Phase 2 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) through a biopsy, have not yet received treatment for it, and have cancer that can be measured on scans — specifically those with Stage II cancer that cannot be removed by surgery, or Stage III cancer being treated without surgery. (Previous surgery or targeted radiation for early-stage disease is allowed.)
• People whose cancer tissue has been tested for a protein called PD-L1 using an approved laboratory test.
• People whose cancer is suitable for the standard non-surgical treatment plan, which includes chemotherapy, radiation therapy given at the same time, and then a maintenance drug called durvalumab.
• People who have had a whole-body PET/CT scan within the 42 days before joining the trial, showing active cancer in the lungs and/or chest lymph nodes.
• People who have had a brain MRI or a head CT scan with contrast dye within the 42 days before joining the trial.
• People who have had lung function tests (breathing tests) within the 42 days before joining the trial.
• People who are reasonably well and able to carry out daily activities, based on a standard medical scale (ECOG score of 0, 1, or 2).
• People whose blood and organ function meet the following levels, as assessed by their doctor:
  • Red blood cell level (haemoglobin) of at least 9.0 g/dL
  • Infection-fighting white blood cell count of at least 1,500 per mm³
  • Platelet count (cells that help blood clot) of at least 100,000 per mm³
  • Liver function markers (bilirubin, AST, ALT, and alkaline phosphatase) within acceptable ranges set by the testing laboratory (confirm with trial site for Gilbert's syndrome exceptions)
  • Kidney function above a certain threshold based on a standard calculation — a higher threshold applies for people planned to receive a specific chemotherapy drug called pemetrexed (confirm with trial site)
• Women who are not pregnant, not breastfeeding, and either cannot become pregnant or agree to use reliable contraception during treatment and for at least 6 months after the last dose of the study drugs cemiplimab and fianlimab, or for at least 6 months after the last dose of chemotherapy (or longer for certain chemotherapy drugs, as determined by regulatory prescribing guidelines).
• Men who agree to use contraception during treatment and for at least 6 months after the last study drug dose, and who agree not to donate sperm during this time.
• People (or their legal representative) who are willing and able to give written consent to participate.

Who may not be able to join:

• People whose lung cancer has specific genetic changes known as EGFR mutations or ALK fusions (testing for these is required for certain cancer types and recommended for others).
• People who have previously been treated with certain immune checkpoint drugs that target PD-1, PD-L1, or LAG-3 pathways.
• People who are currently in, or have recently participated in, another clinical trial involving an experimental treatment or device within the 4 weeks before the first dose.
• People who have another active cancer (besides lung cancer) that requires active treatment beyond hormone therapy, and that the treating doctors believe may affect life expectancy.
• People who have a history of lung inflammation (not caused by infection) that required steroid treatment, or who currently have lung inflammation.
• People with a known history of heart muscle inflammation (myocarditis).
• People with certain elevated heart enzyme levels (troponin T or troponin I) at the start of the trial, above twice the upper limit set by the testing laboratory (some exceptions may apply based on repeat testing and doctor assessment — confirm with trial site).
• People with known active tuberculosis (TB).
• People with known psychiatric conditions or substance use problems that would make it difficult to follow the trial requirements.
• People who are pregnant, as confirmed by a pregnancy test taken within 72 hours before starting treatment (repeat testing required if more than 72 hours pass before the first dose).
• People who have had an autoimmune disease (where the immune system attacks the body) that required treatment with immune-suppressing medicines within the past 2 years. Some conditions are exceptions to this rule, including vitiligo, childhood asthma that has fully resolved, stable low thyroid function managed only with hormone replacement, and mild psoriasis not needing systemic treatment.
• People who have had a significant infection (such as skin infection, pneumonia, or blood infection) requiring antibiotic treatment within the 2 weeks before the first trial dose.
• People who currently have an active infection requiring treatment.
• People with uncontrolled HIV, Hepatitis B, or Hepatitis C infections, or a known immune deficiency linked to chronic infection. (People with well-controlled HIV, Hepatitis B, or Hepatitis C may be permitted under specific conditions, with specialist review required — confirm with trial site.)
• People who have a known immune deficiency condition, or who have been taking steroid or immune-suppressing medications at higher than a specified dose within the 7 days before the first dose.
• People with a known allergy to any of the active or inactive ingredients in the study drugs.
• People who have received a live vaccine within the 30 days before planned start of the study drugs. Special guidance applies for COVID-19 vaccines — participation may need to be delayed after vaccination (confirm with trial site).

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