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 have signed a consent form before any trial procedures begin
• People aged 18 to 80 years old
• People who have been confirmed through tissue or cell testing to have stage IV non-small cell lung cancer (a type of lung cancer that has spread to other parts of the body)
• People whose cancer has spread to the bones, where the treating doctor has assessed that the bone involvement needs local radiation treatment
• People who have not yet received any drug treatment for their lung cancer (such as chemotherapy, targeted therapy, or immunotherapy)
• People with the adenocarcinoma type of lung cancer who have been confirmed through testing to be negative for certain genetic changes (EGFR, ALK, and ROS-1); this genetic testing is not required for people with squamous cell carcinoma
• People who have at least one measurable area of cancer (other than bone) that can be tracked according to standard measurement guidelines
• People whose bone metastases (other than the one being treated with radiation) do not need any additional local treatment such as surgery or radiation, in the treating doctor's assessment
• People with a good general performance level, defined as being fully active or able to carry out light work (ECOG score of 0 or 1)
• People whose life expectancy is estimated to be more than 3 months
• People whose blood test results show that their organs (including liver, kidneys, blood cells, thyroid, heart, and clotting system) are functioning adequately, based on specific laboratory measurements (confirm with trial site for exact values)
• Women who could become pregnant must have a negative pregnancy test within 3 days before starting the study treatment
• All participants who could conceive a child must use highly effective contraception throughout the treatment period and for 120 days (or 180 days, depending on the treatment) after the last dose

Who may not be able to join:

• People whose lung cancer is, or includes, small cell lung cancer
• People whose cancer appears to be in one location only and could potentially be treated with curative intent
• People who the study team assesses as needing surgical treatment
• People whose bone lesion being considered for radiation has already been treated with radiation, or cannot be treated with radiation based on assessment
• People with active cancer spread to the brain
• People who have been diagnosed with another cancer in the 5 years before starting the trial (exceptions may apply for certain fully treated skin cancers or carcinoma in situ — confirm with trial site)
• People currently taking part in another interventional clinical trial, or who have received an experimental drug or device within the past 4 weeks
• People who have previously been treated with certain immune checkpoint therapies (such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or similar drugs) or with certain bone-targeted treatments (such as denosumab or nalusolimab)
• People who have an active autoimmune disease that required systemic medical treatment within the past 2 years (simple hormone replacement therapies are generally not included in this — confirm with trial site)
• People with fluid build-up in the chest or abdomen that is not well controlled
• People who have had an organ transplant (other than a corneal transplant) or a bone marrow/stem cell transplant from another person
• People with active bone metabolism disorders (such as Paget's disease of bone, Cushing's syndrome, or high prolactin levels), rheumatoid arthritis, poorly controlled thyroid conditions, or parathyroid disorders
• People with a known allergy to any of the study drugs or their ingredients, including sintilimab, pemetrexed, carboplatin, cisplatin, paclitaxel, or nalusopaimab
• People who have not adequately recovered from side effects of a previous treatment (except for mild tiredness or hair loss)
• People with a known HIV infection
• People with untreated active hepatitis B, defined by specific blood test results (confirm with trial site)
• People with low calcium levels in the blood that cannot be corrected with treatment
• People with a history of or current bone infection (osteomyelitis) or bone death in the jaw, unhealed dental surgery, an active dental or jaw condition needing oral surgery, or who plan to have invasive dental work during the study
• People who have used certain bone-related medications (such as parathyroid hormone, calcitonin, or osteoprotegerin) in the 6 months before joining the trial
• People who have received a live vaccine within 30 days before the first dose
• Women who are pregnant or breastfeeding
• People with serious or uncontrolled health conditions, including but not limited to:
  • Significant heart rhythm problems or serious, hard-to-control heart symptoms
  • Unstable chest pain, heart failure, or a heart failure classification of NYHA grade 2 or higher
  • A heart attack within the 6 months before joining
  • Blood pressure that is not well controlled
  • A history of lung inflammation requiring steroid treatment within the past year, or currently active lung inflammation
  • Active tuberculosis
  • An active or uncontrolled infection requiring treatment
  • Active bowel conditions such as diverticulitis, abdominal abscess, or bowel obstruction
  • Serious liver disease such as cirrhosis or active hepatitis
  • Poorly controlled diabetes (with fasting blood sugar above 10 mmol/L)
  • Significant protein in the urine, confirmed by a 24-hour urine test
  • A mental health condition that would prevent cooperation with treatment
  • Any other condition the investigator considers would make participation unsafe or would affect the trial results

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