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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,200
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.
Time frame: 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.
Time frame: Up to approximately 6 years
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Up to approximately 6 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Paclitaxel
Pemetrexed
Research Site
Prescott, Arizona, United States
Research Site
Hot Springs, Arkansas, United States
Research Site
Springdale, Arkansas, United States
Research Site
Long Beach, California, United States
Research Site
Lone Tree, Colorado, United States
Research Site
Fort Myers, Florida, United States
Research Site
Gainesville, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
St. Petersburg, Florida, United States
Research Site
West Palm Beach, Florida, United States
...and 246 more locations
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.
Time frame: 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.
Time frame: Up to approximately 6 years
Concentration of volrustomig in serum and PK parameters
To assess the PK of volrustomig
Time frame: Up to approximately 6 years
Presence of ADAs against volrustomig in serum
To investigate the immunogenicity of volrustomig.
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 6 years