Pemetrexed
Drugintravenous; administered on Day 1 via infusion in a 21-day cycle
Other names: Alimta
NCT Number: NCT02944396
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
University of Alabama at Birmingham - Main /ID# 155135, Birmingham, Alabama, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
intravenous; administered on Day 1 via infusion in a 21-day cycle
Other names: Alimta
intravenous; administered on Day 1 via infusion in a 21-day cycle
Other names: Opdivo
intravenous; administered on Day 1 via infusion in a 21-day cycle
Other names: Taxol
oral capsule; varying doses administered on Days -2 to 5 in a 21-day cycle
Other names: ABT-888
intravenous; administered on Day 1 via infusion in a 21-day cycle
Other names: Paraplatin
Time frame: Up to approximately 3.5 years
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 6 weeks
Time frame: Up to approximately 3 weeks
Time frame: Up to approximately 3.5 years
Time frame: Up to approximately 3.5 years
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
Time frame: Up to approximately 3 weeks
Time frame: Up to approximately 9 weeks
Time frame: Up to approximately 9 weeks
Time frame: Up to approximately 3.5 years
Time frame: Up to approximately 3.5 years
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 weeks
Time frame: Up to approximately 9 weeks
Time frame: Up to approximately 3.5 years
ORR is defined as the proportion of the participants who have a complete response (CR) or partial response (PR).
AbbVie
Industry
A Phase 1 Dose-Escalation and Phase 2 Randomized, Open-Label Study of Nivolumab and Veliparib in Combination With Platinum Doublet Chemotherapy in Subjects With Metastatic or Advanced Non-Small Cell Lung Cancer (NSCLC)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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