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Brief Title: Study of Veliparib in Combination With Nivolumab and Platinum Doublet Chemotherapy in Participants With Metastatic or Advanced Non-Small Cell Lung Cancer (NSCLC)
Official Title: 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)
Study ID: NCT02944396
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: AbbVie Inc.
Affiliation: AbbVie
Role: STUDY_DIRECTOR