Phase 1 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
• People who have been confirmed to have non-small cell lung cancer that has come back or spread to other parts of the body, with no curative treatment options available
• People whose cancer can be measured on scans using standard criteria (called RECIST v1.1)
• People who have already received standard chemotherapy and/or immunotherapy (there is no limit on how many previous treatments someone has had, and prior immunotherapy targeting PD-1 or PD-L1 is allowed)
• People with a type of lung cancer called adenocarcinoma who have already received all approved targeted treatments relevant to their specific gene mutation (for example, osimertinib for an EGFR mutation, or alectinib for an ALK mutation); this genetic testing requirement does not apply to people with squamous cell lung cancer
• People who are reasonably functional in daily life — specifically, those with an ECOG performance score of 0, 1, or 2 (confirm with trial site what this score means for your situation)
• People whose blood cell counts, kidney function, liver function, and blood clotting results meet specific levels shown in standard blood tests (the trial site will assess these)
• People with a life expectancy of at least 3 months
• People who are willing and able to follow all study procedures
• Women who could become pregnant must have a negative pregnancy blood test at the start of the study, and agree to use highly effective contraception (less than 1% failure rate per year) or remain abstinent during treatment and for 5 months after the last dose of one study drug (atezolizumab) and 24 months after the last dose of another study drug (vismodegib); they must also agree not to donate eggs during this period
• Men with a female partner who could become pregnant or who is pregnant must agree to use a condom or remain abstinent, and not donate sperm, during treatment and for 5 months after the last dose of atezolizumab and 24 months after the last dose of vismodegib
• People willing to sign an informed consent form
• People who can provide a stored tumour tissue sample (a preserved tissue block or at least 10–15 slides) taken within the past year
• People who are willing to have a tumour biopsy taken during treatment (though exceptions may be made if a biopsy is not safely possible)
• People who test negative for HIV, or who test positive but are stable on HIV treatment with a CD4 count above 200 and an undetectable viral load
• People who test negative for hepatitis B, or who have chronic hepatitis B that is being managed with suppressive therapy and shows an undetectable viral load
• People who test negative for hepatitis C, or who test positive for hepatitis C antibodies but then test negative on a follow-up RNA test

Who may not be able to join:

• People with an active autoimmune disease that currently requires treatment (such as lupus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, or others), with some exceptions: people with stable hypothyroidism managed by thyroid hormone replacement, controlled type 1 diabetes managed with insulin, or mild skin conditions (such as eczema, psoriasis, or vitiligo affecting only the skin and covering 10% or less of the body surface, well-controlled with only low-strength topical creams) may still be eligible
• People who are currently enrolled in another clinical trial using an experimental treatment, or who have received an experimental treatment within the past 4 weeks
• People who have been diagnosed with an immune system deficiency, or who are taking steroid medications at doses higher than 10 mg of prednisone (or equivalent) or other immune-suppressing medications within 14 days before starting the trial
• People with moderate to severe liver scarring (cirrhosis rated Child-Pugh B or worse), or cirrhosis with a history of brain confusion caused by liver failure, or significant fluid build-up in the abdomen due to cirrhosis that requires medications or drainage procedures
• People with brain or spinal cord metastases that are causing symptoms; people with treated and stable brain metastases may be eligible if certain additional conditions are met (confirm with trial site)
• People who are pregnant, breastfeeding, or planning to become pregnant during the study or within 5 months of the last dose of atezolizumab or 24 months of the last dose of vismodegib; women who could become pregnant must have a negative blood pregnancy test within 14 days before starting treatment
• People whose medical history, current health conditions, or test results might interfere with their ability to safely complete the trial, as determined by the treating doctor
• People with any other serious disease or finding that would make taking an experimental drug unsafe or make it difficult to interpret results
• People with a history of certain lung inflammation conditions (such as idiopathic pulmonary fibrosis, organising pneumonia, drug-induced lung inflammation, or unexplained lung inflammation), or who show signs of active lung inflammation on a chest CT scan at the start of the study
• People with known active tuberculosis (testing is only required if the treating doctor considers it clinically necessary)
• People who have had a serious heart or blood vessel event (such as a heart attack or stroke) within the past 3 months, or who have an unstable heart rhythm or unstable chest pain
• People who have had a major surgical procedure (not including surgery done for diagnosis purposes only) within the past 4 weeks, or who are expected to need major surgery during the study
• People who have had a severe infection within the past 4 weeks (for example, being hospitalised for an infection, a blood infection, or severe pneumonia), or who have any active infection that could affect their safety
• People who have been treated with antibiotic tablets or intravenous antibiotics (for treatment purposes, not prevention) within the past 2 weeks; people taking preventive antibiotics may still be eligible
• People who have previously had a stem cell transplant from a donor or a solid organ transplant (such as a kidney or liver transplant)
• People who have received a live vaccine (such as a flu nasal spray vaccine) within 4 weeks before starting the trial, during treatment with atezolizumab, or within 5 months after the last dose of atezolizumab
• People who have received certain immune-boosting medications (such as interferon or interleukin-2) within 4 weeks or 5 half-lives of the drug before starting the trial, whichever is longer
• People who have had a severe allergic reaction to certain types of antibody-based medicines
• People with a known allergy to the components of atezolizumab or to products made using Chinese hamster ovary cells (a type of cell used in manufacturing some medicines)
• People who previously had a serious side effect from a checkpoint inhibitor immunotherapy, specifically a Grade 3 or higher side effect, a Grade 2 or higher immune-related side effect, or any heart, eye, or brain-related side effect of any severity; people who had a hormone-related side effect from a checkpoint inhibitor may still be eligible if they are stable on replacement therapy and have no symptoms

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