Thoracic Radiotherapy Plus Maintenance Durvalumab After First Line Carboplatin and Etoposide Plus Durvalumab in Extensive-stage Disease Small Cell Lung Cancer (ED-SCLC).

Exclusion Criteria

• •Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥ 1 week prior to registration
• •Prior chemotherapy treatment for ED-SCLC
• •Any history of radiotherapy to the chest. Radiation therapy outside of the chest for palliative care (i.e., bone metastasis) is allowed but must be completed before first dose of -
• •Prior systemic treatment including immune checkpoint inhibitors against SCLC
• •Concomitant treatment within 30 days of registration with any other experimental drug and/or enrollment in another clinical trial
• •Concomitant use of other anti-cancer drugs or radiotherapy. Except surgery for local pain control
• •Severe or uncontrolled cardiovascular disease
• •* Congestive heart failure NYHA III or IV;
• •* Unstable angina pectoris
• •* History of myocardial infarction within the last 3 months
• •* Serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia)
• •* Uncontrolled hypertension
• •Uncontrolled or symptomatic hypercalcemia, i.e.
• •* \> 1.5 mmol/L ionized calcium
• •* \> 12 mg/dL or \> 3 mmol/L corrected serum calcium
• •Known interstitial lung disease
• •Body weight ≤ 30 kg
• •Major surgical procedure (defined by the investigator) within 28 days prior to the first dose of durvalumab or anticipation of need for a major surgical procedure during the course of the trial
• •Known history of active primary immunodeficiency
• •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 antimicrobial treatment
• •Known history of allogeneic organ transplantation
• •Active or prior documented autoimmune or inflammatory disorders including:
• •* Inflammatory bowel disease (e.g., colitis or Crohn's disease)
• •* Systemic lupus erythematosus
• •* Wegener syndrome (granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.)
• •Patients with eczema, psoriasis, lichen simplex chronicus are not permitted, except they are with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) and meet the following conditions:
• •* Rash must cover less than 10% of body surface area
• •* Disease is well controlled at baseline and only requires low potency topical steroids
• •* No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation \[PUVA\], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, high potency, or oral steroids)
• •Patients with a paraneoplastic syndrome (PNS) of autoimmune nature, requiring systemic treatment (systemic steroids or immunosuppressive agents) or has a clinical symptomatology suggesting worsening of PNS
• •History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening thorax CT scan
• •Receipt of live attenuated vaccine within 30 days prior to the first dose of durvalumab
• •Concomitant or prior use, i.e. within 14 days before the first dose of durvalumab, of immunosuppressive medication including immunosuppressant, such as methotrexate, azathioprine and tumor necrosis factor (TNF)-α blockers, with the exceptions of:
• •* Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
• •* Systemic corticosteroids at physiological doses not to exceed 10 mg/day of prednisone or an equivalent corticosteroid
• •* Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) and premedication for chemotherapy
• •Known hypersensitivity to the drugs used in this trial (carboplatin, etoposide, durvalumab)
• •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.