This is a study for patients with previously-treated advanced non-small cell lung cancer (NSCLC). The study will evaluate the safety of adding an investigational drug, MK-3475 to standard treatment with gemcitabine. The study will also try to identify the best dose of MK-3475 to give in combination with gemcitabine.
This study is an open-label, non-randomized phase I study, followed by open-label non-randomized phase II study. The first cohort of patients will receive 200 milligrams (mg) of MK-3475 by intravenous infusion over a 21-day period called a cycle along with Gemcitabine 1250 mg/m2 given on Days 1 and 8 of each 21-day cycle for up to 6 cycles. Patients will be seen in the study clinic 12 times over 126 days for an evaluation of signs and symptoms that may represent drug toxicity. Patients may continue to receive MK-3475 (without gemcitabine) for up to 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Investigational drug.
Standard care drug.
Providence Oncology & Hematology Care Clinic - Eastside
Portland, Oregon, United States
Providence Oncology & Hematology Care Clinic - Westside
Portland, Oregon, United States
Dose Limiting Toxicities
Patients are seen in clinic 12 times over 126 days to determine any changes in signs or symptoms that may represent drug toxicity. Drug toxicity is defined as events that required holding or delaying treatment.
Time frame: 126 Days (six 21-day cycles)
Progression Free Survival
Patients will have CT scans after every two cycles for up to 2 years to assess changes in tumor sizes.
Time frame: 2 years
Overall Survival
Patients will be contacted every 12 weeks following end of treatment to determine survival status until death, withdrawal of consent, or the end of the study, whichever occurs first.
Time frame: Every 12 weeks (up to 2 years)
Disease Response
Patients will have CT scans to assess changes in tumor sizes.
Time frame: up to 2 years
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