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 and able to attend all planned visits, treatments, and tests, and who sign a consent form before any trial procedures begin.
• People aged 18 to 75 years old, of any gender.
• People who have been diagnosed with squamous cell non-small cell lung cancer (a specific type of lung cancer), confirmed by a tissue or cell sample.
• People who have at least one measurable area of cancer that can be tracked using standard medical imaging guidelines.
• People whose cancer has been assessed by researchers as resectable (surgically removable) stage IIA to IIIB squamous NSCLC, with no prior treatment, based on standard cancer staging guidelines.
• People with a good general performance status, meaning they are either fully active or have only minor restrictions on physical activity (confirm with trial site).
• People with a life expectancy of more than 6 months.
• People whose blood, liver, kidney, and clotting results meet the required levels — including healthy white blood cell, platelet, and haemoglobin counts without recent transfusions or boosting treatments; normal liver enzyme and bilirubin levels; normal kidney function; normal blood clotting; and normal thyroid hormone levels.
• Women of childbearing age who return a negative pregnancy test within 3 days before the first dose.
• All participants with any possibility of conception must use highly effective contraception throughout treatment and for up to 120 days after the last study drug dose (or 180 days after the last chemotherapy dose).

Who may not be able to join:

• People who have had another cancer within the past 5 years, except for certain skin cancers or carcinoma in situ that were fully treated.
• People who are currently taking part in another clinical trial or who have received another experimental drug or device within 4 weeks before the first dose.
• People who have previously been treated with certain immune checkpoint drugs, including anti-PD-1, anti-PD-L1, anti-PD-L2, or similar treatments that affect the immune system's T cells (such as CTLA-4, OX-40, or CD137 therapies).
• People who have had an active autoimmune disease requiring ongoing systemic treatment within the past 2 years (simple hormone replacement therapies such as thyroid or insulin are not considered systemic treatment in this context).
• People who are currently receiving steroid treatment throughout the body (not including inhaled or nasal sprays) or other immune-suppressing therapies within 7 days before the first dose, except for low physiological doses of steroids.
• People who have received an organ transplant (other than a corneal transplant) or a bone marrow/stem cell transplant from another person.
• People who are known to be allergic to the trial drugs — sintilimab, carboplatin, or albumin-bound paclitaxel — or their ingredients.
• People who have not fully recovered from side effects of any previous medical treatment (confirm with trial site).
• People with a known HIV infection.
• People with untreated active Hepatitis B, defined by specific blood test results (confirm with trial site).
• People with active Hepatitis C, confirmed by specific blood test results.
• People who have received a live vaccine within 30 days before the first dose (inactivated flu vaccines are permitted; live nasal flu vaccines are not).
• Women who are pregnant or breastfeeding.
• People with serious or uncontrolled heart conditions, including significant abnormal heart rhythms, unstable angina, heart failure, or a heart attack or stroke within the past 6 months.
• People with a history of non-infectious lung inflammation that required steroid treatment within the past year, or who currently have active interstitial lung disease.
• People with active tuberculosis.
• People with active or uncontrolled infections that require systemic treatment.
• People with serious liver conditions such as cirrhosis or active hepatitis.
• People with poorly controlled diabetes (based on fasting blood sugar levels above a set threshold).
• People with significant protein detected in their urine, confirmed by a 24-hour urine test above a set level.
• People with mental health conditions that would prevent them from cooperating with the treatment.
• People with any other medical history, condition, or test result that researchers believe would interfere with the trial or place the person at unacceptable risk.

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