Safety and Efficacy Study of Abraxane as Maintenance Treatment After Abraxane Plus Carboplatin in 1st Line Stage IIIB / IV Squamous Cell Non-small Cell Lung Cancer

Inclusion Criteria

• Age ≥ 18 years of age at the time of signing the Informed Consent Form.
• Understand and voluntarily provide written consent to the Informed Consent Form prior to conducting any study related assessments/procedures.
• Able to adhere to the study visit schedule and other protocol requirements

Disease Specific

• Histologically or cytologically confirmed Stage IIIB or IV squamous cell Non Small Cell Lung Cancer at study entry.
• No other current active malignancy requiring anticancer therapy.
• Radiographically documented measurable disease at study entry (as defined by the Response Evaluation Criteria In Solid Tumors [RECIST] v1.1 criteria).
• No prior chemotherapy for the treatment of metastatic disease at study entry. Adjuvant chemotherapy is permitted providing cytotoxic chemotherapy was completed 12 months prior to starting the study and without disease recurrence.
• Absolute neutrophil count ≥ 1500 cells/mm^3.
• Platelets ≥ 100,000 cells/mm^3.
• Hemoglobin ≥ 9 g/dL.
• Aspartate transaminase/serum glutamic oxaloacetic transaminase, alanine transaminase/serum glutamic pyruvic transaminase ≤ 2.5 × upper limit of normal range or ≤ 5.0 × upper limit of normal range if liver metastases.
• Total bilirubin ≤ 1.5 × upper limit of normal range except in cases of Gilbert's disease and liver metastases.
• Creatinine ≤ 1.5 mg/dL.
• Expected survival of > 12 weeks for the Induction part of the study.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• For Maintenance part of the study, subjects must have received at least one dose of nab-paclitaxel in each of the 4 cycles during Induction

Pregnancy

• Females of childbearing potential [defined as a sexually mature woman who (1) have not undergone hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or (2) have not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months)] must:
• agree to take a pregnancy test prior to starting study medication and throughout the study participation.
• commit to complete abstinence from heterosexual contact, or agree to use medical doctor-approved contraception throughout the study without interruption, and while receiving study medication or for a longer period if required by local regulations.
• Male subjects must:

c. agree to complete abstinence from heterosexual contact or use a condom during sexual contact with a female of child bearing potential while receiving study medication and within 6 months after last dose of study medication, even if he has undergone a successful vasectomy.

• Females must abstain from breastfeeding during study participation and 3 months after IP discontinuation.

Exclusion Criteria

The presence of any of the following will exclude a subject from enrollment into the Induction and Maintenance parts of the study (except if specified at study entry only):

• Evidence of active brain metastases, including leptomeningeal involvement (prior evidence of brain metastasis are permitted only if treated and stable and off therapy for ≥ 4 weeks prior to first dose of study drug).
• Only evidence of disease is non-measurable at study entry.
• Preexisting peripheral neuropathy of Grade 2, 3, or 4 (per Common Terminology Criteria for Adverse Events v4.0).
• Venous thromboembolism within 6 months prior to signing Informed Consent Form.
• Current congestive heart failure (New York Heart Association class II-IV).
• History of the following within 6 months prior to first administration of a study drug: a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant electrocardiogram (ECG) abnormality, cerebrovascular acciden