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:

• Adults aged 18 or older who have been diagnosed with extensive-stage small cell lung cancer (ES SCLC), confirmed by a laboratory tissue or cell test.
• People whose ES SCLC has not yet been treated with any systemic (whole-body) therapy — meaning the cancer is newly diagnosed and untreated. People previously treated for limited-stage SCLC may also be considered, provided they had at least 6 months free of disease after finishing all prior treatment.
• People who have recovered from side effects of any previous cancer treatments, with most side effects reduced to mild or back to their normal baseline level. Those with certain hormone-related side effects being managed with replacement therapy, or mild-to-moderate nerve-related side effects, may still be considered.
• People who provide written consent to participate (or whose legal representative does so on their behalf).
• People who have measurable disease that can be tracked using standard imaging criteria (RECIST 1.1). Tumours in previously treated areas may count if they have shown signs of growth.
• People who can provide a tumour tissue sample — either a stored sample or a newly taken biopsy from a tumour that has not been previously treated with radiation.
• People with asymptomatic (not causing symptoms) brain metastases may be considered.
• People with a good general physical functioning level, rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light work), assessed within 3 days before starting treatment.
• People with a life expectancy of more than 3 months.
• People whose liver, kidneys, blood, and other organs are functioning adequately, based on blood tests taken within 10 days before starting treatment.
• Women who are not pregnant, not breastfeeding, and either cannot become pregnant, or who agree to use reliable contraception during treatment and for at least 120 days after the last dose of study treatment.

Who may not be able to join:

• People who have previously been treated with certain types of immune checkpoint therapy (such as anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or similar agents targeting the immune system's T-cell receptors, such as CTLA-4 therapies).
• People who have received systemic cancer treatment, biological therapies, or experimental treatments within 4 weeks before starting the trial.
• People who have received radiotherapy, chemotherapy, or targeted drug therapy within 2 weeks before starting the trial and have not recovered from the side effects, or who needed steroids to manage radiation-related side effects. (Short palliative radiotherapy to non-brain areas may be permitted if the last treatment was at least 7 days before the first trial dose — confirm with trial site.)
• People who have not recovered from side effects of a previously received cancer treatment (side effects rated Grade 2 or higher are considered not recovered). Note: nerve damage or hair loss of any grade are exceptions to this rule.
• People who have previously received a specific class of chemotherapy drugs called topoisomerase 1 inhibitors.
• People who have received a live or live-attenuated vaccine within 30 days before the first dose of trial treatment.
• People who have used another experimental drug within 28 days or 5 half-lives of the first dose (whichever is longer).
• People with a known allergy or sensitivity to any of the study drugs or their ingredients.
• People with an immune deficiency condition, or who are taking high-dose steroid medication (more than 10 mg of prednisone or equivalent per day) or other immune-suppressing treatments within 7 days before the first dose.
• People who have another cancer that is currently active or has required treatment within the past 3 years. Some exceptions apply — such as certain skin cancers treated with curative intent, or low-risk early prostate cancer under active monitoring with stable disease (confirm with trial site).
• People with active, spreading cancer in the brain or the lining of the brain (carcinomatous meningitis). People with previously treated and now stable brain metastases may be considered, provided they have shown no signs of progression for at least 4 weeks, are clinically stable, and have not needed steroid treatment for at least 14 days before starting the trial.
• People with an active autoimmune disease that has needed systemic treatment within the past 2 years. Hormone or standard physiologic replacement therapies are generally not excluded (confirm with trial site).
• People who have had inflammation of the lungs (pneumonitis or interstitial lung disease) that required steroid treatment in the past, or who currently have this condition.
• People with an active infection that requires treatment with systemic medications.
• People with active chronic inflammatory bowel disease (such as ulcerative colitis or Crohn's disease), or who have had a bowel perforation within the past 6 months.
• People with a history of, or currently active, hepatitis B or hepatitis C infection.
• People who have not fully recovered from a major surgery or who have ongoing surgical complications.
• People with any other medical condition, treatment history, or circumstance that the treating doctor believes could affect the trial results or make participation not in the person's best interest.
• People with known psychiatric conditions or substance use disorders that would make it difficult to follow the trial requirements.
• People who are pregnant, breastfeeding, or planning to conceive a child during the study period or within 120 days after the last dose of treatment (applies to all participants, including those who could father children).
• People who have received an organ or tissue transplant from another person (allogeneic transplant).
• People with a known history of HIV infection.

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