Phase 1 Lung Cancer Trial, Recruiting

Written by an AI model from the 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 at the time of signing the consent form
• People who have a confirmed diagnosis (through tissue or cell testing) of an advanced solid tumour affecting the skin, tissue under the skin, soft tissue, or lymph nodes — including cases where the cancer has spread to other parts of the body
• People whose cancer can be measured using standard imaging guidelines, with at least one tumour lesion of a certain minimum size (details vary depending on which part of the trial applies, so confirm with trial site)
• For one specific group (Part 2 Dose Expansion): People with confirmed Stage III or Stage IV non-small cell lung cancer
• For another specific group (Part 3): People with confirmed high-risk locally advanced or metastatic squamous cell skin cancer that cannot be treated with surgery, as decided by a specialist medical team
• People whose cancer has continued to grow, has stopped responding to, or who were unable to tolerate standard available treatments — or whose condition means standard treatments are not an option for them
• People with a good general level of physical functioning (able to carry out daily activities with no or minimal limitations)
• People with a life expectancy of more than 12 weeks
• People with adequate bone marrow, liver, and kidney function
• People with a normal or acceptable heart trace (ECG) result prior to starting the trial
• People living with HIV, provided they are on HIV medication and their HIV is well controlled
• People whose last cancer treatment (including experimental treatments) ended at least 28 days before starting the trial; whose last radiotherapy ended at least 14 days before (targeted palliative radiotherapy to lesions not planned for injection is allowed); or whose last surgery was at least 21 days before starting
• People who have recovered from side effects of previous cancer treatments (except hair loss or skin pigment changes) to a mild or resolved level before starting
• People willing to provide tumour tissue samples before and after treatment, if it is safe to do so
• People who are able to understand and follow the requirements of the trial

Who may not be able to join:

• People whose tumours that would be injected are pressing on major airways or blood vessels
• People who have previously been treated with a protein called recombinant interleukin-12 (IL-12)
• People who have received immune-suppressing medications within 28 days before starting the trial
• People who have received live vaccines within 28 days before starting the trial
• People who have a condition that weakens the immune system, such as leukaemia or lymphoma
• Women who could become pregnant and have a positive pregnancy blood test within 72 hours before starting treatment, or women who are currently breastfeeding
• People who have previously had an organ transplant
• People with a known history of hepatitis B, active hepatitis C, or a positive hepatitis test result taken within 28 days before starting the trial
• People living with HIV who also have a history of Kaposi sarcoma or a condition called Multicentric Castleman Disease
• People with an active autoimmune disease, or who need ongoing high-dose steroid or immune-suppressing medication (at or above a certain dose level) within 28 days before starting the trial
• People with cancer that has spread to and is currently active in the brain or spinal cord
• People with significant heart conditions, including certain types of heart failure, active coronary artery disease, new or unstable chest pain, or serious heart rhythm problems
• People with uncontrolled bleeding conditions within 4 weeks before starting the trial, or known bleeding disorders (for Part 2, this also applies to people on blood-thinning medication that cannot be safely paused for procedures)
• People with a known allergic reaction to substances similar to IL-12, aluminium hydroxide, or a substance called polysorbate-20
• People with other health conditions or organ problems that, in the treating doctor's opinion, could affect the trial's safety or results
• People with serious mental health conditions or substance use disorders that, in the treating doctor's opinion, make participation unsuitable
• For Part 3 only: People who previously experienced a severe (Grade 3 or higher) immune-related side effect from a type of cancer immunotherapy that targets the PD-1/PD-L1 pathway
• For Part 3 only: People with a known allergy to the drug cemiplimab or any of its ingredients, or for whom cemiplimab is medically contraindicated according to approved local guidelines

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