Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Adults Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers
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ClinicalTrials.gov Identifier: NCT02264990 |
Recruitment Status :
Completed
First Posted : October 15, 2014
Results First Posted : February 26, 2021
Last Update Posted : February 26, 2021
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Non-squamous Non-small Cell Lung Cancer |
Interventions |
Drug: Paclitaxel Drug: Carboplatin Drug: Cisplatin Drug: Veliparib Drug: Pemetrexed |
Enrollment | 595 |
Recruitment Details | Participants were enrolled at 131 sites in 20 countries (Argentina, Australia, Canada, Czech Republic, Denmark, Finland, Germany, Hungary, Israel, Japan, South Korea, Netherlands, New Zealand, Russian Federation, South Africa, Spain, Taiwan, Turkey, United Kingdom, and United States). |
Pre-assignment Details | Participants were randomized in a 1:1 ratio to veliparib in combination with carboplatin and paclitaxel (C/P) or investigator's choice of platinum doublet chemotherapy. Randomization was stratified by smoking status (current versus former), by the investigators' preferred platinum doublet therapy (carboplatin/paclitaxel versus cisplatin/pemetrexed versus carboplatin/pemetrexed), by gender (male versus female) and by Eastern Cooperative Oncology Group (ECOG) performance status (0 versus 1). |
Arm/Group Title | Investigator's Choice Chemotherapy | Veliparib + Carboplatin + Paclitaxel |
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Participants received investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred. |
Participants received 120 mg veliparib twice a day (BID) on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles. After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred. |
Period Title: Overall Study | ||
Started | 297 | 298 |
Received Treatment | 288 | 293 |
Received Maintenance Therapy | 148 | 123 |
Completed | 37 | 39 |
Not Completed | 260 | 259 |
Reason Not Completed | ||
Death | 255 | 250 |
Withdrawal by Subject | 4 | 5 |
Lost to Follow-up | 1 | 3 |
Other | 0 | 1 |
Arm/Group Title | Investigator's Choice Chemotherapy | Veliparib + Carboplatin + Paclitaxel | Total | |
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Participants received investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred. |
Participants received 120 mg veliparib BID on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles. After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred. |
Total of all reporting groups | |
Overall Number of Baseline Participants | 297 | 298 | 595 | |
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The intention-to-treat (ITT) population included all randomized participants.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 297 participants | 298 participants | 595 participants | |
63.1 (8.99) | 62.7 (9.02) | 62.9 (9.0) | ||
Age, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 297 participants | 298 participants | 595 participants | |
< 65 years |
153 51.5%
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163 54.7%
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316 53.1%
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≥ 65 years |
144 48.5%
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135 45.3%
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279 46.9%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 297 participants | 298 participants | 595 participants | |
Female |
90 30.3%
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92 30.9%
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182 30.6%
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Male |
207 69.7%
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206 69.1%
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413 69.4%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 297 participants | 298 participants | 595 participants | |
Hispanic or Latino |
22 7.4%
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26 8.7%
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48 8.1%
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Not Hispanic or Latino |
275 92.6%
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272 91.3%
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547 91.9%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 297 participants | 298 participants | 595 participants | |
White |
233 78.5%
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229 76.8%
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462 77.6%
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Black |
11 3.7%
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11 3.7%
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22 3.7%
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Asian |
53 17.8%
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57 19.1%
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110 18.5%
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Other |
0 0.0%
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1 0.3%
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1 0.2%
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Region
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 297 participants | 298 participants | 595 participants | |
US and Western Europe and Australia and Canada |
177 59.6%
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157 52.7%
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334 56.1%
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Eastern Europe/Russia |
68 22.9%
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88 29.5%
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156 26.2%
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Japan |
37 12.5%
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35 11.7%
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72 12.1%
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Other Asian |
15 5.1%
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18 6.0%
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33 5.5%
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Smoking Status
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 297 participants | 298 participants | 595 participants | |
Current smoker |
153 51.5%
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152 51.0%
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305 51.3%
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Past smoker |
144 48.5%
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146 49.0%
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290 48.7%
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Investigators' Preferred Platinum Doublet Therapy
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 297 participants | 298 participants | 595 participants | |
Carboplatin/paclitaxel |
71 23.9%
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70 23.5%
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141 23.7%
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Cisplatin/pemetrexed |
95 32.0%
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100 33.6%
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195 32.8%
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Carboplatin/pemetrexed |
131 44.1%
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128 43.0%
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259 43.5%
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[1]
Measure Description: The investigator's preferred choice of platinum doublet therapy, prior to randomization, which was used as a stratification factor. Note that while the investigator's pre-randomization preferred choice for the doublet is summarized, all participants on the veliparib arm received carboplatin and paclitaxel as chemotherapy.
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Eastern Cooperative Oncology Group (ECOG) Performance Status
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 297 participants | 298 participants | 595 participants | |
Grade 0 (fully active) |
113 38.0%
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116 38.9%
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229 38.5%
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Grade 1 (restricted but ambulatory) |
184 62.0%
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182 61.1%
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366 61.5%
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[1]
Measure Description:
ECOG performance status is used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis.
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Lung Subtype Panel (LSP) Assay Results
[1] [2] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 93 participants | 114 participants | 207 participants | |
LSP positive |
40 43.0%
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40 35.1%
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80 38.6%
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LSP negative |
53 57.0%
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74 64.9%
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127 61.4%
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[1]
Measure Description:
LSP positive: Patients with tumors classified as positive for the gene expression-based lung subtype panel (LSP) biomarker LSP negative: Patients with tumors classified as negative for the gene expression-based lung subtype panel (LSP) biomarker [2]
Measure Analysis Population Description: Participants with a tumor tissue sample available with sufficient tumor content for LSP status evaluation, and with an analytically valid LSP result.
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Name/Title: | Global Medical Services |
Organization: | AbbVie |
Phone: | 800-633-9110 |
EMail: | abbvieclinicaltrials@abbvie.com |
Responsible Party: | AbbVie |
ClinicalTrials.gov Identifier: | NCT02264990 |
Other Study ID Numbers: |
M14-359 2014-002565-30 ( EudraCT Number ) |
First Submitted: | October 9, 2014 |
First Posted: | October 15, 2014 |
Results First Submitted: | February 8, 2021 |
Results First Posted: | February 26, 2021 |
Last Update Posted: | February 26, 2021 |