Phase 2 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:

• Adults aged 18 or older
• People with locally advanced or metastatic non-small cell lung cancer (a type of lung cancer that has spread or cannot be surgically removed), confirmed by laboratory testing of tissue or cells, where standard treatments have not worked, are not available, or have caused intolerable side effects
• People whose lung cancer tissue samples can be tested at a central laboratory for a specific genetic change called EGFR C797S mutation (this applies to certain phases of the trial)
• People who have at least one tumour that can be measured using standard imaging criteria (called RECIST 1.1)
• People with a general health and activity level rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light work) (confirm with trial site)
• People with a life expectancy of more than 12 weeks
• Women of childbearing age who agree to use adequate contraception during the trial and for 6 months after the last dose, and who are not breastfeeding
• Men who agree to use adequate contraception during the trial and for 6 months after the last dose
• Women who have confirmed evidence that they are not able to become pregnant
• People who have read, understood, and signed the informed consent form

Who may not be able to join:

• People who have previously received or are currently receiving a treatment that targets the EGFR C797S mutation
• People who have received certain cancer treatments — including chemotherapy, anticancer traditional Chinese medicine, or targeted small molecule drugs — within 14 days before the first dose
• People who have received experimental treatments or large-molecule antibody therapies within 28 days before the first dose
• People who have had local radiation therapy for symptom relief within 2 weeks before the first dose, or who have had radiation covering more than 30% of the bone marrow, or large-scale radiotherapy within 4 weeks before the first dose
• People who have had major surgery (such as brain, chest, or abdominal surgery) within 4 weeks before the first dose
• People with poor bone marrow function or serious problems with how major organs are working
• People with uncontrolled fluid build-up around the lungs, abdomen, or heart
• People with known brain or spinal cord spread of cancer that has not been treated or is currently active
• People with active autoimmune diseases or active infections
• People who have persistent nausea, vomiting, chronic digestive conditions, or who are unable to swallow tablets or capsules
• People who have had an allergic reaction to the study drug (HS-10375) or to similar types of drugs
• People the trial investigator believes are unlikely to follow the study procedures and requirements
• People whose safety cannot be adequately ensured during the trial, as judged by the investigator
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study
• People with a history of nerve-related conditions or mental health disorders, including epilepsy or dementia

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