Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Adults Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers

NCT02264990 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 595

Last updated 2021-02-26

Study results available
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Summary

The purpose of this study is to evaluate the safety and efficacy of veliparib plus carboplatin and paclitaxel versus the Investigator's choice of standard chemotherapy in adults with metastatic or advanced non-squamous non-small cell lung cancer.

Conditions

  • Non-squamous Non-small Cell Lung Cancer

Interventions

DRUG

Paclitaxel

Administered by Intravenous infusion on Day 1 of each 21-day cycle

DRUG

Carboplatin

Administered by Intravenous infusion on Day 1 of each 21-day cycle

DRUG

Cisplatin

Administered by Intravenous infusion on Day 1 of each 21-day cycle

DRUG

Veliparib

Oral capsule, administered twice daily for 7 days in each 21-day cycle

DRUG

Pemetrexed

Administered by Intravenous infusion on Day 1 of each 21-day cycle

Sponsors & Collaborators

Principal Investigators

  • AbbVie Inc. · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2019-11-14
Completion
2020-02-21
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Canada
  • Czechia
  • Denmark
  • Finland
  • Germany
  • Hungary
  • Israel
  • Japan
  • Netherlands
  • New Zealand
  • Russia
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02264990 on ClinicalTrials.gov