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 willing to voluntarily agree to take part and follow the study's rules
• You are between 18 and 75 years old
• Your doctors expect you to live for at least 3 more months
• You are willing to have a specific blood test (called ctDNA testing) during the screening period
• You have been confirmed through a biopsy or lab test to have locally advanced or metastatic non-small cell lung cancer (NSCLC)
• You are willing to provide a stored or fresh tissue sample from your cancer
• You have at least one area of cancer that can be measured on a scan, according to standard medical guidelines
• You are fairly active and able to care for yourself, with only minor limitations (confirm with trial site)
• Any side effects from previous cancer treatments have mostly resolved
• Your heart is pumping well enough, with the heart's pumping strength measured at 50% or above
• Your liver, kidneys, blood, and other organs are working well enough without needing recent transfusions or certain supportive medications
• Your blood clotting levels are within an acceptable range
• Your urine does not contain too much protein
• If you are a woman who could become pregnant or a man whose partner could become pregnant, you agree to use reliable contraception throughout the trial and for 24 weeks after the last dose; women must also have a negative pregnancy test before starting

Who may not be able to join:

• Certain genetic changes in your cancer were already identified before you agreed to take part (confirm with trial site)
• For one part of the study (Phase II): if you are suitable for and willing to have local treatment, or if you have already received systemic chemotherapy
• You have brain or nervous system spread of cancer that is causing symptoms, and the doctor considers this a problem for joining
• You have taken part in another clinical trial within the past 4 weeks
• You have had chemotherapy, immunotherapy, biological therapy, or certain other cancer treatments within the past 4 weeks, or targeted therapy or radiotherapy for pain relief within the past 2 weeks
• You have had major surgery within the past 4 weeks
• You need to take steroid tablets or medicines that suppress your immune system on a regular basis
• You have a serious lung disease, a history of a specific type of lung scarring (interstitial lung disease), or signs of it during screening
• You have another ongoing lung condition that is significantly affecting your breathing
• You have had an unstable blood clot requiring treatment within the past 6 months (not counting clots related to a medical line or catheter)
• You currently have an active infection that requires antibiotics or antiviral medicines given through a drip
• Your scans show that the cancer is growing into or wrapping around major blood vessels in the chest, neck, or throat, which could raise the risk of bleeding
• You have previously had a serious immune reaction (grade 3 or above) from immunotherapy, or a heart inflammation reaction (grade 2 or above) from immunotherapy
• You have had a live vaccine within the past 4 weeks
• You have taken certain immune-boosting or immune-modifying medications within the past 14 days
• You have an active autoimmune disease or a history of one
• You have had another type of cancer in the past 5 years
• You have HIV, active tuberculosis, active hepatitis B, or active hepatitis C
• Your blood pressure is poorly controlled (above 150/100 mmHg)
• You have a history of serious heart or stroke-related conditions
• You have a significant or poorly controlled build-up of fluid in your body cavities (such as around the lungs or abdomen)
• You have previously had a stem cell, bone marrow, or organ transplant from another person
• You have ever had a serious allergic reaction to similar antibody-based medicines or to any ingredients in the study drugs (SI-B001 or SI-B003)
• You have previously had any stem cell transplant (from yourself or another person)
• You are currently pregnant or breastfeeding
• The trial doctor feels there is any other reason you should not take part

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