Squamous Non-Small Cell Lung Cancer
Conditions
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
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).
Interventions
DRUGCarboplatin
Carboplatin administered intravenously over approximately 15 to 30 minutes at (AUC 6 mg/mL/min) immediately following paclitaxel infusion.
DRUGVeliparib
Capsules taken orally twice a day, 12 hours apart.
DRUGPaclitaxel
Paclitaxel administered intravenously over 3 hours at a dose of 200 mg/m².
Capsules taken orally twice a day, 12 hours apart.
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) in current smokers | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) in all subjects | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life: European Organisation for Research and Treatment of Cancer Quality of Life Core 30 Question Questionnaire (EORTC-QLQ-C30). | From Screening (prior to dosing) up to 2 years | — |
| Duration of Response | 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. |
| Change in Quality of Life: European Organisation for Research and Treatment of Cancer Quality of Life Lung Cancer 13 Question Questionnaire (EORTC-LC13). | From Screening (prior to dosing) up to 2 years | — |
| Change in Eastern Cooperative Oncology Group (ECOG) Performance Status | 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) | From Screening (prior to dosing) up to 2 years | — |
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, Russia, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey (Türkiye), Ukraine, United Kingdom, United States
Outcome results
None listed