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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02106546
• Date of registration: 04/04/2014
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: 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
• Scientific 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)
• Date of first enrolment: April 10, 2014
• Target sample size: 970
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02106546
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: AbbVie Inc.
• Affiliation: AbbVie

Key inclusion & exclusion 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 (including definitive
chemoradiotherapy) for NSCLC, except for adjuvant or neoadjuvant therapy.



Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Squamous Non-Small Cell Lung Cancer

Intervention(s)

Drug: Paclitaxel

Drug: Veliparib

Drug: Placebo to veliparib

Drug: Carboplatin

Primary Outcome(s)

Overall Survival (OS) in current smokers [Time Frame: Up to 3 years from first dose of study drug]

Secondary Outcome(s)

Objective Response Rate (ORR) in current smokers and in all subjects [Time Frame: Up to 3 years from first dose of study drug]

Progressive-Free Survival (PFS) in current smokers and in all subjects [Time Frame: Up to 3 years from first dose of study drug]

Overall Survival (OS) in all subjects [Time Frame: Up to 3 years from first dose of study drug]

Secondary ID(s)

2013-005020-42

M11-089

Source(s) of Monetary Support

Please refer to primary and secondary sponsors