Study on Whether Durvalumab and Radiation Therapy Can Slow Down Non-Small Cell Lung Cancer

Inclusion Criteria

• Able to give informed consent and follow study requirements.
• Age 18 or older.
• Newly diagnosed or returning locally advanced NSCLC (stage II-III) that can be treated with radiation and Durvalumab.
• Cannot have surgery or chemotherapy due to medical reasons or other approved reasons.
• Confirmed diagnosis of NSCLC through standard biopsy.
• ECOG/WHO performance status of 0-2.
• Suitable for radiation therapy of 60 Gy in 30 fractions.
• Body weight over 30 kg.
• Normal organ and bone marrow function, including:
  • Hemoglobin of at least 9.0 g/dL.
  • Neutrophil count of at least 1500 per mm3.
  • Platelet count of at least 75,000 per mm3.
  • Bilirubin level within 1.5 times the normal limit.
  • AST/ALT levels within 2.5 times the normal limit.
  • Creatinine clearance over 15 mL/min.
• Post-menopausal status or negative pregnancy test for women of childbearing age.
• Willing to comply with study procedures and visits.
• Life expectancy of at least 12 weeks.

Exclusion Criteria

• Participating in another clinical study with an investigational product in the last 4 weeks.
• Enrolled in another clinical study unless it's observational.
• Previous chest radiation that prevents further radiation.
• Active or past autoimmune or inflammatory disorders, with some exceptions.
• Unresolved side effects from previous cancer treatments, except for certain conditions.
• Recent treatment with certain antibodies or chemotherapy.
• Prior use of specific immune therapies.
• Recent use of immunosuppressive medication, with some exceptions.
• Major surgery within 28 days before starting the study.
• History of organ transplantation.
• Severe concurrent illness, including:
  • Psychiatric or substance abuse disorders.
  • Additional progressing cancer.
  • Active infections like tuberculosis or hepatitis.
  • Lung disease or heart conditions.
• Pregnant or breastfeeding women, or those not using effective birth control.
• Recent live vaccination.
• Connective tissue disorders affecting the lungs or esophagus.
• Known EGFR or ALK mutations.
• Contraindications to radiotherapy.
• Allergies to study drugs or their components.