Phase 1 Lung Cancer Trial, Recruiting

Written by an AI model from the 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 who have fully understood the trial and are willing to sign a consent form voluntarily
• People aged 18 or older at the time of signing the consent form, of any gender
• People diagnosed with non-small cell lung cancer, confirmed through tissue or cell samples
• People who have at least one measurable area of cancer that has not been treated locally, as assessed by the investigating doctor using standard criteria
• People who agree to provide blood and/or tumour tissue samples for genetic testing
• People whose bone marrow and organ function are in good condition, without having needed a blood transfusion or bone marrow growth factor treatment in the 2 weeks before starting the trial
• People with an ECOG performance score of 0 or 1 (meaning fully active or able to carry out light activity — confirm with trial site)
• People with an expected survival of at least 12 weeks
• People who are able to swallow normally
• Women of childbearing potential who have a negative pregnancy blood test within 7 days before the first dose and who are not breastfeeding; women of childbearing potential and men who could father a child must use effective contraception from signing the consent form until 6 months after the last dose

Who may not be able to join:

• People who have previously received anti-cancer treatment specifically targeting the C797S mutation
• People who carry other known cancer-driving gene changes
• People who have received any systemic anti-cancer treatment within 2 weeks before the first dose, or within 5 half-lives of the drug (whichever is longer); or who have received long-acting drugs such as immune checkpoint inhibitors within 4 weeks; or certain chemotherapy drugs with lasting side effects within 6 weeks
• People who have received certain immune-modifying agents, or traditional Chinese medicine preparations with approved anti-cancer indications, within 2 weeks before the first dose
• People who have taken strong inhibitors of certain liver enzymes (CYP3A, P-gp, or BCRP) within 7 days before the first dose, or strong inducers of those enzymes within 3 weeks (confirm with trial site)
• People who have had radiotherapy to non-bone areas within 4 weeks before the first dose, or bone radiotherapy within 2 weeks before the first dose
• People who have or have had another type of cancer besides the primary tumour being studied
• People with known cancer spread to the membranes around the brain, brainstem, spinal cord, or active brain metastases; those with previously treated, stable brain metastases may be considered if clinically stable for at least 4 weeks and not requiring steroids or seizure medications for at least 14 days before the first dose
• People whose tumour is growing into nearby important organs or blood vessels, or where there is a risk of abnormal connections forming between the food pipe and airway or lungs
• People whose side effects from previous cancer treatment have not reduced to a mild level, except for certain types of hair loss or nerve-related side effects
• People with existing heart or blood vessel disease, or significant risk factors for such conditions
• People with uncontrolled systemic (whole-body) diseases
• People with a history of lung inflammation (non-infectious interstitial lung disease or non-infectious pneumonia) that required steroid treatment, or who currently have or are suspected of having such conditions
• People with serious lung damage from pulmonary complications, including any underlying lung disease, autoimmune or inflammatory conditions that may affect the lungs, or previous surgical removal of one entire lung
• People with severe acute or ongoing infections
• People currently taking long-term systemic steroid medication (such as prednisone above 10 mg/day or equivalent) or any form of immune-suppressing treatment; those using inhalers, topical steroids, or short-term steroids to prevent allergic reactions may still be considered
• People who have had major surgery within 4 weeks before the first dose, or who are expected to have major surgery during the study
• People who have had significant bleeding episodes within 4 weeks before the first dose, such as gastrointestinal bleeding, stomach ulcer bleeding, or coughing up blood
• People with known serious digestive system problems, such as uncontrolled recurring diarrhoea, gastrointestinal blockage, Crohn's disease, ulcerative colitis, or gastrointestinal perforation
• People known to be allergic to any ingredients in the trial medication
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study
• People who, in the investigating doctor's judgement, have other factors that could affect the study results or their safety, such as alcohol or drug misuse, serious other illnesses, significant abnormal test results, or circumstances that could affect the collection of trial data

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