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 understand, agree to, and sign a consent form before any screening begins.
• Adults aged 18 or older, of any sex.
• People who have been diagnosed with non-small cell lung cancer (a type of lung cancer) that has spread or cannot be treated with standard curative treatment, confirmed by laboratory testing of tissue or cells.
• For the dose-finding stage of the trial: people whose cancer has gotten worse despite standard treatment, who were unable to tolerate standard treatment, who chose not to receive it, or for whom no standard treatment exists.
• For the later expansion stage of the trial: people whose lung cancer has a specific genetic change called an EGFR exon 20 insertion mutation, confirmed by an approved local laboratory, plus any additional criteria specific to their assigned group within the trial.
• People who have at least one tumour that can be measured using standard imaging methods (called RECIST v1.1 criteria).
• People who are reasonably active and able to carry out daily activities, as measured by a standard medical scale (ECOG score of 0 or 1).
• People whose doctors estimate they have a life expectancy of at least 3 months.
• People whose organs (such as kidneys, liver, and bone marrow) are functioning adequately, as confirmed by blood tests.
• People whose blood salt and mineral levels (magnesium, sodium, and potassium) fall within the acceptable ranges set by the trial.
• People whose blood pressure is adequately controlled (at or below 150/90 mmHg at screening), with or without blood pressure medication, and whose blood pressure medication has not changed in the week before the trial starts.
• For the food effect part of the trial only: people who are able to eat a standardised high-fat meal within 30 minutes, and who are able to fast for 10 hours.
• People who are not surgically sterilised and who could potentially have children must agree to use highly effective contraception during the trial and for approximately 6 months after the last dose; men who have had a vasectomy must also use a condom.

Who may not be able to join:

• People who have a known allergy or sensitivity to any ingredient in the study drug.
• People whose lung cancer has a specific genetic change called the EGFR C797S mutation.
• People who have had another type of cancer, with some exceptions: adequately treated non-melanoma skin cancer or cervical cancer in situ may be acceptable; prostate cancer that has been definitively treated and has not spread may be acceptable; or another cancer where the person has been free of relapse for at least 3 years since that diagnosis may be acceptable (confirm with trial site).
• People who are unable to swallow capsules, or who have conditions that significantly affect how the stomach or intestines absorb or process food or medication — such as removal of the stomach or small bowel, inflammatory bowel disease, bowel blockage, or ongoing diarrhoea (confirm with trial site if this applies).
• People who have received anti-cancer treatment — including chemotherapy, radiation, targeted therapy, immunotherapy, or other experimental drugs — within 4 weeks before starting the trial.
• People who have had major surgery within 4 weeks before starting the trial, or who have a surgical wound that has not fully healed.
• People who still have significant side effects (above a mild level) from previous cancer treatments, with a few exceptions such as hair loss, skin colour changes, stable thyroid conditions managed with medication, or mild nerve-related side effects.
• People who have recently taken certain medications that strongly affect how the body processes drugs (CYP3A inhibitors or inducers) within 2 weeks before starting the trial (or 3 weeks for St John's Wort), or who have consumed grapefruit, pomegranate, starfruit, pomelo, Seville oranges, or their juices within 3 days before starting.
• People who have spinal cord compression or cancer that has spread to the lining of the brain or spinal cord, whether or not it is causing symptoms.
• People with significant heart problems or reduced heart function.
• People with HIV/AIDS or who test positive for HIV.
• People with active hepatitis B infection, though those who test positive for certain hepatitis B markers but have no detectable virus in the blood may still be considered (confirm with trial site).
• People with active hepatitis C infection, though those who test positive for hepatitis C antibodies but have no detectable virus in the blood may still be considered (confirm with trial site).
• People with uncontrolled fluid build-up in the abdomen, around the lungs, or around the heart, or who have needed a procedure to drain such fluid within 2 weeks before starting the trial.
• People with current lung inflammation (pneumonitis) that required steroid treatment, unresolved drug-related lung inflammation, or a history or current evidence of a condition called interstitial lung disease.
• People who are pregnant or breastfeeding.
• People who have received a live or live-attenuated vaccine within 4 weeks before starting the trial (inactivated vaccines, such as standard flu shots or inactivated COVID-19 vaccines, are generally not excluded — confirm with trial site).
• People with current or previous eye conditions affecting the cornea (the clear front surface of the eye), such as corneal damage, abrasion, or ulceration, that could increase the risk of eye-related side effects.
• People with other significant health conditions that, in the treating doctor's judgement, could make it unsafe to participate or affect the reliability of the trial results.
• People who have a major surgery planned during the trial period.

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