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Study of Veliparib in Combination With Nivolumab and Platinum Doublet Chemotherapy in Participants With Metastatic or Advanced Non-Small Cell Lung Cancer (NSCLC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02944396
Recruitment Status : Completed
First Posted : October 25, 2016
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE October 19, 2016
First Posted Date  ICMJE October 25, 2016
Last Update Posted Date October 23, 2019
Actual Study Start Date  ICMJE December 23, 2016
Actual Primary Completion Date October 2, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2018)
  • Progression-free survival (PFS) [ 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.
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 24, 2016)
  • 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 ]
  • Progression-free survival (PFS) [ 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2018)
  • Tmax for pemetrexed [ Time Frame: Up to approximately 3 weeks ]
  • AUC for nivolumab [ Time Frame: Up to approximately 3.5 years ]
  • Overall Survival (OS) [ 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.
  • 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) [ 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.
  • 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) [ 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2016)
  • Overall Survival (OS) [ 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.
  • Objective Response Rate (ORR) [ 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).
  • Duration of Overall Response (DOR) [ 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.
  • Maximum observed plasma concentration (Cmax) for veliparib [ Time Frame: Up to approximately 9 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 plasma concentration (Cmax) for pemetrexed [ Time Frame: Up to approximately 3 weeks ]
  • Tmax for pemetrexed [ Time Frame: Up to approximately 3 weeks ]
  • AUC for pemetrexed [ Time Frame: Up to approximately 3 weeks ]
  • Maximum observed serum concentration (Cmax) of nivolumab anti-drug antibody (ADA) [ Time Frame: Up to approximately 3.5 years ]
  • Tmax for nivolumab [ Time Frame: Up to approximately 3.5 years ]
  • AUC for nivolumab [ Time Frame: Up to approximately 3.5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: pemetrexed
    intravenous; administered on Day 1 via infusion in a 21-day cycle
    Other Name: Alimta
  • Drug: nivolumab
    intravenous; administered on Day 1 via infusion in a 21-day cycle
    Other Name: Opdivo
  • Drug: paclitaxel
    intravenous; administered on Day 1 via infusion in a 21-day cycle
    Other Name: Taxol
  • Drug: veliparib
    oral capsule; varying doses administered on Days -2 to 5 in a 21-day cycle
    Other Name: ABT-888
  • Drug: carboplatin
    intravenous; administered on Day 1 via infusion in a 21-day cycle
    Other Name: Paraplatin
Study Arms  ICMJE
  • Experimental: Veliparib and nivolumab with platinum doublet chemotherapy
    Veliparib and nivolumab in combination with platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed)
    Interventions:
    • Drug: pemetrexed
    • Drug: nivolumab
    • Drug: paclitaxel
    • Drug: veliparib
    • Drug: carboplatin
  • Experimental: Veliparib with platinum doublet chemotherapy
    Veliparib in combination with platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed)
    Interventions:
    • Drug: pemetrexed
    • Drug: paclitaxel
    • Drug: veliparib
    • Drug: carboplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 21, 2019)
25
Original Estimated Enrollment  ICMJE
 (submitted: October 24, 2016)
184
Actual Study Completion Date  ICMJE October 2, 2019
Actual Primary Completion Date October 2, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Czechia
 
Administrative Information
NCT Number  ICMJE NCT02944396
Other Study ID Numbers  ICMJE M15-534
2016-001658-16 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP