This is a 2-arm, Phase 3 study to evaluate the safety and efficacy of veliparib plus carboplatin and paclitaxel versus the Investigator's choice of standard chemotherapy in Lung Subtype Panel (LSP) positive subjects with metastatic or advanced non-squamous non-small cell lung cancer.
Name: Paclitaxel
Name: Pemetrexed
Name: Carboplatin
Name: Cisplatin
Name: Veliparib
Description: Overall survival is defined as the number of days from the date that the participant was randomized to the date of the participant's death.
Measure: Overall Survival (OS) in the LSP (Lung Subtype Panel) positive subgroup Time: Up to 3 years from first dose of study drug.Description: Objective response rate is defined as the proportion of participants with complete or partial response as determined by the investigator per Response Evaluation Criteria In Solid Tumors (version 1.1).
Measure: Objective Response Rate (ORR) in the LSP (Lung Subtype Panel) positive subgroup and all participants Time: Up to 3 years from first dose of study drugDescription: Progression-free survival is defined as the number of days from participant randomization to the date the participant experiences an event of disease progression (PD) or death (all causes of mortality), if PD is not reached.
Measure: Progression Free Survival (PFS) in the LSP (Lung Subtype Panel) positive subgroup and all participants Time: Up to 5 years from first dose of study drugDescription: Overall survival is defined as the number of days from the date that the participant was randomized to the date of the participant's death.
Measure: Overall Survival (OS) in all participants Time: Up to 5 years from first dose of study drug.Description: Participants will answer the European Quality of Life-5 Dimensions-5 Levels Questionnaire (EQ-5D-5L) and the Functional Assessment of Cancer Therapy (FACT) Lung Symptom Index-17 questionnaire.
Measure: Change in Quality of Life in the LSP (Lung Subtype Panel) positive subgroup and in all participants Time: From Screening (prior to dosing) up to 2 yearsDescription: The duration of overall response for a participant is defined as the number of days from when the criteria is met for a complete or partial response (whichever occurs first), to the date that progressive disease (PD) is objectively documented.
Measure: Duration of overall response (DOR) in the LSP (Lung Subtype Panel) positive subgroup and in all participants Time: Up to 3 years from randomization.Allocation: Randomized
Parallel Assignment
There is one SNP
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