Phase 2 Lung Cancer Trial, Not Yet 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 who are willing to voluntarily take part in the study
• People who have been confirmed through tissue or cell testing to have a specific early-stage lung cancer (non-small cell lung cancer, stage Ia, with a tumour between 1 cm and 3 cm), diagnosed during a cryoablation procedure — people with a type of lung lesion called ground-glass nodules are not included
• People whose lung cancer does not have certain gene changes (in the EGFR, ALK, or ROS1 genes)
• People who a medical team has decided are not suitable for, or who have chosen not to have, surgery or radiotherapy
• People who have at least one measurable area of cancer that can be assessed using standard imaging, checked within 4 weeks before starting the trial
• People with a general health and activity score rated as 0 or 2 on a standard medical scale (confirm with trial site)
• People with a life expectancy of at least 12 weeks
• People whose blood, liver, kidney, and clotting test results fall within the ranges required by the trial, without recent medical support such as transfusions or certain growth factor treatments, tested within 14 days before starting
• Female participants who have a negative pregnancy test within 14 days before starting, and who agree to use effective contraception during the trial and for at least 6 months after the last dose — breastfeeding is not permitted during the study
• Male participants who agree to use effective contraception or avoid heterosexual intercourse during the trial and for at least 6 months after the last dose, and who agree to use condoms if their partner is pregnant or could become pregnant

Who may not be able to join:

• People with a known history of a severe allergic reaction (grade 3 or higher) to any monoclonal antibody medicine
• People who have previously been treated with certain immune-based cancer therapies (such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 medicines)
• People who have a medical reason that makes the cryoablation procedure unsafe for them
• People who have had an active infection requiring antibiotic or antifungal treatment in the 14 days before starting the trial
• People with a history of heart attack in the past 6 months, certain uncontrolled heart rhythm problems, significant heart failure, reduced heart pumping function, or fluid build-up around the heart, lungs, or abdomen that requires treatment
• People with uncontrolled high calcium levels in the blood
• People with a history of or current serious lung conditions such as interstitial lung disease, dust-related lung disease, radiation- or drug-related lung damage, or other significant lung problems
• People with active hepatitis B, active hepatitis C, active syphilis infection, or known HIV infection
• People with an active or suspected condition where the immune system attacks the body — people with a stable autoimmune condition that does not need ongoing immune-suppressing medication may still be considered
• People who have had another active cancer in the past 5 years, with some exceptions for certain skin or localised cancers that were fully treated and have been in remission for 5 or more years
• People who have received a live or weakened vaccine within 28 days before starting, or who plan to receive one during the trial — standard inactivated flu vaccines are allowed
• People who have had intensive radiotherapy within 3 months before starting the trial, or who have spinal cord compression that has not been controlled by surgery or radiotherapy
• People with a history of deep vein thrombosis (blood clots in a vein), people currently taking blood-thinning or anti-clotting medication, or people with a history of serious bleeding related to certain cancer treatments
• People with poorly controlled high blood pressure (at or above 160/100 mmHg despite treatment)
• People who have had major surgery within 28 days before starting the trial
• People who have taken part in another interventional clinical trial within the past 3 months or within 5 half-lives of the other trial drug, whichever is longer
• People who have had or are planned to have an organ or bone marrow transplant
• People with a known history of serious psychiatric illness or substance use disorder that may affect their ability to follow the trial requirements
• People who the trial doctor considers unsuitable for any other reason

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