Phase 3 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 sign a consent form and agree to follow the study requirements
• People who are 18 years of age or older
• People whose doctors expect them to live for at least 3 more months
• People who have locally advanced non-small cell lung cancer that cannot be removed by surgery or treated with full-dose radiation therapy aimed at a cure
• People whose cancer has tested positive for a specific gene change called an EGFR sensitive mutation, found in either a tumour tissue sample or a blood test
• People who agree to provide a stored or freshly collected tumour tissue sample for testing, including testing for the type of EGFR mutation present
• People who have at least one tumour that can be measured on a scan, according to standard measurement guidelines
• People with a general health and activity level rated as fully active or restricted only in physically strenuous activity (as rated by a standard scale called ECOG 0 or 1)
• People whose side effects from any previous cancer treatment have mostly resolved to a mild level or better
• People with no serious heart problems, and whose heart pumping function is at 50% or above on testing
• People whose liver, kidney, blood, and other organ functions meet the required levels, without needing a blood transfusion or certain growth factor injections in the 14 days before screening
• People whose urine protein levels fall within an acceptable range
• Women who could become pregnant must have a negative pregnancy test within 7 days before starting treatment and must not be breastfeeding; all participants, regardless of sex, are advised to use effective barrier contraception during treatment and for 6 months after treatment ends

Who may not be able to join:

• People whose cancer has been found to contain small cell lung cancer or a mixture of small cell and non-small cell components
• People who have previously received any systemic (whole-body) cancer treatment
• People who have previously been treated with a type of targeted therapy called an EGFR-TKI
• People who have had full-dose curative radiation therapy, major surgery, or large-area radiation treatment in the 4 weeks before joining the study
• People with a history of serious heart or stroke-related conditions
• People who have had an unstable blood clot requiring treatment in the 6 months before screening (clots related to an intravenous line are not included in this)
• People with certain heart rhythm problems, including QT prolongation, complete left bundle branch block, third-degree heart block, or frequent uncontrolled irregular heartbeat
• People who have been diagnosed with another active cancer within the past 3 years
• People with high blood pressure that remains poorly controlled despite taking two blood pressure medications (above 150/100 mmHg)
• People with poorly controlled blood sugar levels
• People with a history of a lung condition called interstitial lung disease (ILD) that required steroid treatment, or who currently have ILD or significant radiation-related lung inflammation, or are suspected of having these conditions
• People with other serious lung diseases that significantly affect breathing
• People with active cancer spread to the brain or spinal cord that is currently causing symptoms or is unstable
• People who had a serious infection in the 4 weeks before joining the study
• People with large or symptomatic fluid build-up around the lungs, heart, or abdomen that is not well controlled
• People whose scans show the tumour has grown into or wrapped around major blood vessels in the chest, abdomen, neck, or throat
• People with serious wounds, ulcers, or broken bones that have not healed in the 4 weeks before signing the consent form
• People who have had significant bleeding or a clear tendency to bleed in the 4 weeks before signing the consent form
• People with a history of inflammatory bowel disease, removal of a large portion of the bowel, immune-related bowel inflammation, bowel blockage, or long-term diarrhoea
• People with a known allergy to the study drug (BL-B01D1) or any of its ingredients
• People who have previously had a stem cell transplant, either from their own cells or from a donor
• People who test positive for HIV, or who have active hepatitis B or hepatitis C infection
• People with a history of serious neurological or psychiatric illness
• People who have taken part in another clinical trial using an unapproved drug or treatment in the 4 weeks before joining this study
• People who are planned to receive a vaccine or who have received a live vaccine in the 28 days before joining the study
• People who the study doctor considers unsuitable for any other medical or personal reason

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