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 at the time of signing the consent form.
• People with a solid tumour that cannot be cured, who have had detailed genetic testing of their tumour (called whole genome and transcriptome analysis) through a program such as Personalized OncoGenomics (POG) or a similar program.
• People whose tumour was successfully analysed, reviewed by a specialist genomics team, found to have specific markers called "CAPTIV-8 factors" (including a score called IBV of 5 or higher), and assigned to a specific patient group that is currently open for enrolment.
• People whose general health and ability to carry out daily activities meets a standard medical rating of 0, 1, or 2 on a scale used by doctors to measure this (confirm with trial site).
• People who have measurable tumours that can be tracked using standard imaging guidelines.
• People with a life expectancy of at least 12 weeks.
• People whose blood counts and organ function fall within acceptable ranges, based on blood tests taken within 28 days before starting the trial — including healthy enough levels of white blood cells, red blood cells, platelets, liver enzymes, kidney function, and blood clotting (confirm specific values with trial site).
• Women who could become pregnant must agree to either avoid heterosexual intercourse or use highly effective contraception (less than 1% failure rate per year) during treatment and for at least 5 months after the last dose of the study drug atezolizumab.
• Men must agree to either avoid heterosexual intercourse with a partner who could become pregnant or is pregnant, or use highly effective contraception (less than 1% failure rate per year), and must also agree not to donate sperm, during treatment and for at least 5 months after the last dose of atezolizumab.
• People who have brain or spinal tumours but have no symptoms from them may still be considered, provided they have no history of bleeding in the brain or spine, have not had certain recent brain treatments or surgery within specified timeframes, are not currently taking steroids to manage brain tumour symptoms, and still have measurable disease elsewhere (confirm details with trial site).
• People who are able to understand and agree to the study procedures and give informed consent.

Who may not be able to join:

• People who have previously been treated with a type of immunotherapy drug that targets the PD-1 or PD-L1 pathway (including certain antibody-based drugs or experimental treatments of this type).
• People who have received any approved or experimental cancer treatment, or who are currently in another clinical trial with a treatment purpose, within 14 days or five half-lives of the drug (whichever is longer) before joining — except for people taking hormone-suppressing injections (GnRH analogues), who may be able to continue those.
• People who are pregnant or breastfeeding.
• People who have had a serious allergic or severe hypersensitivity reaction to certain types of laboratory-made antibody treatments in the past.
• People with a known allergy to the study drug atezolizumab or to products made using a particular type of laboratory cell (Chinese hamster ovary cells).
• People who have had an active autoimmune disease at any point in the last 2 years — this includes a wide range of conditions such as lupus, rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, and others (confirm full list with trial site). Note: people with autoimmune-related thyroid disease on stable thyroid medication, or with well-controlled Type 1 diabetes on stable insulin, may still be considered.
• People with certain skin conditions such as eczema or psoriasis may be excluded unless their condition affects less than 10% of their body surface, is well controlled with only mild topical treatments, and has not flared up requiring stronger treatments in the last 12 months.
• People with a history of certain lung scarring or inflammation conditions, or who show signs of active lung inflammation on a scan taken at screening. A history of lung scarring caused by radiation treatment in a specific area is generally acceptable.
• People who test positive for HIV (people with a history of HIV or symptoms may still be considered if blood tests come back negative).
• People with hepatitis B virus infection, depending on the results of specific blood tests for hepatitis B (confirm details with trial site).
• People who test positive for both hepatitis C antibodies and active hepatitis C virus in the blood.
• People with active tuberculosis.
• People who have had a serious infection requiring hospitalisation within 2 weeks before starting treatment.
• People with significant heart problems, such as a heart attack within the past 3 months, unstable heart rhythm, unstable chest pain, or moderate-to-severe heart failure.
• People who have had a major surgical procedure within 21 days before starting treatment, or who are expected to need major surgery during the trial.
• 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 certain immune-boosting drugs (such as interferons or IL-2) within 6 weeks or five half-lives of the drug (whichever is shorter) before starting treatment.
• People who have taken steroid medications or other immune-suppressing drugs (such as prednisone, methotrexate, or similar) within 2 weeks before starting treatment, or who are expected to need such medications during the trial.
• People who have received a live vaccine within 4 weeks before starting treatment, or who may need one during treatment or within 5 months after the last dose of atezolizumab.
• People whom the treating doctor considers unfit to participate in this trial for any other reason.

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