This is a phase II trial in patients with locally advanced or metastatic non-small cell lung cancer harboring HER2 gene abnormalities (amplification or overexpression)with a performance status of 0 to1 who are planned to receive first-line treatment or who have falied the first-line treatment
This is a Phase II study aimed at evaluating the efficacy and safety of Trastuzumab Rezetecan (SHR-A1811) combined with ivonescimab (AK112) in the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 gene abnormalities (amplification or overexpression). The study was divided into two cohorts: Cohort 1 included patients with HER2 amplification or overexpression who had failed first-line treatment; Cohort 2 included patients with HER2 amplification or overexpression who were diagnosed for the first time and had PD-L1 expression ≥ 1%. All eligible patients received intravenous administration of SHR-A1811 at 4.8 mg/kg combined with AK112 at 20 mg/kg, once every 3 weeks. The primary endpoint was the progression-free survival (PFS) evaluated by the investigators according to RECIST v1.1; secondary endpoints included duration of response (DOR), objective response rate (ORR), overall survival (OS), and safety indicators (adverse events, serious adverse events, etc.).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
4.8 mg/kg Intravenous injection until disease progression
20 mg/kg Intravenous injection until disease progression
Department of Medical Oncology,Cancer Center of Sun Yat-Sen University
Guangzhou, Guangdong, China
Progression free survival
The time from the first treatment to disease progression or death due to any cause (whichever occurs first)
Time frame: assessed up to 36 months
Duration of Response
The time from the first assessment of the tumor as being in an objective remission (PR or CR) to the first assessment of disease progression (PD) or death due to any cause prior to PD;
Time frame: up to 36 months
Objective Response Rate
The proportion of patients with the best overall therapeutic effect of CR and PR
Time frame: up to 36 months
Overall survival
The time from the first trial treatment to death due to any cause
Time frame: up to 60 months
Incidence and severity of adverse events (AEs)
Overall incidence of AEs; the incidence of grade 3 or above AEs; the incidence of severe adverse events (SAE); the incidence of drug-related AEs; the incidence of AEs resulting in permanent withdrawal of drugs; the incidence of AEs leading to dose adjustment
Time frame: through study completion, an average of 60 months
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