Immunotherapy in Combination With Chemotherapy in Small-cell Lung Cancer

PAVE(Phased Avelumab combined with chemotherapy as first-line treatment for patients with advanced small-cell lung cancer) is a Greek, investigator- initiated, single arm open- label phase II study of Avelumab in combination with cisplatin or carboplatin/ etoposide. The study will include an initial safety run-in, open-label, singlearm part (Part 1), and the actual phase II study (Part 2). The total number of patients will not change (the safety run-in patients will be included in the final total number of participants). The safety run-in period will not alter the total study timelines, as phase II accrual will follow immediately after the safety run-in.

Inclusion Criteria: * Signed written informed consent * Male or female patients aged more than or equal to (≥) 18 years * With Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry * At least 1 measurable tumor lesion by RECIST 1.1 * With histologically confirmed metastatic (Stage IV) small cell lung cancer (SCLC) * Patients must not have received any previous systemic treatment for small cell lung cancer * Patients must have an estimated life expectancy of more than 12 weeks * Patients must have an available recently-obtained, formalin-fixed, paraffin-embedded (FFPE) tissue sample containing tumor (biopsy preferably within 6 months) or a minimum number of 10 unstained slides, suitable for PD-L1 expression assessment. 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.