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 diagnosed with small-cell lung cancer (SCLC), confirmed by a tissue or cell sample test.
• People aged 18 or older, of any gender.
• People whose doctors estimate they have a life expectancy of at least 12 weeks.
• People whose cancer got worse at least 60 days after finishing a first course of treatment that included at least 4 cycles of platinum-etoposide chemotherapy combined with either atezolizumab or durvalumab (and who have not received any other treatment since, except for immunotherapy as maintenance).
• People who have not previously had radiation therapy to the one site where the cancer is now progressing — unless that site later showed new signs of the cancer getting worse.
• People with a functional ability score of 0, 1, or 2 on the ECOG scale, meaning they are able to carry out some or all daily activities (confirm with trial site).
• People who have brain metastases that have already been treated, or that are present but causing no symptoms, and who are either not taking steroids or are on a low, stable steroid dose (no more than the equivalent of 10 mg of prednisone per day) — provided radiation treatment to the brain was completed at least 14 days before joining and side effects have mostly resolved.
• Women who are past menopause (no period for 12 or more months), have had surgery to prevent pregnancy, or — if able to become pregnant — have a negative pregnancy blood test before joining and agree to use two effective forms of contraception at the same time for 5 months after the last dose of study treatment, or to abstain from sex in a way consistent with their usual lifestyle.
• Men who agree to use effective barrier contraception (such as condoms) throughout treatment and for 6 months after the last dose, or to abstain from sex in a way consistent with their usual lifestyle — even if they have had a vasectomy.
• People whose blood test results meet the required levels for immune cells, platelets, red blood cells, liver function, kidney function, and blood clotting (confirm specific values with trial site).
• People who have tested negative for HIV, or who are HIV-positive but stable on HIV treatment with adequate immune cell counts and undetectable virus levels.
• People who have tested negative for active hepatitis B and hepatitis C infections (specific test combinations apply — confirm with trial site).
• People who have been in a stable health condition, with no serious infections, sudden worsening of ongoing illness, or major surgery in the 4 weeks before joining.
• People who have mostly recovered from side effects of previous cancer treatment (side effects should be mild or gone, except for hair loss).
• People who had prior radiation therapy, provided it was completed more than 2 weeks before starting this trial and side effects have mostly resolved.
• People who are able to follow the trial requirements and provide written consent to participate.

Who may not be able to join:

• People who have already received more than one course of treatment for their small-cell lung cancer.
• People whose first treatment did not include either atezolizumab or durvalumab.
• People whose first-line chemotherapy did not use the platinum-etoposide combination.
• People who received fewer than 4 cycles of platinum-etoposide as first-line treatment.
• People whose cancer came back or got worse within 60 days of finishing first-line chemotherapy, or whose cancer progressed during the first 4 cycles of treatment.
• People with brain metastases causing symptoms, or spinal cord compression, that require urgent radiation treatment.
• People whose brain metastases are located in certain parts of the brain (the midbrain, pons, medulla, or spinal cord) (confirm with trial site).
• People who show signs of cancer spreading to the lining around the brain or spinal cord.
• People with other health conditions or unresolved side effects that would prevent them from safely receiving second-line chemotherapy.
• People who have received a live-virus vaccine within 30 days before planned treatment (seasonal flu shots and COVID vaccines without live virus are permitted).
• People who have recently received certain immune-boosting medications (such as interferon or IL-2) within 4 weeks or 5 drug half-lives before starting treatment — except for PD-L1 inhibitor maintenance from first-line treatment.
• People who need regular systemic steroid or immunosuppressant treatment, with some exceptions such as low-dose steroids, inhaled or topical steroids, or steroids used to prevent allergic reactions.
• People who have been diagnosed with or treated for another cancer in the past 3 years, or who still have signs of a previous cancer — with some exceptions for certain types of fully removed skin cancer or non-spreading cell changes.
• People currently receiving other cancer treatments outside of this trial.
• People who have taken another experimental drug within 30 days before starting this trial, or who are currently enrolled in another interventional clinical trial.
• People who have had a serious infection requiring intravenous antibiotics within 14 days before the first dose.
• People who have previously had a bone marrow or organ transplant from another person.
• Women who are pregnant, have a positive pregnancy test, or are breastfeeding.
• People who have had major surgery within 4 weeks before joining the trial (or minor surgery within 2 weeks) and have not fully recovered — note that insertion of a vascular access device is allowed.
• People who had significant or severe side effects (grade 3 or higher) from their first-line immunotherapy.
• People who are unwilling or unable to follow the trial requirements or work with the trial team.

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