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 who are able to give written, signed consent and agree to follow the trial's requirements
• People who are 18 years of age or older at the time of signing the consent form, of any gender
• People whose physical functioning is rated at ECOG score 0 or 1 (meaning they are either fully active or have some limits on heavy physical work but can do light work) (confirm with trial site)
• People with a life expectancy of at least 3 months
• People whose non-small cell lung cancer (NSCLC) has been confirmed by tissue or cell testing, is newly diagnosed, and is either locally advanced (stage IIIB/C) or has spread to other parts of the body (stage IV), and cannot be treated with surgery or high-dose radiotherapy aimed at a cure
• People whose cancer tests positive for a protein marker called PD-L1 (using the 22C3 test) at a level of 1% or higher
• People who have at least one tumour that can be measured using standard imaging guidelines (RECIST v1.1)
• People whose blood counts and organ function meet the following levels without the need for medications or transfusions to support them: a neutrophil count of at least 1.5×10⁹/L; platelets of at least 100×10⁹/L; haemoglobin of at least 9 g/dL; liver enzyme levels (ALT and AST) within acceptable ranges; total bilirubin within acceptable ranges (with a higher allowance for people with a condition called Gilbert syndrome); and kidney function meeting minimum levels by blood or urine testing (confirm with trial site for exact values)
• People who have cancer that has spread to the brain (CNS metastases) may still be eligible if they have no neurological symptoms, or their symptoms have been stable for at least 2 weeks after local treatment, they do not need steroids or anti-seizure medicines, and any local brain treatment (surgery or radiotherapy) was completed at least 2 weeks before starting the trial, with side effects from that treatment reduced to a low level
• Women who could become pregnant must have a negative pregnancy test within 7 days before the first dose; women who could become pregnant, and men whose partners could become pregnant, must agree to use effective contraception from the time of signing the consent form until 6 months after the last dose of the study drug

Who may not be able to join:

• People with lung adenocarcinoma who have specific gene mutations (EGFR deletion 19 or L858R, or ALK or ROS-1 fusion gene mutations) confirmed by testing (note: genetic testing is not required for people with non-adenocarcinoma types)
• People who have already received systemic chemotherapy, biological therapy, targeted therapy, or immunotherapy for advanced or metastatic NSCLC
• People who are known to have interstitial pneumonia, immune pneumonia, or interstitial changes in the lungs
• People who have cancer that has spread to the lining of the brain (meningeal metastases), the brainstem, the spinal cord, or who have active brain metastases
• People currently taking part in another interventional clinical trial, or who have taken an experimental drug without enough time having passed since their last dose (at least 5 half-lives of the drug, or as discussed with the research team)
• People who received palliative radiotherapy within 2 weeks before the first dose, or extensive radiotherapy affecting more than 30% of the bone marrow within 4 weeks before the first dose
• People currently taking, or unable to stop (at least one week before the first dose), certain medications, herbal supplements, or foods that strongly affect how the body processes a specific enzyme called CYP3A (confirm with trial site for specific examples)
• People who still have side effects from a previous treatment above a low level (CTCAE grade 1) at the time of enrolment, except for any degree of hair loss
• People who have had a solid organ transplant or blood system transplant, including a bone marrow transplant, or who have received a whole blood transfusion within 120 days of a study-related sample collection
• People with severely reduced lung function (FEV1 or DLCO below 60% of what is expected), or a history of interstitial lung disease, drug-induced lung disease, or radiation-related lung inflammation that required steroid treatment, or grade 3 or higher immune-related pneumonia from prior immunotherapy
• People who have an active autoimmune disease that required systemic treatment within the 2 years before the first dose (replacement therapies such as thyroid hormone or low-dose steroids for hormone deficiencies are not counted as systemic treatment)
• People who have been diagnosed with an immune deficiency condition, or who have been on systemic steroid or other immunosuppressive therapy within 7 days before the first dose (low daily doses of steroids equivalent to 10 mg or less of prednisone are permitted)
• People who have been diagnosed with another cancer within the past 5 years, except for certain skin cancers or carcinoma in situ that have been assessed as fully treated and cured
• People who received a live or live-attenuated vaccine within 30 days before the first dose (inactivated vaccines are allowed)
• People assessed by the trial doctor as having active tuberculosis, based on skin tests, blood tests, chest imaging, or other routine screening results (except those assessed as fully recovered after standard tuberculosis treatment)
• People with active infections including active hepatitis C (HCV), active HIV, or untreated active hepatitis B (HBV) with a viral load at or above a certain level; people with certain hepatitis B profiles may still be eligible if they receive ongoing antiviral treatment or monitoring throughout the trial (confirm with trial site)
• People who are allergic to any of the drugs used in this trial or their ingredients
• People who have difficulty swallowing, active digestive system disease, or who have had major bowel or stomach surgery that could significantly affect how the study drug is taken or absorbed (such as ulcers, inability to swallow tablets, uncontrollable nausea, vomiting, diarrhoea, or malabsorption)
• People whom the trial doctor considers unsuitable for the trial for any other reason

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