Immunotherapy in Combination With Chemotherapy in Small-cell Lung Cancer

Exclusion Criteria

• •Patients with brain metastases are excluded, except those with brain metastases that have been treated with surgery or radiation and are clinically stable for at least 2 weeks prior to registration.
• •Prior therapy with any antibody or drug targeting T cell co-regulatory proteins, concurrent anticancer treatment, or immunosuppressive agents
• •Patients on current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)."
• •Known severe hypersensitivity reactions to monoclonal antibodies, history of anaphylaxis, or uncontrolled asthma, and persisting toxicity related to prior therapy of Grade \> 1 NCI-CTCAE v 4.03.
• •Patients with active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent.
• •Patients with prior organ transplantation including allogenic stem-cell transplantation are excluded.
• •Patients with an active infection requiring systemic therapy are excluded.
• •Patients with known history of testing positive for HIV or known acquired immunodeficiency syndrome are excluded.
• •Also excluded are patients with Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive)
• •Vaccination within 4 weeks of the first dose of avelumab and while on trials is prohibited except for administration of inactivated vaccines.
• •Persisting toxicity related to prior therapy
• •Other severe acute or chronic medical conditions.