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:

• Adults aged 18 years or older
• People who have been diagnosed with non-small cell lung cancer (NSCLC) through laboratory testing, and whose cancer does not have certain specific genetic changes (known as EGFR, ALK, ROS1, or RET alterations)
• People whose lung cancer tumour cells show a certain level of a protein called PD-L1 (at least 1%), measured by an approved laboratory test
• People whose NSCLC has spread to other parts of the body, has come back after earlier treatment, or is at an advanced stage where curative surgery or radiation is not possible
• People who have at least one area of cancer that can be measured on scans, according to standard measurement guidelines
• People who are in good general health and able to carry out daily activities, rated as a 0 or 1 on a standard medical scale (ECOG performance status) — both at the time of signing consent and when treatment begins
• People who are willing to provide a stored tissue sample from a previous biopsy, or to have a new biopsy taken if no stored sample is available
• People who are willing to have a biopsy taken during the trial, if the treating doctor considers it safe to do so
• People whose blood test results meet the following levels: platelet count at least 100,000/uL, neutrophil count at least 1,500/uL, and haemoglobin at least 8g/dL
• People whose liver enzyme levels (AST and ALT) are no more than 2.5 times the normal upper limit, and whose creatinine level is no more than 2.0 mg/dL
• People who are able and willing to use effective contraception (hormonal or barrier methods) before, during, and for three months after treatment — this applies to women who could become pregnant and to sexually active men
• Women who could become pregnant must have a negative pregnancy test at the start of the trial; pregnant or breastfeeding women are not eligible
• People who have read, understood, and signed the informed consent form before joining the trial

Who may not be able to join:

• People who have already received chemotherapy, immunotherapy (such as anti-PD-L1, anti-CTLA4, or similar treatments), or immune-modifying therapy for metastatic or recurrent NSCLC — with two exceptions: (1) people who received such treatments as part of an earlier attempt to cure their cancer, where the last dose was more than 24 weeks before signing consent; and (2) people with certain other genetic alterations in their cancer who previously received a targeted therapy (such as a MET inhibitor), provided enough time has passed since stopping that treatment (confirm with trial site)
• People who have had another active cancer within the last 2 years — though people whose earlier cancer was treated with a curative intent at least 2 years ago with no signs of return may be eligible, as may people with a history of certain skin cancers or previously treated non-invasive cancers (confirm with trial site)
• People with brain metastases that are causing symptoms, or who have needed steroids or increasing doses of anti-seizure medication within 7 days before starting treatment; people with large areas of brain metastases may be advised to have radiation before joining (confirm with trial site)
• People with spinal cord compression, unless they have already received local treatment, their symptoms have been stable, and they have not needed steroids for at least 7 days before starting study treatment
• People who have an active autoimmune disease that has required immune-modifying medication within the past 365 days — note that standard hormone replacement therapies (such as thyroid hormone or insulin) are generally allowed
• People who are unable to stop taking systemic (whole-body) steroid medications, which must be tapered off at least 7 days before the first dose of the study drug
• People with a known history of a primary immune deficiency condition
• People who have had an organ transplant and are taking immunosuppressant medications as a result
• People who currently have pneumonitis (lung inflammation) with symptoms, or who have ever had pneumonitis related to immunotherapy treatment, regardless of whether it was treated with steroids
• People who have had non-infectious pneumonitis (such as radiation-related lung inflammation) that required steroid treatment within 3 months before starting study treatment
• People who have had radiation therapy within 7 days before starting study treatment
• People who have had major surgery within 21 days, or minor surgery within 14 days, before starting study treatment — placement of a vascular access device or biopsies are not considered surgery for this purpose
• People whose heart rhythm test (ECG) shows a prolonged QT interval on three consecutive tests, or who have a condition called congenital long QT syndrome
• People with severe lung disease (such as COPD) who are unable to stop taking steroids at least 7 days before starting study treatment
• People with serious heart or blood vessel conditions, including: currently unstable chest pain (angina), severe heart failure (NYHA grade above 3), a heart attack within the past 3 months, or a stroke or mini-stroke within the past 3 months
• People with active hepatitis B, hepatitis C, or tuberculosis infections — though people with a history of hepatitis B or C may be eligible if their virus levels are undetectable on local testing (confirm with trial site)
• People with uncontrolled HIV infection — though people with known HIV who are on anti-retroviral therapy, have adequate immune cell counts, and have no history of AIDS-defining infections may be eligible (confirm with trial site)
• People with any other serious or uncontrolled medical condition that, in the investigator's view, would prevent them from completing the study
• People with a significant history of not following medical treatment plans, or who are unable to give reliable informed consent

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