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)

1. Subject must be >= 18 years of age.
2. Life expectancy > 12 weeks (as per Investigator's clinical assessment).
3. Subject must have cytologically or histologically confirmed squamous NSCLC. Subjects with mixed histology tumors will be eligible if the tumor is predominantly squamous histology and does not include tumor cells with small cell histology. If cytology is used for diagnosis, the sample must be unequivocally and predominantly squamous NSCLC. Subjects must have a pathologist's report confirming squamous NSCLC available for collection by the sponsor.
4. 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. 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 CT scan as defined by RECIST (version 1.1).
6. Subject must consent to provide archived sample of squamous NSCLC lesion (primary or metastatic) biomarker analysis.
7. Subject must have no history of brain metastases or evidence of CNS tumors at screening assessment. Subjects with signs or symptoms of CNS involvement will undergo imaging to confirm absence of CNS metastases.
8. Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1.
9. Subject must be able to take oral medication (PO).
10. Subjects with fluid retention, including ascites or pleural effusion, may be allowed at the discretion of the Investigator.
11. Subject must have adequate bone marrow, renal and hepatic function as follows:
• Bone Marrow: Absolute neutrophil count (ANC) >= 1,500/mm3 (1.5 × 109/L); Platelets >= 100,000/mm3 (100 × 109/L); Hemoglobin >= 9.0 g/dL (5.6 mmol/L);
• Renal function: serum calculated creatinine clearance > 50 mL/min according to the Cockcroft and Gault equation or urine creatinine clearance >50 mL/min;
• Hepatic function: AST and ALT <= 2.5 × ULN unless liver metastases are present, then AST and ALT < 5.0 × ULN; bilirubin <= 1.5 × ULN; or subjects with Gilbert's Syndrome may have a bilirubin >= 1.5 × ULN.
Female and male patients of fertile age, and/or theirs partners should use
contraception for at least 6 months after treatment with paclitaxel. If male, subject
and subject's female partner(s) of childbearing potential should practice at least
one of the following methods of birth control. If female, subject must be either
postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation,
bilateral oophorectomy or hysterectomy), or the subject and the subject's male
partner(s) practicing at least one of the following methods of birth control:
* total abstinence from sexual intercourse (if it is the subject's preferred and
usual lifestyle; for minimum one complete menstrual cycle prior to study drug
administration and to extend 6 months after treatment);
* vasectomized subject or partner(s);
* hormonal contraceptives (oral, parenteral or transdermal) for at least 90 days
prior to study drug administration) for the subject or subject's female
partner(s);
* intrauterine device (IUD) for the subject or subject's female partner(s); or
* double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal
ring with spermicidal jellies or creams) for the subject or subject's female
partner(s).
If hormonal contraceptives are used, the specific contraceptive must have been
used for at least 90 days prior to study drug administration. If the subject or
subject's female partner(s) is currently using a hormonal contraceptive, she should
also use a barrier method during this study and for 6 months (or per local labels)
after study drug completion.
Female subjects must have negative results for pregnancy tests performed at Screening on a serum specimen obtained within 21 days prior to initial study drug administration, and prior to dosing on a urine sample obtained C1D-2 unless the serum pregnancy test was collected within 7 days of C1D-2.
13. Subject must be capable of understanding and complying with parameters as outlined in the protocol and able to consent to participate prior to the initiation of any screening or study-specific procedures.

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 EGFR mutation of exon 19 deletion or L858R mutation in exon 21, or a known ALK gene rearrangement. According to NCCN guidelines, EGFR and ALK testing should be performed in subjects with squamous NSCLC who have never smoked or in case of small biopsy specimens (as judged by the investigator) or mixed histology. Such subjects should be tested to confirm absence of EGFR mutation or ALK gene rearrangement according to local standard of care prior to study entry.
5. A history of seizure within 12 months prior to study entry.
6. Subject has received prior cytotoxic chemotherapy (including definitive chemoradiotherapy) for NSCLC, except for adjuvant or neoadjuvant therapy.
7. Subject has received adjuvant or neoadjuvant chemotherapy <= 12 months prior to randomization.
8. Subject has received herbal remedies or non-prescription anti-cancer supplements
for cancer treatment <= 2 weeks prior to randomization.
9. Subject has undergone focal External Beam Radiation Therapy (EBRT) <= 2 weeks prior
to randomization. EBRT to larger fields (i.e., 100 cm2) should be excluded if < 4 weeks prior to randomization. Radiated lesions may not be considered target lesions.
10. Clinically significant and uncontrolled major medical condition(s) including but
not limited to:
* Uncontrolled nausea/vomiting/diarrhea;
* Active uncontrolled infection;
* Symptomatic congestive heart failure;
* Unstable angina pectoris or cardiac arrhythmia;
* Psychiatric illness/social situation that would limit compliance with study
requirements;
* History of gross hemoptysis;
* Any medical condition, which in the opinion of the Investigator, places the
subject at an unacceptably high risk for toxicities.
11. Subject is pregnant or lactating.
12. Subject has previously been treated with a known PARP inhibitor.
13. The subject has a history of another cancer within the past 3 years except cervical cancer in situ, in situ carcinoma of the bladder, squamous or basal cell carcinoma of the skin or another in situ cancer that is considered cured by the Investigator (e.g., in situ prostate cancer).
14. Any subjects will be excluded if prohibited from participation according to local law.