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 voluntarily sign a consent form and follow the study requirements
• People of any gender
• People aged 18 years or older
• People whose doctors expect them to live for at least 3 more months
• People who have been confirmed through a tissue or cell sample to have locally advanced or metastatic non-small cell lung cancer
• People whose tumor or blood samples show specific EGFR gene mutations known to be sensitive to treatment
• People who agree to provide stored or fresh tumor tissue samples (taken within the past 2 years) for biomarker testing
• People who have at least one measurable area of cancer that meets specific size and imaging standards (confirm with trial site)
• People who are largely able to care for themselves and carry out light activity, as measured by a standard performance scale (ECOG score of 0 or 1)
• People whose side effects from previous cancer treatments have mostly resolved to a mild level or better
• People with healthy heart function, including a heart pumping strength of at least 50%
• People whose blood, kidney, and liver function meet required levels — without having had a blood transfusion or growth factor injections in the 14 days before screening
• People with normal blood clotting results within the required ranges (confirm with trial site)
• People with low or manageable levels of protein in their urine
• People who are able to have children (both female and male) who agree to use reliable contraception from 7 days before the first dose until 6 months after the last dose; female participants who could become pregnant must have a negative pregnancy blood test within 7 days before the first dose

Who may not be able to join:

• People who have previously received any systemic cancer treatment
• People who have previously been treated with EGFR-TKI medications (a type of targeted cancer drug)
• People who participated in another clinical trial within the 4 weeks before starting this study
• People who received radiotherapy within 4 weeks before starting the study, or certain Traditional Chinese Medicine treatments with anti-tumour purposes within 2 weeks before starting (confirm with trial site)
• People who had major surgery within 4 weeks before the first dose
• People with a history of serious heart disease or stroke-related conditions
• People who had blood clot events requiring treatment within 6 months before screening (clots related to infusions are not excluded)
• People with certain heart rhythm or electrical conduction problems, including prolonged QT interval, complete left bundle branch block, third-degree heart block, or frequent uncontrolled irregular heartbeat
• People with a history of lung scarring or inflammation (interstitial lung disease) that required steroid treatment, or who currently have this condition, or have had moderate to severe radiation-related lung inflammation
• People with other serious lung conditions that significantly affect breathing
• People who had a severe infection anywhere in the body within 4 weeks before screening
• People who have or are at risk of an active autoimmune disease, or have a history of autoimmune disease
• People who have had another type of cancer within the 5 years before the first dose
• People who test positive for HIV, or who have active tuberculosis, active hepatitis B, or active hepatitis C infection
• People with high blood pressure that remains poorly controlled despite taking two different blood pressure medications
• People with poorly controlled blood sugar levels
• People with large or poorly controlled fluid build-up in body cavities causing significant symptoms
• People who have active cancer spread to the brain or central nervous system
• People whose scans show the cancer has grown into or wrapped around major blood vessels in the chest, abdomen, neck, or throat
• People with serious wounds, ulcers, or fractures that have not healed within the 4 weeks before signing consent
• People who had significant bleeding or a clear tendency to bleed in the 4 weeks before signing consent
• People with a history of receiving someone else's stem cells, bone marrow, or organ transplant
• People with a known allergy to recombinant humanised antibodies or to any ingredient in the study drug BL-B01D1
• People with a history of serious neurological or psychiatric illness
• People who are pregnant or currently breastfeeding
• People who received a live vaccine within 28 days before joining the study, or who are planned to receive one during the study
• People who the trial investigator considers unsuitable for participation for any other reason

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