1st Line Durvalumab in PS 2 NSCLC Patients

Exclusion Criteria

• •Any potential patient who meets any of the following criteria has to be excluded from entering the trial.
• •History of hematologic or primary solid tumor malignancy, unless in remission for at least 3 years before registration with the exception of pT1-2 prostate cancer Gleason score \<6, adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer
• •Prior adjuvant systemic anti-cancer treatment within 6 months before registration
• •Prior systemic treatment for metastatic NSCLC
• •Prior treatment with a PD-1 or PD-L1 inhibitor
• •Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses (i.e. which must not exceed 10 mg/day of prednisone or an equivalent corticosteroid)
• •Concomitant drugs contraindicated for use with durvalumab such as corticosteroids, methotrexate, azathioprine and tumor necrosis factor (TNF)-α blockers
• •Concurrent treatment with other experimental drugs or other anticancer therapy, treatment in a clinical trial within 28 days prior to registration
• •Major surgical procedure within 14 days prior to registration
• •Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]). The following are exceptions to this criterion:
• •* Patients with vitiligo or alopecia
• •* Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
• •* Any chronic skin condition that does not require systemic therapy
• •* Patients without active disease in the last 5 years may be included but only after consultation with the coordinating investigator
• •* Patients with celiac disease controlled by diet alone
• •Uncontrolled diabetes mellitus
• •Known history of human immunodeficiency virus (HIV) or active chronic Hepatitis C or Hepatitis B Virus infection or any uncontrolled active systemic infection requiring intravenous (iv) antimicrobial treatment
• •Known history of tuberculosis
• •Known history of primary immunodeficiency
• •Known history of allogeneic organ transplant
• •Receipt of live attenuated vaccine within 28 days prior to registration
• •Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV; unstable angina pectoris, history of myocardial infarction within the last six months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia), significant QT-prolongation, uncontrolled hypertension
• •Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.
• •Patients with dyspnea grade ≥ 3 according to the modified Medical Research Council (mMRC) dyspnea scale.
• •Patients with symptomatic pneumonitis (grade ≥ 2) or active lung infection. Patients having fully recovered from active lung infection can be included assumed they have completed antibiotics and/or corticosteroids
• •Patients with disseminated intravascular coagulopathy
• •Patient with a baseline CT scan older than 21 days prior to registration.