Back to resultsStudy of Veliparib in Combination With Nivolumab and Platinum Doublet Chemotherapy in Participants With Metastatic or Advanced Non-Small Cell Lung Cancer (NSCLC)
Primary Purpose
Non-Small Cell Lung Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
pemetrexed
nivolumab
paclitaxel
veliparib
carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring metastatic, non-small cell lung cancer, Eastern Cooperative Oncology Group (ECOG), veliparib, nivolumab, Platinum Doublet Chemotherapy, carboplatin, paclitaxel, pemetrexed, Response Evaluation Criteria In Solid Tumors (RECIST), Common Terminology Criteria for Adverse Events (CTCAE), Poly (ADP) ribose polymerase (PARP), Immuno Oncology, Metastatic or Advanced Non-Small Cell Lung Cancer (NSCLC)
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- University of Alabama at Birmingham - Main /ID# 155135
- Icri /Id# 155593
- Univ of Colorado Cancer Center /ID# 153820
- University of Chicago /ID# 153824
- Goshen Center for Cancer Care /ID# 153822
- Duke University Medical Center /ID# 153821
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Veliparib and nivolumab with platinum doublet chemotherapy
Veliparib with platinum doublet chemotherapy
Arm Description
Veliparib and nivolumab in combination with platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed)
Veliparib in combination with platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed)
Outcomes
Primary Outcome Measures
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.
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).
Secondary Outcome Measures
Tmax for pemetrexed
AUC for nivolumab
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.
Tmax for nivolumab
AUC for pemetrexed
Time to Cmax (peak time, Tmax) for veliparib
Area under the plasma concentration-time curve (AUC) for veliparib
Maximum observed serum concentration (Cmax) of nivolumab anti-drug antibody (ADA)
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.
Maximum observed plasma concentration (Cmax) for pemetrexed
Maximum observed plasma concentration (Cmax) for veliparib
Objective Response Rate (ORR)
ORR is defined as the proportion of the participants who have a complete response (CR) or partial response (PR).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02944396
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 Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
December 23, 2016 (Actual)
Primary Completion Date
October 2, 2019 (Actual)
Study Completion Date
October 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
metastatic, non-small cell lung cancer, Eastern Cooperative Oncology Group (ECOG), veliparib, nivolumab, Platinum Doublet Chemotherapy, carboplatin, paclitaxel, pemetrexed, Response Evaluation Criteria In Solid Tumors (RECIST), Common Terminology Criteria for Adverse Events (CTCAE), Poly (ADP) ribose polymerase (PARP), Immuno Oncology, Metastatic or Advanced Non-Small Cell Lung Cancer (NSCLC)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Veliparib and nivolumab with platinum doublet chemotherapy
Arm Type
Experimental
Arm Description
Veliparib and nivolumab in combination with platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed)
Arm Title
Veliparib with platinum doublet chemotherapy
Arm Type
Experimental
Arm Description
Veliparib in combination with platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed)
Intervention Type
Drug
Intervention Name(s)
pemetrexed
Other Intervention Name(s)
Alimta
Intervention Description
intravenous; administered on Day 1 via infusion in a 21-day cycle
Intervention Type
Drug
Intervention Name(s)
nivolumab
Other Intervention Name(s)
Opdivo
Intervention Description
intravenous; administered on Day 1 via infusion in a 21-day cycle
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Other Intervention Name(s)
Taxol
Intervention Description
intravenous; administered on Day 1 via infusion in a 21-day cycle
Intervention Type
Drug
Intervention Name(s)
veliparib
Other Intervention Name(s)
ABT-888
Intervention Description
oral capsule; varying doses administered on Days -2 to 5 in a 21-day cycle
Intervention Type
Drug
Intervention Name(s)
carboplatin
Other Intervention Name(s)
Paraplatin
Intervention Description
intravenous; administered on Day 1 via infusion in a 21-day cycle
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
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
Title
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
Secondary Outcome Measure Information:
Title
Tmax for pemetrexed
Time Frame
Up to approximately 3 weeks
Title
AUC for nivolumab
Time Frame
Up to approximately 3.5 years
Title
Overall Survival (OS)
Description
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
Title
Tmax for nivolumab
Time Frame
Up to approximately 3.5 years
Title
AUC for pemetrexed
Time Frame
Up to approximately 3 weeks
Title
Time to Cmax (peak time, Tmax) for veliparib
Time Frame
Up to approximately 9 weeks
Title
Area under the plasma concentration-time curve (AUC) for veliparib
Time Frame
Up to approximately 9 weeks
Title
Maximum observed serum concentration (Cmax) of nivolumab anti-drug antibody (ADA)
Time Frame
Up to approximately 3.5 years
Title
Duration of Overall Response (DOR)
Description
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
Title
Maximum observed plasma concentration (Cmax) for pemetrexed
Time Frame
Up to approximately 3 weeks
Title
Maximum observed plasma concentration (Cmax) for veliparib
Time Frame
Up to approximately 9 weeks
Title
Objective Response Rate (ORR)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham - Main /ID# 155135
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Icri /Id# 155593
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Univ of Colorado Cancer Center /ID# 153820
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Chicago /ID# 153824
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1443
Country
United States
Facility Name
Goshen Center for Cancer Care /ID# 153822
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Facility Name
Duke University Medical Center /ID# 153821
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710-3000
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Veliparib in Combination With Nivolumab and Platinum Doublet Chemotherapy in Participants With Metastatic or Advanced Non-Small Cell Lung Cancer (NSCLC)
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