Phase 2 Lung Cancer Trial, Recruiting

Written by an AI model from the 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 to take part voluntarily, sign a consent form, and attend follow-up appointments as required.
• People aged 18 to 75 years old (both ages included).
• People whose general physical functioning is rated as reasonably good, based on a standard scale used by doctors to measure how cancer affects daily activities (ECOG score of 0–2).
• People whose doctors estimate they are likely to live for at least 3 more months.
• People whose lung cancer has been classified as Stage IV (meaning it has spread to other parts of the body) using the standard TNM staging system.
• People whose lung cancer has been confirmed by laboratory testing of tissue or cell samples, and whose cancer does not have a specific gene change called an EGFR mutation.
• People who have not yet received any treatment targeting the whole body for their cancer, and whose doctor plans to treat them with a type of immunotherapy drug (called a PD-1/PD-L1 inhibitor) either alone or combined with chemotherapy, as their first treatment.
• People whose major organs (blood, liver, and kidneys) are functioning within acceptable ranges, as measured by standard blood tests (confirm specific values with the trial site).
• Women who could become pregnant must have had a negative pregnancy test within 7 days before joining, and must agree to use reliable contraception during the trial and for 8 weeks after the last dose. Men must agree to use reliable contraception during the trial and for 8 weeks after the last dose, or must have had a surgical sterilisation procedure.

Who may not be able to join:

• People who have previously taken any EGFR tyrosine kinase inhibitor medication (a specific type of targeted cancer drug).
• People who have previously received any chemotherapy for lung cancer.
• People who have previously received radiotherapy for lung cancer, except for palliative (pain-relieving) radiotherapy directed at bone metastases.
• People who have had major surgery within 4 weeks before the first dose of the study drug.
• People who have taken certain strong medications that affect how the body processes drugs (strong CYP3A4 inhibitors or inducers) within 7 days before the first dose.
• People who currently have another cancer, except for certain low-risk skin cancers (basal cell carcinoma) or cancers that have not spread beyond where they started (in situ cancer).
• People with uncontrollable fluid build-up around the lungs or heart.
• People who are allergic to the contrast dye used in CT or MRI scans, or who cannot have an MRI scan for any reason.
• People with serious or poorly controlled conditions such as uncontrolled high blood pressure, active abnormal bleeding, or a current serious infection, as assessed by the trial doctor.
• People with significant stomach or digestive problems that may affect how the body takes in medication — for example, inability to swallow tablets, uncontrolled nausea or vomiting, major bowel surgery, ongoing diarrhoea, atrophic gastritis, conditions requiring long-term use of stomach acid-reducing drugs, Crohn's disease, or ulcerative colitis.
• People with liver-related conditions including liver failure affecting the brain (hepatic encephalopathy), a condition where the kidneys fail due to severe liver disease (hepatorenal syndrome), or liver cirrhosis.
• People with certain heart abnormalities, including a prolonged heart rhythm interval on an ECG (QTcF above 470 msec), specific abnormalities in how electrical signals travel through the heart, a personal or family history of a condition that affects heart rhythm (long QT syndrome), a history of unexplained sudden death in a close family member under age 40, or reduced heart pumping function (left ventricular ejection fraction below 50%).
• People whose blood test results show that bone marrow or organ function does not meet the required levels — including low white blood cell, platelet, or red blood cell counts, or liver or kidney function outside acceptable ranges, or low blood protein (albumin) levels (confirm specific values with the trial site).
• People with an active infection caused by fungus, bacteria, or a virus that currently requires treatment.
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study period.
• People with a history of certain lung conditions, including interstitial lung disease, lung inflammation caused by previous drugs or radiation treatment, or any currently active interstitial lung disease.
• People who the trial doctor believes may have difficulty following the study's procedures or requirements, such as those with significant neurological or mental health conditions.
• People whom the trial doctor judges to have any other condition that could affect their safety or make it difficult to properly assess the results of the study.

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