Tests HS-10504 in adults with advanced non-small cell lung cancer

Who can take part

• 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

Who cannot take part

• Subjects who have any grade ≥2 residual toxicities from prior therapies
• Prior history of significant neurological or mental disorders
• Subjects who have history of other primary malignancies
• Subjects with severe or poorly controlled diabetes, cardiovascular diseases or hypertension; subjects with severe arteriovenous thrombotic events, severe infection, clinically significant bleeding symptoms or clinically significant gastrointestinal dysfunction
• Hypersensitivity to any ingredient of HS-10504
• Moderate to severe pulmonary diseases
• Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments
• Subjects with known oncogenic driver genes other than EGFR
• Treatment with any of the following:; 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; Any local radiotherapy 2 weeks prior to the first dose of study treatment; have received irradiation of more than 30% of bone marrow prior to the first dose; Uncontrolled pleural effusion or ascites or pericardial effusion; Major surgery within 4 weeks before the first dose; CNS metastases with symptomatic or active progression
• Subjects with mixed cell histologic or with phenotypic transformation
• Inadequate bone marrow reserve or hepatic and renal functions
• Women who are breastfeeding or pregnant or planned to be pregnant during the study period
• Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator