The aim of the study to evaluate the safety and efficacy of Sacituzumab Tirumotecan in combination with osimertinib or as monotherapy for neoadjuvant treatment in patients with resectable Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer.
This is a randomized, open-label, multicenter, Phase 2 study to evaluate the safety and efficacy of Sacituzumab Tirumotecan in combination with osimertinib or as monotherapy for neoadjuvant treatment in patients with resectable Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Sacituzumab Tirumotecan: 4mg/kg, intravenous (IV) infusion
80mg, QD
Major Pathological Response (MPR) rate
MPR rate is defined as the proportion of participants achieving ≤ 10% residual viable tumor cells in the postoperative surgical specimen.
Time frame: up to 60 months
pathological Complete Response (pCR) rate
pCR rate is defined as the proportion of participants achieving absence of any residual viable tumor cells in the postoperative surgical specimen.
Time frame: up to 60 months
Residual viable tumor percentage (RVT%)
RVT% is defined as the proportion of residual viable tumor cells in the postoperative surgical specimen.
Time frame: up to 60 months
R0 resection rate
Proportion of participants achieving R0 resection
Time frame: up to 60 months
Pathological lymph node downstaging rate
Pathological lymph node downstaging rate is defined as the proportion of participants achieving pathological lymph node downstaging
Time frame: up to 60 months
Pathological primary tumor downstaging rate
Pathological primary tumor downstaging rate is defined as the proportion of participants achieving pathological primary tumor downstaging
Time frame: up to 60 months
ORR
ORR is defined as a partial or complete response according to RECIST, version 1.1.
Time frame: up to 60 months
EFS
EFS is defined as the time from randomization to progression of disease, recurrence of disease, or death from any cause.
Time frame: up to 60 months
DFS
DFS is defined as the time from surgery to disease progression (recurrence or metastasis) or death due to any cause.
Time frame: up to 60 months
OS
OS is defined as the time from randomization to death from any cause.
Time frame: up to 60 moths
Incidence of Adverse events (AEs) and serious adverse events (SAEs) as assessed by NCI CTCAE v5.0
Incidence (based on NCI CTCAE v5.0) of adverse events (AEs) and serious adverse events (SAEs).
Time frame: up to 60 months
Severity of Adverse events (AEs) and serious adverse events (SAEs) as assessed by NCI CTCAE v5.0
Severity (based on NCI CTCAE v5.0) of adverse events (AEs) and serious adverse events (SAEs).
Time frame: up to 60 months
Maximum observed plasma concentration (Cmax) of Sacituzumab Tirumotecan-ADC, Sacituzumab Tirumotecan-TAB, and free KL610023
To assess the pharmacokinetic (PK) profile of Sacituzumab Tirumotecan.
Time frame: up to 60 months
Anti-drug Antibodies (ADA) of Sacituzumab Tirumotecan
Immunogenicity test results of Sacituzumab Tirumotecan.
Time frame: up to 60 months
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