IMMUNO-Resist: This study is recruiting people with non-small cell lung cancer who are planning to receive radiation therapy treatment to test different types of scansDefining the Immunophenotype of immunotherapy resistance with 89Zr- Durvalumab (MEDI4736) and CD8 T-cell PET/CT in any stage non-small cell lung cancer

Exclusion

Current or prior use of immunosuppressive medication within 28 days before the first dose of study drug, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. Systemic steroid administration required to manage toxicities arising from radiation therapy delivered as part of the chemoradiation therapy for locally advanced NSCLC is allowed.



For patients who have received prior immunotherapy, including anti PD-1, PD-L1 and CTLA-4 therapy:



Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of greater than 10 mg prednisone or equivalent per day.



All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline prior to screening for this study.

Must not have experienced a greater than or equal to Grade 3 immune related AE or an immune related neurologic or ocular AE of any grade while receiving prior immunotherapy. NOTE: Patients with endocrine AE of greater than or equal to Grade 2 are permitted to enrol if they are stably maintained on appropriate replacement therapy and are asymptomatic.



Vascular access or EBUS or mediastinal biopsy) that would prevent administration of study drug.



Active or prior documented autoimmune disease within the past 2 years. NOTE: Patients with vitiligo, Grave’s disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.



Active or prior documented inflammatory bowel disease (e.g. Crohn’s disease, ulcerative colitis)



History of primary immunodeficiency.



History of organ transplant that requires therapeutic immunosuppression.



Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any patient known to have hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent.



Known active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or HBV core antibody (anti-HBc), at screening. Participants with a past or resolved HBV infection (defined as the presence of antiHBc and absence of HBsAg) are eligible. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.



Participants co-infected with HBV and HCV, or co-infected with HBV and HDV, namely: HBV positive (presence of HBsAg and/or anti HBcAb with detectable HBV DNA); AND



HCV positive (presence of anti-HCV antibodies); OR



HDV positive (presence of anti-HDV antibodies).



Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV?1/2 antibodies) or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).



Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving study drug.



History of another primary malignancy within 5 years prior to starting study drug, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study.



Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control



PET contraindications, e.g. Total serum bilirubin greater than 1.5 times upper limit of normal (abnormal hepatic metabolism may interfere with hepatic excretion)



Any condition that, in the opinion of the investigator, would interfere with evaluation or interpretation of patient safety or study results