Study of Durvalumab following radiation therapy in patients with stage 3 unresectable NSCLC ineligible for chemotherapy - DUART

Exclusion Criteria

• 1. Patients with locally-advanced NSCLC whose disease has progressed following radiation therapy.
• 2. Mixed small cell lung cancer and NSCLC histology.
• 3. History of allogeneic organ transplantation.
• 4. Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome).
• 5. Uncontrolled intercurrent illness (e.g., ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris)
• 6. History of another primary malignancy except for (a) malignancy treated with curative intent and with no known active disease ≥ 5 years before the first study drug administration, (b) adequately treated nonmelanoma skin cancer or lentigo maligna without evidence of disease, and c) treated carcinoma in situ without evidence of disease.
• 7. History of leptomeningeal carcinomatosis
• 8. History of active primary immunodeficiency
• 9. Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus
• 10. Any unresolved toxicity NCI CTCAE Grade ≥ 2 from previous anticancer therapy with the exception of alopecia, vitiligo, lymphopenia, and the laboratory values defined in the inclusion criteria
• 11. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
• 12. Receipt of live attenuated vaccine within 30 days prior to the first dose of durvalumab
• 13. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of durvalumab.
• 14. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
• 15. Participation in another clinical study with an IP administered in the last 4 weeks.
• 16. Concurrent enrollment in another clinical study, unless it is an observational (noninterventional) clinical study or during the follow-up period of an interventional study
• 17. Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment arm assignment
• 18. Patients who refuse chemotherapy by their own decision.
• 19. Involvement in the planning and/or conduct of the study
• 20. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control.
• 21. Judgment by the Investigator that the patient should not participate in the study
• 22. Genetics research study (optional):
• Exclusion criteria for participation in the optional genetics research component of the study include: a) Previous allogeneic bone marrow transplant b)Nonleukocyte-depleted whole blood transfusion within 120 days of genetic sample collection.