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 have been diagnosed with non-small cell lung cancer (NSCLC) that has spread locally or to other parts of the body
• People whose thyroid-stimulating hormone (TSH) blood level is within the normal range
• People whose cancer can be measured on scans according to a standard set of medical guidelines
• People who are generally active and able to carry out daily activities with little or no restriction (confirm with trial site what level of activity is required)
• People who are expected to live for more than 12 weeks
• People whose heart tracing (ECG) does not show signs of a heart attack in progress or an abnormally long heart rhythm interval
• Women who could become pregnant and are sexually active with men must agree to use at least two highly effective forms of contraception
• Men who are not sterile must agree to use a reliable form of birth control or to abstain from sexual activity
• People living with HIV who are on HIV treatment and whose HIV is well controlled
• People whose side effects from any previous cancer treatment have largely resolved before starting the trial
• People willing to provide a fresh tissue sample from their tumour
• People who are able to understand and follow the trial requirements
• People who are willing to give written consent to take part

Who may not be able to join:

• People in Group A (Cohort A) who experienced severe (Grade 3 or higher) side effects from a previous immunotherapy treatment
• People in Group B (Cohort B) who have previously been treated with a type of cancer drug called an immune checkpoint inhibitor
• People whose lung cancer has specific genetic changes known as EGFR or ALK mutations
• People who have previously been treated with a medication called recombinant interleukin-12 (IL-12)
• People who have recently taken medications that suppress the immune system, even for a short time, before starting the trial
• People with an active autoimmune disease, or any condition that requires ongoing use of steroids or other immune-suppressing medications
• People who have received a live vaccine within 28 days before starting the trial
• People who have a condition, whether present from birth or developed over time, that causes a weakened immune system
• Women who are pregnant (shown by a positive blood pregnancy test) or who are currently breastfeeding
• People who have had an organ or tissue transplant from another person
• People with known active, uncontrolled hepatitis B or hepatitis C infection
• People living with HIV who have a history of a condition called Kaposi sarcoma or Multicentric Castleman Disease
• People whose cancer has spread to the brain and is currently active and uncontrolled
• People with heart failure, active coronary artery disease, new or unstable chest pain, or significant heart rhythm problems
• People with uncontrolled bleeding disorders before starting the trial
• People currently taking the blood-thinning medication warfarin (also known as coumadin)
• People who have had lung inflammation not caused by infection (non-infectious pneumonitis) within the past five years
• People in Group A (Cohort A) with a history of allergy to protein-based medicines, significant drug allergies, or known sensitivity to a specific study drug called cetrelimab — OR people in Group B (Cohort B) with a known allergy or sensitivity to the type of immunotherapy drug being used as standard care in that group
• People with other serious conditions affecting organs or body systems that could interfere with the trial
• People with serious ongoing mental health conditions or substance use disorders that would make participation unsuitable

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