Description:
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).
Randomized, Double-Blind, Multicenter, Study Comparing <span class="go-doc-concept go-doc-intervention">Veliparib</span> Plus <span class="go-doc-concept go-doc-intervention">Carboplatin</span> and <span class="go-doc-concept go-doc-intervention">Paclitaxel</span> Versus <span class="go-doc-concept go-doc-intervention">Placebo</span> Plus <span class="go-doc-concept go-doc-intervention">Carboplatin</span> and <span class="go-doc-concept go-doc-intervention">Paclitaxel</span> in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell <span class="go-doc-concept go-doc-disease">Lung Cancer</span>
Title
Brief Title: Randomized, Double-Blind, Multicenter, 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
Official Title: Randomized, Double-Blind, Multicenter, Phase 3 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 (NSCLC)
Clinical Trial IDs
NCT ID: NCT02106546
ORG ID: M11-089
NCI ID: 2013-005020-42
Trial Conditions
Squamous Non-Small Cell Lung Cancer
Trial Interventions
Drug |
Synonyms |
Arms |
veliparib |
ABT-888 |
veliparib and carboplatin and paclitaxel |
carboplatin |
|
veliparib and carboplatin and paclitaxel, placebo and carboplatin and paclitaxel |
paclitaxel |
|
veliparib and carboplatin and paclitaxel, placebo and carboplatin and paclitaxel |
placebo |
|
placebo and carboplatin and paclitaxel |
Trial Purpose
This is a 2 arm Phase 3 study 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 subjects with advanced or metastatic squamous NSCLC.
Detailed Description
Trial Arms
Name |
Type |
Description |
Interventions |
veliparib and carboplatin and paclitaxel |
Experimental |
veliparib on Days -2 to 5 (7days) and carboplatin and paclitaxel on Day 1 of a 21 day cycle |
veliparib, carboplatin, paclitaxel |
placebo and carboplatin and paclitaxel |
Placebo Comparator |
placebo on Days -2 to 5 (7days) and carboplatin and paclitaxel on Day 1 of a 21 day cycle |
carboplatin, paclitaxel, placebo |
Eligibility Criteria
Inclusion Criteria:
1. Life expectancy > 12 weeks
2. Subject must have cytologically or histologically confirmed squamous NSCLC.
3. Subject must have advanced or metastatic squamous NSCLC that is not amenable to
surgical resection or radiation with curative intent at time of study Screening.
4. Subjects with recurrent squamous NSCLC after surgical treatment that is not amenable
to surgical resection or radiation with curative intent are eligible.
5. Subject must have at least 1 unidimensional measurable NSCLC lesion on a Computerized
Tomography (CT) scan as defined by Response Evaluation Criteria In Solid Tumors
(RECIST - version 1.1).
Exclusion Criteria:
1. Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with
polyethoxylated castor oil (Cremophor).
2. Subject has a known hypersensitivity to platinum compounds.
3. Subject has peripheral neuropathy >= grade 2.
4. Subject has non-squamous NSCLC, or a known Epidermal Growth Factor Receptor (EGFR)
mutation of exon 19 deletion or L858R mutation in exon 21, or a known Anaplastic
Lymphoma Kinase (ALK) gene rearrangement.
5. Subject has received prior cytotoxic chemotherapy for advanced or metastatic NSCLC.
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both
Primary Outcome Measures
Secondary Outcome Measures
Progression-Free Survival (PFS)
Objective Response Rate (ORR)
Trial Keywords
Advanced
carboplatin
Overall Survival
non-small cell lung cancer
paclitaxel
placebo controlled
Randomized
Squamous
veliparib
ABT-888
Metastatic
Poly Adenosine diphosphate (ADP)-ribose Polymerase (PARP)