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 measurable, advanced (stage IV) or inoperable non-small cell lung cancer (such as squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma) with at least one tumour that can be surgically removed to collect immune cells (note: neuroendocrine tumours are not eligible)
• People who have three or fewer brain tumours, each smaller than 1 cm, that are not causing symptoms — or who have had brain tumours surgically removed; if brain tumours were treated with a focused radiation technique, they must have been stable for at least one month after that treatment
• People who have already received at least one standard first-line treatment for their cancer and whose cancer has continued to grow or spread after that treatment
• People with a general health and activity level rated as ECOG 0 or 1, meaning fully active or able to carry out light activity (confirm with trial site)
• People aged 18 to 72 years old
• People who are willing to use birth control from the time of joining the trial until 12 months after the last chemotherapy dose (for those who could become pregnant), or for four months after treatment (for those who could father a child)
• People who are willing to sign a durable power of attorney document
• People who are able to understand and sign the informed consent form
• People whose blood test results meet the following levels without recent medical support: white blood cell count at or above a minimum safe level, neutrophil count above a minimum safe level, haemoglobin above 8.0 g/dl (a transfusion may be given to reach this level), and platelet count at or above a minimum safe level (confirm specific values with trial site)
• People whose blood tests show they do not have HIV, active hepatitis B, or active hepatitis C infection (a follow-up RNA test is required if the hepatitis C antibody test comes back positive)
• People whose liver and kidney function blood test results are within acceptable ranges (confirm specific values with trial site)
• People who could become pregnant must have a negative pregnancy test or other evidence of not being pregnant before treatment begins
• People who have completed any previous cancer treatments before enrolling
• People for whom at least two weeks have passed since any treatment for major airway blockage or bleeding, and any side effects from that treatment have mostly resolved
• People who are also enrolled in a related study (protocol 03-C-0277)

Who may not be able to join:

• People who are currently breastfeeding, due to potential risks to the infant
• People who currently need medications that suppress the immune system, including steroid medicines
• People who have an active serious infection, blood clotting disorder, or another serious uncontrolled medical condition
• People who have a major airway blockage or bleeding that cannot be adequately managed or treated
• People who have a primary immune system disorder (such as Severe Combined Immunodeficiency Disease or AIDS)
• People who have an active opportunistic infection (an infection that occurs when the immune system is weakened)
• People who have had a severe allergic reaction to any of the medicines used in this trial
• People whose heart pumping function (ejection fraction) is at or below 45%, for those whose medical history requires a heart assessment
• People whose lung breathing capacity (FEV1) is at or below 50%, for those whose medical history requires a lung assessment
• People who are currently participating in any other clinical trial involving an experimental treatment
• People who have had more than two invasive chest procedures, have poor physical exercise tolerance, are over 66 years of age, or have other significant medical history that the lead doctor believes would make the higher-dose treatment arm unsafe — these individuals may still be assessed for eligibility for the lower-dose treatment arm (confirm with trial site)

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