The purpose of this is to evaluate the efficacy and safety of imetelstat (GRN163L) as maintenance therapy for patients with advanced stage NSCLC who have not progressed after 4 cycles of platinum based therapy. Participants will be randomized in a 2:1 ratio to imetelstat + standard of care versus standard of care alone. Participants who received bevacizumab with their induction chemotherapy will continue to receive bevacizumab on this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
116
9.4 mg/kg over a 2 hour IV infusion on Day 1 and Day 8 of each 21 day cycle until disease progression.
Dosage and duration will be according to the FDA-approved bevacizumab package insert. Bevacizumab will be administered on Day 1 of each 21-day cycle.
Progression-free survival
Defined as the time from randomization to documented disease progression or death, whichever occurs earlier,as determined by the Investigator's assessment according to RECIST, or death from any cause, whichever occurs earlier.
Time frame: From randomization to documented disease progression or death, whichever occurs earlier, through the end of the study period (8 mos. after the last participant is randomized)
Objective response
Objective response (partial response plus complete response) occurring post-randomization as determined by the Investigator's assessment according to RECIST criteria using post-induction tumor dimensions as a baseline.
Time frame: Occurring post randomization through end of study period (8 mos. after the last participant is randomized)
Time to all-cause mortality
Defined as the time from the date of radomization to death from any cause during the study period.
Time frame: From the date of randomization through end of study period (8 mos. after the last participant is randomized)
Safety and tolerability
Safety and tolerability will be assessed by the incidence, nature, and severity of adverse events, laboratory abnormalities, and vital signs.
Time frame: From the date of randomization through the end of the study period (8 mos. after the last participant is randomized)
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Achieve Clinical Research, Llc
Birmingham, Alabama, United States
Clearview Cancer Institute
Huntsville, Alabama, United States
Pacific Cancer Medical Center, Inc.
Anaheim, California, United States
Cancer Care Associates of Fresno Medical Group Inc
Fresno, California, United States
St. Joseph's Hospital
Orange, California, United States
Kaiser Permanente Medical Center
Vallejo, California, United States
University of Colorado Denver School of Medicine
Aurora, Colorado, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Integrated Community Oncology Network
Jacksonville, Florida, United States
H. Moffitt Lee Cancer Center
Tampa, Florida, United States
...and 23 more locations