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:

• People who are willing and able to sign a written consent form before any study-related procedures begin.
• Adults aged 18 to 75 years old.
• People whose general health and ability to carry out daily activities is rated at a good level (a performance score of 0 or 1 on a standard medical scale).
• People whose doctors expect them to live for at least 12 weeks.
• People who have been diagnosed through a tissue or cell sample with advanced non-small cell lung cancer (NSCLC) that has spread or cannot be removed by surgery — specifically stage IIIB, IIIC, or stage IV — and who have not yet received systemic (whole-body) treatment for advanced or metastatic disease.
• People who received chemotherapy or chemoradiotherapy before or after surgery as part of earlier treatment, as long as that treatment finished at least 12 months before the current advanced or metastatic diagnosis.
• People with non-squamous type NSCLC must not have certain genetic changes (EGFR sensitive mutation, ALK fusion, or ROS1 fusion) detected in their tumour.
• People who have at least one tumour that can be measured on a scan, according to standard criteria (RECIST v1.1).
• People who have brain metastases (cancer that has spread to the brain) that are either causing no symptoms, or whose symptoms have been stabilised by local treatment, provided certain additional conditions are met (confirm with trial site).
• People whose recent blood test results meet specific thresholds for blood cell counts, liver function, kidney function, and blood clotting (tests must be done within 14 days before starting treatment).
• People whose heart function meets specific requirements, including an adequate pumping strength (LVEF of 50% or more), a heart function rating below class 3, and a normal baseline heart tracing (ECG) without certain rhythm abnormalities.
• Women who could become pregnant must have a negative pregnancy test within 3 days before the first dose, and all people at risk of conception must use highly effective contraception throughout treatment and for 120 days (or 180 days, depending on the drug) after the last dose.

Who may not be able to join:

• People who are currently taking part in another interventional clinical trial or receiving another experimental drug (observational studies may be permitted — confirm with trial site).
• People who have previously been treated with certain immune checkpoint therapies, including anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 drugs, or any similar therapy targeting T-cell pathways.
• People who have received certain Chinese herbal medicines with anti-tumour effects or immune-modifying drugs within 2 weeks before the first dose.
• People who are currently taking oral or intravenous beta-blocker medications and for whom switching to a different type of medication is not considered safe.
• People who have medical conditions that make beta-blocker medications unsafe to use, including (but not limited to): asthma or risk of airway spasm; certain types of diabetic complications; severely slow heart rate or certain heart rhythm problems; heart failure of a certain severity; low blood pressure; severe circulation problems in the limbs; unstable chest pain; uncontrolled diabetes (confirm specific thresholds with trial site); or recent use of a specific type of blood pressure medication called a non-dihydropyridine calcium channel blocker.
• People with serious liver conditions such as hepatic encephalopathy, hepatorenal syndrome, or moderate-to-severe cirrhosis (Child-Pugh class B or worse).
• People who have had a bowel obstruction caused by their tumour in the past 3 months, or who have a history of inflammatory bowel disease, significant bowel removal surgery, Crohn's disease, or ulcerative colitis.
• People who completed palliative radiotherapy within 7 days before the first dose.
• People who currently have active diverticulitis, an abdominal abscess, or a gastrointestinal blockage.
• People with a history of substance abuse or addiction.
• People with a known allergy to any ingredient in the study drugs.
• People with a known primary immune system deficiency, or who are currently receiving systemic steroids or other immune-suppressing treatments.
• People who have used immune-suppressing medications within 4 weeks before the first dose, with some exceptions for low-dose or locally applied steroids (confirm with trial site).
• People who have not adequately recovered from side effects of previous treatments (side effects must have resolved to a mild level or returned to baseline, except for fatigue or hair loss).
• People who received a live attenuated vaccine (such as a live flu nasal spray) within 4 weeks before the first dose, or who plan to receive one during the study.
• People who have had major surgery (such as brain, chest, or abdominal surgery) within 4 weeks before the first dose, or who are expected to need major surgery during the study; or people who had laparoscopic exploratory surgery within 2 weeks before the first dose.
• People with brain metastases that are currently causing symptoms, or with cancer that has spread to the lining of the brain (carcinomatous meningitis), which is excluded regardless of stability.
• People with uncontrolled fluid build-up around the lungs or abdomen that requires ongoing drainage.
• People with bone metastases that place them at risk of spinal cord compression or paralysis.
• People with a known or suspected autoimmune disease, or a history of one within the past 2 years (some milder conditions that do not require systemic treatment may still be eligible — confirm with trial site).
• People with known active tuberculosis.
• People who have had an organ transplant or bone marrow/stem cell transplant from a donor.
• People known to be HIV-positive.
• People with active hepatitis B or hepatitis C infection meeting specific viral load thresholds (confirm with trial site).
• People with active syphilis requiring treatment.
• People with interstitial lung disease that requires steroid treatment.
• People with serious active infections that are not well controlled.
• People with serious heart or blood vessel conditions, such as a recent heart attack, stroke, blood clots in the arteries, severe heart failure (class 3 or 4), chest pain requiring treatment, severe vascular disease in the limbs, or uncontrolled high blood pressure despite medication.
• People who have had another cancer diagnosed within the past 5 years, with some exceptions for cancers in full remission, certain treated skin cancers, or treated pre-invasive cancers (confirm with trial site).
• Women who are currently pregnant or breastfeeding.
• People with other significant medical conditions, mental health conditions, or abnormal test results that the trial doctors believe would make participation unsafe or affect the study results.

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