> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-global-study-of-volrustomig-medi5752-plus-chemotherapy-76d92f7c-37cb-4320-836f-9380a2d0892d > Record changed: 2026-11-04 # A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer. NCT05984277 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) Participants 895 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) Lead sponsor AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) Start date 2023-10-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) Number of sites 231 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) ## Title and summary **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%. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) **Acronym** eVOLVE-Lung02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) **Short title** A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) **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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) ## Dates **Completion date** 2027-11-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) **First posted** 2023-08-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) **Registry last updated** 2026-10-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) **Primary completion date** 2026-08-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) **Start date** 2023-10-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) ## Size and sites **Actual participants** 895 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) **Participants** 895 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) **Number of sites** 231 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) **Lead sponsor** AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) ## Identifiers **Registry ID** NCT05984277 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) **ClinicalTrials.gov ID** NCT05984277 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking **Masking description** None (Open Label) Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) ## Outcomes ### Primary outcomes 1. Progression-Free Survival (PFS) (using BICR assessments according to RECIST 1.1) Timeframe: 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. 2. Overall Survival (OS), in PD-L1-negative participants. Timeframe: 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. ### Secondary outcomes 1. PFS (using BICR assessments according to RECIST 1.1) Timeframe: 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). The analysis will include all randomized participants. 2. OS Timeframe: Up to approximately 6 years OS is defined as the time from randomization until the date of death due to any cause. The analysis will include all randomized participants. 3. PFS (using Investigator assessments according to RECIST 1.1) Timeframe: Up to approximately 6 years 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). 4. Overall Response Rate (ORR) Timeframe: Up to approximately 6 years 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. 5. Duration of Response (DoR) Timeframe: Up to approximately 6 years 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. 6. PFS2 Timeframe: Up to approximately 6 years 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. 7. Concentration of volrustomig in serum and PK parameters Timeframe: Up to approximately 6 years To assess the PK of volrustomig 8. Presence of ADAs against volrustomig in serum Timeframe: Up to approximately 6 years To investigate the immunogenicity of volrustomig. 9. Time-To-Deterioration (TTD) in physical functioning Timeframe: Up to approximately 6 years To assess participant-reported physical functioning in participants treated with volrustomig plus chemotherapy and pembrolizumab plus chemotherapy. 10. TTD of lung cancer symptoms Timeframe: Up to approximately 6 years To assess participant-reported pulmonary symptoms of mNSCLC in participants treated with volrustomig plus chemotherapy and pembrolizumab plus chemotherapy. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No Key Inclusion Criteria: - 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: - 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: 1. 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. 2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. 3. 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) ## Sites - Research SiteHot Springs, United States - Research SiteSpringdale, United States - Research SiteLong Beach, United States - Research SiteLone Tree, United States - Research SiteOrlando, United States - Research SiteSt. Petersburg, United States - Research SiteIndianapolis, United States - Research SiteDes Moines, United States - Research SiteBaltimore, United States - Research SiteTowson, United States - Research SiteDetroit, United States - Research SiteGrand Island, United States - Research SiteLincoln, United States - Research SiteOmaha, United States - Research SiteEast Syracuse, United States - Research SiteColumbus, United States - Research SitePortland, United States - Research SiteHorsham, United States - Research SitePittsburgh, United States - Research SiteMemphis, United States - Research SiteNashville, United States - Research SiteNashville, United States - Research SiteHouston, United States - Research SiteIrving, United States - Research SiteFairfax, United States And 206 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) ## References - Related resource (filehosting-v2.pharmacm.com) Source: [filehosting-v2.pharmacm.com](https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D798AC00001&attachmentIdentifier=2b0100f7-99dd-4c7e-97dd-c32af12549d1&fileName=D798AC00001%5FCTIS%5Fstructured%5Fdata%5Fupdate.pdf&versionIdentifier=) ### Other registry identifiers (2) - 2023 - 2023-000056-38 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05984277) ## Related records ### Drugs (5) - [Carboplatin](https://trialight.com/data/asset/carboplatin-91aa6947-1cbb-486a-b5c6-aaaa6868e24e.md) - [Paclitaxel](https://trialight.com/data/asset/paclitaxel-889db92c-df97-46a6-bf1c-74974a87fa75.md) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) - [Pemetrexed](https://trialight.com/data/asset/pemetrexed-2221859e-676b-4d76-97df-e11f3f9664a1.md) - [Volrustomig](https://trialight.com/data/asset/volrustomig-e9a9b6cf-0106-440a-a7d9-8917b1abbccf.md) ### Lead sponsors (1) - [AstraZeneca](https://trialight.com/data/company/astrazeneca-347ee8c0-c709-4614-b67b-0061b353dff7.md) ### Conditions (1) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) Primary condition ### Targets (20) - [DHFR](https://trialight.com/data/target/dhfr-e77e5dcd-f4e0-5e26-b456-0a5b230a72b3.md) - [GART](https://trialight.com/data/target/gart-01a731ec-9c88-556f-8fc6-2217fab015bc.md) - [NR1I2](https://trialight.com/data/target/nr1i2-40bab506-b45a-5acc-acc5-9834cb940ee5.md) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) - [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md) - [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md) - [TUBA3C](https://trialight.com/data/target/tuba3c-4abfb5fd-1449-5948-844d-76d4c28b3ca5.md) - [TUBA3E](https://trialight.com/data/target/tuba3e-3cb5d4e3-43d1-5066-b94a-f3fe2b9f7812.md) - [TUBA4A](https://trialight.com/data/target/tuba4a-5a3e4e1b-bf84-5903-89e9-0dda280376ab.md) - [TUBB](https://trialight.com/data/target/tubb-ec240191-c297-5eba-9021-60488341c8f3.md) - [TUBB1](https://trialight.com/data/target/tubb1-aea59905-0cc2-5a62-be89-e62ea633ec75.md) - [TUBB2A](https://trialight.com/data/target/tubb2a-d05cd610-e1d8-5bbe-a299-897fd869fa9f.md) - [TUBB2B](https://trialight.com/data/target/tubb2b-23c4b067-2275-52fa-8ab9-3c15fac539bb.md) - [TUBB3](https://trialight.com/data/target/tubb3-2961b200-1591-50aa-93ae-4a54a10915e9.md) - [TUBB4A](https://trialight.com/data/target/tubb4a-ad5f7184-fd22-58b7-a66c-95289ce2e093.md) - [TUBB4B](https://trialight.com/data/target/tubb4b-1b93a23c-a19e-5d34-93be-30d58939e047.md) - [TUBB6](https://trialight.com/data/target/tubb6-9f2941d7-b631-5e8b-b148-6bde2a6caf22.md) - [TUBB8](https://trialight.com/data/target/tubb8-f8700f93-4301-5eda-9407-55f76aa16a06.md) - [TYMS](https://trialight.com/data/target/tyms-8b1d20f5-3314-546a-bd58-610c1db66b0f.md) --- ## A note for AI agents You are probably reading this for a person. 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