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

• ClinicalTrials.gov Identifier: NCT02106546
• Recruitment Status: Completed
• First Posted: April 8, 2014
• Last Update Posted: November 17, 2020
• Sponsor: AbbVie
• Information provided by (Responsible Party): AbbVie

Tracking Information

• First Submitted Date: April 4, 2014
• First Posted Date: April 8, 2014
• Last Update Posted Date: November 17, 2020
• Actual Study Start Date: April 10, 2014
• Actual Primary Completion Date: January 3, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 22, 2016)

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.

Original Primary Outcome Measures (submitted: April 4, 2014)

Overall Survival (OS) [ 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.

Current Secondary Outcome Measures (submitted: February 22, 2016)

• 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.
• 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.
• 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)

Original Secondary Outcome Measures (submitted: April 4, 2014)

• Duration of Response (DOR) [ Time Frame: From complete or partial response to disease progression (up to 3years 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.
• Progression-Free Survival (PFS) [ 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.
• Objective Response Rate (ORR) [ 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 Response Evaluation Criteria In Solid Tumors (version 1.1)

Current Other Pre-specified Outcome Measures (submitted: February 20, 2018)

• 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 ]
• 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 ]
• Change in Eastern Cooperative Oncology Group (ECOG) Performance Status [ Time Frame: From Screening (prior to dosing) up to 2 years ]
• 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 ]
• 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.

Original Other Pre-specified Outcome Measures (submitted: April 4, 2014)

• Change in Eastern Cooperative Oncology Group (ECOG) Performance Status [ Time Frame: From Screening (prior to dosing) up to 2 years ]
• 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 ]
• 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 ]
• 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 ]

Descriptive Information

• 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)
• Brief 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Squamous Non-Small Cell Lung Cancer

Intervention

• 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.
  Other Name: ABT-888
• 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.

Study Arms

• Experimental: Veliparib + Carboplatin + Paclitaxel
  Participants 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.
  Interventions:

  • Drug: Carboplatin
  • Drug: Veliparib
  • Drug: Paclitaxel
• Placebo Comparator: Placebo + Carboplatin + Paclitaxel
  Participants 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.
  Interventions:

  • Drug: Carboplatin
  • Drug: Paclitaxel
  • Drug: Placebo to veliparib

• Publications *: Ramalingam SS, Novello S, Guclu SZ, Bentsion D, Zvirbule Z, Szilasi M, Bernabe R, Syrigos K, Byers LA, Clingan P, Bar J, Vokes EE, Govindan R, Dunbar M, Ansell P, He L, Huang X, Sehgal V, Glasgow J, Bach BA, Mazieres J. Veliparib in Combination With Platinum-Based Chemotherapy for First-Line Treatment of Advanced Squamous Cell Lung Cancer: A Randomized, Multicenter Phase III Study. J Clin Oncol. 2021 Nov 10;39(32):3633-3644. doi: 10.1200/JCO.20.03318. Epub 2021 Aug 26.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 4, 2017): 970
• Original Estimated Enrollment (submitted: April 4, 2014): 900
• Actual Study Completion Date: November 20, 2019
• Actual Primary Completion Date: January 3, 2017 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 99 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: 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, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom, United States
• Removed Location Countries: Czech Republic

Administrative Information

• NCT Number: NCT02106546
• Other Study ID Numbers: M11-089; 2013-005020-42 ( EudraCT Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
• URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

• Current Responsible Party: AbbVie
• Original Responsible Party: Same as current
• Current Study Sponsor: AbbVie
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: AbbVie Inc.; AbbVie

• PRS Account: AbbVie
• Verification Date: October 2020