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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

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).

Related Conditions:
  • Squamous Cell Lung Carcinoma
Recruiting Status:

Completed

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT02106546

Trial Eligibility

Document

Title

  • Brief 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
  • 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

  • ORG STUDY ID: M11-089
  • SECONDARY ID: 2013-005020-42
  • NCT ID: NCT02106546

Conditions

  • Squamous Non-Small Cell Lung Cancer

Interventions

DrugSynonymsArms
CarboplatinPlacebo + Carboplatin + Paclitaxel
VeliparibABT-888Veliparib + Carboplatin + Paclitaxel
PaclitaxelPlacebo + Carboplatin + Paclitaxel
Placebo to veliparibPlacebo + Carboplatin + Paclitaxel

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
Veliparib + Carboplatin + PaclitaxelExperimentalParticipants received veliparib 120 mg orally twice daily (BID) on Days -2 to 5 (7 consecutive days) of each 21-day cycle and carboplatin at an area under the concentration-time curve (AUC) 6 mg/mL/min and paclitaxel 200 mg/m² by intravenous (IV) infusion on Day 1 of each 21-day cycle for up to a maximum 6 cycles of treatment, until treatment toxicity which, in the Investigator's opinion, prohibited further therapy, or until radiographic progression.
  • Carboplatin
  • Veliparib
  • Paclitaxel
Placebo + Carboplatin + PaclitaxelPlacebo ComparatorParticipants received placebo orally BID on Days -2 to 5 (7 consecutive days) of each 21-day cycle and carboplatin at an AUC 6 mg/mL/min and paclitaxel 200 mg/m² by IV infusion on Day 1 of each 21-day cycle for up to a maximum 6 cycles of treatment, until treatment toxicity which, in the Investigator's opinion, prohibited further therapy, or until radiographic progression.
  • Carboplatin
  • Paclitaxel
  • Placebo to veliparib

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 (including definitive
             chemoradiotherapy) for NSCLC, except for adjuvant or neoadjuvant therapy.
Maximum Eligible Age:99 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Survival (OS) in current smokers
Time Frame:Up to 3 years from first dose of study drug
Safety Issue:
Description: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 Outcome Measures

Measure:Overall Survival (OS) in all subjects
Time Frame:Up to 3 years from first dose of study drug
Safety Issue:
Description: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.
Measure:Progressive-Free Survival (PFS) in current smokers and in all subjects
Time Frame:Up to 3 years from first dose of study drug
Safety Issue:
Description: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.
Measure:Objective Response Rate (ORR) in current smokers and in all subjects
Time Frame:Up to 3 years from first dose of study drug
Safety Issue:
Description: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)

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:AbbVie

Trial Keywords

  • veliparib
  • carboplatin
  • paclitaxel
  • Poly Adenosine diphosphate (ADP)-ribose Polymerase (PARP)
  • Overall Survival
  • Advanced
  • Metastatic
  • ABT-888
  • Squamous
  • Randomized
  • non-small cell lung cancer
  • placebo controlled

Last Updated

November 17, 2020