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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)

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ClinicalTrials.gov Identifier: NCT02944396
Recruitment Status : Active, not recruiting
First Posted : October 25, 2016
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: pemetrexed Drug: nivolumab Drug: paclitaxel Drug: veliparib Drug: carboplatin Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 28, 2016
Estimated Primary Completion Date : January 2, 2019
Estimated Study Completion Date : January 2, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Veliparib and nivolumab with platinum doublet chemotherapy
Veliparib and nivolumab in combination with platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed)
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

Experimental: Veliparib with platinum doublet chemotherapy
Veliparib in combination with platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed)
Drug: pemetrexed
intravenous; administered on Day 1 via infusion in a 21-day cycle
Other Name: Alimta

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




Primary Outcome Measures :
  1. 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.

  2. 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 Measures :
  1. Tmax for pemetrexed [ Time Frame: Up to approximately 3 weeks ]
  2. AUC for nivolumab [ Time Frame: Up to approximately 3.5 years ]
  3. 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.

  4. Tmax for nivolumab [ Time Frame: Up to approximately 3.5 years ]
  5. AUC for pemetrexed [ Time Frame: Up to approximately 3 weeks ]
  6. Time to Cmax (peak time, Tmax) for veliparib [ Time Frame: Up to approximately 9 weeks ]
  7. Area under the plasma concentration-time curve (AUC) for veliparib [ Time Frame: Up to approximately 9 weeks ]
  8. Maximum observed serum concentration (Cmax) of nivolumab anti-drug antibody (ADA) [ Time Frame: Up to approximately 3.5 years ]
  9. 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.

  10. Maximum observed plasma concentration (Cmax) for pemetrexed [ Time Frame: Up to approximately 3 weeks ]
  11. Maximum observed plasma concentration (Cmax) for veliparib [ Time Frame: Up to approximately 9 weeks ]
  12. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02944396


Locations
United States, Alabama
University of Alabama /ID# 155135
Birmingham, Alabama, United States, 35233
United States, California
Icri /Id# 155593
Whittier, California, United States, 90603
United States, Colorado
Univ of Colorado Cancer Center /ID# 153820
Aurora, Colorado, United States, 80045
United States, Illinois
University of Chicago /ID# 153824
Chicago, Illinois, United States, 60637-1443
United States, Indiana
Goshen Center for Cancer Care /ID# 153822
Goshen, Indiana, United States, 46526
United States, North Carolina
Duke Univ Med Ctr /ID# 153821
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02944396     History of Changes
Other Study ID Numbers: M15-534
2016-001658-16 ( EudraCT Number )
First Posted: October 25, 2016    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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

Keywords provided by AbbVie:
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)

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Nivolumab
Veliparib
Albumin-Bound Paclitaxel
Carboplatin
Pemetrexed
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Poly(ADP-ribose) Polymerase Inhibitors