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

NCT02944396 | Completed Phase 1 FDA Drug

• 2 other identifiers: M15-5342016-001658-16
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 6

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.

Conditions

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)

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to approximately 3.5 years

• 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 Outcomes (12)

• Tmax for pemetrexed

  Up to approximately 3 weeks

• AUC for nivolumab

  Up to approximately 3.5 years

• Overall Survival (OS)

  Up to approximately 3.5 years

• Tmax for nivolumab

  Up to approximately 3.5 years

• AUC for pemetrexed

  Up to approximately 3 weeks

Study Arms (2)

Veliparib and nivolumab with platinum doublet chemotherapy

EXPERIMENTAL

Veliparib and nivolumab in combination with platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed)

Drug: pemetrexed; Drug: nivolumab; Drug: paclitaxel; Drug: veliparib; Drug: carboplatin

Veliparib with platinum doublet chemotherapy

EXPERIMENTAL

Veliparib in combination with platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed)

Drug: pemetrexed; Drug: paclitaxel; Drug: veliparib; Drug: carboplatin

Interventions

pemetrexed DRUG

intravenous; administered on Day 1 via infusion in a 21-day cycle

Also known as: Alimta

Veliparib and nivolumab with platinum doublet chemotherapy; Veliparib with platinum doublet chemotherapy

nivolumab DRUG

intravenous; administered on Day 1 via infusion in a 21-day cycle

Also known as: Opdivo

Veliparib and nivolumab with platinum doublet chemotherapy

paclitaxel DRUG

intravenous; administered on Day 1 via infusion in a 21-day cycle

Also known as: Taxol

Veliparib and nivolumab with platinum doublet chemotherapy; Veliparib with platinum doublet chemotherapy

veliparib DRUG

oral capsule; varying doses administered on Days -2 to 5 in a 21-day cycle

Also known as: ABT-888

Veliparib and nivolumab with platinum doublet chemotherapy; Veliparib with platinum doublet chemotherapy

carboplatin DRUG

intravenous; administered on Day 1 via infusion in a 21-day cycle

Also known as: Paraplatin

Veliparib and nivolumab with platinum doublet chemotherapy; Veliparib with platinum doublet chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (6)

University of Alabama at Birmingham - Main /ID# 155135

Birmingham, Alabama, 35233, United States

Location

Icri /Id# 155593

Whittier, California, 90603, United States

Location

Univ of Colorado Cancer Center /ID# 153820

Aurora, Colorado, 80045, United States

Location

University of Chicago /ID# 153824

Chicago, Illinois, 60637-1443, United States

Location

Goshen Center for Cancer Care /ID# 153822

Goshen, Indiana, 46526, United States

Location

Duke University Medical Center /ID# 153821

Durham, North Carolina, 27710-3000, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis

Interventions

Pemetrexed; Nivolumab; Paclitaxel; veliparib; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2016
• First Posted: October 25, 2016
• Study Start: December 23, 2016
• Primary Completion: October 2, 2019
• Study Completion: October 2, 2019
• Last Updated: October 23, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)