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 read, understand, and sign a consent form.
• People who are 18 years of age or older.
• People who have advanced or metastatic cancer (cancer that has spread or cannot be surgically removed) with measurable tumours — not including liver cancer (hepatocellular carcinoma), sarcomas, or brain tumours called gliomas.
• People whose cancer has stopped responding to standard treatments, whose body could not tolerate standard treatments, who are not eligible for standard treatments, or for whom no standard treatment exists.
• People who are relatively well and active, with a performance status score of 0 or 1 on the ECOG scale (confirm with trial site).
• People who are expected to live for at least 3 months.
• People whose recent blood test results (taken within 14 days before joining) meet all of the following:
  • Kidney function is adequate, with a creatinine clearance of at least 30 mL/min
  • Liver markers (bilirubin, AST, and ALT) are within acceptable ranges (slightly higher limits apply for people with liver metastases or a condition called Gilbert's syndrome)
  • Blood counts are within acceptable ranges — including haemoglobin, platelets, and neutrophils (a type of white blood cell) — without needing growth factor injections to boost them
  • Heart rhythm measurement (QTc interval) is within an acceptable range
• Women who could become pregnant must have a negative pregnancy test within 3 days before the first dose of the study drug.
• Women who could become pregnant, and men whose female partners could become pregnant, must agree to use reliable contraception throughout the trial and for 90 days after the last dose.
• People who are willing to follow the trial schedule and its rules and restrictions.
• People who have a tumour site that can be safely biopsied, or who have stored tumour tissue available from a previous procedure. (People without a suitable biopsy site may be considered after discussion with the trial team.)
• People who are not currently enrolled in another clinical trial and are not receiving any other cancer treatment.
• People who are willing to have small skin samples (biopsies) taken before and after treatment.

Who may not be able to join:

• People who have received certain cancer treatments — including radioimmunotherapy, antibody-drug conjugates, immune or cytokine therapies, or monoclonal antibodies such as checkpoint inhibitors — within 28 days or five half-lives of the drug (whichever is shorter) before starting the trial.
• People who are still experiencing significant side effects (above Grade 1) from previous cancer treatment, with some exceptions such as hair loss, skin colour changes, mild nerve symptoms, or well-controlled thyroid or hormonal conditions.
• People who have had major surgery within 2 months before starting the trial (minor procedures such as fitting a port or IV line are generally excluded from this restriction).
• People who have had radiation therapy within 28 days before starting the trial. (Limited radiation for pain relief may be allowed in some circumstances — confirm with trial site.)
• People who have had, or are expected to have, an organ transplant or stem cell transplant at any time.
• People who have a diagnosed condition affecting their immune system (either from birth or acquired).
• People who have taken systemic (whole-body) steroids or other immune-suppressing medicines within 14 days before starting the trial. (Inhaled or topical steroids, including medicated mouthwash, and low-dose replacement steroids, may be allowed in some cases.)
• People who have an active or past autoimmune disease that required immune-suppressing treatment. (Exceptions may be possible — confirm with trial site.)
• People who have had a severe allergic or intolerance reaction to monoclonal antibodies, certain protein-based medicines, or IV immunoglobulin, or who have a known allergy to any of the study medications or their ingredients.
• People who have cancer involving the brain or spinal fluid covering that has not been fully treated, is still active, is causing symptoms, or has required steroid treatment within the past 28 days.
• People who have cancer spread to the membranes surrounding the brain and spinal cord (leptomeningeal carcinomatosis), regardless of prior treatment.
• People who currently have another active cancer (exceptions include certain non-melanoma skin cancers, adequately treated early-stage cancers, or slow-growing prostate cancer being monitored). A past cancer history is generally allowed if the person has been free of recurrence for 2 or more years, or was treated with curative intent within the past 2 years and is unlikely to have a recurrence, in the opinion of the treating doctor.
• People with an active and significant bacterial, fungal, or viral infection, including known Hepatitis A, B, C, or HIV.
• People who have received a live vaccine within the past 30 days. (Non-live/inactivated vaccines are allowed; seasonal vaccines should have been given more than 30 days before starting the trial.)
• Women who are pregnant or breastfeeding.
• People who have experienced any of the following heart or blood vessel conditions within the 6 months before starting the trial:
  • Severe heart failure (New York Heart Association Grade III or IV)
  • Unstable chest pain (angina)
  • Heart attack
  • Unstable or symptomatic reduced blood flow to the heart
  • High blood pressure that is not controlled despite treatment
  • Significant heart rhythm problems (above Grade 2)
  • Stroke or other serious brain blood vessel events, or other serious heart conditions such as fluid around the heart or stiffening of the heart muscle. (Stable atrial fibrillation on consistent blood-thinning medication may be allowed.)
• People who have any medical reason that would prevent them from undergoing the scans or other procedures required by the trial.
• People who have any medical or personal situation that, in the treating doctor's opinion, could increase their risk, affect their ability to follow the trial requirements, or make it difficult to interpret the trial results.

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