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

The sponsor used 15 Sep 2017 as the database cut-off date.

Inclusion Criteria:

1. Age ≥ 18 years of age at the time of signing the Informed Consent Form.

2. Understand and voluntarily provide written consent to the Informed Consent Form prior
to conducting any study related assessments/procedures.

3. Able to adhere to the study visit schedule and other protocol requirements

Disease Specific

4. Histologically or cytologically confirmed Stage IIIB or IV squamous cell Non Small
Cell Lung Cancer at study entry.

5. No other current active malignancy requiring anticancer therapy.

6. Radiographically documented measurable disease at study entry (as defined by the
Response Evaluation Criteria In Solid Tumors [RECIST] v1.1 criteria).

7. 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.

8. Absolute neutrophil count ≥ 1500 cells/mm^3.

9. Platelets ≥ 100,000 cells/mm^3.

10. Hemoglobin ≥ 9 g/dL.

11. 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.

12. Total bilirubin ≤ 1.5 × upper limit of normal range except in cases of Gilbert's
disease and liver metastases.

13. Creatinine ≤ 1.5 mg/dL.

14. Expected survival of > 12 weeks for the Induction part of the study.

15. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

16. 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

17. 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:

1. agree to take a pregnancy test prior to starting study medication and throughout
the study participation.

2. 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.

18. 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.

19. 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):

1. 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).

2. Only evidence of disease is non-measurable at study entry.

3. Preexisting peripheral neuropathy of Grade 2, 3, or 4 (per Common Terminology Criteria
for Adverse Events v4.0).

4. Venous thromboembolism within 6 months prior to signing Informed Consent Form.

5. Current congestive heart failure (New York Heart Association class II-IV).

6. 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 accident, transient
ischemic attack, or seizure disorder.

7. Treatment with any investigational product within 28 days prior to signing Informed
Consent Form.

8. History of allergy or hypersensitivity to nab-paclitaxel or carboplatin.

9. Currently enrolled in any other clinical protocol or investigational trial that
involved administration of experimental therapy and/or therapeutic devices.

10. Any other clinically significant medical condition and/or organ dysfunction that will
interfere with the administration of the therapy according to this protocol.

11. Subject has any other malignancy within 5 years prior to randomization. Exceptions
include the following: squamous cell carcinoma of the skin, in-situ carcinoma of the
cervix, uteri, non-melanomatous skin cancer, carcinoma in situ of the breast, or
incidental histological finding of prostate cancer (TNM stage of T1a or T1b) — all
treatments that should have been completed 6 months prior to signing informed consent
form (ICF).

12. Subject has received radiotherapy ≤ 4 weeks or limited field radiation for palliation
≤ 2 weeks prior to starting investigational product (IP), and/or from whom ≥ 30% of
the bone marrow was irradiated. Prior radiation therapy to a target lesion is
permitted only if there has been clear progression of the lesion since radiation was
completed.

13. Pregnant and nursing females.