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.
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.
Subjects with known oncogenic driver genes other than EGFR.
Subjects with mixed cell histologic or with phenotypic transformation.
Prior or concurrent treatment with fourth-generation EGFR tyrosine kinase inhibitors.
Cytotoxic chemotherapy, any other investigational drugs, traditional Chinese medicine with anti-tumor indications, or other anti-tumor drugs within 14 days prior to the first dose of HS-10504 or require continued treatment with these drugs during the study.