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 have been diagnosed with small cell lung cancer (SCLC), confirmed through a laboratory test of tumour tissue or cells.
• People who have already completed at least 4 cycles, and no more than 6 cycles, of a standard chemotherapy and immunotherapy combination (platinum-etoposide chemotherapy plus either atezolizumab or durvalumab), where the cancer either responded or stayed stable during that treatment. Up to 2 missed doses of the immunotherapy drug are permitted.
• People aged 18 or older.
• People who weigh at least 50 kg.
• People who are able to swallow tablets or capsules.
• People whose general health and ability to carry out daily activities meets a certain level, as assessed using a standard medical scale (ECOG score of 2 or less, or Karnofsky score of 60% or more), measured after completing 4 cycles of the standard chemotherapy and immunotherapy.
• People whose blood test results meet certain minimum levels, including white blood cells, a type of white blood cell called lymphocytes, another type called neutrophils, red blood cell levels (haemoglobin), and platelets.
• People whose blood protein (albumin) levels are at or above a certain level.
• People whose liver function blood test results are within acceptable ranges.
• People whose kidneys are filtering blood at an adequate rate (GFR of at least 45 mL/min).
• People living with HIV who are on effective treatment and have had an undetectable viral load within the past 6 months.
• People with a history of hepatitis B virus (HBV) who are on appropriate treatment and have an undetectable viral load.
• People with a history of hepatitis C virus (HCV) who have been fully treated and cured, or who are currently on treatment with an undetectable viral load.
• People who have brain metastases (cancer that has spread to the brain) that have been treated, provided steroid doses are not being increased. People with very small, symptom-free, untreated brain metastases (5 mm or smaller, without significant swelling) may also be eligible, provided these did not appear after chemotherapy was completed.
• People who have had or currently have another type of cancer, provided that other cancer and its treatment are not expected to interfere with this trial's safety or results.
• Women who are post-menopausal or who have a negative pregnancy test before joining. Post-menopausal status is defined differently depending on age, and the trial site can clarify which conditions apply.
• Women of childbearing potential and men whose partners could become pregnant who agree to use reliable contraception (hormonal methods, barrier methods, or abstinence) from before joining the trial until 150 days after the last dose of study treatment.
• Women of childbearing potential who agree not to donate or freeze eggs during the trial and for 150 days after the last dose.
• Male participants, including those who have had a vasectomy, who agree not to donate or freeze sperm during the trial and for 150 days after the last dose.
• People who are willing and able to provide written informed consent. A legally authorised representative may provide consent on a participant's behalf.

Who may not be able to join:

• People who received maintenance immunotherapy before the trial's first treatment day.
• People currently taking certain antidepressant medications — specifically tranylcypromine or phenelzine — which interact with one of the trial drugs.
• People who have not yet recovered from moderate or severe side effects (grade 2 or higher) from previous cancer treatment, with the exception of hair loss, a skin condition called vitiligo, and blood results that fall within the ranges listed in the inclusion criteria. People with moderate or severe nerve-related side effects will be reviewed individually by the study doctor.
• People who are currently taking part in another clinical trial or receiving any other cancer treatment within 4 weeks (or within a time period based on how long that drug stays in the body, whichever is shorter) before joining.
• People who have received immune-stimulating treatments (such as interferon or interleukin-2) within 4 weeks or five drug half-lives before the first treatment day, whichever is longer.
• People who have received immune-suppressing medications (such as prednisone, methotrexate, or anti-TNF drugs) within 2 weeks before joining, or who are expected to need such medications during the trial. Some exceptions apply, such as single short-course doses, or low-dose corticosteroids used for specific conditions such as asthma or low blood pressure — the trial site can confirm whether a particular medication is an exception.
• People with a history of serious allergic reactions to drugs chemically similar to the trial treatments, including reactions to certain types of antibody-based medicines.
• People who need to take immune-stimulating agents, immune-suppressing medications, herbal remedies, or natural supplements during the trial. People taking herbal or alternative treatments must stop these at least 1 week before joining.
• People who need to take EGFR-targeted therapy (a specific type of cancer drug) alongside durvalumab.
• People who need to take preventive blood cell-stimulating injections (such as G-CSF) alongside iadademstat, or who use any complementary or alternative medicines.
• People who have received an organ transplant from another person (allogeneic transplant).
• People with active tuberculosis (TB).
• People with other serious uncontrolled medical conditions that would make participation unsafe.
• People with a history of certain lung conditions, including idiopathic pulmonary fibrosis, drug-induced lung inflammation, or organising pneumonia. People with evidence of active lung inflammation on a recent chest scan are also excluded. A history of radiation-related lung scarring (fibrosis) is permitted.
• People with certain heart conditions, including unstable chest pain (angina), uncontrolled abnormal heart rhythm, a heart attack or stroke within the past 3 months, a specific type of abnormal heart electrical reading on a screening test (QTcF above 480 ms), or moderate to severe heart failure (NYHA class 2, 3, or 4). People with a past history of moderate to severe heart failure may still be considered if a recent heart scan shows the heart is pumping adequately (left ventricular ejection fraction of 45% or higher) (confirm with trial site).
• People with a history of certain autoimmune conditions (where the immune system attacks the body), such as lupus, rheumatoid arthritis, multiple sclerosis, and others. Some exceptions may apply, including people with well-controlled underactive thyroid on stable medication, people with well-controlled Type 1 diabetes (HbA1c below 8%) on a stable insulin dose, and people with certain skin conditions covering less than 10% of the body that are well controlled without strong medications. People without active autoimmune disease in the past 5 years may also be considered after consultation with the study doctor.
• People who have received a live attenuated vaccine within 30 days before the first dose. Participants are also asked not to receive most vaccines during the trial and for 30 days after the last dose; exceptions include flu vaccines and vaccines for COVID-19 and pneumococcal infection.
• People who have had major surgery within 4 weeks before joining.
• People who have had radiation therapy within 4 weeks before joining, except for palliative radiation or radiation to the brain or spine.
• People who have a condition affecting how the gut absorbs medication (such as from previous bowel surgery or bowel disease), or who have a bowel stoma, as this may affect how the trial drug is absorbed.
• People with a history of serious bleeding, including any bleeding in the brain, or gastrointestinal bleeding within the past 3 months.
• People with known permanent bleeding disorders or who are taking antiplatelet medications (blood-thinning drugs that prevent clotting) for other health reasons.
• People with uncontrolled disseminated intravascular coagulation (a serious blood clotting condition) (confirm with trial site).
• People who are unwilling or unable to receive blood products if needed.
• Women who are pregnant (due to potential risks to the developing baby from the trial drugs).
• Women who are breastfeeding, unless they agree to stop breastfeeding for the duration of the trial.

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