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 (confirmed by tissue or cell testing) with a specific type of lung cancer called adenocarcinoma that has spread and cannot be surgically removed (stage IIIB/C or stage IV), and whose cancer does not have certain specific genetic changes (EGFR, ALK, ROS1, BRAF, RET, NTRK, or MET ex14)
• People whose cancer can be measured on scans, following a standard measurement system called RECIST 1.1
• People who are able to provide a stored tumor tissue sample — at least 10 unstained slides — for testing, and whose tumor has been tested for a protein called PD-L1
• People who received chemotherapy or immunotherapy in the past as an early-stage (adjuvant) treatment, provided that treatment ended more than 6 months before joining the trial; local treatments such as surgery or radiotherapy to individual non-target spots are also acceptable
• People who have had brain metastases that have already been treated, provided symptoms are stable, treatment finished more than 2 weeks ago, and no more than 10mg per day of prednisone (or equivalent) is needed
• People with a good general level of physical functioning, rated 0 or 1 on a standard scale called ECOG Performance Status
• People who weigh more than 30 kg
• People whose blood and organ function results fall within acceptable ranges when tested within 14 days of joining the trial (including blood counts, liver function, kidney function, and bilirubin levels)
• People with a life expectancy of at least 12 weeks, in the opinion of the enrolling doctor
• People who are able and willing to use effective contraception from screening through to 3 months after the last dose of study treatment (applies to women who could become pregnant and men whose partners could become pregnant)
• People who are willing to give written consent before any research-related tests or procedures are carried out

Who may not be able to join:

• People who are pregnant or breastfeeding, or women of childbearing age who have a positive or unknown pregnancy test result
• People who have difficulty swallowing or cannot swallow tablets or capsules
• People whose lung cancer is a different type, such as squamous cell, large cell, NSCLC not otherwise specified, or a mixed tumour type
• People who have untreated brain metastases or cancer that has spread to the lining of the brain or spinal cord (leptomeningeal carcinomatosis)
• People with a known allergy or sensitivity to any of the study medications
• People who have received immunotherapy or any experimental drug within 4 weeks before the first study dose (or within 6 weeks for monoclonal antibody treatments)
• People who have previously been treated with certain immune checkpoint therapies (such as anti-PD-1, PD-L1, or PD-L2 agents, including durvalumab), unless that treatment was given as early-stage (adjuvant) therapy and ended more than 6 months ago
• People who have used immunosuppressive medications in the 28 days before the first study dose (with some exceptions such as low-dose inhaled or nasal steroids, or physiological-dose systemic steroids not exceeding 10mg per day of prednisone or equivalent)
• People who have had major surgery within 4 weeks before joining (not including minor procedures such as placing a vascular access line)
• People with an active or recently treated autoimmune disease within the past 2 years that required systemic treatment; however, conditions such as vitiligo, Grave's disease, or psoriasis not needing systemic treatment are not excluded, and standard hormone or gland replacement therapy is not considered systemic treatment for this purpose
• People with active inflammatory bowel disease (such as Crohn's disease or ulcerative colitis) who require immunosuppression, or who need more than 10mg per day of prednisone or equivalent
• People with a history of primary immune deficiency
• People who have had an organ transplant requiring ongoing immunosuppressive medication
• People who are currently taking daily probiotic supplements (those who stopped taking probiotics more than 4 weeks before the first dose may be eligible)
• People with HIV who have been on anti-retroviral treatment for less than 6 months and have a CD4 cell count below 500; people with HIV who do not meet both of those conditions may be eligible (confirm with trial site)
• People with active Hepatitis B (positive surface antigen and detectable virus) or active Hepatitis C (positive antibody and detectable virus), unless specific conditions around treatment and test results are met (confirm with trial site)
• People with serious uncontrolled health conditions, including active infections, heart failure, uncontrolled high blood pressure, unstable chest pain, irregular heart rhythm, active stomach ulcers, or active uncontrolled bleeding
• People who have had a heart attack or stroke within the 3 months before joining
• People with moderate to severe heart failure symptoms (classified as NYHA Class III or IV)
• People with a current or past history of lung inflammation (pneumonitis) that required steroid treatment, or who have a condition called interstitial lung disease
• People with a psychiatric illness or personal situation that would make it difficult to follow the trial requirements or to give informed consent
• People with a known history of active tuberculosis; those with a past history of latent (inactive) tuberculosis may be eligible if they were previously treated with a medicine called isoniazid
• People who have been on long-term antibiotic treatment (60 or more consecutive days within the 12 weeks before joining the trial)
• People who have received a live vaccine within 30 days before starting the trial or within 30 days of receiving the study treatment
• People who have had another cancer (other than certain non-melanoma skin cancers) within the past 5 years, unless they received potentially curative treatment and have had no signs of the cancer returning for at least 5 years
• People with any other condition that, in the opinion of the trial doctor, could affect the safety of the study or the reliability of the results

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