Phase 3 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:

• Adults aged 18 or older at the time of signing the consent form
• People who have been diagnosed with stage IV non-squamous non-small cell lung cancer (a specific type of advanced lung cancer), confirmed by a tissue biopsy
• People who have at least one measurable tumour in the chest area that a doctor can reach either through a scope passed into the airways or by a needle through the skin
• People whose cancer has been shown on at least 3 consecutive scans to be growing while they have been on pembrolizumab (an immunotherapy drug) for at least 12 weeks — and whose cancer did not immediately worsen when first starting pembrolizumab (confirm with trial site)
• People who have previously received a platinum-based chemotherapy treatment (a standard type of chemotherapy) at some point during their treatment
• People who are currently being treated with pembrolizumab, either alone or combined with chemotherapy, and whose cancer is progressing on that treatment
• People who are considered reasonably well and able to carry out daily activities, based on a standard medical fitness scale (called ECOG 0 or 1)
• People whose blood counts meet the required minimum levels for platelets, red blood cells, and infection-fighting white blood cells
• People whose liver, kidney, and blood clotting functions are within acceptable ranges as measured by standard blood tests
• People who have finished previous cancer treatments and whose side effects have mostly settled, with appropriate time gaps observed since the last dose (at least 14 days for chemotherapy, longer for certain antibody-based treatments)
• People who are expected to live at least 12 weeks, in the treating doctor's judgement
• People who test negative for pregnancy at screening (where applicable)
• People who are able and willing to use contraception methods specified by the trial, if there is any possibility of pregnancy during the study period

Who may not be able to join:

• People whose lung cancer has a specific known genetic change (such as EGFR, ALK, or ROS1) for which an approved targeted drug already exists, or who have previously received a targeted drug for these genetic changes
• People who have previously been treated with a chemotherapy drug called docetaxel, whether alone or in combination with other drugs
• People who have previously received a type of immunotherapy called a CTLA-4 inhibitor (such as ipilimumab)
• People who have had serious immune-related side effects from immunotherapy in the past
• People who have an active autoimmune disease (where the immune system attacks the body) that has required immune-suppressing medication within the past 2 years — though people on low-dose steroid replacement therapy may still be considered (confirm with trial site)
• People with a known allergy or sensitivity to a medication called valacyclovir
• People with an active infection that is not under control and is currently being treated with systemic medication
• People who have active or worsening cancer spread to the brain or the lining around the brain
• People who have ongoing painful symptoms from cancer that has spread to the bones
• People who have cancer spread throughout more than half of the liver
• People who have had radiation therapy within 2 weeks before starting the study treatment
• People with a history of significant lung inflammation or scarring (such as interstitial lung disease grade 2 or above), ongoing lung inflammation requiring treatment, severe lung conditions requiring more than 2 litres per minute of supplemental oxygen at rest, certain autoimmune conditions affecting the lungs, or people who have had a whole lung removed
• People who are currently taking part in another clinical trial or have used an experimental treatment or device within the past 4 weeks
• People who still have significant ongoing side effects (above a mild level, except for hair loss) from previous cancer treatments
• People with a known history of HIV or AIDS
• People with a known active or past Hepatitis B or active Hepatitis C infection
• People with significant or uncontrolled heart problems, including certain abnormal heart rhythms, a heart attack or unstable chest pain within the past 6 months, significant heart failure, an ejection fraction (a measure of how well the heart pumps) below 40%, or uncontrolled high blood pressure
• People who have another cancer currently requiring active treatment — though certain low-risk or treated cancers such as some skin cancers, treated cervical in-situ cancer, or cancers being monitored without treatment (such as low-risk prostate cancer or early breast duct changes) may still be considered (confirm with trial site)
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the study
• People with significant physical, medical, or psychiatric conditions that, in the treating doctor's opinion, would make it difficult to participate safely or cooperate with the study requirements

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