Phase 2 Lung Cancer Trial, Not Yet 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 aged 18 or older
• People whose general health and ability to carry out daily activities falls within an acceptable range, as measured by a standard oncology scoring system called ECOG (scores 0, 1, or 2 — meaning fully active to capable of limited self-care)
• People diagnosed with advanced non-small cell lung cancer (NSCLC), confirmed by laboratory tissue or cell testing, at stage IIIB or stage IV
• People whose NSCLC does not have a known targetable gene mutation, and who have already been treated with both an immunotherapy drug (anti-PD-1/PD-L1) and platinum-based chemotherapy (together or one after the other), and whose cancer has continued to grow or spread after those treatments — or people who were unable to receive or did not tolerate platinum-based chemotherapy, as long as they have had prior immunotherapy and their cancer has progressed
• People whose NSCLC does have a known targetable gene mutation (such as EGFR, ALK, ROS1, or BRAF), and who have already received all approved targeted treatments for that mutation, and whose cancer has continued to grow or spread after those treatments
• People who have at least two measurable areas of cancer that can be tracked using standard imaging criteria (called RECIST 1.1)
• People who have at least one area of cancer that a doctor can reach with a special light-based treatment, either by inserting a fibre-optic device into the tumour or by shining light on it from outside the body
• People whose blood test results show that immune cell counts, platelet counts, liver function, and kidney function all fall within the ranges required by the trial
• People who have not received a blood transfusion in the two weeks before screening
• Women who could become pregnant must have a negative pregnancy test at the start of screening, and must agree to use two highly effective forms of contraception, or be surgically sterile, or abstain from heterosexual activity throughout the study and for 120 days after the last dose of the anti-PD-1 treatment; if pregnancy occurs or is suspected during the study, the treating doctor must be informed immediately
• Men must agree to use a highly effective form of contraception from the first dose of study treatment through to 120 days after the last dose of the anti-PD-1 treatment
• People who understand the investigational nature of the study and sign the required consent form before any study procedures begin

Who may not be able to join:

• People who have received another experimental treatment within 30 days before starting this trial, or within a timeframe shorter than four half-lives of a previous drug
• People who have had major surgery requiring general anaesthetic within four weeks before the first dose, or who will not have fully recovered from surgery by the time the first dose is given
• People who received chemotherapy or a combination of chemotherapy and immunotherapy within 21 days before scheduled procedures, or who have not yet recovered from side effects of those treatments
• People who received high-dose or curative radiation therapy to the tumour/s being targeted within 30 days before the planned light-based treatment
• People who still have side effects from previous cancer treatments that have not settled back to a mild level or baseline (with some exceptions, such as hair loss, skin colour changes, mild nerve-related symptoms, or stable hormone-related conditions)
• People who had to permanently stop a previous cancer treatment because of a serious immune-related side effect
• People who have had an organ transplant or a stem cell transplant
• People with certain heart rhythm or electrical problems detected on a heart tracing (ECG) that fall outside acceptable limits — although people with a clinically stable pacemaker may still be eligible (confirm with trial site)
• People who have had a serious heart-related event within the six months before signing the consent form, such as a heart attack, severe chest pain, heart bypass surgery, serious irregular heartbeat, severe heart failure, stroke, mini-stroke, or heart muscle inflammation
• People who have an active bleeding disorder, or who need blood-thinning medication that cannot be safely paused or changed around the time of procedures
• People whose brain cancer spread (brain metastases) is untreated or causing symptoms — however, people whose brain metastases have been treated and have been stable for at least 28 days since their last radiation treatment, and who do not need steroids to manage symptoms, may be eligible
• People with a known history of hepatitis B, hepatitis C, or HIV — with some specific exceptions based on test results (confirm with trial site)
• People with an active autoimmune condition that requires systemic steroids or immune-suppressing medications — some mild autoimmune skin conditions or hormone-related conditions managed with hormone replacement may be exceptions (confirm with trial site)
• People who have taken immune-suppressing medications such as steroids (beyond short-term or replacement use), azathioprine, tacrolimus, or cyclosporine within four weeks before joining the study
• People who have had a severe (grade 3 or higher) allergic reaction to a drug called cetuximab
• People with interstitial lung disease or current active non-infectious inflammation of the lungs
• People with active or previously documented autoimmune or inflammatory conditions such as inflammatory bowel disease, lupus, sarcoidosis, rheumatoid arthritis, or similar conditions — with some exceptions including vitiligo, hair loss, stable hypothyroidism on hormone replacement, chronic skin conditions not needing systemic treatment, no active disease in the last five years, or celiac disease managed by diet alone
• People with serious uncontrolled illnesses such as active infections, uncontrolled heart failure, unstable chest pain, uncontrolled irregular heartbeat, or mental health or social circumstances that would make it difficult to follow the study requirements
• People whom the treating doctor considers unsuitable to receive the study drug (ASP-1929) or the light-based or immunotherapy treatments, for any reason
• People who are pregnant or breastfeeding
• People who are unwilling or unable to follow the study's requirements

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