This is an open-label, multicenter, Phase II clinical study designed to evaluate the safety and efficacy of JSKN033 in the treatment of patients with advanced NSCLC. The study is divided into two phases: Part 1 (Dose Selection) and Part 2 (Cohort Expansion). Enrolled subjects are patients with locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) NSCLC who are not eligible for curative treatment. Part 1 (Dose Selection): It consists of two dose groups, with a maximum of 20 subjects enrolled in each group. Part 2 (Cohort Expansion): It consists of two cohorts, with a maximum of 60 subjects enrolled in each cohort.
Subjects can understand the informed consent form,voluntarily participate in the study, and sign the informed consent form.
Subjects are≥18 years old on the day of signing the informed consent form, regardless of gender.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Expected survival time ≥3 months.
Presence of any small cell carcinoma component in the histological pathology.
History of other malignant tumors within 5 years prior to the first dose administration.
History of brainstem, meningeal, or spinal cord metastases/compression, or carcinomatous meningitis; presence of active brain metastases.
Imaging during the screening phase shows tumor invasion, compression, or location in surrounding vital organs.
Single group
JSKN033 Injection
DrugJSKN033 is a fixed-dose combination consisting of JSKN003 (a HER2-targeted ADC) and envafolimab (a PD-L1 inhibitor)
Number and Severity of Treatment-emergent Adverse Events (TEAEs)
The incidence and severity of TEAEs and TRAEs (Treatment-related Adverse Events, graded according to NCI CTCAE 5.0), Serious AEs (SAEs), laboratory tests, etc.
Objective response rate (ORR)
ORR was defined as the proportion of subjects achieving Complete Response (CR) or Partial Response (PR)
Duration of response (DoR)
Duration of response for responders (CR or PR) is defined as the time interval between the date of earliest qualifying response and the date of PD or death for any cause, whichever occurs earlier
Disease control rate (DCR)
DCR was defined as the proportion of subjects whose best overall response is CR, PR, or Stable Disease (SD)
Clinical benefit rate (CBR)
Clinical benefit rate (CR+PR+\[stable disease (SD) ≥ 6 months\]) is defined as those participants with best response as CR or PR or else SD with a duration of at least 6 months. SD for 6 months duration was defined as the time from the first dose to the first documentation of PD or to the last adequate response assessment prior to data cut-off date, whichever is earlier.
Progression-free Survival (PFS)
PFS is defined as the time from the date of first study dose to disease progression or death whichever occurs first. Subjects without event (no disease progression or alive at last visit) will be censored at the date of "last tumor assessment".
Correlation between biomarkers (HER2 mutation status, HER2/PD-L1 expression levels) in tumor tissue samples and efficacy.
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