non-small cell lung cancer
Conditions
Brief summary
Pathological complete response (pCR) rate in the resected primary tumor and all resected lymph nodes, defined as the proportion of patients whose resected samples are negative for residual viable tumor cells
Detailed description
Major pathological response (MPR) rate in the resected primary tumor and all resected lymph nodes (defined as the proportion of patients whose resected samples show 10% or less residual viable tumor cells), Objective response rate (ORR) following completion of neoadjuvant therapy assessed by imaging using RECIST 1.1. Surgical resection rate. Time to surgery following C4D1, Disease-free survival, DFS (inclusion to any recurrence of disease or death from any cause in the intent-to-treat population), Overall survival, OS (inclusion to death from any cause in the intent-to-treat population). Adverse events, AE (CTCAE 5), Quality of life, QoL (EORTC-QLQ-C30 and EQ-5D-5L)
Interventions
DRUGZimberelimab
DRUGTrodelvy 200 mg powder for concentrate for solution for infusion
Sponsors
AIO-Studien gGmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response (pCR) rate in the resected primary tumor and all resected lymph nodes, defined as the proportion of patients whose resected samples are negative for residual viable tumor cells | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathological response (MPR) rate in the resected primary tumor and all resected lymph nodes (defined as the proportion of patients whose resected samples show 10% or less residual viable tumor cells), Objective response rate (ORR) following completion of neoadjuvant therapy assessed by imaging using RECIST 1.1. Surgical resection rate. Time to surgery following C4D1, Disease-free survival, DFS (inclusion to any recurrence of disease or death from any cause in the intent-to-treat population), Overall survival, OS (inclusion to death from any cause in the intent-to-treat population). Adverse events, AE (CTCAE 5), Quality of life, QoL (EORTC-QLQ-C30 and EQ-5D-5L) | — |
Countries
Germany
Outcome results
None listed