A phase I study evaluating the safety and efficacy of SGI-110 followed by combined durvalumab(MEDI4736) plus tremelimumab in subjects with extensive-stage small cell lung cancer (ES-SCLC)

Protocol: 
AAAQ8257
Phase: 
I

A phase I study evaluating the safety and efficacy of SGI-110 followed by combined durvalumab(MEDI4736) plus tremelimumab in subjects with extensive-stage small cell lung cancer (ES-SCLC)

You are being asked to participate in this study because you have advanced small cell lung cancer (SCLC) that has not responded (or is no longer responding) to standard chemotherapy. This trial is only enrolling patients with your type of lung cancer. SCLC is typically first treated with a combination of platinum (cisplatin or carboplatin) and etoposide, which you have already received or were unable to receive. The purpose of this study is to determine if a combination of investigational agents is safe to give to people with SCLC after standard chemotherapy has been attempted. If you enroll in this trial you will receive 3 investigational drugs (each described below): SGI-110 (guadecitabine), durvalumab (MEDI4736) and tremelimumab.

Are you Eligible? (Inclusion Criteria)

(1) Subjects must have a histologically confirmed diagnosis of small cell lung
carcinoma. A fresh,
pre-treatment tumor biopsy will be required if adequate tissue is not available
to evaluate tumor
infiltrating lymphocytes, PD-L1 IHC staining, and LINE-1 methylation
(2) Patient has not had any previous treatment with a PD1 or PD-L1 inhibitor,
including durvalumab
or an anti-CTLA4, including tremelimumab
(3) Subjects must have extensive-stage disease (by NCCN criteria) that is
progressive or relapsed
after platinum-based chemotherapy
(4) Tumor burden must be radiographically measurable by RECIST criteria

Specialty Area(s)

Immunotherapy

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States