Phase 3 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 have been diagnosed with non-small cell lung cancer (NSCLC) that is advanced, has come back, or has spread to other parts of the body, confirmed through a tissue or cell sample.
• People whose cancer has tested positive for a specific gene change called a ROS1 rearrangement.
• People who have at least one tumour that can be measured on a scan, as assessed by the study doctor.
• People who have brain tumours that were found by chance and are not causing symptoms, or who have already completed brain treatment (surgery and/or radiation) at least 7 days before joining and are stable without needing increasing doses of steroid or seizure medications.
• People aged 18 or older (or 20 or older, depending on local rules).
• People who are largely able to carry out daily activities, with only mild limitations (assessed using a standard scale called ECOG, scores 0 or 1).
• People with a life expectancy of at least 3 months.
• People whose liver, kidney, blood cell, and platelet levels meet the specific healthy ranges required by the trial (confirm with trial site for exact values).
• People whose side effects from any previous cancer treatment have mostly resolved before joining the trial.
• People who are willing and able to give written consent to participate.

Who may not be able to join:

• People who have previously taken an experimental cancer drug for NSCLC as part of another trial.
• People who have previously taken any targeted therapy drug called a TKI, including ones that specifically target ROS1.
• People who have previously received immunotherapy (immune checkpoint inhibitors) for advanced or metastatic disease.
• People who have received more than one round of systemic cancer treatment (such as chemotherapy) for advanced or metastatic disease.
• People who have had major surgery within 28 days before joining (minor procedures such as a biopsy or catheter placement are generally permitted).
• People who have brain tumour symptoms at the time of screening, or whose brain tumour symptoms required increasing steroid doses within the 7 days before joining.
• People who have spinal cord compression detected on imaging, whether or not it is causing symptoms.
• People who have had uncontrolled fluid build-up around the lungs, abdomen, or heart within 28 days before joining that has required drainage more than once a month.
• People who have been diagnosed with another type of cancer, unless it was certain treated skin cancers, cervical cancer in situ, fully treated non-spreading prostate cancer, or another cancer from which the person has been cancer-free for at least 3 years.
• People who have had serious heart or blood vessel problems within the past 6 months, such as a heart attack, heart failure, stroke, blood clots, or pulmonary embolism.
• People with uncontrolled high blood pressure (those with high blood pressure that is being managed with treatment may still be considered).
• People with significant heart rhythm problems, uncontrolled irregular heartbeat, an abnormal reading on a heart electrical test (ECG) beyond set thresholds, a very slow heart rate within the past 6 months, or who are taking certain medications known to affect heart rhythm.
• People with an active serious infection, including active hepatitis B, hepatitis C, HIV, or AIDS-related illness.
• People who currently have or have a history of scarring or inflammation of the lung tissue (interstitial lung disease or certain types of pneumonitis) that required steroid treatment.
• People who are pregnant or breastfeeding.

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