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:

• You are male or female and are older than 18 years of age.
• You have been diagnosed with non-small cell lung cancer (confirmed by a tissue or cell sample) that has continued to grow or spread after receiving a first round of treatment.
• You have a build-up of fluid around your lungs (called malignant pleural effusion), confirmed by testing, that is moderate or large in size, needs medical treatment, and has not yet been treated.
• Your last cancer treatment (such as chemotherapy, immunotherapy, or radiation) ended at least 4 weeks ago, or you have waited the required time based on the specific drug used — unless your fluid has worsened or is new after at least 2 cycles of treatment.
• Any side effects from your previous cancer treatments have mostly resolved to mild or no symptoms, with some exceptions (such as hair loss, mild nerve problems, or ongoing thyroid issues) (confirm with trial site).
• You are reasonably active and able to carry out daily activities, based on a standard performance scoring system (score of 0–2).
• Your doctors expect you to live for at least 12 weeks or more.
• Your blood counts, liver function, and kidney function are within acceptable ranges based on recent lab tests (confirm with trial site for specific values).
• You are willing and able to understand and sign a consent form to take part in the study.

Who may not be able to join:

• Your fluid around the lungs is not causing symptoms and does not need treatment, or you have fluid around both lungs, or the fluid has become separated/compartmentalized in a way that makes treatment difficult.
• You have cancer that has spread to your brain and is causing symptoms or needs treatment — though you may still be considered if your brain metastases were treated, have been stable and symptom-free for at least 4 weeks, and you are not taking steroids or seizure medications.
• You have a known serious allergy to the study drug (M701) or similar types of large-molecule drugs (such as antibody-based treatments).
• You have a medical condition that makes it unsafe for doctors to drain fluid from around your lungs.
• You had a major surgical operation within the 4 weeks before starting the trial.
• More than 70% of your liver is affected by cancer spread.
• You have an active, uncontrolled infection that is considered moderate or worse.
• You require long-term use of steroids or immune-suppressing medications (for example, due to an active autoimmune disease or after an organ transplant) — some exceptions apply, such as controlled type 1 diabetes or thyroid conditions managed with replacement therapy (confirm with trial site).
• You have a serious lung disease that the doctors feel makes participation unsafe, or you have a condition called interstitial pneumonia.
• You have a significant heart condition, such as a heart attack in the last 6 months, severe heart failure, unstable chest pain, or uncontrolled high blood pressure, or you have previously had heart bypass surgery or a stent placed.
• You have certain heart rhythm abnormalities, a personal or family history of a specific heart electrical condition (long or short QT syndrome), or you have had a device implanted to control dangerous heart rhythms.
• You have had another type of cancer within the past 3 years — some exceptions may apply for certain low-risk skin cancers or non-invasive conditions (confirm with trial site).
• You have active hepatitis B, active hepatitis C, active syphilis, or HIV (confirm with trial site for specific test thresholds).
• You are pregnant, breastfeeding, or planning to become pregnant within six months.
• You have a confirmed history of a neurological or mental health condition, including epilepsy or dementia.
• The trial doctors decide for any other reason that the trial is not appropriate for you.

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