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).
Name: Carboplatin
Name: Veliparib
Name: Paclitaxel
Name: Placebo to veliparib
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: Overall Survival (OS) in current smokers Time: Up to 3 years from first dose of study drugDescription: 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: Overall Survival (OS) in all subjects Time: Up to 3 years from first dose of study drugDescription: 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: Progressive-Free Survival (PFS) in current smokers and in all subjects Time: Up to 3 years from first dose of study drugDescription: 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)
Measure: Objective Response Rate (ORR) in current smokers and in all subjects Time: Up to 3 years from first dose of study drugDescription: 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.
Measure: Duration of Response Time: From complete or partial response to disease progression (up to 3 years from randomization).Allocation: Randomized
Parallel Assignment
There is one SNP
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. --- L858R ---