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.
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
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
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
France15 sites
Research Site
Angers, 49055
Research Site
Avignon, 84902
Research Site
Bayonne, 64100
Research Site
Bordeaux, 33076
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Caen, 14033
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Lille, 59037
Research Site
Limoges, 87042
Research Site
Marseille, 13273
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Paris, 75248
Research Site
Quimper, 29000
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Reims, 51092
Research Site
St-Malo, 35403
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Strasbourg, 67098
Research Site
Suresnes, 92150
Research Site
Toulon Naval, 83800
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
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
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Porto Alegre, 91350200
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Rio de Janeiro, 22281-100
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Santa Cruz do Sul, 96810-110
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São Paulo, 01221-020
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
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
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
Argentina8 sites
Research Site
CABA, 1425
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CABA, C1061
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CABA, C1425
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Córdoba, 5000
Research Site
Córdoba, X5800HHW
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La Plata, 1900
Research Site
La Plata, B1900AVG
Research Site
Rosario, 2000
Italy8 sites
Research Site
Bari, 70124
Research Site
Bergamo, 24125
Research Site
Milan, 20162
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Padova, 35128
Research Site
Parma, 43126
Research Site
Pavia, 27100
Research Site
Ravenna, 48100
Research Site
Roma, 00128
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
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
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
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
Spain7 sites
Research Site
Alicante, 03010
Research Site
Barcelona, 08003
Research Site
Barcelona, 08025
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Bilbao (Vizcaya), 48013
Research Site
Madrid, 28040
Research Site
Málaga, 29011
Research Site
Palma, 07198
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
Poland6 sites
Research Site
Lublin, 20-090
Research Site
Poznan, 60-569
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Przemyśl, 37-700
Research Site
Radom, 26-600
Research Site
Warsaw, 01-138
Research Site
Warsaw, 02-781
Australia5 sites
Research Site
Clayton, 3168
Research Site
Fitzroy, 3065
Research Site
Heidelberg, 3084
Research Site
South Brisbane, 4101
Research Site
Sydney, NSW 2145
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
Belgium3 sites
Research Site
Aalst, 9300
Research Site
Antwerp, 2020
Research Site
Ghent, 9000
Czechia3 sites
Research Site
Olomouc, 77900
Research Site
Ostrava - Vitkovice, 703 84
Research Site
Prague, 128 08
Netherlands3 sites
Research Site
Amsterdam, 1081 HV
Research Site
Nieuwegein, 3435 CM
Research Site
Tilburg, 5042AD
Thailand3 sites
Research Site
Lampang, 52000
Research Site
Muang, 50200
Research Site
Songkhla, 90110
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.
- Conditions
- Metastatic Non-small Cell Lung Cancer
- 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.
VolrustomigDrug
Volrustomig
PembrolizumabDrug
Pembrolizumab
CarboplatinDrug
Carboplatin
PaclitaxelDrug
Paclitaxel
PemetrexedDrug
Pemetrexed
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Volrustomig plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion Receives: Drug: Volrustomig; Drug: Carboplatin; Drug: Paclitaxel; Drug: Pemetrexed |
| Arm 2 | Active comparator | Pembrolizumab 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.
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
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)
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
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
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
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
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
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
Concentration of volrustomig in serum and PK parameters
To assess the PK of volrustomig
Measured: Up to approximately 6 years
Presence of ADAs against volrustomig in serum
To investigate the immunogenicity of volrustomig.
Measured: Up to approximately 6 years
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
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.
- First posted9 Aug 2023
- Study start24 Oct 2023
- Primary completion17 Aug 2026
- Study completion12 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 895 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT05984277
- Acronym / sponsor ID
- eVOLVE-Lung02 / D798AC00001
- Conditions
- Metastatic Non-small Cell Lung Cancer
- Keywords
- metastatic non-small cell lung cancer, non-squamous tumors, squamous tumors, PD-L1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 895 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 17 Aug 2026 (actual)
- Study completion
- 12 Nov 2027 (estimated)
- First posted
- 9 Aug 2023 (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.
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%.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Volrustomig, Drug: Carboplatin, Drug: Paclitaxel, Drug: PemetrexedVolrustomig plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion |
| Arm 2 | Active comparator | Drug: Pembrolizumab, Drug: Carboplatin, Drug: Paclitaxel, Drug: PemetrexedPembrolizumab plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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:
- As judged by the investigator, any condition that would interfere with evaluation of the study intervention or interpretation of participant safety or study results.
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 |
|---|---|---|
| VolrustomigVolrustomig | Drug | Arm 1 |
| PembrolizumabPembrolizumab | Drug | Arm 2 |
| CarboplatinCarboplatin | Drug | Arm 1, Arm 2 |
| PaclitaxelPaclitaxel | Drug | Arm 1, Arm 2 |
| PemetrexedPemetrexed | Drug | Arm 1, Arm 2 |
Primary outcome
Progression-Free Survival (PFS) (using BICR assessments according to RECIST 1.1)
Time frame: Up to approximately 6 years
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.
Overall Survival (OS), in PD-L1-negative participants.
Time frame: Up to approximately 6 years
OS is defined as the time from randomization until the date of death due to any cause, in PD-L1-negative participants.
10 secondary outcomes
PFS (using BICR assessments according to RECIST 1.1)
Time frame: Up to approximately 6 years
OS
Time frame: Up to approximately 6 years
PFS (using Investigator assessments according to RECIST 1.1)
Time frame: Up to approximately 6 years
Overall Response Rate (ORR)
Time frame: Up to approximately 6 years
Duration of Response (DoR)
Time frame: Up to approximately 6 years
PFS2
Time frame: Up to approximately 6 years
Concentration of volrustomig in serum and PK parameters
Time frame: Up to approximately 6 years
Presence of ADAs against volrustomig in serum
Time frame: Up to approximately 6 years
Time-To-Deterioration (TTD) in physical functioning
Time frame: Up to approximately 6 years
TTD of lung cancer symptoms
Time frame: Up to approximately 6 years
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 9 Oct 2026.
- CTIS structured data updateLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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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.
231 sites in 25 countries: see every site and its status.
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.