Phase 1 Lung Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 or older, of any gender
• People who have been diagnosed with locally advanced or metastatic non-small cell lung cancer (a type of lung cancer that has spread or cannot be removed), confirmed by laboratory testing of tissue or cells
• People whose cancer has continued to grow or spread during or after treatment with a type of targeted therapy called EGFR-TKIs (medicines that target a specific gene change in lung cancer)
• People whose tumor has tested positive for a specific gene change called EGFR, based on local or central laboratory testing
• People who have at least one measurable tumour that can be tracked during the trial, according to standard measurement guidelines
• People with a good general level of physical functioning (able to carry out everyday activities with little or no limitation, scored 0 or 1 on a standard scale used by doctors)
• People with a life expectancy of more than 12 weeks
• People who are willing and able to use adequate contraception throughout the study
• Women who have documented evidence that they are not able to become pregnant (confirm with trial site)
• People who have read, understood, and signed the informed consent form

Who may not be able to join:

• People whose cancer is driven by known gene changes other than EGFR
• People whose cancer has mixed cell types or has undergone a change in its cell type (confirm with trial site)
• People who have previously received or are currently receiving a fourth-generation EGFR-targeted therapy
• People who have received chemotherapy, other experimental drugs, traditional Chinese medicine used for cancer, or other anti-cancer treatments within 14 days before starting the trial drug, or who would need to continue these during the study
• People who have had local radiotherapy within 2 weeks before starting the trial drug, or who have previously had radiation covering more than 30% of their bone marrow
• People with uncontrolled fluid build-up around the lungs, abdomen, or heart
• People who have had major surgery within 4 weeks before starting the trial drug
• People who have brain or central nervous system metastases (cancer that has spread to the brain or spinal cord) that are causing symptoms or are actively getting worse
• People who still have significant side effects (grade 2 or higher) remaining from previous cancer treatments
• People who have a history of another separate primary cancer
• People with insufficient bone marrow function, or poor liver or kidney function
• People with severe or poorly controlled diabetes, heart or blood vessel disease, or high blood pressure; or those with serious blood clot events, severe infection, significant bleeding, or significant problems affecting the digestive system
• People who have a known allergy or sensitivity to any ingredient in the trial drug HS-10504
• People with moderate to severe lung disease (separate from their cancer)
• People with a significant history of neurological (brain or nerve) or mental health disorders
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study
• People who, in the opinion of the trial doctor, are unlikely to follow the study procedures and requirements
• People who have any other condition that, in the opinion of the trial doctor, could affect their safety or the accuracy of the study results

Important: Always verify eligibility with the trial site directly before applying.