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Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer

NCT02106546 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 970

Last updated 2020-11-17

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of the addition of veliparib plus carboplatin and paclitaxel versus the addition of placebo plus carboplatin and paclitaxel in adults with advanced or metastatic squamous non-small cell lung cancer (NSCLC).

Conditions

  • Squamous Non-Small Cell Lung Cancer

Interventions

DRUG

Carboplatin

Carboplatin administered intravenously over approximately 15 to 30 minutes at (AUC 6 mg/mL/min) immediately following paclitaxel infusion.

DRUG

Veliparib

Capsules taken orally twice a day, 12 hours apart.

DRUG

Paclitaxel

Paclitaxel administered intravenously over 3 hours at a dose of 200 mg/m².

DRUG

Placebo to veliparib

Capsules taken orally twice a day, 12 hours apart.

Sponsors & Collaborators

Principal Investigators

  • AbbVie Inc. · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-10
Primary Completion
2017-01-03
Completion
2019-11-20
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belarus
  • Brazil
  • Canada
  • Croatia
  • Czechia
  • Denmark
  • Egypt
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Latvia
  • Lithuania
  • Mexico
  • Netherlands
  • New Zealand
  • Norway
  • Poland
  • Portugal
  • Puerto Rico
  • Russia
  • Serbia
  • Slovakia
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT02106546 on ClinicalTrials.gov