Phase 3 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 who are able to understand and are willing to sign a written consent form, and are able to attend trial visits and follow the trial procedures.
• People who are at least 18 years old (or the legal age of adulthood in their country, whichever is higher). For the Japan-specific safety portion of the trial, participants must be Japanese people living in Japan.
• People who have been diagnosed with advanced or metastatic squamous non-small cell lung cancer (a specific type of lung cancer) that cannot be surgically removed, confirmed through laboratory testing of tumour tissue. (For the Japan-specific safety portion only, any type of advanced solid tumour may be eligible.)
• People whose cancer has continued to grow or spread after being treated with both an immune checkpoint therapy (a type of immunotherapy that targets PD-1 or PD-L1) and a platinum-based chemotherapy combination, given either together or one after the other as prior treatment(s).
• People who previously received immunotherapy aimed at curing locally advanced disease (Stage II or III) alongside platinum-based chemotherapy, and whose cancer came back within 6 months of finishing that chemotherapy. (This criterion does not apply to the Japan-specific safety portion.)
• People who can provide a tumour tissue sample — either a recent biopsy or a stored sample collected within the past 2 years. (Not required for the Japan-specific safety portion.)
• People who have at least one measurable area of cancer that can be detected on a CT or MRI scan.
• People whose general physical health and ability to carry out daily activities is rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity).
• People whose life expectancy is expected to be at least 3 months.
• Women who could become pregnant must have a negative pregnancy test before joining and must agree to use at least one highly effective form of contraception plus one barrier method throughout treatment and for 6 months after the last dose. Men who could father a child must agree to use a condom, preferably alongside another accepted form of contraception, during treatment and for 6 months after the last dose.
• Women who are currently breastfeeding must agree to stop breastfeeding completely during the entire treatment period and for 6 months after the last dose.

Who may not be able to join:

• Women who are pregnant, currently breastfeeding, or planning to become pregnant during or within 6 months after treatment. Also excluded are women of childbearing potential who are not willing to use the required contraception, and men with female partners who could become pregnant who are not willing to use acceptable contraception.
• People whose cancer has a known specific gene mutation or alteration for which targeted therapies exist, including certain changes in genes such as EGFR, KRAS, ALK, ROS1, BRAF, NTRK, MET, RET, or HER2. (This exclusion does not apply to the Japan-specific safety portion.)
• People who have brain metastases (cancer that has spread to the brain) that are growing or causing symptoms. People with stable, treated, or small symptom-free brain metastases may still be considered if certain additional conditions are met (confirm with trial site).
• People whose blood test results show abnormally low red blood cell levels, low white blood cell levels, or low platelet counts at the time of enrolment.
• People whose blood chemistry results show abnormal liver function, abnormal kidney function, or low protein (albumin) levels at the time of enrolment.
• People whose blood clotting test results are outside acceptable ranges at the time of enrolment.
• People who have had a serious blood clot — such as a deep vein thrombosis or a clot in the lungs — within the 30 days before joining the trial.
• People with active, uncontrolled bleeding, a known tendency to bleed abnormally, or where the treating doctor judges there to be a significant risk of a life-threatening bleed during the trial.
• People with significant heart or blood vessel problems, including uncontrolled irregular heartbeat, severe heart rhythm disorders, a QT interval (a measure of heart electrical activity) that is too long, uncontrolled high blood pressure, history of heart muscle inflammation, reduced heart pumping function, heart failure, recent heart attack or coronary procedure within 6 months, recent stroke or mini-stroke within 6 months, or uncontrolled seizures.
• People with abnormal cardiac enzyme levels in blood tests that suggest possible heart damage (confirm with trial site for borderline results).
• People with a history of or current scarring or inflammation of the lungs (such as pulmonary fibrosis or pneumonitis), active lung infection, active tuberculosis within the past year, severely reduced lung function, certain autoimmune lung conditions, or who have had a whole lung surgically removed.
• People with a history of severe, poorly controlled allergies, severe asthma, or severe eczema (except eczema caused by immunotherapy). A remote history of childhood asthma does not exclude someone.
• People with uncontrolled fluid build-up in body cavities (such as around the lungs, abdomen, or heart) that requires repeated draining.
• People with a recent flare-up of inflammatory bowel disease (within 6 months) or significant ongoing diarrhoea (within 2 weeks before the first dose).
• People with an active autoimmune disease that has required systemic treatment within the past 2 years. Hormone or supplement replacement therapies are not considered exclusionary.
• People who have previously received an organ transplant or a bone marrow/stem cell transplant from another person.
• People with a known or suspected allergy to the trial drug or its ingredients, or a known severe reaction to docetaxel or products containing polysorbate 80.
• People who had to permanently stop an immune checkpoint therapy in the past because of a serious reaction to it.
• People who still have unresolved side effects (rated above mild) from a previous cancer treatment, with some exceptions such as hair loss, fatigue, or certain manageable hormonal or metabolic conditions.
• People who have not fully recovered from a previous surgery, or who have had major surgery within the 4 weeks before starting the trial.
• People with pain caused by their tumour that is not well controlled, or with high calcium levels in the blood caused by cancer.
• People with uncontrolled HIV infection, active syphilis, active hepatitis B, or active hepatitis C. People with HIV, hepatitis B, or hepatitis C may still be considered if specific viral load and treatment conditions are met (confirm with trial site).
• People with a serious active infection, an infection requiring intravenous antibiotics, or an unexplained fever within 2 weeks before the first dose.
• People with any other medical condition, past treatment, or test result that the trial doctor judges could affect safety, interfere with consent, or affect how well the trial can be conducted.
• People with a psychiatric illness, significantly altered mental state, or substance use that would prevent them from understanding the consent process or completing trial requirements.
• People who, in the trial doctor's judgement, would be unable to meet the trial's requirements for any known or foreseeable reason.
• People who have been diagnosed with another cancer in the past 5 years, with some exceptions for certain low-risk or fully treated cancers (confirm with trial site for specific exceptions).
• People who have previously received docetaxel (a specific chemotherapy drug used in this trial), more prior immunotherapy lines than allowed, or other systemic cancer treatments beyond what is permitted by the trial.
• People who have received certain treatments too recently before the trial start, including chemotherapy, immunotherapy antibodies, radiotherapy for symptom relief, live vaccines, immune-suppressing medications at higher doses, or certain traditional herbal medicines with anti-cancer properties (specific timeframes apply — confirm with trial site).

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