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Completed

NCT Number: NCT02106546

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

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).

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Key information

Conditions

Squamous Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Southern Medical Day Care Ctr /ID# 125604, Wollongong, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Life expectancy > 12 weeks
  • Subject must have cytologically or histologically confirmed squamous NSCLC.
  • 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.
  • Subjects with recurrent squamous NSCLC after surgical treatment that is not amenable to surgical resection or radiation with curative intent are eligible.
  • 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

  • Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (Cremophor).
  • Subject has a known hypersensitivity to platinum compounds.
  • Subject has peripheral neuropathy >= grade 2.
  • 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.
  • Subject has received prior cytotoxic chemotherapy (including definitive chemoradiotherapy) for NSCLC, except for adjuvant or neoadjuvant therapy.

Treatment and study plan

carboplatin

Drug

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

Veliparib

Drug

Capsules taken orally twice a day, 12 hours apart.

Other names: ABT-888

paclitaxel

Drug

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

Placebo to veliparib

Drug

Capsules taken orally twice a day, 12 hours apart.

Primary outcomes

  1. Overall Survival (OS) in current smokers

    Time frame: Up to 3 years from first dose of study drug

    Time to death for a given subject will be defined as the number of days from the date that the subject was randomized to the date of the subject's death.

Secondary outcomes

  1. Overall Survival (OS) in all subjects

    Time frame: Up to 3 years from first dose of study drug

    Time to death for a given subject will be defined as the number of days from the date that the subject was randomized to the date of the subject's death.

  2. Progressive-Free Survival (PFS) in current smokers and in all subjects

    Time frame: Up to 3 years from first dose of study drug

    Defined as the number of days from the date that the subject was randomized to the date the subject experiences an event of disease progression or to the date of death (all causes of mortality) if disease progression is not reached.

  3. Objective Response Rate (ORR) in current smokers and in all subjects

    Time frame: Up to 3 years from first dose of study drug

    Objective response rate is defined as the proportion of subjects with complete or partial response as determined by the investigator per RECIST (version 1.1)

Other outcomes

  1. Change in Quality of Life: European Organisation for Research and Treatment of Cancer Quality of Life Core 30 Question Questionnaire (EORTC-QLQ-C30).

    Time frame: From Screening (prior to dosing) up to 2 years

  2. Change in Quality of Life: European Organisation for Research and Treatment of Cancer Quality of Life Lung Cancer 13 Question Questionnaire (EORTC-LC13).

    Time frame: From Screening (prior to dosing) up to 2 years

  3. Change in Eastern Cooperative Oncology Group (ECOG) Performance Status

    Time frame: From Screening (prior to dosing) up to 2 years

  4. Change in Quality of Life: European Quality of Life-5 Dimensions-5 Levels Questionnaire (EQ-5D-5L)

    Time frame: From Screening (prior to dosing) up to 2 years

  5. Duration of Response

    Time frame: From complete or partial response to disease progression (up to 3 years from randomization).

    The duration of overall response for a given subject will be defined as the number of days from the day the criteria are met for Complete or Partial Response (whichever is recorded first) to the date that Progressive Disease (PD) is objectively documented.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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)

Important dates

Study start
2014
Primary completion
2017
Study completion
2019
First posted
Apr 8, 2014
Registry last updated
Nov 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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