Immunotherapy in Combination With Chemotherapy in Small-cell Lung Cancer

Korábbi kezelés

• 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
• 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.
• 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

Más betegség

• 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)."
• 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)
• Other severe acute or chronic medical conditions.

• 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.