Solid Tumors, SQ, NSQ NSCLC
Conditions
Brief summary
The safety and tolerability of volrustomig in combination with other anticancer drugs in participants with specified solid tumors will be assessed., 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).
Detailed description
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)., 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)., OS is defined as the time from randomization or first dose until the date of death due to any cause., The serum concentrations volrustomig alone and when used in combination with other anticancer agents in participants with pre-specified solid tumors will be assessed., The trough concentrations volrustomig alone and when used in combination with other anticancer agents in participants with pre-specified solid tumors will be assessed., 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., The incidence of ADAs against volrustomig or other anticancer agents in serum will be assessed., 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.
Interventions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety and tolerability of volrustomig in combination with other anticancer drugs in participants with specified solid tumors will be assessed., 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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)., 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)., OS is defined as the time from randomization or first dose until the date of death due to any cause., The serum concentrations volrustomig alone and when used in combination with other anticancer agents in participants with pre-specified solid tumors will be assessed., The trough concentrations volrustomig alone and when used in combination with other anticancer agents in participants with pre-specified solid tumors will be assessed., 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., The incidence of ADAs against volrustomig or other anticancer agents i | — |
Countries
France, Greece, Italy, Portugal, Romania, Spain
Outcome results
None listed