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 aged between 18 and 70 years old (inclusive)
• People diagnosed with a type of lung cancer called non-small cell lung cancer (NSCLC), whose cancer has come back or gotten worse after standard treatment, and who have cancer cells detected in the fluid around the brain and spine, or have been diagnosed with cancer spreading to the lining of the brain (leptomeningeal metastasis) on an MRI scan
• People whose overall health and ability to function meets a certain minimum level, as measured by a standard scoring system (PS score of 3 or below)
• People whose doctor determines they are suitable for a small device called an Ommaya reservoir to be placed (a device used to deliver medication directly to the fluid around the brain)
• People whose doctors expect them to live for at least 3 more months
• People whose blood counts, clotting function, liver, and kidney are working at acceptable levels based on blood tests (specific thresholds apply — confirm with trial site)
• People who are willing to take part and have signed a consent form after being fully informed about the study
• People (and their partners) who are able to have children and agree to use effective contraception during treatment and for 6 months after the last dose; male participants must agree not to donate sperm during this period
• Women who are able to become pregnant must have a negative blood pregnancy test within 7 days before the first dose, and must be willing to have additional pregnancy tests during the study
• People who are willing and able to follow all study procedures and attend all required check-ups and follow-up visits
• People who have previously been treated with a type of cancer medication called tyrosine kinase inhibitors (TKIs) for more than two weeks, where only the brain cancer has worsened — these people must continue taking their current TKI and must not switch to a different one during the study

Who may not be able to join:

• People who have received certain cancer treatments in the two weeks before the first dose, including intravenous chemotherapy, chemotherapy delivered into the spinal fluid, or whole-brain radiotherapy (immunotherapy is excluded from this restriction)
• People who received immunotherapy within 6 weeks before the first dose
• People who took traditional Chinese medicines with anti-cancer properties within 2 weeks before the first dose
• People with epilepsy (seizures) that is not well controlled
• People who took part in another clinical trial and received an experimental drug within 4 weeks before the first dose
• People who had major surgery (not including minor procedures like biopsy) or a serious injury within 4 weeks before the first dose, or who are expected to need planned surgery during the study
• People who have previously received cell therapy, gene therapy, or treatment using oncolytic viruses
• People who are known or suspected to be allergic to any ingredient in the study drug or to contrast agents used in imaging scans
• People who have had an organ transplant in the past, or who are expected to need one during the study
• People who have an active infection requiring intravenous antibiotics or other treatment, an uncontrolled infection, or an unexplained fever above 38.5°C at or before the start of the study
• People with serious blood clotting problems or signs of significant bleeding risk, a history of gastrointestinal bleeding, or any moderate or severe bleeding event in the past 6 months
• People who took immune-suppressing medications (such as azathioprine, cyclophosphamide, methotrexate, or thalidomide) within 14 days before the first dose
• People whose side effects from previous cancer treatment have not sufficiently improved (side effects must have settled to a mild or absent level, with some exceptions such as hair loss — confirm with trial site)
• People with a history of immune deficiency conditions, including those who test positive for HIV
• People with active hepatitis B, active hepatitis C, or a positive test for syphilis (specific laboratory thresholds apply — confirm with trial site)
• People whose blood pressure remains poorly controlled despite standard treatment (systolic pressure at or above 160 mmHg and/or diastolic pressure at or above 100 mmHg)
• People with a history of serious heart conditions, including certain irregular heartbeats, a prolonged heart electrical interval (QTc above 480 ms), heart attack, heart failure, stroke, or other serious heart events within the past 6 months; or people with moderate or severe heart function problems
• People who have had another cancer within the past 3 years that has not been fully treated (some very early-stage or easily curable conditions may be excepted — confirm with trial site)
• People with active or recurring autoimmune diseases (such as lupus or rheumatoid arthritis), except for stable autoimmune thyroid conditions
• People who received a live, weakened, or recombinant vaccine within 4 weeks before the first dose, or an inactivated vaccine within 2 weeks before the first dose
• People who previously experienced a severe (grade 3 or higher) immune-related side effect from immunotherapy
• People whose lung cancer has spread to the brainstem, or whose brain metastases are spreading rapidly throughout the brain
• People whose brain MRI shows the cancer is growing into the walls of the brain's fluid-filled spaces, or who have a communication between brain cavities following surgery (confirm with trial site)
• People with a history of brain inflammation (encephalitis), multiple sclerosis, or other infections of the brain or nervous system
• People who have or have had cerebral herniation syndrome (a serious condition where brain tissue is displaced — confirm with trial site)
• People with a confirmed dependence on alcohol or drugs
• People with psychiatric conditions or who are unlikely to follow the study requirements
• Women who are pregnant or breastfeeding
• People whose doctor determines, for any other reason related to serious health conditions, that participation in this trial would not be appropriate

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