Study on ILKN421H and Pembrolizumab for Advanced Non-Small Cell Lung Cancer

Inclusion Criteria

• Must be 18 years or older.
• Have a confirmed diagnosis of advanced non-small cell lung cancer (NSCLC) that cannot be surgically removed or has spread.
• Have not responded to previous PD-1/L1 inhibitor treatments or have not received any prior cancer therapy.
• Have at least one measurable tumor.
• Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have a life expectancy of at least 12 weeks.
• Have adequate organ and bone marrow function as determined by specific blood tests.
• Women must not be pregnant and must agree to use effective contraception during the study and for a specified period after the last dose.
• Men must agree to use contraception during the study and for a specified period after the last dose.
• Be willing to comply with study schedules and procedures.

Exclusion Criteria

• Have an allergy to any component of the study drugs.
• Have participated in another clinical trial and received treatment within 28 days before the first dose.
• Have used certain immune-modulating drugs recently.
• Have received CAR-T therapy or other specific cancer treatments within a specified time before the study.
• Have had major surgery recently or have unhealed wounds.
• Have received a live vaccine recently.
• Have active or untreated brain metastases.
• Have uncontrolled fluid buildup in the body.
• Have had another type of cancer within the past five years, except for certain non-threatening cancers.
• Have active autoimmune or inflammatory diseases.
• Have active infections like hepatitis B, hepatitis C, or HIV.
• Have severe heart or lung conditions.
• Have a history of severe allergic reactions to pembrolizumab.
• Be pregnant or breastfeeding.
• Have any condition that may interfere with the study or the ability to provide informed consent.