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 aged 18 to 75 years, either male or female, who have signed and dated a consent form before any study steps begin.
• People who have been diagnosed with small cell lung cancer (SCLC), confirmed through a tissue or cell sample test.
• People with Stage I, II, or III SCLC (limited-stage disease), where all affected areas can be treated within a single radiotherapy plan; Stage I or II must be considered unsuitable for surgery.
• People with a life expectancy of at least 12 weeks.
• People with a general health score of 0 or 1 on the WHO Performance Status scale, meaning they are fully active or able to carry out light activity.
• Women who are past menopause, or women who have had a negative pregnancy test within 7 days before starting treatment.
• Women who are not breastfeeding.
• Women who could become pregnant must agree to use contraception during treatment and for 3 months after the last dose of the study drug.
• Men who have sexual contact with women who could become pregnant must agree to use contraception during treatment and for 5 months after the last dose of the study drug.
• Men who have a medical condition causing no sperm production (azoospermia) are not required to follow the contraception rules.
• Women who could become pregnant but are not sexually active are not required to use contraception, but pregnancy testing is still required.
• People whose lungs, blood, kidneys, and liver are functioning at acceptable levels as measured by specific laboratory tests (confirm details with trial site).

Who may not be able to join:

• People who are currently taking part in another clinical trial that involves an active treatment or intervention.
• People whose lung cancer has been identified as a mixed type containing both small cell and non-small cell lung cancer.
• People diagnosed with extensive-stage SCLC, meaning the cancer has spread beyond what can be treated in a single radiotherapy plan.
• People who have been confirmed to have cancer-related fluid build-up around the lungs or heart.
• People with a tumour near the airways that is causing coughing up of more than 50 ml of blood per day.
• People who have used immune-suppressing medications within 28 days before the first dose of the study drug (low-dose steroids at or below 10 mg of prednisone daily, or steroids used to manage side effects from treatment, are exceptions).
• People who have previously been treated with a type of immunotherapy drug known as anti-PD-1 or anti-PD-L1 antibodies.
• People who have had major surgery (not including procedures for placing a vascular access line) within 4 weeks before joining the study.
• People with a history of certain autoimmune diseases in the past 2 years, such as lupus, rheumatoid arthritis, multiple sclerosis, or similar conditions (confirm full list with trial site).
• People with a history of a condition where the immune system does not work properly from birth (primary immunodeficiency).
• People who have had an organ transplant that requires ongoing immune-suppressing medication.
• People whose heart's electrical activity shows a prolonged QT interval on three separate ECG readings (confirm threshold details with trial site).
• People with ongoing or poorly controlled health conditions such as active infections, heart failure, uncontrolled high blood pressure, unstable chest pain, certain heart rhythm problems, active stomach ulcers, bleeding disorders, hepatitis C, HIV, active hepatitis B (with high viral levels), or certain mental health or social conditions that could affect study participation.
• People with a known history of tuberculosis.
• People who have received a live vaccine within 30 days before starting the study.
• People who have had another type of cancer within the past 5 years, except for certain early-stage or skin cancers that have been fully treated (confirm exceptions with trial site).
• People who are pregnant, breastfeeding, or not using effective contraception when required.
• People with any other condition that could interfere with assessing how well or how safely the study drug works, as determined by the treating doctor.
• People who, in the opinion of the treating doctor, are not suitable for any other reason.

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