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 or older at the time of signing the consent form
• People who have been diagnosed with extensive-stage small-cell lung cancer (a type of lung cancer that has spread widely), confirmed through a tissue or cell sample, with measurable disease visible on scans
• People whose cancer has spread to other parts of the body, or whose cancer is too widespread for standard radiation treatment fields (as assessed by a radiation specialist)
• People who are reasonably active and able to care for themselves, with a functional ability score rated 0, 1, or 2 on a standard medical scale (confirm with trial site)
• People whose blood test results meet certain minimum levels for white blood cells, platelets, and red blood cells (specific thresholds will be checked by the trial team)
• People whose liver function blood tests are within an acceptable range
• People whose kidney function is within an acceptable range
• People whose blood clotting results are within an acceptable range, or who are on a stable blood-thinning medication
• People who test negative for HIV, or who test positive but are stable on HIV treatment, have an adequate immune cell count, and have an undetectable viral load
• People who test negative for Hepatitis B
• People who have cancer that has spread to the brain, provided it is being managed appropriately if causing symptoms
• Women who are not pregnant and not breastfeeding
• Women who could potentially become pregnant and who are willing to use highly effective contraception (failure rate below 1% per year) during treatment and for 5 months after the last dose of the study drug atezolizumab
• Men with a female partner who could become pregnant, who are willing to use a condom plus an additional highly effective contraceptive method during treatment and for 5 months after the last dose of atezolizumab, and who agree not to donate sperm during this period
• Men with a pregnant partner who are willing to use a condom during treatment and for 5 months after the last dose of atezolizumab
• People whom the study doctor considers suitable for an immunotherapy-based treatment plan
• People who are able to provide written informed consent

Who may not be able to join:

• People who have had major surgery requiring general anaesthesia within 4 weeks before enrolling, if this would prevent participation in the treatment plan
• People with a significant active or chronic infection, including active tuberculosis, Hepatitis C not on a stable antiviral treatment, or Hepatitis B requiring current antiviral treatment
• People who have had a serious heart or blood vessel event (such as a heart attack or stroke) within 3 months before starting treatment, or who have an unstable heart rhythm or unstable chest pain
• People with high blood pressure that is not controlled by medication (unless an effective blood pressure treatment is started before joining)
• People who have had another cancer within the past 3 years, with some exceptions for low-risk skin cancers or other cancers with a very low chance of spreading or causing death
• People who have already received chemotherapy or cancer-targeting biological or immunotherapy treatment for this current cancer, with one exception: one cycle of a first-line treatment that matches what is used in this trial may be allowed
• People who have had previous radiation treatment that would make it unsafe to deliver the radiation planned in this trial
• People who have received a live vaccine within 28 days before starting treatment, or within 5 months after the last dose of atezolizumab
• People taking certain medications that are not permitted during the trial (confirm with trial site for the full list)
• People currently enrolled in another clinical trial (unless it is an observational study or a follow-up phase)
• People with a confirmed cancerous fluid buildup around the lungs
• People with uncontrolled fluid buildup around the lungs, heart, or abdomen that requires drainage more than once a month (people with a permanent drainage tube in place may still be eligible)
• People with a history of cancer spreading to the lining of the brain or spinal cord
• People with pain from their cancer that is not well controlled, unless they are on a stable pain medication regimen
• People with uncontrolled high calcium levels in the blood
• People with an active autoimmune disease or immune system disorder (such as lupus, rheumatoid arthritis, multiple sclerosis, or inflammatory bowel disease), with some exceptions for well-controlled thyroid conditions, well-controlled Type 1 diabetes, and certain mild skin conditions that meet specific criteria
• People with a history of serious lung scarring or inflammation conditions, or who have signs of active lung inflammation on a recent chest scan
• People who have had a severe infection requiring hospitalisation within 4 weeks before starting treatment
• People who have received antibiotic treatment (by mouth or through a drip) within 2 weeks before starting treatment, unless the antibiotics are being taken to prevent infection rather than treat one
• People who have previously received a donor stem cell or organ transplant
• People with any other serious illness, abnormal test finding, or condition that the study doctor believes would make participation unsafe or affect the reliability of the results
• People who have taken another experimental treatment within 28 days before starting this trial
• People who have previously been treated with certain types of immune checkpoint therapy, including anti-CTLA-4 or anti-PD-L1 antibodies
• People who have received immune-stimulating medications (such as interferon or IL-2) within 4 weeks, or within 5 half-lives of that drug, before starting treatment
• People who have received immune-suppressing medications (such as corticosteroids, methotrexate, or certain other drugs) within 2 weeks before starting treatment, with some exceptions for low-dose or short-course use
• People with a history of severe allergic reactions to certain types of laboratory-produced antibody medications
• People with a known allergy to any ingredient in the study drug atezolizumab, or to products made using a particular cell manufacturing process (confirm with trial site)
• People who are pregnant, breastfeeding, or planning to become pregnant during treatment or within 5 months of the last dose of atezolizumab; women who could potentially become pregnant must have a negative pregnancy blood test within 14 days before starting treatment

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