A Study of HS-10504 in Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer(NSCLC)
Trial Parameters
Brief Summary
HS-10504 is a fourth-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor targeting EGFR C797S mutation. This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of HS-10504 in Chinese locally advanced or metastatic NSCLC.
Eligibility Criteria
Inclusion Criteria: * Males or females, aged ≥ 18 years. * Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC * Progressive disease on or after prior treatment with EGFR-TKIs. * Enrollment will be restricted to participants with evidence of EGFR-positive in tumor as determined by local or central testing. * At least 1 target lesion according to RECIST 1.1. * ECOG PS score: 0-1. * Estimated life expectancy\> 12 weeks. * Men or women should be using adequate contraceptive measures throughout the study. * Women must have the evidence of non-childbearing potential. * Signed and dated Informed Consent Form. Exclusion Criteria: * Subjects with known oncogenic driver genes other than EGFR. * Subjects with mixed cell histologic or with phenotypic transformation. * Treatment with any of the following: 1. Prior or concurrent treatment with fourth-generation EGFR tyrosine kinase inhibitors. 2. Cytotoxic chemotherapy, any other investigational drugs, tradi