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 are willing to take part voluntarily, are able to communicate with the research team, and are prepared to follow the study procedures and sign a consent form.
• People aged 18 or older at the time of signing the consent form, of any gender.
• People who have a confirmed diagnosis of locally advanced or metastatic non-small cell lung cancer (a specific type and stage of lung cancer), with laboratory results showing a positive PD-L1 marker on their cancer cells.
• People who have not previously received systemic treatment for their locally advanced or metastatic lung cancer; those who had earlier preventative or post-surgery treatments may still be considered, as long as those treatments ended more than 6 months before the cancer returned.
• People whose lung cancer does not have certain specific gene changes (EGFR, ROS1, or ALK); people with other specific gene changes may still be eligible, as long as an approved targeted therapy for that mutation is not already available (confirm with trial site).
• People whose doctors estimate they are expected to live at least 3 months or more.
• People who have at least one measurable area of cancer that can be tracked on scans, following standard measurement guidelines.
• People who have a good general level of physical functioning, rated as 0 or 1 on a standard scale used by doctors (meaning fully active or able to carry out light activity), and whose condition has not worsened in the week before starting the trial.
• People who agree to use effective contraception from the time of signing the consent form until 180 days after the last dose of the study drug; women who could potentially become pregnant must have a negative pregnancy test within 7 days before the first dose, and must not be pregnant or breastfeeding during the study and for 6 months after the last dose (including those who agree to stop breastfeeding during this period).

Who may not be able to join:

• People who have received certain Chinese herbal medicines or immune-boosting drugs used for cancer treatment within 2 weeks before the first dose.
• People who have had high-dose radiation therapy to the lungs (more than 30 Gy) within the 6 months before the first dose.
• People who completed palliative (symptom-relieving) radiotherapy within 7 days before the first dose.
• People who are expected to need any other type of cancer treatment during the study period.
• People who have fluid around the heart that is causing concern, or uncontrolled or symptomatic fluid around the lungs or in the abdomen that requires draining; a small, stable amount of fluid around the heart may still be considered (confirm with trial site).
• People who have cancer that has spread to the brain stem, the lining of the brain or spinal cord, or who have spinal cord involvement.
• People with known brain metastases (cancer that has spread to the brain), unless their brain metastases have been previously treated and have been clinically stable for at least 4 weeks before the first dose, with no new or growing areas, and steroids stopped 7 days before the first dose; people with known untreated but symptom-free brain metastases that have been stable for at least 4 weeks and meet certain size and symptom criteria may also be considered (confirm with trial site).
• People who have been taking higher-dose steroid medications (more than 10 mg of prednisone or an equivalent amount daily) or other immune-suppressing drugs within the 2 weeks before the first dose.
• People who have had a serious infection requiring intravenous antibiotics for more than 7 days within the 2 weeks before the first dose, or who have an unexplained fever above 38.5°C during the screening period.
• People who have had another type of cancer within the 5 years before the first dose, with some exceptions for certain fully treated early-stage or skin cancers (confirm with trial site for specific exceptions).
• People whose overall health or other circumstances are judged by the trial doctors to make participation unsafe or unsuitable.

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