Study of Veliparib in Combination With Nivolumab and Platinum Doublet Chemotherapy in Participants With Metastatic or Advanced Non-Small Cell Lung Cancer (NSCLC)
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT02944396
- Lead Sponsor
- AbbVie
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- Participant must have a life expectancy greater than 12 weeks,
- Participant must have cytologically or histologically confirmed Non-small Cell Lung Cancer (NSCLC).
- Participant must have metastatic or advanced NSCLC (Stage IIIB or IV) that is not amenable to surgical resection or radiation or chemoradiation with curative intent at time of study screening.
- Participant must have at least 1 unidimensional measurable NSCLC lesion on a computed tomography (CT) scan as defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1).
- Participant must have resolution to Grade 1 or lower of any toxic effects (excepting alopecia) of the most recent therapy prior to Cycle 1 Day 2.
- Participant must have an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 to 1.
- Participant must have adequate bone marrow, renal, and hepatic function.
- Participant has received prior cytotoxic chemotherapy (including chemotherapy in combination with radiotherapy) for NSCLC, except for adjuvant or neoadjuvant therapy accompanied by surgery with curative intent that was completed one year prior to Cycle 1 Day -2.
- Participant has received prior therapy with a Poly-(ADP-ribose)-Polymerase (PARP) inhibitor.
- Participant has received prior treatment with any anti-programmed cell death protein-1 (anti-PD-1), or PD Ligand-1 (PD-L1) or PD Ligand-2 (PD-L2) agent or an antibody targeting other immunoregulatory receptors or mechanisms.
- Participant has received radiation therapy to lung greater than 30 Gy within 6 months, or antineoplastic biologic therapy within 21 days, or major surgery within 21 days, or tyrosine kinase inhibitor therapy within 7 days, or palliative radiation within 7 days of the first dose of study medication.
- Participant has untreated central nervous system (CNS) metastases.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Veliparib and nivolumab with platinum doublet chemotherapy pemetrexed Veliparib and nivolumab in combination with platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed) Veliparib and nivolumab with platinum doublet chemotherapy paclitaxel Veliparib and nivolumab in combination with platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed) Veliparib with platinum doublet chemotherapy pemetrexed Veliparib in combination with platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed) Veliparib and nivolumab with platinum doublet chemotherapy nivolumab Veliparib and nivolumab in combination with platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed) Veliparib and nivolumab with platinum doublet chemotherapy carboplatin Veliparib and nivolumab in combination with platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed) Veliparib and nivolumab with platinum doublet chemotherapy veliparib Veliparib and nivolumab in combination with platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed) Veliparib with platinum doublet chemotherapy paclitaxel Veliparib in combination with platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed) Veliparib with platinum doublet chemotherapy veliparib Veliparib in combination with platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed) Veliparib with platinum doublet chemotherapy carboplatin Veliparib in combination with platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed)
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) 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.
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). Up to 6 weeks
- Secondary Outcome Measures
Name Time Method Maximum observed plasma concentration (Cmax) for veliparib Up to approximately 9 weeks AUC for nivolumab Up to approximately 3.5 years Tmax for nivolumab Up to approximately 3.5 years Time to Cmax (peak time, Tmax) for veliparib Up to approximately 9 weeks Objective Response Rate (ORR) 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).
Overall Survival (OS) 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.
Duration of Overall Response (DOR) 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.
Maximum observed plasma concentration (Cmax) for pemetrexed Up to approximately 3 weeks Tmax for pemetrexed Up to approximately 3 weeks Area under the plasma concentration-time curve (AUC) for veliparib Up to approximately 9 weeks AUC for pemetrexed Up to approximately 3 weeks Maximum observed serum concentration (Cmax) of nivolumab anti-drug antibody (ADA) Up to approximately 3.5 years
Trial Locations
- Locations (6)
University of Chicago /ID# 153824
🇺🇸Chicago, Illinois, United States
Duke University Medical Center /ID# 153821
🇺🇸Durham, North Carolina, United States
University of Alabama at Birmingham - Main /ID# 155135
🇺🇸Birmingham, Alabama, United States
Goshen Center for Cancer Care /ID# 153822
🇺🇸Goshen, Indiana, United States
Icri /Id# 155593
🇺🇸Whittier, California, United States
Univ of Colorado Cancer Center /ID# 153820
🇺🇸Aurora, Colorado, United States