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 who are willing to sign a consent form approved by an ethics committee before any study procedures begin.
• People who have been diagnosed with non-small cell lung cancer (confirmed by a tissue or cell sample), whose tumour tests positive for a protein called IMP3, and who have either tried standard treatments and they have not worked, cannot tolerate standard treatments, or have chosen not to pursue standard treatments.
• People whose cancer has specific gene changes (EGFR, ALK, or ROS1) must have already tried at least three lines of treatment, including at least one targeted therapy matched to that gene change; people without those gene changes must have already tried at least two lines of treatment including a platinum-based chemotherapy.
• People who have at least one tumour that can be measured or assessed on scans, according to standard criteria called RECIST v1.1.
• People whose general health and ability to carry out daily activities falls within a certain range on a standard scale (ECOG score of 0, 1, or 2).
• People whose doctors estimate they have a life expectancy of at least 3 months.
• People whose blood, liver, kidney, and heart function test results meet specific minimum levels, as checked within 7 days before starting treatment (confirm specific values with the trial site).
• People who are willing to use effective non-oral contraception (such as condoms, intrauterine devices, or spermicides) from the time of signing consent until 6 months after completing the vaccination schedule; female participants must have a negative pregnancy test and agree not to breastfeed during the study and for at least 18 months after receiving the study vaccine.
• People who have completed previous cancer treatments with sufficient time since the last treatment — generally at least 4 weeks since most therapies, at least 5 half-lives since targeted therapies, at least 2 weeks since palliative radiotherapy, at least 3 months since chest radiotherapy, and at least 4 weeks of recovery since major surgery.

Who may not be able to join:

• People who have had another type of cancer in the past, unless it was a cancer considered cured by the investigator (such as certain skin cancers, early-stage bladder cancer, or cervical carcinoma in situ, with no recurrence in the past 5 years).
• People with any serious uncontrolled medical condition — such as heart, lung, digestive, nerve, blood, hormonal, or mental health conditions — that in the investigator's view could interfere with the study or put the person at risk.
• People with an active autoimmune disease (where the immune system attacks the body) or a history of one, such as lupus, multiple sclerosis, inflammatory bowel disease, or similar conditions — though people with well-controlled type 1 diabetes on a stable insulin dose, or vitiligo, may still be considered; people with asthma that requires ongoing medication are not eligible.
• People with active cancer spread to the brain or spinal cord; however, people with brain metastases that have been treated and have been stable for at least 2 weeks — with no ongoing steroid use for at least 4 weeks — may be considered.
• People with a known allergy to any ingredient in the study drug, or a history of severe allergic reactions to any drug, food, or vaccine (such as anaphylactic shock or severe breathing difficulties).
• People who have a skin condition, injury, wound, or tattoo at the planned injection site that could interfere with monitoring the injection area, or who have significant bleeding or clotting problems.
• People who have previously received an organ transplant or a bone marrow/stem cell transplant from a donor.
• People who have previously received a cancer vaccine or cell-based immunotherapy as a cancer treatment.
• People who have participated in another clinical drug or device trial within 4 weeks before screening.
• People who have had major surgery within 4 weeks before the first vaccination, or whose surgical recovery is not yet sufficiently complete.
• People who have been taking moderate-to-high-dose steroid tablets or other immune-suppressing medications within 14 days before the first vaccination (low-dose inhaled, topical, or replacement steroids may be acceptable — confirm with trial site).
• People who still have unresolved side effects from previous cancer treatments that are rated above a mild level (above grade 1), with exceptions for hair loss of any grade or certain nerve-related side effects from prior platinum chemotherapy.
• People with known or confirmed active hepatitis B, hepatitis C, HIV, or syphilis infections, or who test positive on screening blood tests for these infections above certain levels.
• People with active tuberculosis, a history of active tuberculosis, or a serious ongoing infection requiring treatment; also people with evidence of lung scarring, interstitial lung disease, radiation damage to the lungs, or significantly reduced lung function.
• People with a history of drug or alcohol misuse, or known psychological or social conditions that could affect participation.
• People who are pregnant, breastfeeding, planning to become pregnant, or whose male partner plans for their female partner to become pregnant, from screening until 12 months after completing all study injections.
• People who have received any other vaccine within 30 days before the study vaccine, or who plan to receive another vaccine during the study period.
• People who have had a blood clot in a deep vein or a blood clot in the lungs within the 6 months before enrolling.
• People with an uncontrolled infection (fungal, bacterial, viral, or other) currently requiring antibiotic treatment (minor infections such as an uncomplicated urinary tract infection may be assessed individually — confirm with trial site).
• People with a history of or current neurological conditions affecting the brain or central nervous system, such as seizures, stroke, dementia, or cerebellar disease.
• People with a significantly weakened immune system.
• People whose tumour tissue tests negative for IMP3, or whose IMP3 status cannot be confirmed.
• People whom the investigator considers unsuitable for any other reason, or who are unwilling or unable to follow the study requirements.

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