This study will determine the frequency of adverse events (side effects) in patients with relapsed or refractory small cell lung cancer (SCLC) when given nivolumab and irinotecan together followed by nivolumab maintenance. This study will test the safety of the study treatments when given together and see what effect (good or bad) it has on participants and their cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
PD-1 inhibitor approved by the US FDA for treatment of patients with lung cancer.
Chemotherapy drug currently FDA approved for treatment of multiple tumors, including small cell lung cancer.
Georgia Cancer Center at AU Medical Center
Augusta, Georgia, United States
Evaluate the frequency and severity of adverse events in patients with small cell lung cancer after receiving nivolumab plus irinotecan followed by nivolumab maintenance.
CTCAE v.4.0. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Time frame: through study completion, an average of 1 year
Overall response rate
Tumor response evaluation with RECIST
Time frame: through study completion, an average of 1 year
Progression-free survival (PFS)
PFS as measured from start of therapy till disease progression.
Time frame: through study completion, an average of 1 year
Overall survival (OS)
OS as measured from start of therapy till date of death or last follow up assessment.
Time frame: through study completion, an average of 1 year.
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