A Phase 2, randomized, open-label, multicenter study to assess safety and efficacy of nab®-paclitaxel
(ABI-007) with epigenetic modifying therapy of CC-486, and nab®-paclitaxel
monotherapy as second-line treatment in subjects with advanced nonsquamous non-small cell
lung cancer (NSCLC): ABOUND.2L

1.Age >= 18 years the time of signing the Informed Consent Form (ICF).
2.Understand and voluntarily provide written informed consent prior to
the conduct of any study related assessments/procedures.
3.Able to adhere to the study visit schedule and other protocol
requirements
4.Histologically or cytologically confirmed advanced nonsquamous
NSCLC.
5.No other current active malignancy requiring anticancer therapy.
6.Radiographically documented measurable disease (defined by the
presence of >= 1 radiographically documented measurable lesion).
7.One prior platinum-containing chemotherapy for the treatment of advanced disease.
8.Absolute neutrophil count (ANC) >= 1500 cells/mm3.
9.Platelets >= 100,000 cells/mm3.
10.Hemoglobin (Hgb) >= 9 g/dL.
11.Aspartate transaminase (AST/serum glutamic oxaloacetic
transaminase [SGOT]) and alanine transaminase (ALT/serum glutamic
pyruvic transaminase [SGPT]) <= 2.5 × upper limit of normal range (ULN)
or <= 5.0 × ULN if liver metastases.
12.Total bilirubin <= 1.5 ULN (unless there is a known history of Gilberts
Syndrome).
13.Serum creatinine <= 1.5 x ULN, or calculated creatinine clearance >= 60
mL/min (if renal impairment is suspected 24-hour urine collection for
measurement is required).
14.Eastern Cooperative Oncology Group (ECOG) performance status 0 or
1.
15.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 (ie, has had menses at any time during the
preceding 24 consecutive months)] must:
a.Have a negative pregnancy test (ß-hCG) as verified by the study doctor
within 72 hours prior to starting study therapy. She must agree to
ongoing pregnancy testing during the course of the study, and after end
of study therapy. This applies even if the subject practices true
abstinence* from heterosexual contact.
b.Either commit to true abstinence* from heterosexual contact or agree
to use, and be able to comply with, effective contraception without
interruption, 28 days prior to starting investigational product (IP),
during the study therapy (including dose interruptions), and for 3
months after discontinuation of study therapy.
Male subjects must:
a.Practice true abstinence* or agree to use a condom during sexual
contact with a pregnant female or a female of childbearing potential
while participating in the study, during dose interruptions and for at
least 6 months following IP discontinuation, even if he has undergone a
successful vasectomy.
16.Females must abstain from breastfeeding during study participation
and 3 months after IP discontinuation.

1.Squamous cell NSCLC.
2.Prior taxane therapy.
3.Evidence of active brain metastases, including leptomeningeal
involvement (prior evidence of brain metastasis are permitted only if
asymptomatic and clinically stable for at least 8 weeks following
completion of therapy). MRI of the brain (or CT scan w/contrast) is
preferred.
4.Only evidence of disease is non-measurable.
5.Known EGFR mutation.
6.Known EML4-ALK mutation.
7.Preexisting peripheral neuropathy of Grade > 2 (per NCI CTCAE v4.0).
8.Venous thromboembolism within 1 month prior to Cycle 1 Day 1.
9.Current congestive heart failure (New York Heart Association Class IIIV).
10.History of the following within 6 months prior to Cycle 1 Day 1: 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.
11.Known hepatitis B or C virus (HBV/HCV) infection, known history of
human immunodeficiency virus (HIV) infection, or receiving
immunosuppressive or myelosuppressive medications that would in the
opinion of the investigator, increase the risk of serious neutropenic
complications.
12.Active, uncontrolled bacterial, viral, or fungal infection(s) requiring
systemic therapy, defined as ongoing signs/symptoms related to the
infection without improvement despite appropriate antibiotics, antiviral
therapy, and/or other treatment.
13.History of interstitial lung disease, sarcoidosis, silicosis, idiopathic
pulmonary fibrosis, or pulmonary hypersensitivity pneumonitis.
14.Subject has a clinically significant malabsorption syndrome,
persistent diarrhea, or known sub-acute bowel obstruction > NCI CTCAE
Grade 2, despite medical management.
15.Treatment with any investigational product within 28 days prior to
signing the ICF.
16.History of or suspected allergy to nab-paclitaxel, azacitidine, human
albumin or mannitol.
17.Currently enrolled in any other clinical protocol or investigational trial
that involves administration of experimental therapy and/or therapeutic
devices.
18.Any other clinically significant medical condition, psychiatric illness,
and/or organ dysfunction that will interfere with the administration of
the therapy according to this protocol or which, in the views of
investigator, preclude combination chemotherapy.
19.Any other malignancy within 5 years prior to randomization, or
advanced malignant hepatic tumors, with the exception of adequately
treated 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
Classification of Malignant Tumours (TNM) stage of T1a or T1b). (All
treatment of which should have been completed 6 months prior to
signing ICF).
20.Any condition including the presence of laboratory abnormalities,
which places the subject at unacceptable risk if he/she were to
participate in the study.
21.Any medical condition that confounds the ability to interpret data
from the study.
22.Pregnant or breastfeeding females.