Thoracic RadiothErapy With Atezolizumab in Small Cell lUng canceR Extensive Disease

Exclusion Criteria

• •1. Previous treatment with CD137 agonists, immune-checkpoint blockade therapies, anti-PD-1, or anti-PD-L1 therapeutic antibodies (with the exclusion of prior immunotherapy as defined in inclusion criterion 6).
• •2. Prior therapy for limited-stage SCLC with curative intent.
• •3. Prior radiotherapy of lung and mediastinal lymph nodes within the past 5 years before the first dose of study drug.
• •4. Oxygen-dependent medical condition.
• •5. History or current radiology suggestive of interstitial lung disease (ILD) (including but not limited to idiopathic pulmonary fibrosis (IPF)/usual interstitial pneumonia (UIP)/cryptogenic fibrosing alveolitis (CFA)), non-infectious pneumonitis, drug-induced pneumonitis, idiopathic pneumonitis.
• •6. Criterion removed.
• •7. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study, or during the follow-up period of an interventional study.
• •8. Participation in another clinical study with an investigational product within 21 days prior to the first dose of the study treatment.
• •9. Any concurrent chemotherapy, investigational product (IMP), biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer related conditions (e.g., hormone replacement therapy) is acceptable.
• •10. Major surgery (as defined by the Investigator) within 4 weeks prior to enrollment into the study; patients must have recovered from effects of any major surgery. Note: Local non-major surgery for palliative intent is acceptable.
• •11. Active or prior documented autoimmune or inflammatory disorders (including but not limited to diverticulitis \[with the exception of diverticulosis\], celiac disease, systemic lupus erythematosus, Sarcoidosis, or Wegener's syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis). The following are exceptions to this criterion:
• •* Patients with vitiligo or alopecia
• •* Patients with hypothyroidism (e.g., following Hashimoto's disease) stable on hormone replacement
• •* Patients with controlled Type I diabetes mellitus on an insulin regimen
• •* 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 study physician.
• •12. Active, uncontrolled inflammatory bowel disease \[e.g. ulcerative colitis or Crohn's disease\]. Patients in stable remission for more than 1 year may be included.
• •13. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, interstitial lung disease, gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
• •14. History of another primary malignancy except for:
• •* Malignancy treated with curative intent and with no known active disease ≥ 3 years before the first dose of IMP and of low potential risk for recurrence
• •* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
• •* Adequately treated carcinoma in situ without evidence of disease
• •15. History of active primary immunodeficiency
• •16. History of allogenic organ or tissue transplantation.
• •17. Clinical diagnosis of active tuberculosis.
• •18. Positive testing for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
• •19. Positive testing for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
• •20. Current or prior use of immunosuppressive medication within 14 days before the first dose of atezolizumab. The following are exceptions to this criterion:
• •* Intranasal, inhaled, topical steroids, or local steroid injections (e.g. intra articular injection)
• •* Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
• •* Steroids as premedication for hypersensitivity reactions (e.g. CT scan premedication)
• •21. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 5 months after the last dose of atezolizumab monotherapy.
• •22. Known allergy or hypersensitivity to the IMP or any of the constituents of the product.
• •23. Any co-existing medical condition that in the investigator's judgement will substantially increase the risk associated with the patient's participation in the study.
• •24. Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities.
• •25. Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts.