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).
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%.
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.
Key Inclusion Criteria:
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:
As judged by the investigator, any condition that would interfere with evaluation of the study intervention or interpretation of participant safety or study results.
CABA, 1425, Argentina
CABA, C1061, Argentina
CABA, C1425, Argentina
Ostrava - Vitkovice, 703 84, Czechia
Toulon Naval, 83800, France
Berlin-Zehlendorf, 14165, Germany
Gyöngyös - Mátraháza, 3200, Hungary
Kawasaki-shi, 216-8511, Japan
Sagamihara-shi, 252-0375, Japan
Ube-shi, 755-0241, Japan
Yunlin, 640, Taiwan
Muang, 50200, Thailand
Fatih-Istanbul, 34098, Turkey (Türkiye)