Study identifier:D798AC00001
ClinicalTrials.gov identifier:NCT05984277
EudraCT identifier:2023-000056-38
CTIS identifier:2023-503298-39-00
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).
metastatic non-small cell lung cancer
Phase 3
No
Volrustomig, Pembrolizumab, Carboplatin, Paclitaxel, Pemetrexed
All
900
Interventional
18 Years - n/a
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Mar 2025 by AstraZeneca
AstraZeneca
-
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%.
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.
Location
Status
Location
Jinju-si, Republic of Korea, 52727
Status
Recruiting
Location
Seoul, Republic of Korea, 03080
Status
Recruiting
Location
Seoul, Republic of Korea, 06351
Status
Recruiting
Location
Cheongju-si, Republic of Korea, 28644
Status
Recruiting
Location
Linz, Austria, 4021
Status
Recruiting
Location
Tomaszów Mazowiecki, Poland, 97-200
Status
Withdrawn
Location
Warszawa, Poland, 01-138
Status
Recruiting
Location
Rzeszów, Poland, 35-241
Status
Withdrawn
Arms | Assigned Interventions |
---|---|
Experimental: Arm 1 Volrustomig plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion | Drug: Volrustomig Volrustomig Drug: Carboplatin Carboplatin Drug: Paclitaxel Paclitaxel Drug: Pemetrexed Pemetrexed |
Active Comparator: Arm 2 Pembrolizumab plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion | Drug: Pembrolizumab Pembrolizumab Drug: Carboplatin Carboplatin Drug: Paclitaxel Paclitaxel Drug: Pemetrexed Pemetrexed |
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