Phase 2 Lung Cancer Trial, Recruiting

Written by an AI model from the 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 newly diagnosed with small cell lung cancer (SCLC), confirmed by a tissue or cell sample.
• People whose cancer is at an advanced (extensive) stage, meaning it has spread to distant parts of the body (Stage IV).
• People who have at least one tumour that can be measured using standard imaging guidelines (known as RECIST 1.1), as assessed by the trial site.
• People with a life expectancy of at least 3 months.
• People who are generally able to carry out basic daily activities with little to no limitation (rated 0 or 1 on a standard medical scale called the ECOG scale).
• People who are 18 years of age or older at the time of signing the consent form.
• People who are willing and able to provide written consent to participate (or have a legally accepted representative do so on their behalf).
• People whose liver, kidneys, and other organs are functioning adequately, as assessed by the trial site.
• People who have hepatitis B and are on antiviral treatment for at least 4 weeks, with no detectable virus in the blood before starting treatment.
• People with a history of hepatitis C whose virus is undetectable at the screening stage, and who have completed curative antiviral treatment at least 4 weeks before starting the trial.
• Male participants who agree to use contraception during treatment and for at least 180 days after the last dose, and agree not to donate sperm during this time.
• Female participants who are not pregnant and not breastfeeding.

Who may not be able to join:

• People who have previously received any systemic (whole-body) treatment for SCLC.
• People who have had radiotherapy within 2 weeks before starting the trial, or who have not fully recovered from radiation side effects, or who needed steroids due to radiation, or who have had radiation-related lung inflammation (confirm with trial site for details on short-course palliative radiation exceptions).
• People who are currently taking part in another clinical trial or who have received an experimental treatment or used an experimental device within 4 weeks before the first dose.
• People who are expected to need any other cancer treatment for SCLC, including radiation, while taking part in the trial.
• People with active, spreading cancer in the brain or the lining around the brain. People with previously treated and stable brain metastases may still be considered, provided they meet specific stability criteria assessed by the trial site.
• People who have had major surgery within 3 weeks before the first dose, or who have not fully recovered from a previous surgical procedure.
• People who have an active autoimmune disease that has required systemic medical treatment in the past 2 years (hormone replacement therapies such as thyroxine or insulin are not considered systemic treatment under this criterion).
• People with significant fluid build-up around the lungs, abdomen, or heart that is causing symptoms. People whose condition has been treated and is considered clinically stable may still be considered.
• People who have another cancer that is currently active or has required treatment within the past 3 years (certain treated skin cancers and non-bladder carcinoma in situ may not be excluded — confirm with trial site).
• People who have had a severe allergic reaction (Grade 3 or above) to pembrolizumab or plinabulin, or any of their ingredients.
• People who have a history of non-infectious lung inflammation (pneumonitis or interstitial lung disease) that required steroid treatment, or who currently have this condition.
• People with a known history of HIV infection.
• People with known psychiatric conditions or substance use disorders that would make it difficult to follow the trial requirements.
• People who have previously received certain immune checkpoint therapy drugs (such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or similar), or who have previously taken part in a clinical trial of pembrolizumab or plinabulin.
• People who have had an organ or tissue transplant from another person.
• People who have received a live vaccine (such as measles, chickenpox, yellow fever, or live nasal flu spray) within 30 days before the first dose. Standard injected flu vaccines are generally permitted — confirm with the trial site.
• People with a known history of active tuberculosis (TB).
• People with other serious medical conditions that the trial investigator considers would put them at excessive risk, such as uncontrolled diabetes, severe infection, liver failure, or significant mental status changes.
• People who are pregnant, breastfeeding, or planning to conceive or father a child during the trial period or within 180 days after the last dose.
• People with an active, uncontrolled bacterial, viral, or fungal infection that requires systemic treatment.
• People who have been diagnosed with an immune deficiency condition, or who are receiving high-dose steroid therapy (above 10 mg of prednisone daily or equivalent) or other immune-suppressing treatment within 7 days before the first dose.

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