Phase 4 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 have been confirmed through a tissue or cell sample to have stage III non-small cell lung cancer (a specific type that does not involve certain lymph node areas called N3), before starting combined chemotherapy and radiation treatment.
• People whose cancer spread to nearby lymph nodes (N2) has been confirmed through specialised procedures to look inside the chest (confirm with trial site).
• People whose medical team has recommended a non-surgical treatment plan involving combined chemotherapy and radiation (using a platinum-based drug combination, at a specific dose and schedule), followed by a drug called durvalumab.
• People who are able to understand and sign a consent form agreeing to take part in the study.
• People who are older than 18 years at the time of signing the consent form.
• People who have a good general level of physical functioning, scored 0 or 1 on a standard scale used by doctors (ECOG scale), at the time of re-assessment.
• People who weigh more than 30 kg.
• People whose heart, liver, kidneys, and blood counts are at levels the treating doctor considers acceptable for combined chemotherapy and radiation treatment.
• People who are willing and able to attend all required appointments and follow all study procedures for the full length of the trial.
• People who have a life expectancy of at least 12 weeks.

Who may not be able to join:

• People whose cancer has spread to certain lymph node areas (N3) or to other parts of the body (M1/distant spread).
• People whose lung cancer has a known genetic change that can be targeted with specific treatments.
• People who would receive a chemotherapy and radiation schedule different from the one specified in the study protocol.
• People considered unable to have surgery due to heart or lung function problems or other serious health conditions.
• People who are unable to have a CT scan using an injected contrast dye.
• People who are unable to lie flat on their back for at least 15 minutes for a PET/low-dose CT scan.
• People who have previously been treated with certain types of immunotherapy drugs that work on immune checkpoint pathways (such as anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 medicines).
• People who have taken part in another clinical trial involving an experimental treatment in the past 4 weeks.
• People currently enrolled in another clinical trial involving an active treatment (observational studies or follow-up phases may be exceptions — confirm with trial site).
• People who still have significant side effects (grade 2 or higher on a standard scale) from a previous cancer treatment, with some exceptions such as hair loss or skin colour changes (confirm with trial site).
• People who received their last cancer treatment within 4 weeks before the first study dose, or who may need a longer gap depending on the specific treatment previously used.
• People currently receiving any other chemotherapy, immunotherapy, targeted therapy, or hormonal cancer treatment at the same time (hormonal treatment for non-cancer conditions may be acceptable — confirm with trial site).
• People who have had a major surgical procedure within 28 days before the first study dose.
• People who have had an organ transplant from another person.
• People with a current or past history of autoimmune or inflammatory conditions (such as inflammatory bowel disease, lupus, rheumatoid arthritis, or similar conditions), with some exceptions including well-controlled thyroid conditions, vitiligo, alopecia, certain skin conditions not needing systemic treatment, celiac disease controlled by diet, or conditions with no active disease in the last 5 years (confirm with trial site).
• People with serious uncontrolled illnesses such as active infections, heart failure, uncontrolled high blood pressure, unstable chest pain, irregular heart rhythms, lung inflammation, serious bowel conditions causing diarrhoea, or significant mental health or social circumstances that could affect participation.
• People with a history of another cancer, unless it was treated with the aim of cure, has shown no signs of returning for at least 5 years, and carries a low risk of coming back — with some exceptions for certain treated skin conditions or pre-cancerous changes (confirm with trial site).
• People with a history of cancer spreading to the lining around the brain or spinal cord.
• People with a history of a primary immune deficiency condition.
• People with active hepatitis infection, or certain positive hepatitis B or C test results at screening, with some exceptions for past resolved infections depending on specific test results (confirm with trial site).
• People known to be HIV positive or to have an active tuberculosis infection.
• People who have used immune-suppressing medications in the 14 days before the first dose of durvalumab, with some exceptions for low-dose steroids, inhaled or topical steroids, or steroids used to prevent allergic reactions (confirm with trial site).
• People who have received a live vaccine within 30 days before the first study dose.
• People who are pregnant or breastfeeding, or people of reproductive potential who are not willing to use effective contraception from the start of screening until 90 days after the last dose of durvalumab.
• People with a known allergy or sensitivity to any of the study drugs or their ingredients.
• People who have previously taken part in another clinical trial involving durvalumab.
• People whom the trial doctor considers unsuitable to participate or unlikely to follow study requirements.

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