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%. - eVOLVE-Lung02

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031230678

Enrollment

1200

Registered

2024-03-06

Start date

2023-10-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Interventions

- Experimental: Volrustomig plus chemotherapy. Participants in the volrustomig plus chemotherapy arm will receive volrustomig plus histology-specific platinum based chemotherapy (see below) by intra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically or cytologically documented squamous or non-squamous NSCLC. 2. Stage IV NSCLC (according to Version 8 of the IASLC Staging Manual in Thoracic Oncology 2016), not amen able to curative surgery or radiation. 3. Tumours with no specific abnormality of the genes. - Sensitizing EGFR mutations and ALK and ROS1 rearrangements. - 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.

Exclusion criteria

Exclusion criteria: 1. Mixed small-cell lung cancer and NSCLC histology or sarcomatoid variant. Rare subtypes are excluded. 2. Spinal cord compression. 3. Brain metastases unless asymptomatic and stable. Please ask the study doctor for the details. 4. History of another primary malignancy except for patients treated with curative intent. Please ask the study doctor for the details. 5. Judgement by the study doctor that the individual should not participate in the study.

Design outcomes

Primary

Measure	Time frame
1. 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. 2. 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.	—

Measure

Time frame

1. 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. 2. 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.

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Countries

Argentina, Australia, Austria, Brazil, Canada, China, Czechia, France, Germany, Hungary, Italy, Japan, Mexico, Netherlands, Poland, Republic of Korea, Slovakia, South Africa, Spain, Taiwan, Thailand, Turkey, United Kingdom

Contacts

Public ContactKazushige Hibi

Astrazeneka K.K

RD-clinical-information-Japan@astrazeneca.com+81-6-4802-3533

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026