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:

• People who are willing to take part, have been fully informed about the study, and have signed a consent form agreeing to follow all trial procedures
• People aged 18 to 75 years old at the time of signing the consent form
• For the early phase (Phase Ib): people with an advanced or metastatic solid tumour confirmed by laboratory testing, where previous treatments have stopped working or no standard treatment is available; for the later phase (Phase II): people with advanced or metastatic non-small cell lung cancer (a type of lung cancer) confirmed by laboratory testing, with a specific gene change called an EGFR mutation, where previous targeted or chemotherapy treatments have failed or could not be tolerated
• People who have at least one tumour that can be measured on a scan, assessed within 4 weeks before starting the trial
• People who are able to provide a suitable tumour tissue sample so that a protein called PD-L1 can be measured
• People with a general health score of 0 or 1 on a standard scale (meaning fully active or restricted in strenuous activity only), assessed within 7 days before starting treatment
• People with an expected survival of at least 12 weeks
• People whose major organs (such as liver, kidneys, and bone marrow) are functioning within acceptable levels, confirmed by blood tests within 14 days before starting treatment, and without having needed blood transfusions or certain supportive treatments in that period
• Women who could become pregnant must have a negative blood pregnancy test within 7 days before starting treatment, agree to use at least one highly effective form of contraception during the trial and for at least 6 months after the last dose, and must not be breastfeeding
• Men must agree to use at least one highly effective form of contraception during the trial and for at least 6 months after the last dose

Who may not be able to join:

• People who have had another cancer within the past 3 years, unless it was an early-stage cancer that was fully treated (such as certain skin cancers, early cervical, prostate, breast, or thyroid cancers)
• People who have previously had a severe (Grade 3 or higher) side effect related to the immune system during immunotherapy
• People who have fluid build-up around the lungs, heart, or abdomen that requires medical treatment
• People with active or uncontrolled cancer that has spread to the brain or spinal cord and is causing symptoms (note: people with stable, symptom-free brain or spinal cord involvement may still be considered — confirm with trial site)
• People with a history of or current serious lung conditions such as interstitial lung disease, radiation damage to the lungs, or drug-related lung problems that could make it difficult to monitor for lung side effects
• People with poorly controlled heart or blood vessel problems, including moderate-to-severe heart failure, unstable chest pain, a heart attack or stroke in the past 6 months, certain uncontrolled heart rhythm problems, or high blood pressure that is not well managed despite treatment
• People with a history of immune system diseases, a positive HIV test, other conditions that weaken the immune system, or a history of organ transplant
• People with active tuberculosis
• People with active hepatitis B, hepatitis C, or both at the same time
• People with a known active or suspected autoimmune disease (those with a stable autoimmune condition that does not require immune-suppressing medication may still be considered — confirm with trial site)
• People who have needed high-dose steroid tablets or other immune-suppressing medicines within 14 days before starting the trial (low-dose, topical, inhaled, or preventive use may be permitted — confirm with trial site)
• People who have had an active infection requiring antibiotic or antiviral treatment in the 14 days before starting the trial
• People who have had major surgery within 28 days before starting the trial (minor procedures such as fluid drainage or lymph node biopsy may be permitted)
• People who have taken certain strong medications that affect how the body processes drugs (strong CYP2D6 or CYP3A inhibitors or inducers) within 2 weeks before starting the trial
• People who have received a live virus vaccine within 28 days before starting the trial (certain inactivated vaccines, such as for flu or COVID-19, may be permitted)
• People currently in another clinical trial, or who finished a previous trial less than 14 days ago, or whose last cancer treatment was less than 5 half-lives ago
• People with a known severe allergy to any monoclonal antibody (a type of medicine)
• People considered unsuitable for the trial by the trial doctor for any other medical or laboratory reason

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