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 18 or older who have been diagnosed with one of the following advanced or metastatic cancers: (1) non-squamous non-small cell lung cancer that cannot be surgically removed and has gotten worse after at least one prior treatment; (2) triple negative breast cancer (a type that tests negative for estrogen receptors, progesterone receptors, and HER2) that has gotten worse after at least one prior treatment, or where a doctor has determined standard first-line treatment is not appropriate; or (3) hormone receptor-positive, HER2-negative breast cancer that has gotten worse after hormone-based therapy including a CDK4/6 inhibitor, and at least one round of chemotherapy and/or a type of targeted drug called an antibody-drug conjugate.
• People who have a general health and activity level rated as 0, 1, or 2 on a standard medical scale used to measure how cancer affects daily living (confirm with trial site).
• People whose heart pumping function, measured by a specific heart scan, shows the heart is working at 50% or above, tested within 28 days before joining.
• People who have cancer that can be measured on scans using a standard set of medical rules (confirm with trial site).
• People whose blood counts and organ function test results fall within acceptable ranges, checked within 14 days before starting treatment — including healthy enough levels of platelets, red blood cells, white blood cells, kidney function, and liver function.
• People who have waited long enough after their last cancer treatment before starting this trial — the required waiting period depends on the type of treatment previously received (confirm with trial site for specifics).
• People who are capable of having children and who agree to use highly effective contraception throughout the study and for at least 7 months after the last dose (for females) or 4 months (for males).
• Male participants who agree not to freeze or donate sperm during the study and for at least 4 months after the last dose.
• Female participants who agree not to breastfeed or donate or retrieve eggs for personal use during the study and for at least 7 months after the last dose.
• People who are willing and able to give written informed consent and follow the study requirements.
• People who are willing to report their mouth pain levels using specific rating scales throughout the study, and who report no mouth pain at the start of the study.
• People who are willing to keep a daily diary recording any mouth-related symptoms.
• People who have a life expectancy of at least 3 months.

Who may not be able to join:

• People who have a second active cancer that could affect how the study results are understood.
• People who have a history of lung inflammation (not caused by infection) that required steroid treatment, currently have lung inflammation, or where lung inflammation cannot be ruled out by scans at the screening stage.
• People who have a significant eye or cornea condition.
• People who have had a severe allergic reaction to the study drug or any of its ingredients (including polysorbate 80).
• People who have had a severe allergic reaction to other similar types of drugs called monoclonal antibodies.
• People who are still experiencing side effects from previous radiation treatment.
• People who have an active, uncontrolled infection currently being treated with intravenous antibiotics, antivirals, or antifungal medications.
• People who have HIV that is not well managed.
• People who have active or uncontrolled hepatitis B or hepatitis C infection.
• People who are pregnant or breastfeeding, confirmed by a pregnancy test taken within 7 days before joining.
• People who have serious lung problems caused by autoimmune, connective tissue, or inflammatory conditions.
• People who have significant or uncontrolled heart problems — including a heart attack or unstable chest pain within the past 6 months, moderate to severe heart failure, uncontrolled high blood pressure, or uncontrolled heart rhythm problems.
• People who have a history of abnormal heart rhythm (specifically a prolonged QT interval) caused by another medication that had to be stopped because of it, or who are currently taking any medication known to cause this type of heart rhythm problem.
• People who have an inherited condition causing abnormal heart rhythm (long QT syndrome), a family history of it, or a close family member who died suddenly and unexpectedly before the age of 40.

(Note: People with certain heart rhythm readings above a specific threshold may still be considered for the trial based on the treating doctor's assessment — confirm with trial site.)

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