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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedpemetrexed and nivolumab

Plus 3 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 23, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?6 U.S. locations

Locations may change over time.

Who runs it?AbbVie

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: AbbVie
Interventions being studied: Drug: pemetrexed; Drug: nivolumab; Drug: paclitaxel; Drug: veliparib; Drug: carboplatin

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Metastatic or stage IV→

Treatment approach

Immunotherapy→Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

University of Alabama at Birmingham - Main /ID# 155135Birmingham, Alabama
Icri /Id# 155593Whittier, California
Univ of Colorado Cancer Center /ID# 153820Aurora, Colorado
University of Chicago /ID# 153824Chicago, Illinois
Goshen Center for Cancer Care /ID# 153822Goshen, Indiana
Duke University Medical Center /ID# 153821Durham, North Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 23, 2019. Always confirm current availability with the study team.

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