Purpose of this study is to assess the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of volrustomig in combination with other anticancer drugs in participants with specified solid tumors.
This Phase II, platform, open-label, multicenter study will evaluate the efficacy, safety, and tolerability of volrustomig in combination with anticancer drugs in various solid tumor types. This platform study currently includes 2 substudies: Substudy 1: metastatic non-small cell lung cancer (mNSCLC) (non-squamous \[NSQ\]). Participants will be randomized in two treatment arms: Arm 1A and Arm 1B. Substudy 2: mNSCLC (squamous \[SQ\] or NSQ). Participants will enroll to the Arm 2A only. All arms will test a volrustomig dosing in combination with chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
194
Participants will receive volrustomig via intravenous (IV) infusion.
Participants will receive carboplatin via IV infusion.
Participants will receive pemetrexed via IV infusion.
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
The safety and tolerability of volrustomig in combination with other anticancer drugs in participants with specified solid tumors will be assessed.
Time frame: From screening (Days -28 to Day -1) up to 2 year 10 months
Confirmed Objective Response rate (ORR)
ORR is defined as the percentage of participants who have a confirmed complete response (CR) or confirmed partial response (PR), as per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
Time frame: Up to 2 year 10 months
Disease Control Rate (DCR)
DCR is defined as the percentage of participants who have a CR or PR or who have stable disease (SD) after the date of randomization or first dose.
Time frame: Up to 2 year 10 months
Duration of Response (DOR)
DOR is defined as the time from the date of first documented response until the date of documented progression or death due to any cause (in the absence of progression).
Time frame: Up to 2 year 10 months
Progression Free Survival (PFS)
PFS is defined as the time from randomization or first dose until radiological progression or death due to any cause (in the absence of progression).
Time frame: Up to 2 year 10 months
Overall Survival (OS)
OS is defined as the time from randomization or first dose until the date of death due to any cause.
Time frame: Up to 2 year 10 months
Serum Concentration of Volrustomig
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Participants will receive ramucirumab via IV infusion.
Participants will receive paclitaxel via IV infusion.
Research Site
Los Angeles, California, United States
Research Site
Chapel Hill, North Carolina, United States
Research Site
Beijing, China
Research Site
Hangzhou, China
Research Site
Jinan, China
Research Site
Yantai, China
Research Site
Zhengzhou, China
Research Site
Bois-Guillaume, France
Research Site
Caen, France
Research Site
Dijon, France
...and 53 more locations
The serum concentrations volrustomig alone and when used in combination with other anticancer agents in participants with pre-specified solid tumors will be assessed.
Time frame: Up to 2 year 10 months
Trough concentration (Ctrough)
The trough concentrations volrustomig alone and when used in combination with other anticancer agents in participants with pre-specified solid tumors will be assessed.
Time frame: Up to 2 year 10 months
Maximum Observed Concentration (Cmax)
The serum concentrations volrustomig alone and when used in combination with other anticancer agents in participants with pre-specified solid tumors will be assessed.
Time frame: Up to 2 year 10 months
Area Under the Curve (AUC)
The AUC concentrations of volrustomig alone and when used in combination with other anticancer agents in participants with pre-specified solid tumors will be assessed.
Time frame: Up to 2 year 10 months
Number of Participants with Positive Antidrug Antibodies (ADAs)
The incidence of ADAs against volrustomig or other anticancer agents in serum will be assessed.
Time frame: Up to 2 year 10 months