This study seeks to establish the recommended Phase 2 dose (RPTD) of veliparib in combination with nivolumab and platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed) (Phase 1 portion) and to assess whether the addition of nivolumab to veliparib in combination with platinum doublet chemotherapy results will improve progression free survival (PFS) compared to veliparib with platinum doublet chemotherapy alone in participants with metastatic or advanced Non-small Cell Lung Cancer (NSCLC) (Phase 2 portion). A strategy decision was made not to proceed to Phase 2 portion of this study due to change in standard of care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
intravenous; administered on Day 1 via infusion in a 21-day cycle
intravenous; administered on Day 1 via infusion in a 21-day cycle
intravenous; administered on Day 1 via infusion in a 21-day cycle
oral capsule; varying doses administered on Days -2 to 5 in a 21-day cycle
intravenous; administered on Day 1 via infusion in a 21-day cycle
University of Alabama at Birmingham - Main /ID# 155135
Birmingham, Alabama, United States
Icri /Id# 155593
Whittier, California, United States
Univ of Colorado Cancer Center /ID# 153820
Aurora, Colorado, United States
University of Chicago /ID# 153824
Chicago, Illinois, United States
Goshen Center for Cancer Care /ID# 153822
Goshen, Indiana, United States
Duke University Medical Center /ID# 153821
Durham, North Carolina, United States
Progression-free survival (PFS)
PFS is defined as the number of days from the date of randomization to the date of earliest disease progression (radiographic progression per RECIST version 1.1 or clinical disease progression) or death. If the participant does not experience disease progression or death, then the data will be censored at the date of the last disease assessment.
Time frame: Up to approximately 3.5 years
Recommended Phase 2 dose (RPTD) of veliparib (ABT-888) in combination with nivolumab and platinum doublet chemotherapy in participants with metastatic or advanced Non-Small Cell Lung Cancer (NSCLC).
Time frame: Up to 6 weeks
Tmax for pemetrexed
Time frame: Up to approximately 3 weeks
AUC for nivolumab
Time frame: Up to approximately 3.5 years
Overall Survival (OS)
OS is defined as the number of days from the date of randomization to the date of death. For subjects who did not die, their data will be censored at the date of last study visit or the last known date to be alive, whichever is later.
Time frame: Up to approximately 3.5 years
Tmax for nivolumab
Time frame: Up to approximately 3.5 years
AUC for pemetrexed
Time frame: Up to approximately 3 weeks
Time to Cmax (peak time, Tmax) for veliparib
Time frame: Up to approximately 9 weeks
Area under the plasma concentration-time curve (AUC) for veliparib
Time frame: Up to approximately 9 weeks
Maximum observed serum concentration (Cmax) of nivolumab anti-drug antibody (ADA)
Time frame: Up to approximately 3.5 years
Duration of Overall Response (DOR)
DOR is defined as the number of days from the date of first response (CR or PR) to the earliest documentation of progressive disease or death due to disease progression.
Time frame: Up to approximately 3.5 years
Maximum observed plasma concentration (Cmax) for pemetrexed
Time frame: Up to approximately 3 weeks
Maximum observed plasma concentration (Cmax) for veliparib
Time frame: Up to approximately 9 weeks
Objective Response Rate (ORR)
ORR is defined as the proportion of the participants who have a complete response (CR) or partial response (PR).
Time frame: Up to approximately 3.5 years
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