants
Where
231 sitesin 25 countries
Study dates
24 Oct 2023to 12 Nov 2027
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically documented squamous or non-squamous NSCLC.
  • Stage IV NSCLC (according to Version 8 of the IASLC Staging Manual in Thoracic Oncology 2016), not amenable to curative surgery or radiation.
  • Absence of sensitizing EGFR mutations and ALK and ROS1 rearrangements.
  • 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 first-line therapies.

Who cannot join

  • Mixed small-cell lung cancer and NSCLC histology or sarcomatoid variant. Rare subtypes are excluded.
  • Spinal cord compression.
  • Symptomatic brain metastases. Brain metastases may be treated or untreated, but participants must be asymptomatic and off steroids for at least 14 days prior to start of study intervention. A minimum of 2 weeks must have elapsed between the end of brain radiotherapy and study enrollment.
  • History of another primary malignancy except for:
  • Malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence.
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
  • Adequately treated carcinoma in situ without evidence of disease.
  • As judged by the investigator, any condition that would interfere with evaluation of the study intervention or interpretation of participant safety or study results.

Trial locations and contacts

231 sites in 25 countries.

231 sites in 25 countries

China28 sites
  • Research Site

    Beijing, 100021

  • Research Site

    Beijing, 101149

  • Research Site

    Changchun, 130021

  • Research Site

    Changsha, 410013

  • Research Site

    Chengdu, 610000

  • Research Site

    Chengdu, 611135

  • Research Site

    Chongqing, 400030

  • Research Site

    Fuzhou, 350011

  • Research Site

    Guangzhou, 510080

  • Research Site

    Hangzhou, 310020

  • Research Site

    Hangzhou, 310022

  • Research Site

    Lanzhou, 730000

  • Research Site

    Nanchang, 330006

  • Research Site

    Nanchang, 330008

  • Research Site

    Nanjing, 210009

  • Research Site

    Nanning, 530021

  • Research Site

    Shanghai, 200030

  • Research Site

    Shanghai, 200032

  • Research Site

    Shanghai, 200433

  • Research Site

    Shenzhen, 518116

  • Research Site

    Taiyuan, 030000

  • Research Site

    Tianjin, 300060

  • Research Site

    Wuhan, 430022

  • Research Site

    Wuhan, 430030

  • Research Site

    Wuhan, 430079

  • Research Site

    Xi'an, 710000

  • Research Site

    Yangzhou, 225001

  • Research Site

    Zhengzhou, 450008

Other trials in China

United States26 sites
  • Research Site

    Baltimore, Maryland, 21201

  • Research Site

    Columbus, Ohio, 43210

  • Research Site

    Des Moines, Iowa, 50309

  • Research Site

    Detroit, Michigan, 48202

  • Research Site

    East Syracuse, New York, 13057

  • Research Site

    Fairfax, Virginia, 22031

  • Research Site

    Grand Island, Nebraska, 68803

  • Research Site

    Horsham, Pennsylvania, 19044

  • Research Site

    Hot Springs, Arkansas, 71913

  • Research Site

    Houston, Texas, 77090

  • Research Site

    Indianapolis, Indiana, 46202

  • Research Site

    Irving, Texas, 75063

  • Research Site

    Lincoln, Nebraska, 68506

  • Research Site

    Lone Tree, Colorado, 80124

  • Research Site

    Long Beach, California, 90806

  • Research Site

    Memphis, Tennessee, 38104

  • Research Site

    Nashville, Tennessee, 37203

  • Research Site

    Nashville, Tennessee, 37212

  • Research Site

    Omaha, Nebraska, 68130

  • Research Site

    Orlando, Florida, 32827

  • Research Site

    Pittsburgh, Pennsylvania, 15213

  • Research Site

    Portland, Oregon, 97239

  • Research Site

    Springdale, Arkansas, 72762

  • Research Site

    St. Petersburg, Florida, 33705

  • Research Site

    Tacoma, Washington, 98405

  • Research Site

    Towson, Maryland, 21204

Other trials in United States

Germany17 sites
  • Research Site

    Berlin-Zehlendorf, 14165

  • Research Site

    Bonn, 53113

  • Research Site

    Braunschweig, 38114

  • Research Site

    Dresden, 01307

  • Research Site

    Freiburg im Breisgau, 79106

  • Research Site

    Gauting, 82131

  • Research Site

    Georgsmarienhütte, 49124

  • Research Site

    Gütersloh, 33332

  • Research Site

    Halle, 06120

  • Research Site

    Hamburg, 22087

  • Research Site

    Heidelberg, 69126

  • Research Site

    Immenhausen, 34376

  • Research Site

    Koblenz, 56068

  • Research Site

    Ludwigsburg, 71640

  • Research Site

    Nuremberg, 90419

  • Research Site

    Tübingen, 72076

  • Research Site

    Velbert, 42551

Other trials in Germany

France15 sites
  • Research Site

    Angers, 49055

  • Research Site

    Avignon, 84902

  • Research Site

    Bayonne, 64100

  • Research Site

    Bordeaux, 33076

  • Research Site

    Caen, 14033

  • Research Site

    Lille, 59037

  • Research Site

    Limoges, 87042

  • Research Site

    Marseille, 13273

  • Research Site

    Paris, 75248

  • Research Site

    Quimper, 29000

  • Research Site

    Reims, 51092

  • Research Site

    St-Malo, 35403

  • Research Site

    Strasbourg, 67098

  • Research Site

    Suresnes, 92150

  • Research Site

    Toulon Naval, 83800

Other trials in France

Japan15 sites
  • Research Site

    Bunkyō City, 113-8677

  • Research Site

    Fukuoka, 812-8582

  • Research Site

    Kashiwa, 277-8577

  • Research Site

    Kawasaki-shi, 216-8511

  • Research Site

    Kōtoku, 135-8550

  • Research Site

    Matsuyama, 791-0280

  • Research Site

    Nagoya, 464-8681

  • Research Site

    Okayama, 700-8558

  • Research Site

    Osaka, 541-8567

  • Research Site

    Sagamihara-shi, 252-0375

  • Research Site

    Sakai, 590-0197

  • Research Site

    Sapporo, 001-0013

  • Research Site

    Sendai, 980-0873

  • Research Site

    Ube-shi, 755-0241

  • Research Site

    Yokohama, 241-8515

Other trials in Japan

Brazil10 sites
  • Research Site

    Barretos, 14784-400

  • Research Site

    Curitiba, 80730-150

  • Research Site

    Florianópolis, 88034-000

  • Research Site

    Fortaleza, 60336-045

  • Research Site

    Natal, 59075-740

  • Research Site

    Porto Alegre, 90619-900

  • Research Site

    Porto Alegre, 91350200

  • Research Site

    Rio de Janeiro, 22281-100

  • Research Site

    Santa Cruz do Sul, 96810-110

  • Research Site

    São Paulo, 01221-020

Other trials in Brazil

Canada10 sites
  • Research Site

    Barrie, Ontario, L4M 6M2

  • Research Site

    Calgary, Alberta, T2N 5G2

  • Research Site

    Chicoutimi, G7H 5H6

  • Research Site

    Edmonton, Alberta, T6G 1Z2

  • Research Site

    Halifax, Nova Scotia, B3H 1V7

  • Research Site

    Lévis, Quebec, G6V 3Z1

  • Research Site

    Oshawa, Ontario, L1G 2B9

  • Research Site

    Toronto, Ontario, M4N 3M5

  • Research Site

    Trois-Rivières, Quebec, G8Z 3R0

  • Research Site

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Hungary10 sites
  • Research Site

    Budapest, 1083

  • Research Site

    Budapest, 1121

  • Research Site

    Budapest, 1122

  • Research Site

    Debrecen, 4032

  • Research Site

    Gyöngyös, 3200

  • Research Site

    Gyöngyös - Mátraháza, 3200

  • Research Site

    Győr, 9024

  • Research Site

    Pécs, 7624

  • Research Site

    Szekszárd, 7100

  • Research Site

    Törökbálint, 2045

Other trials in Hungary

Taiwan9 sites
  • Research Site

    Kaohsiung City, 80756

  • Research Site

    New Taipei City, 220

  • Research Site

    Tainan, 70403

  • Research Site

    Tainan, 73657

  • Research Site

    Taipei, 100

  • Research Site

    Taipei, 112

  • Research Site

    Taipei, 11490

  • Research Site

    Taoyuan, 33305

  • Research Site

    Yunlin, 640

Other trials in Taiwan

Argentina8 sites
  • Research Site

    CABA, 1425

  • Research Site

    CABA, C1061

  • Research Site

    CABA, C1425

  • Research Site

    Córdoba, 5000

  • Research Site

    Córdoba, X5800HHW

  • Research Site

    La Plata, 1900

  • Research Site

    La Plata, B1900AVG

  • Research Site

    Rosario, 2000

Other trials in Argentina

Italy8 sites
  • Research Site

    Bari, 70124

  • Research Site

    Bergamo, 24125

  • Research Site

    Milan, 20162

  • Research Site

    Padova, 35128

  • Research Site

    Parma, 43126

  • Research Site

    Pavia, 27100

  • Research Site

    Ravenna, 48100

  • Research Site

    Roma, 00128

Other trials in Italy

South Africa8 sites
  • Research Site

    eManzimtoti, 4126

  • Research Site

    George, 6529

  • Research Site

    Johannesburg, 2193

  • Research Site

    Johannesburg, 2196

  • Research Site

    Pietermaritzburg, 3245

  • Research Site

    Pretoria, 0002

  • Research Site

    Rondebosch, 7700

  • Research Site

    Soweto, 2013

Other trials in South Africa

South Korea8 sites
  • Research Site

    Cheongju-si, 28644

  • Research Site

    Incheon, 21565

  • Research Site

    Jinju, 52727

  • Research Site

    Seoul, 03080

  • Research Site

    Seoul, 06351

  • Research Site

    Seoul, 07061

  • Research Site

    Suwon, 16247

  • Research Site

    Suwon, 16499

Other trials in South Korea

Turkey (Türkiye)8 sites
  • Research Site

    Ankara, 6500

  • Research Site

    Antalya, 07059

  • Research Site

    Çankaya, 06680

  • Research Site

    Diyarbakır, 21280

  • Research Site

    Fatih-Istanbul, 34098

  • Research Site

    Istanbul, 34722

  • Research Site

    Izmir, 35100

  • Research Site

    Pamukkale, 20070

Other trials in Turkey (Türkiye)

United Kingdom8 sites
  • Research Site

    Birmingham, B9 5SS

  • Research Site

    Blackpool, FY3 8NR

  • Research Site

    Bury St Edmunds, IP332QZ

  • Research Site

    Colchester, CO4 5JL

  • Research Site

    London, EC1A 7BE

  • Research Site

    London, SW10 9NH

  • Research Site

    London, SW170QT

  • Research Site

    Truro, TR1 3LJ

Other trials in United Kingdom

Spain7 sites
  • Research Site

    Alicante, 03010

  • Research Site

    Barcelona, 08003

  • Research Site

    Barcelona, 08025

  • Research Site

    Bilbao (Vizcaya), 48013

  • Research Site

    Madrid, 28040

  • Research Site

    Málaga, 29011

  • Research Site

    Palma, 07198

Other trials in Spain

India6 sites
  • Research Site

    Bengaluru, 560085

  • Research Site

    Hyderabad, 500032

  • Research Site

    Kolkata, 700094

  • Research Site

    Mysuru, 570017

  • Research Site

    Nagpur, 440001

  • Research Site

    Varanasi, 221005

Other trials in India

Poland6 sites
  • Research Site

    Lublin, 20-090

  • Research Site

    Poznan, 60-569

  • Research Site

    Przemyśl, 37-700

  • Research Site

    Radom, 26-600

  • Research Site

    Warsaw, 01-138

  • Research Site

    Warsaw, 02-781

Other trials in Poland

Australia5 sites
  • Research Site

    Clayton, 3168

  • Research Site

    Fitzroy, 3065

  • Research Site

    Heidelberg, 3084

  • Research Site

    South Brisbane, 4101

  • Research Site

    Sydney, NSW 2145

Other trials in Australia

Slovakia5 sites
  • Research Site

    Banská Bystrica, 97517

  • Research Site

    Bratislava, 82606

  • Research Site

    Bratislava, 833 01

  • Research Site

    Košice, 041 91

  • Research Site

    Trnava, 917 75

Other trials in Slovakia

Belgium3 sites
  • Research Site

    Aalst, 9300

  • Research Site

    Antwerp, 2020

  • Research Site

    Ghent, 9000

Other trials in Belgium

Czechia3 sites
  • Research Site

    Olomouc, 77900

  • Research Site

    Ostrava - Vitkovice, 703 84

  • Research Site

    Prague, 128 08

Other trials in Czechia

Netherlands3 sites
  • Research Site

    Amsterdam, 1081 HV

  • Research Site

    Nieuwegein, 3435 CM

  • Research Site

    Tilburg, 5042AD

Other trials in Netherlands

Thailand3 sites
  • Research Site

    Lampang, 52000

  • Research Site

    Muang, 50200

  • Research Site

    Songkhla, 90110

Other trials in Thailand

Austria2 sites
  • Research Site

    Linz, 4021

  • Research Site

    Wels, 4600

Other trials in Austria

About this study

Official title: A Phase III, Two-Arm, Parallel, Randomized, Multi-Center, Open-Label, Global Study to Determine the Efficacy of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for First-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer (mNSCLC).

The purpose of eVOLVE-Lung02 is to test the effectiveness (efficacy) and measure the safety of volrustomig in combination with chemotherapy compared with pembrolizumab in combination with chemotherapy as 1L treatment in participants with mNSCLC in PD-L1 < 50%.

Read the detailed description

Adult patients with a histologically or cytologically documented metastatic NSCLC, with tumors that lack activating EGFR, ALK, and ROS1 alterations are eligible for enrollment. Patients will be randomized in a 1:1 ratio to receive treatment with volrustomig + chemotherapy or pembrolizumab + chemotherapy. Tumor evaluation scans will be performed until disease progression as efficacy assessment. All patients will be followed for survival until the end of the study. An data monitoring committee (DMC) composed of independent experts will be convened to confirm the safety and tolerability of the proposed dose and schedule.

Being tested
Volrustomig, Pembrolizumab, Carboplatin, Paclitaxel, Pemetrexed
Keywords
metastatic non-small cell lung cancer, non-squamous tumors, squamous tumors, PD-L1
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.

Study groups in NCT05984277
Study groupRoleWhat they receive
Arm 1ExperimentalVolrustomig plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion
Receives: Drug: Volrustomig; Drug: Carboplatin; Drug: Paclitaxel; Drug: Pemetrexed
Arm 2Active comparatorPembrolizumab plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion
Receives: Drug: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Pemetrexed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS) (using BICR assessments according to RECIST 1.1)

    PFS is defined as the time from randomization until radiological progression per RECIST 1.1 as assessed by BICR, or death due to any cause (in the absence of progression), in PD-L1-negative participants.

    Measured: Up to approximately 6 years

  2. Overall Survival (OS), in PD-L1-negative participants.

    OS is defined as the time from randomization until the date of death due to any cause, in PD-L1-negative participants.

    Measured: Up to approximately 6 years

Secondary outcomes (10)
  1. PFS (using BICR assessments according to RECIST 1.1)

    PFS is defined as the time from randomization until radiological progression per RECIST 1.1 as assessed by BICR, or death due to any cause (in the absence of progression). The analysis will include all randomized participants.

    Measured: Up to approximately 6 years

  2. OS

    OS is defined as the time from randomization until the date of death due to any cause. The analysis will include all randomized participants.

    Measured: Up to approximately 6 years

  3. PFS (using Investigator assessments according to RECIST 1.1)

    PFS is defined as the time from randomization until radiological progression per RECIST 1.1 as assessed by investigator, or death due to any cause (in the absence of progression).

    Measured: Up to approximately 6 years

  4. Overall Response Rate (ORR)

    ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined by BICR assessments using RECIST 1.1.

    Measured: Up to approximately 6 years

  5. Duration of Response (DoR)

    DoR is defined as the time from the date of first documented response until the date of documented progression per BICR assessments using RECIST 1.1 or death due to any cause (in the absence of progression). These analyses will include participants who have a confirmed response.

    Measured: Up to approximately 6 years

  6. PFS2

    PFS2 is defined as the time from randomization until the earliest of the progression event (following the initial investigator-assessed progression) after the start of the first subsequent therapy, or death. The date of second progression will be recorded by the investigator in the eCRF and defined according to local standard clinical practice.

    Measured: Up to approximately 6 years

  7. Concentration of volrustomig in serum and PK parameters

    To assess the PK of volrustomig

    Measured: Up to approximately 6 years

  8. Presence of ADAs against volrustomig in serum

    To investigate the immunogenicity of volrustomig.

    Measured: Up to approximately 6 years

  9. Time-To-Deterioration (TTD) in physical functioning

    To assess participant-reported physical functioning in participants treated with volrustomig plus chemotherapy and pembrolizumab plus chemotherapy.

    Measured: Up to approximately 6 years

  10. TTD of lung cancer symptoms

    To assess participant-reported pulmonary symptoms of mNSCLC in participants treated with volrustomig plus chemotherapy and pembrolizumab plus chemotherapy.

    Measured: Up to approximately 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2023
  2. Study start24 Oct 2023
  3. Primary completion17 Aug 2026
  4. Study completion12 Nov 2027 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
895 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05984277
Sponsor's protocol ID
D798AC00001
Other IDs
2023-000056-38, 2023
Acronym
eVOLVE-Lung02
Status last verified
Oct 2026
First submitted
2 Aug 2023
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Volrustomig, Pembrolizumab and Carboplatin in people with Metastatic Non-small Cell Lung Cancer, run by AstraZeneca at 231 sites in 25 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 4 inclusion and 8 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 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 231 sites in China, United States, Germany, France, Japan and 20 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Progression-Free Survival (PFS) (using BICR assessments according to RECIST 1.1) (time frame: Up to approximately 6 years). 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 9 Oct 2026.

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