A Phase 2, Open-Label, Multi-Center Study to Assess Safety and Efficacy of Second/Third-Line Treatment With NAB®-Paclitaxel (ABI-007) In Combination With Epigenetic Modifying Therapy Of CC-486, Or Immunotherapy of Durvalumab (MEDI4736), Or As Monotherapy In Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC): Abound.2L+
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: Celgene

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nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
1
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
TITLE PAGE
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
INVESTIGATIONAL PRODUCTS:
CC-486, nab-Paclitaxel (ABI-007)
PROTOCOL NUMBER:
ABI-007-NSCL-006
DATE FINAL:
29 May 2014
AMENDMENT 2 FINAL:
18 Jul 2014
EudraCT NUMBER
2014-001105-41
IND NUMBER
123160
SPONSOR NAME / ADDRESS:
Celgene Corporation
86 Morris Avenue
Summit, NJ 07901
United States
CONFIDENTIAL
This protocol is provided to you as an Investigator, potential Investigator, or consultant for review by 
you, your staff, and ethics committee/institutional review board. The information contained in this 
document is regarded as confidential and, except to the extent necessary to obtain informed consent, 
may not be disclosed to another party unless such disclosure is required by law or regulations.
Persons to whom the information is disclosed must be informed that the information is confidential 
and may not be further disclosed by them.
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nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
2
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
MEDICAL MONITOR / EMERGENCY CONTACT INFORMATION 
Contact Information:
Name:
Title:
Address: 
86 Morris Avenue
Summit, NJ 07901
United States
Phone:
E-mail:
Contact Information:
Name:
Title:
Address: 
86 Morris Avenue
Summit, NJ 07901
United States
Phone:
E-mail:
Note: The back-up 24 hour global emergency contact call center should only be used if you 
are not able to reach the Clinical Research Physician(s) or Medical Monitor or designee for 
emergency calls.
Back-up 24 Hour Global Emergency Contact Call Center: 
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nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
3
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
CELGENE THERAPEUTIC AREA HEAD SIGNATURE PAGE
{See appended electronic signature page}.
Signature of Celgene Therapeutic Area Head
dd mmm yyyy
 
Printed Name of Celgene Therapeutic Area Head and Title
By my signature, I indicate I have reviewed this protocol and find its content to be 
acceptable.
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nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
4
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
SITE PRINCIPAL INVESTIGATOR SIGNATURE PAGE
Signature of Site Principal Investigator
dd mmm yyyy
Printed Name of Site Principal Investigator
Institution Name:_______________________________________
By my signature, I agree to personally supervise the conduct of this study at my study 
site and to ensure its conduct is in compliance with the protocol, informed consent, 
Institutional Review Board (IRB)/Ethics Committee (EC) procedures, instructions from 
Celgene representatives, the Declaration of Helsinki, ICH Good Clinical Practices 
Guidelines, and local regulations governing the conduct of clinical studies.
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
5
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
COORDINATING PRINCIPAL INVESTIGATOR SIGNATURE PAGE
Signature of Coordinating Principal Investigator
dd mmm yyyy
Printed Name of Coordinating Principal Investigator
Institution Name:_______________________________________
By my signature, I agree the protocol has been written to comply with ICH Good 
Clinical Practices guidelines and agree to offer guidance throughout the study as 
needed.
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
6
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
PROTOCOL SUMMARY
Study Title
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
Indication
Second-line treatment of advanced nonsquamous NSCLC.
Objectives
Primary
!
To assess the efficacy of nab-paclitaxel1 administered intravenously (IV) on Days 8 
and 15 with epigenetic modifying therapy of CC-486 once daily (QD) on Days 1 to 
14 every 21 days, and nab-paclitaxel monotherapy administered IV on Days 1 and 8 
every 21 days as second-line treatment for advanced nonsquamous NSCLC, and the 
relative efficacy of these two treatment regimens.
Secondary 
!
To evaluate the safety and tolerability of nab-paclitaxel administered IV on Days 8 
and 15 in combination with epigenetic modifying therapy of CC-486 once daily (QD) 
on Days 1 to 14 every 21 days, and nab-paclitaxel monotherapy administered IV on 
Days 1 and 8 every 21 days as second-line treatment for advanced nonsquamous 
NSCLC.
Exploratory 
!
To assess healthcare resource utilization for the two treatment arms.
!
To assess the quality of life (QoL) for the two treatment arms.
!
To determine baseline tumor characteristics which predict response to nab-paclitaxel 
as a single agent and in combination with epigenetic modifying therapy of CC-486. 
!
To evaluate genomic correlates of response to nab-paclitaxel as a single agent and in 
combination with epigenetic modifying therapy of CC-486.
Study Design
This is a Phase 2, randomized, open-label, multicenter study to assess efficacy and safety of  
nab-paclitaxel in combination with epigenetic modifying therapy of CC-486, and nab-paclitaxel 
monotherapy as second-line treatment in subjects with advanced nonsquamous NSCLC who 
have received one platinum-containing chemotherapy regimen. Approximately 160 subjects with 
advanced nonsquamous NSCLC will be randomized 1:1 into one of the two treatment arms: nab-
paclitaxel / CC-486 combination therapy or nab-paclitaxel monotherapy prior to receiving first 
1 nab® is a registered trademark of Celgene Corporation.
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
7
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
dose of investigational product (IP). Randomization will be centralized and stratified by Eastern 
Cooperative Oncology Group (ECOG) performance status (0 versus 1, see Appendix A), gender
(males versus females), and smoker (yes versus no).
The study will consist of up to a 28-day Screening Period, a Treatment Period and a Follow-up 
Period.
The Screening Period for eligibility determination begins upon subject written informed consent.  
All screening assessments must be completed within 28 days prior to first dose of IP.
The Treatment Period begins with the first dose of IP as described in Section 8.  Subjects will 
receive one of the following treatments based on the randomization assignment:
!
nab-Paclitaxel 100 mg/m2 IV infusion over 30 minutes on Days 8 and 15 and CC-486 
200 mg orally QD on Days  1 to 14 of each 21-day treatment cycle, or  
!
nab-Paclitaxel 100 mg/m2 IV infusion over 30 minutes on Days 1 and 8 of each 21-
day treatment cycle
No additional anticancer agents are allowed during study treatment.  All supportive care
(including but not limited to growth factors, antiemetics, analgesics, zolendronic acid, 
denosumab) is permitted as per the investigator’s discretion and should be administered 
according to local institutional practice. Subjects will continue treatment until disease 
progression, development of an unacceptable toxicity, death, lost to follow-up, withdrawal of 
consent, or termination of the study by the sponsor.
Tumor evaluations will be assessed by the investigative sites and response will be determined 
according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, Version 1.1
(Eisenhauer, 2009).
All scheduled laboratory samples will be sent to a central laboratory for analysis. Local 
hematology and chemistry tests may be performed as required for subject management/treatment 
decisions. Local laboratory values that are considered abnormal and clinically significant will be 
recorded as an adverse event (AE)/serious adverse event (SAE) and also recorded on the 
laboratory electronic Case Report Form (eCRF) (see Section 11.3).
All subjects who discontinue from treatment for any reason other than withdrawal of consent, 
lost to follow-up, death, or termination of the study by the sponsor will enter the Follow-up 
Period. It will consist of a visit 28 days after treatment discontinuation. Thereafter, subjects will 
be followed for survival by phone call contact approximately every 90 days (+/- 14 days) for 12
months after the last subject is randomized or 120 progression-free survival (PFS) events have 
been observed, whichever comes later.
During the study, subjects will have computed tomography (CT) scans every 42 days (-3/+7 
days) until documented progression of disease, withdrawal of consent, lost to follow-up, death, 
or termination of the study by the sponsor. Those subjects entering the Follow-up Period without 
documented progression will continue to have CT scans in accordance with local standard of 
care (or approximately every 90 days) until documented progression of disease, withdrawal of
consent, lost to follow-up, death, or termination of the study by the sponsor. All posttreatment 
anticancer therapies will be recorded during the Follow-up Period.  
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
8
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
Study Population
Male and female subjects with advanced nonsquamous NSCLC who have received one 
platinum-containing chemotherapy regimen for their advanced disease will be eligible for this 
study.
Length of Study
The enrollment of 160 subjects on this study will take approximately 24 months. The total length 
of this Phase 2 study with follow-up is estimated to be approximately 3 years.
The End of Trial is defined as either the date of the last visit of the last subject to complete the 
study, or the date of receipt of the last data point from the last subject that is required for 
primary, secondary and/or exploratory analysis, as pre-specified in the protocol and/or the 
Statistical Analysis Plan, whichever is the later date.
Study Treatments
Subjects will receive nab-paclitaxel in combination with CC-486 or nab-paclitaxel monotherapy 
during the study. The CC-486 and nab-paclitaxel for both arms are designated as IP and will be 
packaged and supplied by Celgene Corporation.
Overview of Statistical Methods
The primary objective of this study is to evaluate the efficacy of the CC-486 and nab-paclitaxel 
combination therapy and that of the nab-paclitaxel monotherapy, and the relative efficacy of 
these two treatment regimens.  
Approximately 160 subjects will be randomized to the two treatment arms in a 1:1 ratio.  A 
permuted-block randomization method will be employed, and the randomization will be carried 
out centrally using an Interactive Response Technology (IRT) system. The randomization will be 
stratified based on the following baseline factors: ECOG performance status (0 versus 1), gender 
(males versus females), and smoker (yes versus no).
Evaluations of the study endpoints will be based primarily on the point estimates and the 
associated 95%  confidence intervals of the within- and between-treatment differences. However, 
nominal p-values from statistical tests may be provided in the clinical study report to indicate the 
strength of the treatment differences evaluated. 
An independent Data Monitoring Committee (DMC) will be established to review the interim 
safety and efficacy data.  
Efficacy Analyses
The intent-to-treat population, which includes all randomized subjects regardless of whether the 
subject receives any IP or has any efficacy assessments performed, will be used for all efficacy 
analyses. The primary efficacy endpoint is PFS, which is defined as the time from the date of 
randomization to the date of disease progression or death (from any cause) on or prior to the data 
cutoff date for analyses, whichever occurs first, based on the investigator’s assessment of the 
data from CT scans using RECIST 1.1 guidelines. Baseline tumor measurements will be 
determined from the radiologic evaluation performed within 28 days before the start of study 
therapy. 
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
9
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
Progression-free survival will be summarized using Kaplan-Meier methods with median PFS 
time (including two-sided 95% confidence interval [CI]) for each treatment arm.  The relative 
treatment effect between the combination and monotherapy arms with respect to PFS will be 
estimated by the hazard ratio (HR) and the associated two-sided 95% CIs using the stratified Cox 
proportional hazard model with ECOG performance status (0 versus 1), gender (males versus 
females), and smoker (yes versus no) as the stratification factors. No statistical inferential tests 
will be performed. 
The secondary endpoints include disease control rate (DCR), overall response rate (ORR), and 
overall survival (OS). Disease control rate and ORR will be summarized within each treatment 
arm by the observed rates and the associated 95% CIs. The relative treatment effect will be 
summarized by the absolute difference and the ratio of the observed rates. Overall survival will 
be analyzed using similar statistical method as that for the PFS endpoint.
Safety Analyses
The treated population, which includes all randomized subjects who receive at least one dose of 
IP, will be the analysis population for all safety analyses. 
Adverse events will be analyzed in terms of treatment-emergent adverse events (TEAEs), 
defined as any AE or SAE occurring or worsening on or after the day of the first dose of the IP
through 28 days after the last dose of IP.  In addition, any SAE with an onset date more than 28 
days after the last dose of IP that is assessed by the investigator as related to IP will be 
considered a TEAE.
Treatment-emergent adverse events, Grade 3 or higher TEAEs, SAEs, TEAEs leading to dose 
reduction, dose delay, and dose interruption, TEAEs leading to treatment discontinuation, and 
TEAEs with an outcome of death will be summarized by treatment arms using MedDRA system 
organ class and preferred terms.
Sample Size
This study is designed to estimate the treatment effect within each of the combination and 
monotherapy arms and the relative effect between the two arms with respect to the primary and 
secondary efficacy endpoints. The sample size was chosen to support the estimation of the 
within- and between-treatment effects with reasonable precision. Table 1 below summarizes the 
precisions that can be achieved given different scenarios of hypothetical observed hazard ratios 
between the two treatment arms for PFS events, assuming a total of 120 events are observed, and 
the time to PFS has an exponential distribution. 
Table 1:
Progression-Free Survival – Two-side 95% Confidence Interval of 
Hypothetical Observed Hazard Ratio between Treatment Arms
Hypothetical Number of 
Events Observed
Hypothetical Observed Hazard 
Ratio of PFS Events
95% Confidence Interval of 
Hazard Ratioa
120
0.60
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0.65
(0.45, 0.93)
0.70
(0.49, 1.00)
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
10
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
Assuming the median times of PFS are 4.17 and 2.5 months, respectively, for the nab-
paclitaxel/CC-486 combination therapy
and nab-paclitaxel
monotherapy arms, and an 
approximate 24 months accrual period for a total of 160 subjects, it is estimated that a total of 
120 PFS events will be observed approximately 2 months after the last subject is randomized, 
assuming an exponential distribution for PFS. 
One nonbinding interim analysis for PFS with early stopping rule for futility will be conducted 
when approximately 60 events are observed. 
Data Monitoring Committee
An independent Data Monitoring Committee (DMC) will be established with the responsibilities 
for safeguarding the interests of study participants and monitoring the overall conduct of the 
study. Final recommendations of the DMC will reflect the judgment of the DMC members and 
will be considered advisory in nature to the sponsor. The decision to implement the 
recommendations of the DMC will be made by the sponsor, following consultation with the trial 
Coordinating Investigator and Steering Committee. A DMC charter will be established.
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TABLE OF CONTENTS
TITLE PAGE..............................................................................................................................1
PROTOCOL SUMMARY ..........................................................................................................6
1.
INTRODUCTION..................................................................................................18
1.1.
Non-small Cell Lung Cancer ..................................................................................18
1.2.
nab-Paclitaxel in NSCLC .......................................................................................19
1.3.
Rationale for nab-Paclitaxel as Second-line Treatment in Subjects with 
Advanced Nonsquamous NSCLC ...........................................................................20
1.4.
Rationale for nab-Paclitaxel in Combination With Epigenetic Modifying 
Therapy of CC-486 as Second-line Treatment in Subjects with Advanced 
Nonsquamous NSCLC............................................................................................21
2.
STUDY OBJECTIVES...........................................................................................24
2.1.
Primary Objective...................................................................................................24
2.2.
Secondary Objective...............................................................................................24
2.3.
Exploratory Objectives ...........................................................................................24
3.
STUDY ENDPOINTS............................................................................................25
3.1.
Primary Endpoint....................................................................................................25
3.2.
Secondary Endpoints ..............................................................................................25
3.2.1.
Efficacy..................................................................................................................25
3.2.2.
Safety.....................................................................................................................25
3.3.
Exploratory Endpoints............................................................................................25
4.
OVERALL STUDY DESIGN ................................................................................26
4.1.
Study Design ..........................................................................................................26
4.1.1.
Screening Period.....................................................................................................26
4.1.2.
Treatment Period ....................................................................................................26
4.1.3.
Follow-up Period....................................................................................................27
4.2.
Study Design Rationale ..........................................................................................27
4.3.
Study Duration .......................................................................................................29
4.4.
End of Trial ............................................................................................................29
5.
TABLE OF EVENTS.............................................................................................30
6.
PROCEDURES......................................................................................................33
6.1.
Medical History......................................................................................................33
6.2.
Prior and Concomitant Medications and Procedures ...............................................33
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5.

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6.3.
Pregnancy Testing ..................................................................................................33
6.4.
Complete Chest Computed Tomography (CT) Scan................................................34
6.5.
Weight and Height..................................................................................................34
6.6.
ECOG Performance Score ......................................................................................34
6.7.
Peripheral Neuropathy Assessment.........................................................................34
6.8.
Adverse Event Reporting........................................................................................35
6.9.
Quality of Life Questionnaires................................................................................35
6.10.
Healthcare Resource Utilization Questionnaire .......................................................35
6.11.
Laboratory Assessments .........................................................................................35
6.12.
Tumor Tissue Sample Collection and Peripheral Blood Collection 
(Exploratory Assessments) .....................................................................................36
6.13.
Electrocardiogram ..................................................................................................37
6.14.
CT Scan of the Head or Brain Magnetic Resonance Imaging (MRI) .......................37
6.15.
Bone Scans and X-rays...........................................................................................37
6.16.
Physical Examinations............................................................................................37
6.17.
Vital Signs..............................................................................................................37
6.18.
Survival..................................................................................................................37
7.
STUDY POPULATION.........................................................................................39
7.1.
Number of Subjects and Sites .................................................................................39
7.2.
Inclusion Criteria....................................................................................................39
7.3.
Exclusion Criteria...................................................................................................40
8.
DESCRIPTION OF STUDY TREATMENTS........................................................42
8.1.
Description of Investigational Products...................................................................42
8.1.1.
nab-Paclitaxel.........................................................................................................42
8.1.2.
CC-486 (Azacitidine for Oral Administration) ........................................................42
8.2.
Treatment Administration and Schedule .................................................................42
8.3.
Dose Omissions and Modifications.........................................................................43
8.3.1.
Rules for Dose Omissions and Modified Schedules ................................................43
8.3.2.
Rules for Dose Modifications .................................................................................43
8.4.
Method of Treatment Assignment...........................................................................46
8.5.
Packaging and Labeling..........................................................................................46
8.6.
Investigational Product Accountability and Disposal ..............................................46
8.7.
Investigational Product Compliance........................................................................47
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8.8.
Overdose ................................................................................................................47
9.
CONCOMITANT MEDICATIONS AND PROCEDURES....................................48
9.1.
Permitted Concomitant Medications and Procedures...............................................48
9.2.
Prohibited Concomitant Medications and Procedures..............................................49
9.3.
Required Concomitant Medications and Procedures for Patients Receiving 
CC-486...................................................................................................................49
9.3.1.
Description of G-CSF.............................................................................................49
9.3.2.
Administration of G-CSF........................................................................................49
10.
STATISTICAL ANALYSES..................................................................................50
10.1.
Overview................................................................................................................50
10.2.
Study Population Definitions ..................................................................................50
10.2.1.
Intent-to-treat Population........................................................................................50
10.2.2.
Per-protocol (PP) Population ..................................................................................50
10.2.3.
Treated Population..................................................................................................51
10.3.
Sample Size and Power Considerations...................................................................51
10.4.
Background and Demographic Characteristics........................................................52
10.5.
Subject Disposition.................................................................................................53
10.6.
Efficacy Analysis....................................................................................................53
10.6.1.
Primary Efficacy Endpoints....................................................................................53
10.6.2.
Secondary Efficacy Endpoints ................................................................................54
10.6.2.1.
Disease Control Rate ..............................................................................................54
10.6.2.2.
Overall Survival .....................................................................................................54
10.6.2.3.
Overall Response Rate............................................................................................54
10.6.3.
Exploratory Endpoints............................................................................................54
10.6.3.1.
HealthCare Utilization............................................................................................54
10.6.3.2.
Quality of Life Questionnaires................................................................................54
10.6.3.3.
Biomarker, Tumor Characteristics, and Genomic Analyses.....................................54
10.7.
Safety Analysis.......................................................................................................54
10.7.1.
Adverse Events.......................................................................................................55
10.7.2.
Laboratory Assessments .........................................................................................55
10.7.3.
Study Drug Exposure..............................................................................................55
10.8.
Study Therapy Termination ....................................................................................55
10.9.
Deaths ....................................................................................................................55
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10.10.
Interim Analysis .....................................................................................................56
10.11.
Data Monitoring Committee ...................................................................................56
10.12.
Scientific Steering Committee ................................................................................56
11.
ADVERSE EVENTS..............................................................................................57
11.1.
Monitoring, Recording and Reporting of Adverse Events .......................................57
11.2.
Evaluation of Adverse Events.................................................................................57
11.2.1.
Seriousness.............................................................................................................57
11.2.2.
Severity / Intensity..................................................................................................59
11.2.3.
Causality ................................................................................................................59
11.2.4.
Duration .................................................................................................................60
11.2.5.
Action Taken..........................................................................................................60
11.2.6.
Outcome.................................................................................................................60
11.3.
Abnormal Laboratory Values..................................................................................60
11.4.
Pregnancy...............................................................................................................60
11.4.1.
Females of Childbearing Potential ..........................................................................61
11.4.2.
Male Subjects.........................................................................................................61
11.5.
Reporting of Serious Adverse Events......................................................................61
11.5.1.
Safety Queries ........................................................................................................62
11.6.
Expedited Reporting of Adverse Events..................................................................62
12.
DISCONTINUATIONS .........................................................................................63
12.1.
Study Treatment Discontinuation............................................................................63
12.2.
Study Discontinuation ............................................................................................63
12.3.
Subject Replacement ..............................................................................................64
13.
EMERGENCY PROCEDURES.............................................................................65
13.1.
Emergency Contact.................................................................................................65
13.2.
Emergency Identification of Investigational Products .............................................65
14.
REGULATORY CONSIDERATIONS...................................................................66
14.1.
Good Clinical Practice............................................................................................66
14.2.
Investigator Responsibilities ...................................................................................66
14.3.
Subject Information and Informed Consent.............................................................66
14.4.
Confidentiality........................................................................................................67
14.5.
Protocol Amendments.............................................................................................67
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4.3.

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14.6.
Institutional Review Board/Independent Ethics Committee Review and 
Approval ................................................................................................................67
14.7.
Ongoing Information for Institutional Review Board / Ethics Committee................68
14.8.
Closure of the Study ...............................................................................................68
15.
DATA HANDLING AND RECORDKEEPING.....................................................69
15.1.
Data/Documents .....................................................................................................69
15.2.
Data Management...................................................................................................69
15.3.
Record Retention....................................................................................................69
16.
QUALITY CONTROL AND QUALITY ASSURANCE........................................71
16.1.
Study Monitoring and Source Data Verification......................................................71
16.2.
Audits and Inspections............................................................................................71
17.
PUBLICATIONS ...................................................................................................72
18.
REFERENCES.......................................................................................................73
19.
APPENDICES........................................................................................................76
Appendix A:
ECOG Performance Status Score.......................................................................76
Appendix B:
Recommendations for Management of Treatment-Induced Diarrhea..................77
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LIST OF TABLES
Table 1:
Progression-Free Survival – Two-side 95% Confidence Interval of 
Hypothetical Observed Hazard Ratio between Treatment Arms................................9
Table 2:
Blinded Radiology Assessment of Overall Response Rate (Intent-to-treat 
Population).............................................................................................................20
Table 3:
Table of Events.......................................................................................................30
Table 4:
Requirements for Collection Based on Archival Tumor Sample Type.....................36
Table 5:
Permanent Dose Reductions for Hematologic and Nonhematologic 
Toxicities and Dosing on the Study.........................................................................45
Table 6:
Disease Control Rate –Two-Sided 95% Confidence Interval of Hypothetical 
Disease Control Rate with a Sample Size of 80 Subjects in a Treatment Arm .........51
Table 7:
Progression-Free Survival – Two-Sided 95% Confidence Interval of 
Hypothetical Observed Hazard Ratio between Treatment Arms..............................52
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LIST OF FIGURES
Figure 1:
Overall Study Design..............................................................................................28
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1.
INTRODUCTION
1.1.
Non-small Cell Lung Cancer
Lung cancer is the leading cause of cancer-related deaths among men and women worldwide, 
with 1.2 million new cases diagnosed each year. Non-small cell lung cancer (NSCLC) is the 
most common type of lung cancer, accounting for 80% of all new cases. There are an estimated 
1.1 million lives lost per year (approximately 500,000 in the United States [US] and European 
Union [EU] alone) due to NSCLC. Smoking is the causative factor for up to 85% of cases 
(http://www.lungcancercoalition.org/en/pages/about/awareness).
The majority of patients are not diagnosed until the tumor has progressed beyond the primary 
site. Despite step-wise advances in patient selection, targeted agents, and optimizing
chemotherapy regimens, patients with advanced NSCLC continue to have an unmet medical 
need (Schiller, 2013).
Platinum-containing chemotherapy regimens remain the standard first-line treatment in the 
majority of patients in the US and Japan. In the EU, a third-generation chemotherapeutic agent 
(docetaxel, gemcitabine, paclitaxel, or vinorelbine), most commonly gemcitabine or vinorelbine, 
plus a platinum drug is used for advanced NSCLC (NICE, 2011). For first-line therapy in 
patients with Stage IV NSCLC and good performance status, the American Society of Clinical 
Oncology (ASCO) clinical practice guideline recommends treatment with a platinum-based 
two-drug combination of cytotoxic drugs (Azzoli, 2009). For patients without disease 
progression, the option of maintenance monotherapy with pemetrexed or erlotinib could also be 
considered (Gerber, 2013; Schiller, 2013). A trend that is becoming more prevalent is 
personalized NSCLC treatment based on tumor histology (squamous versus nonsquamous), on 
molecular characteristics of the tumor, and on the patient’s clinical status using agents targeting 
specific receptors, kinases and pathways (ie, epidermal growth factor receptor [EGFR], 
echinoderm microtubule-associated protein-like 4 [EML4] and anaplastic lymphoma kinase 
[ALK] fusion protein).
Single agent chemotherapy (pemetrexed, EGFR-inhibitors and taxanes) are standards of care for 
second-line treatment of patients with locally advanced or metastatic NSCLC after failure of 
prior platinum-based chemotherapy. Docetaxel has been widely evaluated in this setting, and is 
currently approved by the US Food and Drug Administration (FDA) and the European 
Medicines Agency (EMA) as a single agent for the treatment of patients with locally advanced or 
metastatic NSCLC after failure of prior chemotherapy  (the US label specifies prior platinum-
based chemotherapy). For patients with a good performance status at the time of disease 
progression following first-line chemotherapy, docetaxel, despite a low response rate, was
associated with a 10% to 20% prolongation of 1-year survival and an improved quality of life 
when compared with ifosfamide, vinorelbine, or best supportive care (BSC) alone (Hanna, 
2004). Erlotinib is indicated in the US and EU for the treatment of patients with locally advanced 
or metastatic NSCLC after failure of at least one prior chemotherapy regimen, although no 
survival benefit has been demonstrated in patients with EGFR-IHC negative tumors.  
Pemetrexed is indicated in the US and EU as a single agent for the treatment of patients with 
locally advanced or metastatic nonsquamous NSCLC after prior chemotherapy. However, the 
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approval and subsequent increased use of pemetrexed and erlotinib in the first-line setting poses 
an unmet need in the second-line setting, whereby new therapeutic options are needed.
1.2.
nab-Paclitaxel in NSCLC
nab-Paclitaxel is approved in the first-line setting in combination with carboplatin for patients 
with NSCLC in the US, Japan, Argentina, Australia, and New Zealand.  The approval  was based 
on the evaluation of Phase I and II data (Belani, 2008; Rizvi, 2008; Socinski, 2010), as well as 
the pivotal Phase 3 study (CA031), (Socinski, 2012). The pivotal Phase 3 study was a 
multicenter, randomized, open-label study conducted in 1052 chemo-naïve subjects with Stage 
IIIB/IV NSCLC to compare nab-paclitaxel in combination with carboplatin to paclitaxel 
injection in combination with carboplatin as first-line treatment in patients with advanced 
NSCLC. nab-Paclitaxel was administered as an IV infusion over 30 minutes at a dose of 
100 mg/m2 on Days 1, 8, and 15 of each 21-day cycle. Paclitaxel injection was administered as 
an IV infusion over 3 hours at a dose of 200 mg/m2, following premedication. In both treatment 
arms carboplatin at a dose of area under the curve (AUC) = 6 mg*min/mL was administered IV
on Day 1 of each 21-day cycle after completion of nab-paclitaxel/paclitaxel infusion. Treatment 
was administered until disease progression, development of an unacceptable toxicity or patient 
withdrawal. The primary efficacy outcome measure was overall response rate (ORR) as
determined by a central independent review committee using RECIST guidelines (Version 1.0).
In the intent-to-treat (all-randomized) population, the median age was 60 years, 75% were men, 
81% were white, 49% had carcinoma/adenocarcinoma, 43% had squamous cell lung cancer, 76% 
were ECOG performance status (PS) 1, 15% were ≥70 years of age and 73% were current or 
former smokers. Patients received a median of 6 cycles of treatment in both study arms. Patients 
in the nab-paclitaxel/carboplatin arm had a statistically significantly higher overall response rate 
compared to patients in the paclitaxel injection/carboplatin arm [(33% versus 25%; response rate 
ratio, 1.313; 95% CI, 1.082 to 1.593; p=0.005), see Table 2].
Non-inferiority analysis of overall survival (OS) demonstrated that nab-paclitaxel/carboplatin
(nab-p/C) treatment is not inferior to paclitaxel/carboplatin (P/C) treatment. Overall survival in 
the nab-paclitaxel arm was 12.1 months versus 11.2 months in the control arm (p = 0.271; HR = 
0.922). There was an approximately 10% increase in PFS in the nab-p/C versus P/C arm and PFS 
in the nab-p/C arm was noninferior to PFS in the P/C arm (HRnab-p/C/P/C 95% CI upper bound, 
1.086).
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Table 2:
Blinded Radiology Assessment of Overall Response Rate (Intent-to-treat
Population)
Variable
Category/Statistic
nab-Paclitaxel/
carboplatin
(N=521)
Paclitaxel/
carboplatin
(N=531)
Response Rate 
Ratio
(pA/pT)
p-value
Patients with Confirmed Complete or Partial Overall Response
n (%)
170 (33%)
132 (25%)
1.313
0.005*
Confidence Interval (CI) a
28.6, 36.7
21.2, 28.5
1.082, 1.593
Complete Response, n (%)
0
1 (< 1%)
Partial Response, n (%)
170 (33%)
131 (25%)
PA/PT: response rate of nab-paclitaxel/response rate of paclitaxel.
a 95% CI of response rate and 95.1% CI of response rate ratio.
* Indicates p-value < 0.049.
Note: p-value is based on a chi-square test.
Source: Data on File.
Adverse events (AEs) were assessed in 514 nab-paclitaxel/carboplatin-treated patients and 524 
paclitaxel injection/carboplatin-treated patients. The following common (≥ 10% incidence) AEs
were observed at a similar incidence in nab-paclitaxel/carboplatin and paclitaxel/carboplatin
arms: alopecia 56%, nausea 27%, fatigue 25%, decreased appetite 17%, asthenia 16%, 
constipation 16%, diarrhea 15%, vomiting 12%, dyspnea 12%, and rash 10% (incidence rates are 
for the nab-paclitaxel plus carboplatin treatment group). Toxicities, particularly neuropathy and 
Grade 3/4 neutropenia were less pronounced using nab-paclitaxel in the dose and schedule 
employed. Laboratory-detected abnormalities which occurred with a difference ≥5% for nab-
paclitaxel plus carboplatin versus paclitaxel injection plus carboplatin (Grades 1 to 4 [and Grade 
3/4]) were: anemia (98% vs 91% [28% vs 7%]), neutropenia (85% vs 83% [47% vs 58%]) and 
thrombocytopenia (68% vs 55% [18% vs 9%]).  
1.3.
Rationale for nab-Paclitaxel as Second-line Treatment in Subjects 
with Advanced Nonsquamous NSCLC
Patients who fail first-line chemotherapy are eligible for second-line treatment with single agent 
docetaxel, pemetrexed or erlotinib. In patients with good performance (eg, ECOG PS 0 or 1) and 
general health status, further treatment with chemotherapy is an important consideration that has 
been shown to extend overall survival. Despite the availability of second-line therapy, the trend 
of increased use of pemetrexed, as well as erlotinib (in selected patients) in the first-line and 
maintenance settings, potentially limits the number of available second-line treatment options for 
many patients. Furthermore, the tolerability issues associated with the administration of 
docetaxel once every 3 weeks (q3w) has prompted active research in the past decade to evaluate 
whether weekly regimens of taxanes could be optimized to improve the toxicity profile. The 
availability of an effective second-line cytotoxic chemotherapy with an improved efficacy/safety
profile over current available options would be a valuable addition for both the patient and the 
treating physician. Paclitaxel has also demonstrated potential activity in second-line NSCLC in a 
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
21
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
few studies (Socinski, 1999; Juan, 2002; Socinski, 2002; Sculier, 2002; Buccheri, 2004; Ceresoli, 
2004; Yasuda, 2004).
nab-Paclitaxel exhibits 10-fold higher mean Cmax of free paclitaxel, delivers 33% higher drug 
concentration to tumors in preclinical xenograft models, and demonstrates enhanced transport 
across endothelial cell monolayers, when compared with paclitaxel (Desai, 2006; Gardner, 
2008). The Cremophor EL-free medium enables nab-paclitaxel to be given over a shorter 
duration without the need for premedication to prevent solvent-related hypersensitivity reactions.
When administered with carboplatin in the first-line setting, weekly nab-paclitaxel has 
demonstrated a more favorable efficacy:safety profile compared to the every 3 weeks schedule.  
This weekly schedule of nab-paclitaxel allows the opportunity for closer (ie, shorter interval)
monitoring of side effects and optimizing dose-intensity through timely adjustments.  
As previously noted, nab-paclitaxel 100 mg/m2 weekly (Days 1, 8 and 15) in combination with 
carboplatin (21 day cycle) is approved in the US, Japan, Argentina, Australia, and New Zealand 
for the treatment of locally advanced or metastatic NSCLC in the first-line setting.  However, 
there is limited data of monotherapy nab-paclitaxel in the second-line setting; hence, this study 
will  assess the efficacy and tolerability of weekly nab-paclitaxel, when administered on Days 1 
and 8 of each 21-day cycle.  The allowance of a one week rest period in this study (ie, no 
treatment on Day 15), takes into account research findings from other taxanes, whereby patients 
in the second-line setting are unlikely to tolerate the same dose-intensity compared to chemo-
naïve patients (eg, sharper dose reduction in the second-line setting). Therefore, the proposed 
nab-paclitaxel schedule (2 weeks treatment, 1 week rest) could offer the option of maintaining 
consistent dose-intensity for NSCLC patients in this setting.
1.4.
Rationale for nab-Paclitaxel in Combination With Epigenetic 
Modifying Therapy of CC-486 as Second-line Treatment in Subjects 
with Advanced Nonsquamous NSCLC
CC-486 is an orally bioavailable formulation of the nucleoside analog 5-azacitidine (AZA).  
After its incorporation into a cell’s DNA during the S-phase of the cell cycle, CC-486 forms 
covalent adducts with DNA Methyltransferase 1 (DNMT1) and depletes this enzyme required for 
the maintenance of DNA methylation patterns, thereby altering the epigenetic status of the cell. 
Epigenetic changes are covalent modifications of chromatin (DNA and histone proteins) that 
mediate the stable transmission of a gene’s transcriptional status through cell division.  One of 
the first recognized epigenetic alterations in cancer was DNA methylation.  The addition of a 
methyl group to cytosine in the dinucleotide CpG is catalyzed by DNA methyltransferases 
(DNMTs) and is associated with transcriptional repression of genes with high density of CpGs 
(CpG islands) in the vicinity of their promoters (Jones, 2007).  Genomic methylation patterns are 
precisely regulated during normal embryonic development and differentiation and have been 
found to be altered in specific ways in cancer. Specifically, cancer cell genomes are typified by 
reduced methylation globally with focal areas of aberrant hypermethylation in the CpG islands of 
genes encoding known tumor suppressors such as PTEN and BRCA1 as well as genes encoding 
proteins required for apoptosis, including caspase 8, DAPK and Apaf-1.  DNA methylation-
based silencing can thus contribute to the establishment and maintenance of the transformed state 
and limit the effectiveness of anti-cancer therapies.  The recognition of the role of aberrant 
methylation in carcinogenesis and its reversibility has led to the development of DNMT 
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
22
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
inhibitors for cancer. Subcutaneous (SC) AZA was the first DNMT inhibitor to be approved in 
myelodysplastic syndromes (MDS) in 2004 (Kaminskas, 2005).
The notion that sequential treatment with an epigenetic modifying agent followed by a cytotoxic
agent can result in improved response to the latter is supported by numerous preclinical 
experiments and now by early clinical results.  In breast cancer cell lines, restoring expression of 
the aberrantly methylated pro-apoptotic gene TMS1 with azacitidine can restore taxane 
sensitivity (Gordian, 2009).  In a model of platinum resistant ovarian cancer, azacitidine reversed 
resistance to carboplatin (Li, 2009).  This effect required pretreatment of the cells with 
noncytotoxic levels of azacitidine for 24 hours before the addition of carboplatin and was not 
observed with concurrent exposure to both agents.  More recently, Juergens and colleagues 
observed an unusually high ORR of approximately 20% in multiple-relapsed NSCLC patients 
treated with a variety of regimens after being treated with a combination of SC AZA and another 
epigenetic agent, entinostat, a histone deacetylase inhibitor (Juergens, 2011).  In one case, a 
patient who had previously progressed on a regimen of paclitaxel, carboplatin and bevacizumab 
responded to the same triplet after treatment with SC AZA and entinostat, suggesting that the 
epigenetic modifying agents had reversed acquired resistance to the cytotoxic/anti-angiogenic 
regimen.  In a Phase 1/2 study of SC AZA with nab-paclitaxel in subjects with advanced 
metastatic solid tumors and breast cancer (Dumlao, 2011), escalating doses of SC AZA (75 to
100 mg/m2) were administered on Days 1 through 5, followed by nab-paclitaxel (100 mg/m2) 
intravenous (IV) on Days 8, 15, and 22 of a 28-day cycle.  Of 16 subjects treated at the time of 
publication, clinical activity has included 3 complete responses (CR, 1 Diffuse Large B-cell 
Lymphoma [DLBCL], 2 ovarian), 4 partial responses (PR) in ovarian and endometrial cancer 
and 4 stable diseases (SD, 2 lung, 1 pancreatic, and 1 sarcoma).  
CC-486 entered clinical testing in 2006 in subjects with MDS, chronic myelomonocytic 
leukemia [CMML], and acute myeloid leukemia [AML], with daily extended dosing schedules 
of 14 and 21 out of 28 days in a non-crossover fashion.  Daily doses of 300 mg CC-486 have 
proven to be tolerated on both the 14 and 21 out of 28-day schedules with myelosuppression, 
gastrointestinal symptoms, and fatigue being the most common toxicities (Garcia-Manero, 
2011).  Subjects treated with CC-486 for 14 or 21 days had DNA hypomethylation that persisted 
through the end of cycle.  This contrasts with the lack of persistent hypomethylation at the end of 
cycle when subjects were treated with SC AZA for 7 out of 28 days. 
 
 
 
 
  
 
 
 
 
 
t t 
es s 
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A and anoth
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
23
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
  
 
 
 
 
 
 
 
  
 
 
 
  
 
 
 
 
 
 
This Phase 2 study will test the hypothesis that epigenetic modifying therapy with CC-486 can 
improve the anti-tumor activity of nab-paclitaxel in second-line NSCLC patients (see Section 4.2
for study rationale). Although docetaxel has been assessed in other randomized studies as a 
chemotherapy backbone, the considerable neutropenia-related toxicity could potentially pose 
safety concerns if combined with CC-486, and the steroid premedication could confound the 
epigenetic impact of CC-486.  In addition, the q3w dosing schedule of docetaxel restricts dose 
adjustment options, thus potentially yielding lower chemotherapy dose-intensity.
Please refer to the Investigator’s Brochures (IBs) of CC-486 and nab-paclitaxel (ABI-007) for 
detailed information concerning the available pharmacology, toxicology, drug metabolism, 
clinical studies, and adverse event profile of the IPs.
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
24
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
2.
STUDY OBJECTIVES
2.1.
Primary Objective 
The primary objective of the study is:
!
To assess the efficacy of nab-paclitaxel administered intravenously (IV) on Days 8 
and 15 with epigenetic modifying therapy of CC-486 once daily (QD) on Days 1 to 
14 every 21 days, and nab-paclitaxel monotherapy administered IV on Days 1 and 8 
every 21 days as second-line treatment for advanced nonsquamous NSCLC, and the 
relative efficacy of these two treatment regimens.
2.2.
Secondary Objective
The secondary objective of the study is:
!
To evaluate the safety and tolerability of nab-paclitaxel administered IV on Days 8 
and 15 with epigenetic modifying therapy of CC-486 QD on Days 1 to 14 every 21 
days, and nab-paclitaxel monotherapy administered IV on Days 1 and 8 every 21 
days as second-line treatment for advanced nonsquamous NSCLC.
2.3.
Exploratory Objectives
The exploratory objectives of the study are:
!
To assess healthcare resource utilization for the two treatment arms.
!
To assess the QoL for the two treatment arms.
!
To determine baseline tumor characteristics which predict response to nab-paclitaxel 
as a single agent and with epigenetic modifying therapy of CC-486. 
!
To evaluate genomic correlates of response to nab-paclitaxel as a single agent and 
with epigenetic modifying therapy of CC-486.
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
25
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
3.
STUDY ENDPOINTS
Study efficacy endpoints will be assessed by the investigator using RECIST 1.1 guidelines.
3.1.
Primary Endpoint
The primary endpoint is:
!
Progression free survival.
3.2.
Secondary Endpoints
The secondary endpoints are: 
3.2.1.
Efficacy
!
Disease control rate.
!
Overall response rate.
!
Overall survival.
3.2.2.
Safety
!
The type, frequency, and severity of AEs and SAEs graded using National Cancer 
Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, 
Version 4.0). 
!
Discontinuation rate.
!
The median dose intensity.
!
The incidence of dose reduction.
3.3.
Exploratory Endpoints
!
Healthcare resource utilization during the study using a questionnaire.
!
Changes in the Lung Cancer Symptom Scale (LCSS), European Organisation for 
Research and Treatment of Cancer (EORTC) QLQ C30, and EuroQoL 5D-5L (EQ-
5D-5L).
!
The correlation between pretreatment tumor characteristics and response to the study 
treatment determined using next-generation sequencing methods, 
immunohistochemistry, or other analysis methods.
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
26
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
4.
OVERALL STUDY DESIGN 
4.1.
Study Design
This is a Phase 2, randomized, open-label, multicenter study to assess safety and efficacy of  
nab-paclitaxel in combination with epigenetic modifying therapy of CC-486, and nab-paclitaxel 
monotherapy as second-line treatment in subjects with advanced nonsquamous NSCLC who 
have received one platinum-containing chemotherapy regimen. Approximately 160 subjects with 
advanced nonsquamous NSCLC will be randomized 1:1 into one of the two treatment arms: nab-
paclitaxel / CC-486 or nab-paclitaxel monotherapy prior to receiving first dose of investigational 
product (IP). Randomization will be centralized and stratified by ECOG performance status (0 
versus 1), gender (males versus females), and smoker (yes versus no).
The study will consist of up to a 28-day Screening Period, a Treatment Period and a Follow-up 
Period.  
4.1.1.
Screening Period 
The Screening Period for eligibility determination begins upon subject written informed consent.  
All screening assessments must be completed within 28 days prior to first dose of IP.
4.1.2.
Treatment Period 
The Treatment Period begins with the first dose of IP as described in Section 8. Subjects will 
receive one of the following treatments based on the randomization assignment:
!
nab-Paclitaxel 100 mg/m2 IV infusion over 30 minutes on Days 8 and 15 and CC-486 
200 mg orally QD on Days 1 to 14 of each 21-day treatment cycle, or  
!
nab-Paclitaxel 100 mg/m2 IV infusion over 30 minutes on Days 1 and 8 of each 21-
day treatment cycle.
No additional anticancer agents are allowed during study treatment.  All supportive care
(including but not limited to growth factors, antiemetics, analgesics, zolendronic acid, 
denosumab) is permitted as per the investigator’s discretion and should be administered 
according to local institutional practice. Subjects will continue treatment until disease 
progression, development of an unacceptable toxicity, death, lost to follow-up, withdrawal of 
consent, or termination of the study by the sponsor.
During the study, subjects will have computed tomography (CT) scans every 42 days (-3/+7 
days) until documented progression of disease, withdrawal of consent, lost to follow-up, death, 
or termination of the study by the sponsor. Tumor evaluations will be assessed by the 
investigative sites and response will be determined according to RECIST 1.1 guidelines.
All scheduled laboratory samples will be sent to a central laboratory for analysis. Local 
hematology and chemistry tests may be performed as required for subject management/treatment 
decisions. Local laboratory values that are considered abnormal and clinically significant will be 
recorded as an AE/SAE and also recorded on the laboratory eCRF (see Section 11.3).  
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
27
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
4.1.3.
Follow-up Period
All subjects who discontinue from treatment for reasons other than withdrawal of consent, lost to 
follow-up, death, or termination of the study by the sponsor will enter the Follow-up Period. It 
will consist of a visit 28 days after treatment discontinuation followed by phone follow-up for 
survival approximately every 90 days (+/- 14 days) for up to 12 months after the last subject is 
randomized or 120 PFS events have been observed whichever comes later.
Those subjects entering the Follow-up Period without documented progression will continue to 
have CT scans in accordance with local standard of care (or approximately every 90 days) until 
documented progression of disease, withdrawal of consent, lost to follow-up, death, or 
termination of the study by the sponsor. All posttreatment anticancer therapies will be recorded 
during the Follow-up Period.  
4.2.
Study Design Rationale
This is an open-label, randomized study designed to evaluate the effects of adding CC-486 to 
nab-paclitaxel and nab-paclitaxel monotherapy in second-line NSCLC. A placebo-controlled 
study would not be feasible for this population as blinding would be difficult and would need a 
double dummy design.  A key objective in this study is to determine the chemo-priming effect of
CC-486. The inclusion of only patients with nonsquamous NSCLC histology allows for a more 
homogenous population, hence, reducing the impact of potential confounding factors. Second-
line NSCLC enables a unique setting to evaluate epigenetics: 
a) compared to more heavily treated patients, patients eligible for second-line treatment
have better immune function/reserve which is critical for safety and activation of immune 
cells that target cancer cells,
b) due to the overlapping (and dose-limiting) toxicities of doublet/triplet chemotherapy 
regimens in the first-line setting, it would be very challenging to combine epigenetic 
therapy at a dose level to elicit clinically meaningful benefit.
Although docetaxel has been assessed in other randomized studies as a chemotherapy backbone, 
the considerable neutropenia-related toxicity could potentially pose safety concerns if combined 
with CC-486, and the steroid premedication could confound the epigenetic impact of CC-486.  In 
addition, the q3w dosing schedule of docetaxel restricts dose adjustment options, thus potentially 
yielding lower chemotherapy dose-intensity.
For patients with NSCLC whose disease progressed after initial platinum-based chemotherapy, 
the goal of therapy is to delay further progression for as long as possible; hence, the use of PFS 
as the primary endpoint for efficacy evaluation.  Furthermore, maintaining quality of life during 
this period, especially in reducing/managing toxicity is also an important consideration.  
Therefore, the proposed study is designed to optimize the evaluation of efficacy with a tolerable 
dose/schedule of chemotherapy, and its combination with an epigenetic modifying therapy.
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
28
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
Figure 1:
Overall Study Design
IP = investigational product; PFS = progression-free survival; QD = once daily; OS = overall survival.
Screening for Eligibility  (up to 28 days)
(n=160)
Follow-up Period
28-day Follow-up visit (after last dose of IP)
Followed for OS by phone approximately every 90 days for up o 12 months after last subject is randomized or 120 
PFS events have been observed, whichever is later
nab-paclitaxel 100 mg/m2  IV infusion over 30 
minutes on Days 1 and 8 of each 21-day cycle 
until disease progression
(n = 80)
-
nab-paclitaxel 100 mg/m2  IV infusion over 30 
minutes on Days 8 and 15 of each 21-day cycle 
until disease progression
-
CC-486 200 mg orally QD Days 1 to 14 of each 
21-day cycle until disease progression
(n = 80)
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
29
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
4.3.
Study Duration 
Recruitment is expected to take approximately 24 months, and the analysis of PFS will be 
performed when approximately 120 PFS events have occurred, estimated as approximately 26
months from first subject randomized. The total length of this Phase 2 study with follow-up is 
estimated to last approximately 3 years.
4.4.
End of Trial
The End of Trial is defined as either the:
!
date of the last visit of the last subject to complete the study, or 
!
the date of receipt of the last data point from the last subject that is required for 
primary, secondary and/or exploratory analysis, as pre-specified in the protocol
and/or the Statistical Analysis Plan (SAP), whichever is the later date.
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
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ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
5.
TABLE OF EVENTS
Table 3:
Table of Events
Screening
/ Baseline
Treatment Period
Every 21-day Cycle
Follow-up Period
Assessment
Day -28 
to
Day -1
Day 1
( ±2 
days)
Day 8
(±2 
days)
Day 15
(±2 
days)
Every 42 days 
(-3/+7 days)
(starting Day 1
Cycle 1)
End-of-
Treatment/
Discontinu
ation Visit 
28-day Follow-up 
Visit (after last 
dose of IP)
Survival Follow-upa
Every 90 days (+/- 14 
days) (after 28-day 
follow-up visit)
Informed Consent
X
-
-
-
-
-
-
-
Medical History (including Tobacco Exposure History), 
Prior Medication and Procedures
X
-
-
-
-
-
-
-
Serum β-hCG b
X
-
-
-
-
-
-
-
Urine Pregnancy Test and Reminder to Avoid 
Pregnancyb
-
X
-
-
-
X
-
-
Complete Chest CT Scan and Any Other Studies 
Required for Tumor Imagingc
X
-
-
-
X
X
-
X
Weight and Heightd
X
X
X
X
-
-
-
-
ECOG Status
X
X
-
-
-
X
X
-
Concomitant Medication/Procedures
-
X
X
X
-
X
X
X
Peripheral Neuropathy Assessmente
X
X
-
-
-
X
X
-
Healthcare Resource Utilization Questionnaire
-
X
-
-
-
X
X
-
Hematologyf,g
X
X
X
X
-
X
X
-
Serum Chemistryf,h
X
X
-
-
-
X
X
-
Archived Tumor Tissue Sample for Biomarker (biopsy, 
surgical specimen, or other diagnostic tumor sample)
-
X
(C1D1 
only)
-
-
-
-
-
-
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35
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23
23
23
X
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
31
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
Table 3:
Table of Events (Continued)
Screening/ 
Baseline
Treatment Period
Every 21-day Cycle
Follow-Up Period
Assessment
Day -28 to
Day -1
Day 1
( ±2 days)
Day 8
(±2 
days)
Day 15
(±2 
days)
Every 42 days 
(-3/+7 days)
(starting Day 1
Cycle 1)
End-of-
Treatment/
Discontinu-
ation Visit 
28-day Follow-up 
Visit (after last 
dose of IP)
Survival Follow-Upa
Every 90 days (+/- 14 
days) (after 28-day 
follow-up visit)
Plasma for Biomarker Analyses
-
X
(C1D1 
only
predose)
-
-
-
-
-
-
Blood for Pharmacogenomic Analyses
-
X
(C1D1 
only 
predose)
-
-
-
-
-
-
Adverse Event Evaluation
After signing ICF and until 28 days after the last dose of IP
-
nab-PaclitaxelMonotherapy 
Administration/Accountabilityi
-
X
X
-
-
-
-
nab-Paclitaxel Combination 
Administration/Accountabilityi
-
-
X
X
-
-
-
-
CC-486 Administration/Accountabilityi
-
X
-
-
-
-
LCSS, EORTC QLQ C30 and EQ-5D-5L
-
X
-
-
-
X
X
-
Survival Phone Call
-
-
-
-
-
-
-
Xa
Physical Examinationj
X
X
-
-
-
X
-
-
Vital Signsj
X
X
X
X
-
X
-
-
Electrocardiogram (ECG)
X
Will be done as per standard of care during the Treatment Period and as clinically indicated; however, results 
will not be routinely collected in the eCRFs. If CT/bone scans show lesions pertinent for RECIST 1.1 criteria 
evaluation, data will be collected on the pertinent tumor evaluation eCRFs. If ECGs are abnormal and
clinically significant, the data will be recorded on the AE/SAE eCRF.
Bone Scan (X-rays if needed)
If clinically 
indicated
CT Scan of the Head or Brain Magnetic Resonance 
Imaging (MRI)
If clinically 
indicated 
(mandatory if 
symptomatic)
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
32
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
AE = Adverse Event; β-HCG = beta human chorionic gonadotropin; C1D1 = Cycle 1 Day 1; CT = Computed Tomography; ECOG = Eastern Cooperative Oncology Group; eCRF
= electronic Case Report Form; EORTC QLQ C30 = European Organisation for Research and Treatment of Cancer QLQ C30; EQ-5D-5L = EuroQol 5D-5L; ICF = informed 
consent form; IP = investigational product; LCSS = Lung Cancer Symptom Scale; QD = once daily; RECIST = Response Evaluation Criteria in Solid Tumors; SAE = Serious 
Adverse Event.
a Every 90 (+/-14) days (from 28-day Follow-up Visit ) for up 12 months after the last subject is randomized or 120 PFS events have been observed whichever comes later.
b All males and all women of child-bearing potential must be reminded to avoid pregnancy prior to administration of IP before beginning each new cycle and at the End-of-
Treatment Visit. A pregnancy test is required for women of child-bearing potential only. For women of child-bearing potential a Serum β-hCG pregnancy test must be performed 
to assess eligibility at Screening/Baseline. Note: the screening serum pregnancy test can be used as the Cycle 1 Day 1 test prior to study therapy if it is performed within the 72-
hour timeframe.  A urine pregnancy test must be performed prior to administration of IP before beginning each new cycle and at the End-of-Treatment Visit.
c All subjects must have a radiographically documented measurable tumor(s) by RECIST 1.1 criteria: Complete chest CT scan (including base of neck and adrenal gland) will be 
performed at Screening, every 42 days (-3/+7 days) (starting from Day 1 Cycle 1) until disease progression, withdrawal of consent, lost to follow-up, death, or termination of the 
study by the sponsor. The results of a complete chest CT scan (including base of neck and adrenal gland) performed per Standard of Care may be accepted and not repeated 
during Screening provided it was performed within 28 days of the first dose of study drug (Cycle 1 Day 1). The methods of assessment chosen at baseline to follow tumors are to 
remain consistent throughout study duration. Those subjects entering the Follow-up Period without documented progression will continue to have CT scans in accordance with 
local standard of care (or approximately every 90 days) until documented progression of disease, withdrawal of consent, lost to follow-up, death, or termination of the study by 
the sponsor.
d Height will only be obtained at screening visit. Weight will be obtained at Screening and every visit during the Treatment Period before administration of IP.
e The occurrence of peripheral neuropathy will be reported by the investigator per protocol as an AE or SAE.
f All scheduled laboratory samples will be sent to a central laboratory for analysis. Local hematology and chemistry tests may be performed as required for subject 
management/treatment decisions. Local laboratory values that are considered abnormal and clinically significant will be recorded as an AE/SAE and also recorded on the 
laboratory eCRF (see Section 11.3).
g Hematology panel: hemoglobin, hematocrit, red blood cell count and morphology, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin 
concentration, white blood cell count with absolute and differential and percent (neutrophils, lymphocytes, monocytes, eosinophils, basophils, bands), platelet count, 
reticulocytes, erythrocyte sedimentation rate, international normalized ratio, prothrombin time, partial thromboplastin time. Additional laboratory samples for safety may be 
collected as clinically indicated.
h Serum chemistry panel: sodium, potassium, bicarbonate, calcium, magnesium, phosphorus, blood urea nitrogen, serum creatinine and clearance, uric acid, glucose, lactic
dehydrogenase, total protein, albumin, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, total, direct and indirect 
bilirubin, fibrinogen, ferritin. Additional laboratory samples for safety may be collected as clinically indicated.
i nab-Paclitaxel 100 mg/m2 IV infusion over 30 minutes on Days 8 and 15 and CC-486 200 mg orally QD on Days 1 to14 of each 21-day treatment cycle or nab-paclitaxel 
100 mg/m2 IV infusion over 30 minutes on Days 1 and 8 of each 21-day treatment cycle.
j Physical examination and vital signs assessment should be performed prior to IP administration at these visits. Additional physical examination and vital signs assessments may 
be performed throughout the study as clinically indicated. Only abnormal and clinically significant physical examination data and/or vital signs will be recorded as an AE/SAE 
on the eCRF. Vital signs will be (at a minimum): blood pressure, heart rate, respiratory rate, body temperature.
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
33
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
6.
PROCEDURES
Subjects will be provided with a written Informed Consent Form (ICF), given the opportunity to 
ask any questions concerning the study and will sign an ICF prior to participating in any study 
procedures. After giving written informed consent, subjects will undergo a Screening Period to 
be assessed for eligibility. All subjects who sign an ICF must be entered into the Integrated 
Response Technology (IRT) immediately upon signature on the document. Subjects who do not 
meet the eligibility criteria will be considered screening failures and will not be eligible for the 
study. Subjects who fail initial screening may undergo re-screening up to 2 times at any time 
and an ICF will need to be resigned, as well as all screening procedures repeated (some 
procedures may not need to be done if previously done within 28 days prior to screening again).
Subjects that have met all eligibility criteria after the Screening Period will be eligible for
randomization. 
6.1.
Medical History
A complete medical history including, but not limited to, evaluation for past (up to 5 years) or
present cardiovascular, respiratory, gastrointestinal, renal, hepatic, neurological, endocrine,
lymphatic, hematological, immunologic, dermatological, psychiatric, genitourinary, obstetrical, 
surgical history or any other diseases or disorders will be performed at Screening. All NSCLC-
related medical history should be recorded regardless of time. Smoking status/tobacco exposure 
history will be captured on the eCRF.
6.2.
Prior and Concomitant Medications and Procedures
Prior medications are defined as any medications started before the first dose of IP and stopped 
either prior to the date of the first dose of IP or continued after study treatment. All prior 
medications/procedures of clinically significant or ongoing medical conditions taken up to 28 
days of time of signature on the ICF should be recorded. All NSCLC-related prior 
medications/procedures should be recorded regardless of time.
Concomitant medication is defined as the medication that was either initiated before the first 
dose of IP and continued during the study treatment, or initiated on/after the date of the first dose 
of IP but on or before 28 days after the last dose of IP. All subjects will have concomitant 
medications and procedures (including radiation therapy) recorded at each visit from the time of 
signature on the ICF until the 28-day Follow-up Visit, for conditions that are clinically 
significant or ongoing. During the Follow-up Period only NSCLC-associated concomitant 
medications/procedures (including radiation therapy) will be recorded, ie, subsequent-line(s) of 
anti-cancer therapy.
6.3.
Pregnancy Testing
All males and all women of child-bearing potential must be reminded to avoid pregnancy prior to 
administration of IP before beginning each new cycle and at the End-of-Treatment Visit. A 
pregnancy test is required for women of child-bearing potential only. For women of child-
bearing potential a serum β-hCG pregnancy test with sensitivity of at least 25 mIU/mL must be 
performed to assess eligibility at Screening/Baseline. Note: the screening serum pregnancy test 
e
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rformed at
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ime. Sm
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ations
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ons sta
starte
rte
IP
IP or conti
or cont
gnificant o
gnificant o
F should be
should b
be recorded
e recorded
efined as th
efined a
during th
during t e
28 days afte
28 days aft
ocedures 
edures (in
(in
ICF
ICF unt
until th
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ongoing. D
ngoing. D
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
34
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
can be used as the Cycle 1 Day 1 test prior to study therapy if it is performed within the 72-hour 
timeframe.  A urine pregnancy test must be performed prior to administration of IP before 
beginning each new cycle and at the End-of-Treatment Visit. The subject may not receive 
treatment until the investigator has verified that the result of the pregnancy test is negative. See 
inclusion criteria for pregnancy testing requirements. Any pregnancies that occur in women who 
have received IP must be immediately reported to Celgene Drug Safety (See Section 11.4).
6.4.
Complete Chest Computed Tomography (CT) Scan
A complete chest CT scan (including base of neck and adrenal gland) and any other studies 
required for tumor imaging will be done at Screening, every 42 days (-3/+7 days) (starting from 
Day 1 Cycle 1), and End-of-Treatment, until documented progression of disease, withdrawal of 
consent, lost to follow-up, death, or termination of the study by the sponsor. The results of a 
complete chest CT scan (including base of neck and adrenal gland) performed per Standard of 
Care may be accepted and not repeated during Screening provided it was performed within 28 
days of the first dose of study drug (Cycle 1 Day 1). Those subjects entering the Follow-up 
Period without documented progression will continue to have CT scans in accordance with local 
standard of care (or approximately every 90 days) until documented progression of disease, 
withdrawal of consent, lost to follow-up, death, or termination of the study by the sponsor. 
Additional CT scans may be done at any time during the study if clinically indicated. All CT
scans and reports should be archived at the site according to site regulations and copies provided 
to sponsor if requested. All posttreatment anticancer therapies will be recorded during the 
Follow-up Period.  
6.5.
Weight and Height
Weight will be obtained at Screening and at every visit during the Treatment Period before 
administration of IP. Additional measurements of weight may be collected per local standards at 
any time during the study as needed. Height will only be collected at Screening. All weight and 
height data will be collected on eCRFs.
6.6.
ECOG Performance Score
Eastern Cooperative Oncology Group performance status score will be collected at Screening, 
Day 1 of every treatment cycle, at the End-of-Treatment Visit and at the 28-day Follow-up Visit. 
Additional ECOG assessments may be performed at any time during the study as clinically 
indicated.
6.7.
Peripheral Neuropathy Assessment
Peripheral neuropathy (sensory or motor) assessment will be done at Screening, Day 1 of every 
treatment cycle, at the End-of-Treatment Visit and at the 28-day Follow-up Visit. Changes in 
neuropathy grade from baseline will be reported as an AE as per Section 11. Additional 
peripheral neuropathy assessments may be done at any time during the study as clinically 
indicated.
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
35
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
6.8.
Adverse Event Reporting
Adverse events will be recorded from time of signature on the ICF until 28 days after the last 
dose of IP, including any unscheduled visits. See Section 11 for details. 
6.9.
Quality of Life Questionnaires
The LCSS, EORTC QLQ C30 and EQ-5D-5L questionnaires will be used to measure quality of 
life (QoL) for subjects in the study. The LCSS is comprised of 9 questions to be completed by 
the subject using a visual analogue scale (VAS) to denote intensity of a symptom. The EQ-5D-
5L comprises 5 questions on mobility, self-care, usual activities, pain/discomfort, 
anxiety/depression and a VAS for overall QoL. These questionnaires will be completed by the 
subject prior to interaction with study personnel, at Day 1 of every Cycle, at the End-of-
Treatment Visit and at the 28-day Follow-up Visit.
6.10.
Healthcare Resource Utilization Questionnaire
A healthcare resource utilization questionnaire will be used to capture the additional use of 
healthcare resources, including hospitalizations, emergency room visits, doctor or nurse visits, 
procedures, and/or additional medication during the study period. The assessment will be 
completed on Day 1 of every treatment cycle, at the End-of-Treatment Visit and at the 28-day
Follow-up Visit. 
6.11.
Laboratory Assessments
Blood for hematology and chemistry evaluation will be collected as per Table 3, Table of Events. 
Blood for hematology will be collected at Screening, Days 1, 8, and 15 of every treatment cycle, 
at the End-of-Treatment Visit and at the 28-day Follow-up Visit. Blood for serum chemistry will 
be collected at Screening, Day 1 of every treatment cycle, at the End-of-Treatment Visit and at 
the 28-day Follow-up Visit. Hematology panel will consist of: hemoglobin, hematocrit, red
blood cell count and morphology, mean corpuscular volume, mean corpuscular hemoglobin, 
mean corpuscular hemoglobin concentration, white blood cell count with absolute and 
differential and percent (neutrophils, lymphocytes, monocytes, eosinophils, basophils, bands), 
platelet count, reticulocytes, erythrocyte sedimentation rate, international normalized ratio, 
prothrombin time and partial thromboplastin time. Serum chemistry panel includes: sodium, 
potassium, bicarbonate, calcium, magnesium, phosphorus, blood urea nitrogen, serum creatinine 
and clearance, uric acid, glucose, lactic dehydrogenase, total protein, albumin, alkaline 
phosphatase, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, 
total, direct and indirect bilirubin, fibrinogen and ferritin. Additional laboratory samples for 
safety may be collected as clinically indicated. 
All scheduled laboratory samples will be sent to a central laboratory for analysis. Local 
hematology and chemistry tests may be performed as required for subject management/treatment 
decisions. Local laboratory values that are considered abnormal and clinically significant will be 
recorded as an AE/SAE and also recorded on the laboratory eCRF (see Section 11.3).
Abnormal and clinically significant laboratory assessments at Screening will be recorded as 
medical history, and after Screening, as AE or SAE (clinically significant laboratory 
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
36
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
abnormalities at Screening may result in a subject being ineligible for the study and should not 
be captured as an AE). 
Any abnormal values that persist should be followed at the discretion of the investigator. The 
investigator should file all copies of the reports, including faxes with the subject’s medical chart.
6.12.
Tumor Tissue Sample Collection and Peripheral Blood Collection
(Exploratory Assessments) 
Histologically or cytologically confirmed advanced nonsquamous NSCLC is a required inclusion 
criteria for entry into this study.  If a subject’s previously collected tumor tissue (also known as 
archival tumor) is available, these samples will be collected for biomarker testing as detailed 
below at Cycle 1 Day 1.  If such samples do not exist, have been depleted, or do not contain 
sufficient tumor material to be analyzed, this will not preclude participation in the study and a 
new biopsy or other procedure to collect tumor tissue will not be required.  Table 4 delineates the 
specific requirements for commonly encountered archival tumor types.
Table 4:
Requirements for Collection Based on Archival Tumor Sample Type
Sample Type
Amount to Collect
Collection 
Requirement for 
Biomarkers
Comments/ Exceptions
Core biopsy or surgical 
specimen
10 slides ≥4 ∀M 
thickness. If a block is 
provided, a core of 
viable tumor will also 
be collected.
Mandatory if the sample 
exists. 
If the quantity of material 
is not sufficient, the 
available amount will be 
collected.
Fine needle aspirates 
(FNA)
10 slides ≥4 ∀M. If a 
block is provided, a 
core of viable tumor 
will also be collected. 
Mandatory if the sample 
exists, unless a core 
biopsy or surgical 
sample was provided. 
If the quantity of material 
is not sufficient, the 
available amount will be 
collected.
Transbronchial 
endoscopy samples
10 slides ≥4 ∀M. If a 
block is provided, a 
core of viable tumor 
will also be collected.
Mandatory if the sample 
exists, unless a core 
biopsy or surgical 
sample was provided. 
If the quantity of material 
is not sufficient, the 
available amount will be 
collected.
Bronchial lavage, 
sputum, or other
sample types
Slides or blocks 
representing >100,000 
tumor cells
Collection is strongly 
encouraged when these 
samples contain 
sufficient material.
Collection is strongly 
encouraged when these 
samples contain sufficient 
material.
In addition, test results for tumor mutational status of genes, including but not limited to EGFR,
ALK, and KRAS will be collected and recorded on eCRF if these tests have been performed.
Plasma for cell-free nucleic acids analyses will be collected on Cycle 1 Day 1 prior to first dose 
of IP, as will a sample of whole blood or peripheral blood mononuclear cells for a germ-line 
reference comparison. Types of techniques planned to be used for tumor and plasma analyses 
include:
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
37
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
!
Gene expression by RNA sequencing
!
Immunohistochemistry 
!
DNA sequencing
!
DNA methylation profiling
Details regarding the collection, storage, and shipment of the samples are given in the Laboratory 
Manual.
6.13.
Electrocardiogram
Electrocardiograms (ECGs) will be done at Screening and as per standard of care during the 
Treatment Period, and as clinically indicated. Results will be collected in the eCRFs as AE or 
SAE only if results are abnormal, changed and clinically significant, unless the finding is already 
documented in medical history.
6.14.
CT Scan of the Head or Brain Magnetic Resonance Imaging (MRI)
A CT scan of the head, or preferably brain MRI, will be done as per standard of care at 
Screening, during the Treatment Period, and as clinically indicated. If CT scans show lesions 
pertinent for RECIST 1.1 criteria evaluation, data will be collected on the pertinent tumor 
evaluation eCRFs.
6.15.
Bone Scans and X-rays
Bone scans and x-rays will be done as per standard of care at Screening, during the Treatment 
Period, and as clinically indicated. Results will be collected in the eCRFs. If bone scans or X-
rays show lesions pertinent for RECIST 1.1 criteria evaluation, data will be collected on the 
pertinent tumor evaluation eCRFs.
6.16.
Physical Examinations
Physical examinations will be done at Screening, on Day 1 of every treatment cycle, at the End-
of-Treatment Visit, and as clinically indicated. Results will be collected in the eCRFs as AE or 
SAE only if results are abnormal and clinically significant.
6.17.
Vital Signs
Vital signs (at a minimum blood pressure, heart rate, respiratory rate and body temperature) will 
be done at Screening, prior to IP administration on Days 1, 8, and 15 of every treatment cycle, at 
the End-of-Treatment Visit, and as clinically indicated. Results will be collected in the eCRFs as 
AE or SAE only if results are abnormal and clinically significant.
6.18.
Survival 
After the End-of-Treatment Visit, the subjects will have a 28-day Follow-up Visit followed by a 
phone call approximately every 90 days (+/- 14 days) for at least 12 months after the last subject 
is randomized or 120 PFS events have been observed whichever comes later. The subjects will 
also be asked questions about other medications they may be taking for their NSCLC. Those 
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6.18
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
38
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
subjects entering the Follow-up Period without documented progression will continue to have 
CT scans in accordance with local standard of care (or approximately every 90 days) until 
documented progression of disease, withdrawal of consent, lost to follow-up, death, or 
termination of the study by the sponsor.
&(/*(1(35235,(7$5<,1)250$7,21

('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
39
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
7.
STUDY POPULATION
7.1.
Number of Subjects and Sites
Male and female subjects with advanced nonsquamous NSCLC who have received one 
platinum-containing chemotherapy regimen for their advanced disease will be eligible for this 
study. The study will randomize approximately 160 subjects. The study will be conducted at 
approximately 30 to 60 sites in the United States, Canada, and Europe.
7.2.
Inclusion Criteria
Subjects must satisfy the following criteria to be randomized in the study:
1. Age ≥ 18 years at the time of signing the 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 
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
40
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
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 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. 
7.3.
Exclusion Criteria
The presence of any of the following will exclude a subject from enrollment:
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 II-IV).
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 
                                               
* True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. [Periodic 
abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable 
methods of contraception].
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
41
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
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.
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
42
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
8.
DESCRIPTION OF STUDY TREATMENTS
8.1.
Description of Investigational Products
Subjects will receive open-label nab-paclitaxel / CC-486 or nab-paclitaxel monotherapy during 
the Treatment Period of the study. The nab-paclitaxel and CC-486 are designated as IP and will 
be packaged and supplied by Celgene Corporation.
The reconstitution and IV administration of nab-paclitaxel should follow the local Prescribing 
Information for Abraxane.
8.1.1.
nab-Paclitaxel
nab-Paclitaxel will be supplied by the sponsor, Celgene Corporation, in single-use vials in single 
count cartons. Each single-use 50 mL vial will contain paclitaxel (100 mg) and human albumin 
as a stabilizer.
Please see local prescribing information for Abraxane for detailed instructions on the 
reconstitution, storage conditions and IV administration of nab-paclitaxel. Reconstituted nab-
paclitaxel should be stored in an area accessible only to study personnel.
Temperature records for nab-paclitaxel must be made available to Celgene or other sponsor-
nominated monitoring teams for verification of proper IP storage.
8.1.2.
CC-486 (Azacitidine for Oral Administration)
Celgene Corporation will supply azacitidine 100 mg tablets for oral administration. Each tablet is 
formulated using excipients that are generally regarded as safe and are used in marketed drug 
products.
All tablets will be packaged in blister cards. Only sufficient IP for one cycle of treatment will be 
provided to each subject at the start of each treatment cycle. All tablets should be swallowed 
whole, and should not be broken or chewed. CC-486 may be taken on an empty stomach or with 
food. Subjects should drink 8 ounces (240 mL) of room temperature water with each dose. It is 
strongly recommended that all subjects receive a dose of a prophylactic antiemetic, preferably a 
5-HT3 antagonist, approximately 30 minutes prior to each dose of CC-486.
The IP must be stored as directed on package label at controlled temperature and a temperature 
log must be maintained in the source documents The storage area should be secure and have 
access limited to study personnel. 
8.2.
Treatment Administration and Schedule
Approximately 160 subjects will be treated with nab-paclitaxel / CC-486 or nab-paclitaxel
monotherapy until disease progression, development of an unacceptable toxicity, death, lost to 
follow-up, withdrawal of consent, or termination of the study by the sponsor:
!
nab-Paclitaxel 100 mg/m2 IV infusion over 30 minutes on Days 8 and 15 and CC-486 
200 mg orally QD on Days 1 to 14 of each 21-day treatment cycle
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
43
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
!
nab-Paclitaxel 100 mg/m2 IV infusion over 30 minutes on Days 1 and 8 of each 21-
day treatment cycle
8.3.
Dose Omissions and Modifications
8.3.1.
Rules for Dose Omissions and Modified Schedules
nab-Paclitaxel Monotherapy Arm
If, for administrative reasons, treatment cannot be administered on the planned visit date, IP may 
be administered plus or minus 2 days from the scheduled date.
!
Day 1 Dose Missed
If the dose held or missed was to be given on Day 1 of the next cycle, that next cycle will 
not be considered to start until the day the first dose is actually administered to the 
subject (ie, D1-D8-Rest, X-D1-D8-Rest, etc).
!
Day 8 Dose Missed
That dose will be skipped.  Next dose (if laboratory results permit) will be Day 1 of the 
next scheduled cycle (ie, D1-X-Rest, D1-D8-Rest, etc).
nab-Paclitaxel/CC-486 Combination Arm
If, for administrative reasons, treatment cannot be administered on the planned visit date, IP may 
be administered plus or minus 2 days from the scheduled date.
If any doses of CC-486 are missed, skip that day and resume as appropriate, do not double up on
subsequent days.
For nab-paclitaxel: 
!
Day 8 Dose Missed
That dose will be skipped. Next dose (if laboratory results permit) will be at Day 15 (ie, 
Rest-X-D15, Rest-D8-D15, etc).
!
Day 15 Dose Missed
That dose will be skipped.  Next dose (if laboratory results permit) will be Day 8 of the 
next scheduled cycle (ie, Rest-D8-X, Rest-D8-D15, etc).
8.3.2.
Rules for Dose Modifications
Subjects who experience any of the adverse drug reactions in Table 5 will be dose reduced as per 
Table 5 during treatment. 
nab-Paclitaxel Monotherapy Arm
!
Do not administer nab-paclitaxel on Day 1 of a cycle until ANC is at least 
1500 cells/mm3 and platelet count is at least 100,000 cells/mm3.
!
In subjects who develop severe neutropenia or thrombocytopenia withhold treatment until 
counts recover to an absolute neutrophil count of at least 1500 cells/mm3 and platelet 
count of at least 100,000 cells/mm3 on Day 1 or to an absolute neutrophil count of at least 
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
44
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
500 cells/mm3 and platelet count of at least 50,000 cells/mm3 on Day 8 of the cycle. 
Upon resumption of dosing, permanently reduce nab-paclitaxel doses as outlined in 
Table 5.
!
Withhold nab-paclitaxel for Grade 3 or 4 peripheral neuropathy. Resume nab-paclitaxel 
at reduced doses (Table 5) when peripheral neuropathy improves to Grade 1 or 
completely resolves.
!
For Grade 2 or 3 cutaneous toxicity, Grade 3 mucositis, or Grade 3 diarrhea, interrupt 
treatment until the toxicity improves to ≤Grade 1, then restart treatment according to 
the guidelines in Table 5. For any other Grade 3 or 4 nonhematologic toxicity or other 
investigator defined unacceptable toxicity, interrupt treatment until the toxicity 
improves to ≤Grade 2, then restart treatment according to the guidelines in Table 5.
Re-escalation is not permitted at any time. 
nab-Paclitaxel/CC-486 Combination Arm
!
Do not administer nab-paclitaxel on Day 8 or CC-486 on Day 1 or 8 of a cycle until ANC 
is at least 1500 cells/mm3 and platelet count is at least 100,000 cells/mm3.
!
In subjects who develop severe neutropenia or thrombocytopenia withhold treatment until 
counts recover to an absolute neutrophil count of at least 1500 cells/mm3 and platelet 
count of at least 100,000 cells/mm3 on Day 1 and 8 for CC-486 and Day 8 for nab-
paclitaxel or to an absolute neutrophil count of at least 500 cells/mm3 and platelet count 
of at least 50,000 cells/mm3 on Day 15 of the cycle for nab-paclitaxel. Upon resumption 
of dosing, permanently reduce nab-paclitaxel and/or CC-486 doses as outlined in Table 5.
!
Withhold nab-paclitaxel for Grade 3 or 4 peripheral neuropathy (CC-486 does not need 
to be withheld). Resume nab-paclitaxel at reduced doses (Table 5) when peripheral 
neuropathy improves to Grade 1 or completely resolves. 
!
For Grade 2 or 3 cutaneous toxicity, Grade 3 mucositis, or Grade 3 diarrhea, interrupt 
treatment until the toxicity improves to ≤Grade 1, then restart treatment according to 
the guidelines in Table 5. For any other Grade 3 or 4 nonhematologic toxicity or 
other investigator defined unacceptable toxicity, interrupt treatment until the toxicity 
improves to ≤Grade 2, then restart treatment according to the guidelines in Table 5.
Re-escalation is not permitted at any time. 
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
45
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
Table 5:
Permanent Dose Reductions for Hematologic and Nonhematologic Toxicities and Dosing on the Study
Dose Modification During Treatment
Adverse Drug Reaction
Occurrence
Monotherapy Arm: nab-
paclitaxel Dose (mg/m2)
Combination Arm: nab-
paclitaxel Dose (mg/m2) / 
CC-486 Dose (mg)
Neutropenic Fever (ANC < 500/mm3 with fever >38°C)
OR
Delay of next cycle by > 7 days for ANC < 1500/mm3
OR
ANC < 500/mm3 for > 7 days
First
75
100/100
Second
50
75/100
Third
Discontinue Treatment*
50/100
Fourth
NA
Discontinue Treatment*
Platelet count < 50,000/mm3
First
75
100/100
Second
Discontinue Treatment*
75/100
Third
NA
Discontinue Treatment*
Peripheral Neuropathy Grade ≥3
First
75
75/200
Second
50
50/200
Third
Discontinue Treatment*
Grade 2 or 3 Cutaneous toxicity
Grade 3 Diarrhea
Grade 3 Mucositis
Any other Grade 3 or 4 nonhematologic toxicity or other 
investigator defined unacceptable toxicity
First
75
100/100
Second
50
75/100
Third
Discontinue Treatment*
50/100
Fourth
NA
Discontinue Treatment*
Grade 4 Cutaneous toxicity, Diarrhea or Mucositis
First
Discontinue Treatment*
ANC = absolute neutrophil count; AUC = area under the curve; NA = not applicable.
* If an adverse event that requires dose reduction recurs after the dose has been reduced according to the table above, the subject should generally have treatment 
discontinued unless, at the discretion of the investigator, there is evidence of continuing benefit to the subject that outweighs the risk of recurrent toxicity.
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
46
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
8.4.
Method of Treatment Assignment
The Treatment Period of the study is open-label. Enrollment/randomization will occur 1:1 via 
IRT. 
8.5.
Packaging and Labeling
The label(s) for all IP will include sponsor name, address and telephone number, the protocol 
number, IP name, dosage form and strength (where applicable), amount of IP per container, lot 
number, expiry date (where applicable), medication identification/kit number, dosing 
instructions, storage conditions, and required caution statements and/or regulatory statements as 
applicable. Additional information may be included on the label as applicable per local 
regulations.
8.6.
Investigational Product Accountability and Disposal
Celgene (or designee) will review with the investigator and relevant site personnel the process 
for IP return, disposal, and/or destruction including responsibilities for the site versus the 
responsibilities of Celgene (or designee).
Celgene will instruct the investigator on the return, disposal and/or destruction of IP. Only 
completely unused IP vials should be retained by the site until a representative from Celgene or 
other Celgene-designated personnel have completed an inventory. Partially used and completely 
used vials should be destroyed according to local guidelines, and disposition should be recorded 
on the Investigational Drug Accountability Record Form.
The investigator(s) or designee(s) is responsible for accounting for all IP that is issued to and
returned by the subject during the course of the study according to applicable regulatory
requirements. Any unused CC-486 must be returned by a study subject and retained by the
investigative site for accountability to be conducted by a Celgene representative (or designee). If
any IP is lost or damaged, its disposition should be documented. At the periodic monitoring
visits, a Celgene representative (or designee) will conduct IP accountability and address any
discrepancies. Upon unsatisfactory reconciliation of all IP, returned IP may be destroyed. At the
conclusion of the study, all remaining IP will be counted, reconciled with dispensing records, 
documented, and destroyed at the clinic site or allocated drug destruction location after
completion of drug accountability by a Celgene representative (or designee). The Celgene
representative (or designee) will ensure that a final report of drug accountability to the unit dose
level (ie, tablet) is prepared and placed in both the investigator study file and the central clinical
study file.
Investigational product will not be loaned or dispensed by the investigator to another investigator 
or site. Under certain circumstances, and with sponsor permission, cooperative groups may 
manage IP between locations within their network as clinical trial agreement and local guidelines 
permit.
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
47
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
8.7.
Investigational Product Compliance
All IP will be administered only by study site personnel and accurate recording of all IP 
administration will be made in the appropriate section of the subject’s eCRF and source 
documents.
8.8.
Overdose
Overdose, as defined for this protocol, refers to nab-paclitaxel and CC-486 dosing.
On a per dose basis, an overdose is defined as 10% over the protocol-specified dose of nab-
paclitaxel or CC-486 to a given subject, regardless of any associated adverse events or sequelae. 
On a schedule or frequency basis, an overdose is defined as anything more frequent than the 
protocol required schedule or frequency.
On an infusion rate basis, an overdose is defined as any rate faster than the protocol-specified 
rate.
Complete data about drug administration, including any overdose, regardless of whether the 
overdose was accidental or intentional, should be reported in the case report form. See 
Section 11.1 for the reporting of adverse events associated with overdose.
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
48
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
9.
CONCOMITANT MEDICATIONS AND PROCEDURES
9.1.
Permitted Concomitant Medications and Procedures
Over the course of this study, additional medications may be required to manage aspects of the 
disease state of the subjects, including side effects from study treatments or disease recurrence. 
All supportive care (including but not limited to growth factors, antiemetics, analgesics, 
zolendronic acid, denosumab) is permitted as per the investigator’s discretion and should be 
administered according to local institutional practice. All concomitant treatments, including 
blood and blood products, must be reported on the eCRF.
!
Antiemetics are not required during the study; however, it is strongly recommended 
that all subjects receive a dose of a prophylactic antiemetic, preferably a 5-HT3 
antagonist, approximately 30 minutes prior to each dose of CC-486.
!
Stable, therapeutic doses of anticoagulants are permitted; however, subjects on 
warfarin should have prothrombin time (PT) or international normalized ratio (INR)
and partial thromboplastin time (PTT) monitored as clinically indicated.
!
Subjects on erythropoietin or darbepoetin alfa for at least 4 weeks prior to starting the 
IP may continue their pretreatment doses throughout the study.
#
Note: If the subject is not on a stable dose of an erythropoiesis-stimulating agents 
(ESA) prior to study entry, the subject may not start an ESA during Cycle 1. 
However, medications such as ESAs, granulocyte colony-stimulating factors (G-
CSFs), etc., may be administered according to standard of care after Cycle 1.
!
Use of white blood cell growth factors (eg, filgrastim, G-CSF for the treatment of 
subjects with neutropenic fever is permitted at the investigator’s discretion. Use of 
filgrastim rather than pegylated-filgrastim is indicated, because of the 14 day delay 
of the next cycle following treatment with peg-filgrastim.
!
Use of white blood cell growth factors (eg, filgrastim, G-CSF) for secondary
prophylaxis in subjects who experienced a neutropenic complication from a prior
cycle of chemotherapy (for which primary prophylaxis was not received) is permitted.
!
Flu vaccination is permitted.
!
Routine infectious disease prophylaxis is not recommended, however, antibiotic,
antiviral, antipneumocystis, antifungal, or other prophylaxis may be implemented
during the study at the discretion of the investigator.
!
Treatments with bisphosphonates (eg, pamidronate, zolendronate), or other agents
(eg, denosumab) to prevent or delay progression of bone metastases are permitted.
Maintenance of a stable dosing regimen throughout the study is recommended.
!
Subjects may receive physiologic replacement doses of glucocorticoids as
maintenance therapy for adrenal insufficiency. Glucocorticoids may be administered
as an antiemetic with IV chemotherapy, if directed by local standard of care.
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
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ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
!
Treatment with antidiarrheal medications is recommended at the first sign of diarrhea
as per the guidelines in Appendix B. Pre-medication with antidiarrheal medication for 
subsequent doses of CC-486 may be appropriate.
9.2.
Prohibited Concomitant Medications and Procedures
Other investigational therapies must not be used while the subject is enrolled in the study.
Anticancer therapy (chemotherapy, biologic or investigational therapy, and surgery) other than
the study treatments must not be given to subjects during the study. If such treatment is required,
the subject must be discontinued from the study. Focal palliative radiotherapy for treatment of
cancer-related symptoms is allowed during study treatment at the discretion of the investigator.
The administration of either α-interferon and/or ribavirin, or drugs with known renal toxicity is
prohibited during study treatment.
9.3.
Required Concomitant Medications and Procedures for Patients 
Receiving CC-486
If a subject experiences ≥Grade 3 neutropenia, that subject will be treated with G-CSF 5 ∀g/kg 
daily until the ANC ≥2000/mm3. In subsequent cycles, that subject should receive G-CSF 
5∀g/kg daily beginning on Day 16 and continuing until the ANC ≥2000/mm3. In subjects
receiving G-CSF, the next cycle should begin no sooner than 48 hours after discontinuation of G-
CSF. Data regarding G-CSF administration should be recorded on the eCRF provided for G-CSF 
administration.
9.3.1.
Description of G-CSF
This medication stimulates the blood system (bone marrow) to make white blood cells, helping
fight infections. This medication is given to those whose ability to make white blood cells has
been reduced. Filgrastim (also known as G-CSF, or granulocyte colony stimulating factor) is a
man-made version of a certain natural substance found in the body. It is produced using a certain
bacteria. It will be obtained commercially and relabeled as clinical supplies. It should be stored,
and administered according to the manufacturer’s recommendation.
9.3.2.
Administration of G-CSF
For subjects who experience Grade ≥3 neutropenia, G-CSF 5 ∀g/kg daily will be administered
subcutaneously. During any cycle when Grade ≥3 neutropenia occurs, CC-486 and other 
cytotoxic agents will be held, and G-CSF will begin immediately (a minimum of 24 hours after 
the last dose of CC-486 and chemotherapy). In subsequent cycles, G-CSF will begin on Day 16. 
G-CSF will continue daily until the ANC ≥2000/mm3. For complete details on drug
administration, storage, clinical pharmacology, and the human PK of G-CSF (filgrastim), please
see the G-CSF(filgrastim) package insert.
,
f
gator
gator.
xicit
xicity y isis
Patients
Patients
ed with
d with G-C
hould recei
hould recei
2000
2000/mm
/mm3
8 hours
hour afte
f
ed on the
ed on the
one marrow
ne marro
hose whose
hose whose
-CSF, or g
CSF, or g
substance fo
ubstance 
cially
cially and r
and
y
e manufactu
e manufac
of G
of G-CSF
CS
ience
ence Grade
ra
ing any
ng any cyc
cy
y
will be held
will be held
CC
CC-486 an
486 
continue d
continue d
ration, stora
on, stora
 G-CSF(
CSF(fifi

('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
50
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
10.
STATISTICAL ANALYSES
Statistical analyses for the primary and key secondary endpoints of the study are described 
below.  Additional analyses of these endpoints as well as exploratory endpoints or subgroup 
analyses will be described in detail in the SAP.  The SAP supersedes the analyses described in 
the protocol should there be differences between the two.
Evaluations of the study endpoints will be based primarily on the point estimates and the 
associated 95% confidence intervals of the within- and between-treatment differences. However, 
statistical tests may be conducted and the nominal p-values may be provided in the clinical study 
report to indicate the strength of the treatment differences evaluated.
10.1.
Overview
Approximately 160 subjects will be randomized in a 1:1 ratio to two treatment arms (80 subjects 
per group). Arm A will receive nab-paclitaxel with epigenetic modifying therapy of CC-486 and 
Arm B will receive nab-paclitaxel as a monotherapy.  Both regimens will be administered in 21-
day cycles. All subjects will receive the assigned study treatment until disease progression, 
unacceptable toxicity, death, lost to follow-up, withdrawal of consent, or termination of the 
study by the sponsor, in accordance with local standard of care.  A permuted-block 
randomization method will be employed, and the randomization will be carried out centrally 
using an IRT system. The randomization will be stratified based on the following baseline
factors: 
!
ECOG performance status (0 versus 1)
!
Gender (males versus females)
!
Smoker (yes versus no)
A DMC will be used to review the safety and efficacy data during the study.
10.2.
Study Population Definitions
10.2.1.
Intent-to-treat Population
The primary efficacy analysis will be performed on the intent-to-treat (ITT) population, which 
includes all randomized subjects regardless of whether the subject receives any IP or has any 
efficacy assessments performed. 
10.2.2.
Per-protocol (PP) Population
The PP population is defined as all eligible subjects randomized who receive at least one dose of 
the IP and have been treated in the arm they were assigned.  Additional analyses utilizing the PP 
population will be described in the SAP.
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ever,
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al study
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PP popul
the IP
IP and 
and 
popul
opulata

('06'RF1XPEHU
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Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
51
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
10.2.3.
Treated Population
The treated population will consist of all randomized subjects who receive at least one dose of 
IP. The safety analyses will be based on the treatment as received if different from the assigned 
treatment by randomization.
10.3.
Sample Size and Power Considerations
The primary objective of this study is to evaluate the efficacy of the CC-486/nab-paclitaxel 
combination therapy and that of the nab-paclitaxel monotherapy, and the relative efficacy of 
these two treatment regimens. 
The effect of the two treatment regimens with respect to the efficacy endpoints will be based on 
the point estimates and the associated 95% confidence intervals. The sample size was chosen to 
support the estimation of the within- and between-treatment effects with reasonable precision. 
Table 6 below summarizes the two-sided 95% confidence intervals for a range of hypothetical
observed disease control rates given a sample size of 80 subjects in a treatment arm. If the 
observed disease control rate is 0.30, then the actual width of the 2-sided 95% confidence 
interval is 0.21 (95% CI is [0.20, 0.41]).
Table 6:
Disease Control Rate –Two-Sided 95% Confidence Interval of Hypothetical 
Disease Control Rate with a Sample Size of 80 Subjects in a Treatment Arm
Hypothetical Observed Disease 
Control Rate
Half Width of 95% Confidence 
Interval
95% Confidence Intervala
0.20
0.186
(0.119, 0.304)
0.25
0.199
(0.16, 0.359)
0.30
0.21
(0.203, 0.413)
0.35
0.218
(0.247, 0.465
0.40
0.224
(0.292, 0.516)
0.45
0.227
(0.338, 0.565)
0.50
0.228
(0.386, 0.614)
a Based on the Clopper-Pearson exact method.
Table 7 below summarizes the precision that can be achieved given different scenarios of 
hypothetical observed hazard ratios between the two treatment arms for PFS events, assuming a 
total of 120 events are observed. 
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based on
based on
as chosen t
as chosen 
ble precisio
ble precisi
ange
ange of h
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treatmen
2-
2-sisided 
ded 9
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f 80 Subjec
f 80 Subje
nfidence 
idence
$5
86
86
(7$
0.199
0.199
,(
0.21
0.21
5,
0
35
23
52
35
35
35
( 35
earson exact 
earson exa
summarize
summari
observed 
observed h
20 eve
eventnts a
s a

('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
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Table 7:
Progression-Free Survival – Two-Sided 95% Confidence Interval of 
Hypothetical Observed Hazard Ratio between Treatment Arms
Hypothetical Number of Events 
Observed
Hypothetical Observed Hazard 
Ratio of PFS Events
95% Confidence Interval of 
Hazard Ratioa
120
0.60
(0.42, 0.86)
0.65
(0.45, 0.93)
0.70
(0.49, 1.00)
a Assuming a standard error of 0.18 for the log hazard ratio.
Assuming the median times of PFS are 4.17 and 2.5 months, respectively, for the nab-
paclitaxel/CC-486
combination therapy
and nab-paclitaxel monotherapy arms, and an 
approximate 24 months accrual period for a total of 160 subjects, it is estimated that a total of 
120 PFS events will have been observed approximately 2 months after the last subject is 
randomized, assuming an exponential distribution for PFS. 
Of note, with 120 PFS events, this study has an 80% power (1-sided, Type-1 error of 2.5%)  to 
detect a HR of 0.60 for PFS improvement with the nab-paclitaxel/CC-486 arm over the nab-
paclitaxel monotherapy arm.
One nonbinding interim analysis for PFS with an early stopping rule for futility will be 
conducted when approximately 60 events are observed. The nab-paclitaxel/CC-486 combination 
arm of the study may be stopped early for futility if the observed HR is > 1.10 given an 
approximate 60 PFS events have occurred at the time of the interim analysis. A HR> 1.10 when 
half of the target events of 120 have occurred signals a low probability for observing a 
meaningful difference in favor of the nab-paclitaxel/CC-486 combination therapy should the 
study continue to the end. With the assumptions stated above, it will take approximately 16 
months from the first subject randomized to observe approximately 60 PFS events for the interim 
analysis.
If futility is declared, enrollment in the monotherapy nab-paclitaxel arm will continue up to a 
total of 80 subjects. 
Disease control rate, OS, and ORR will be evaluated within each treatment arm and between the 
treatment arms at the time of the final analysis of the PFS endpoint when approximately 120 PFS 
events have been observed.  
All subjects will continue to be followed for OS up to 12 months after the last subject is 
randomized or 120 PFS events have been observed, whichever comes later.
10.4.
Background and Demographic Characteristics
The baseline characteristics of all randomized subjects will be summarized. Subject’s age, 
height, weight, and baseline characteristics will be summarized using descriptive statistics, while 
gender, race and other categorical variables will be provided using frequency tabulations. 
Selected medical history data will be summarized using frequency tabulations by system organ 
class and preferred term.
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/CC
CC-486 a
86 a
oppi
pping rule 
ng rule
i
The
The nab
nab-
he observe
he obser
time of the 
ime of the
signals a lo
signals a lo
aclitaxel/C
aclitaxel/C
mptions sta
mptions 
ized to obse
ized to o
ent in the m
nt in the m
S, and ORR
S, and OR
e time of th
time of th
observed
observed
will cont
will continu
inu
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or 120 P
.
Bac
Ba
The baselin
The baselin
height, w
height,
nde

('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
53
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
10.5.
Subject Disposition
Subject disposition (analysis population allocation, entered, discontinued, along with primary 
reason for discontinuation) will be summarized using frequency and percent for both Treatment 
and Follow-up Periods. A summary of subjects enrolled by site will be provided. Protocol 
deviations will be summarized using frequency tabulations.
10.6.
Efficacy Analysis
10.6.1.
Primary Efficacy Endpoints 
The primary efficacy endpoint is progression-free survival, which is defined as the time from the 
date of randomization to the date of disease progression or death (any cause) on or prior to the 
data cutoff date for analyses, whichever occurs first, based on the investigator’s assessment of 
the data from CT scans using RECIST 1.1 guidelines. Baseline tumor measurements will be 
determined from the radiologic evaluation performed within 28 days before the start of study 
therapy. 
Subjects who do not have disease progression and are alive as of the data cutoff date for the 
statistical analysis will be censored at the date of the last radiologic assessment prior to the data 
cutoff date.  Similarly, subjects who discontinue from the study prior to disease progression or 
death will be censored at the date of the last radiologic assessment prior to the data cutoff date.  
In the event that a new anticancer treatment occurs prior to documented progression, the subject 
will be censored at the date of the last radiologic assessment where the subject was documented 
to be progression-free prior to the new anticancer treatment. Subjects with a single missing 
radiologic assessment prior to a visit with documented disease progression (or death) will be 
analyzed as a PFS event at the date of the radiologic assessment that shows progression or death 
(whichever is earlier). Subjects with two or more missing radiologic assessments prior to a visit 
with documented disease progression (or death) will be censored at the date of the last radiologic 
assessment where the subject was documented to be progression-free prior to the first of the two 
missing visits.  Subjects who drop out early or die without any postbaseline radiologic tumor 
assessment will be censored on the date of randomization. 
Progression-free survival will be summarized using Kaplan-Meier methods with median PFS 
time (including two-sided 95% CI) for each treatment arm. The Kaplan-Meier curve for PFS will 
be presented graphically for each treatment arm. The relative treatment effect between the 
combination and monotherapy arms on PFS will be estimated by the hazard ratio (HR) and the 
associated two-sided 95% CIs using the stratified Cox proportional hazard model with ECOG 
performance status (0 versus 1), gender (males versus females), and smoker (yes versus no) as 
the stratification factors, given the number of events in each cell is adequate.  No statistical 
inferential tests will be performed.
To assess the impact on PFS of radiologic assessments not occurring at the regularly scheduled 
assessment times, the frequency of these unscheduled/off-scheduled assessments will be 
presented for each treatment arm. In addition, confirmatory and sensitivity analyses will be 
performed to further assess the impact of missed radiologic assessments. An additional analysis 
of PFS, where death or new treatment will be considered as an event, will be conducted to 
address the impact of next line therapy. 
&(/*(1(35235,(7$5<,1)250$7,21
from the
om the
ririor to the
or to the
ssessment o
sessment 
ments will 
ments wil
the start of
the start o
data cutoff
data cutof
c assessme
assessm
y pri
pri
y
or to di
or
sment prio
sment prio
to documen
o documen
sment whe
sment whe
eatment. Su
eatment. S
mented dise
mented dise
iolologic asse
gic asse
r more mis
more mis
or death) wi
r death) w
cumented t
cumente
 out early o
out early
the date of
the date o
will
ill be
be sum
su
ed 95% CI)
ed 95% C
cally
ally fo
for e
mo
monotherap
notherap
sided 
sided 95%
95
status
status (0 
(0 
ficatation fac
fac
ntial tests w
ntial tests w
To assess th
To assess th
assessme
ssessme
esen
esen

('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
54
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
10.6.2.
Secondary Efficacy Endpoints
10.6.2.1.
Disease Control Rate
Disease control rate is defined as the percent of subjects who have a radiologic complete 
response, partial response, or stable disease according to RECIST 1.1 guidelines, as determined 
by the investigator.
Disease control rate for each treatment arm will be summarized by the observed DCR rate and 
the associated two-sided 95% CI. The relative treatment effect will be summarized by the 
absolute difference and ratio of the response rates and the associated two-sided 95% CI.
10.6.2.2.
Overall Survival
Overall survival is defined as the time between randomization and death. All deaths, regardless 
of the cause of death, will be included. All subjects who are lost to follow-up prior to the end of
the study or who are withdrawn from the study will be censored at the time of last contact. 
Subjects who are still receiving treatment as of the data cutoff date will be censored at the cutoff 
date. Overall survival will be analyzed in a similar manner as that for PFS.
10.6.2.3.
Overall Response Rate 
Overall response rate is defined as the percent of subjects who have a radiologic complete or 
partial response according to RECIST 1.1 guidelines determined by the investigator.  
Overall response rate will be assessed using the same statistical methods as those for the DCR 
endpoint.
10.6.3.
Exploratory Endpoints
10.6.3.1.
HealthCare Utilization 
Healthcare utilization will be summarized by treatment. Additional analyses will be described in 
detail in the SAP.
10.6.3.2.
Quality of Life Questionnaires
The score or VAS value and the corresponding change from baseline at each timepoint will be 
summarized by treatment for the EQ-5D-5L, EORTC QLQ C30 and LCSS questionnaires. 
Additional analyses will be described in detail in the SAP. 
10.6.3.3.
Biomarker, Tumor Characteristics, and Genomic Analyses 
Statistical analysis of the biomarkers, tumor characteristics, and genomic correlates will be 
described in a SAP separate from that described above.
10.7.
Safety Analysis
The treated population, which includes all randomized subjects who receive at least one dose of 
IP, will be the analysis population for all safety analyses.
&(/*(1(35235,(7$5<,1)250$7,21
hs, regardle
s, regardl
pririor to the 
or to th
of last cont
of last con
e censored
e censo
PFS.
FS.
ho ha
ho have
v a ra
a r
rmined by
rmined by
statist
statistical
ical
marized by t
rized by 
Questionn
Question
e and the c
e and the c
ment f
ent for th
or t
f
ses will be
ses will be
Biomarker
Biomarker
cal analysis
al analysis
ribed in a S
ribed in a 
&
10.7.
10
e tr

('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
55
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
The safety/tolerability of the two treatment arms will be monitored through continuous reporting 
and evaluated by adverse events and serious adverse events, and incidence of subjects 
experiencing dose modifications, dose interruptions, and/or premature discontinuation of IP.
10.7.1.
Adverse Events
Adverse events will be analyzed in terms of TEAEs, defined as any AE or SAE occurring or 
worsening on or after the day of the first dose of the IP through 28 days after the last dose of IP.  
In addition, any serious AE with an onset date more than 28 days after the last dose of IP that is 
assessed by the investigator as related to IP will be considered a TEAE. 
Adverse events will be coded according to the Medical Dictionary for Regulatory Activities 
(MedDRA). The severity of AEs will be graded based on NCI CTCAE, Version 4.0; 
http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm#ctc_40.
Treatment-emergent adverse events, Grade 3 or higher TEAEs, serious AEs, TEAEs leading to 
dose reduction, dose delay, and dose interruption, TEAEs leading to treatment discontinuation, 
and TEAEs with an outcome of death will be summarized per treatment arms by MedDRA 
system organ class and preferred terms. 
Adverse events of special interest of the nab-paclitaxel/CC-486 combination and nab-paclitaxel 
monotherapy regimens identified in previous studies in a similar population may be identified 
and summarized by worst NCI CTCAE grade, System Organ Class (SOC) and MedDRA
preferred terms.
By-subject listings will be provided for all relevant safety data. Graphical displays and figures 
will be provided where useful to assist in the interpretation of results.
10.7.2.
Laboratory Assessments
Treatment group differences in each laboratory parameter with respect to the NCI CTCAE 
grades will be summarized by the frequency distribution of subjects with the AE grades.  
All laboratory parameters will be summarized by descriptive statistics within each treatment arm, 
as appropriate. 
10.7.3.
Study Drug Exposure
The extent of exposure to the IPs will be assessed based on the descriptive statistics on the 
number of cycles and IP doses administered, cumulative dose, average dose intensity, and 
percentage of protocol dose administered.  The incidences of CC-486 and nab-paclitaxel dose 
reductions, dose interruptions, and dose delays will be summarized by treatment arm.  
10.8.
Study Therapy Termination
Reasons for stopping study therapy will be presented in listings and summarized by frequency of 
occurrence and corresponding percentage of occurrence.
10.9.
Deaths
Deaths reported during treatment (defined as deaths from the first administration of the IP
through 28 days post last dose of the IP) and deaths that occur during the Follow-up Period will 
&(/*(1(35235,(7$5<,1)250$7,21
ties
es 
40.
TEAEs lead
EAEs lea
ent discont
ent discont
arms by M
rms by
ombinat
mbinatioio
ar populati
ar popu
an Class (
n Class (S
afet
afety y data. 
dat
rpretation o
rpretation 
oratory
oratory pa
p
quency
quency dis
 y
e summariz
 summariz
Exposure
Exposur
ure to the
re to the IP
I
and 
and IP
IP dos
dos
protocol do
rotocol d
dose interr
dose interr
Stud
tud
Reasons for 
easons for 
occurren
occurren

('06'RF1XPEHU
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Celgene Corporation
Confidential and Proprietary
56
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
be summarized by frequency of occurrence and corresponding percentage by cause of death per 
period (during treatment or follow-up). 
10.10.
Interim Analysis
One nonbinding interim analysis for PFS with an early stopping rule for futility will be 
conducted when approximately 60 events are observed. The nab-paclitaxel/CC-486 combination 
arm of the study may be stopped early for futility if the observed HR is ≥1.10 given an 
approximate 60 PFS events have occurred at the time of the interim analysis. Should this occur, 
enrollment in the monotherapy nab-paclitaxel arm will continue up to a total of 80 subjects.  
10.11.
Data Monitoring Committee
An independent DMC will be established with the responsibilities for safeguarding the interests 
of study participants and monitoring the overall conduct of the study. Final recommendations of 
the DMC will reflect the judgment of the DMC members and will be considered advisory in 
nature to the sponsor. The decision to implement the recommendations of the DMC will be made 
by the sponsor, following consultation with the coordinating investigator and Steering 
Committee.
Operational details for the DMC will be detailed in the DMC charter. 
10.12.
Scientific Steering Committee
The conduct of this study will be overseen by a Steering Committee. The Steering Committee 
will serve in an advisory capacity to the sponsor.
&(/*(1(35235,(7$5<,1)250$7,21
, , 
g the intere
the inter
ommendat
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ered adviso
ered advis
f the DMC 
the DM
tor
tor and Ste
and Ste
harter.
arter
ing Commi
ing Com

('06'RF1XPEHU
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Protocol ABI-007-NSCL-006
Celgene Corporation
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11.
ADVERSE EVENTS
11.1.
Monitoring, Recording and Reporting of Adverse Events
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may 
appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a 
worsening concomitant illness, an injury, or any concomitant impairment of the subject’s health, 
including laboratory test values (as specified by the criteria in Section 11.3), regardless of 
etiology. Any worsening (ie, any clinically significant adverse change in the frequency or 
intensity of a pre-existing condition) should be considered an AE. A diagnosis or syndrome 
should be recorded on the AE page of the eCRF rather than the individual signs or symptoms of 
the diagnosis or syndrome. 
For the purposes of this study, progressive disease (PD) of NSCLC will not require reporting as 
an adverse event.
An overdose, accidental or intentional, whether or not it is associated with an AE, or abuse, 
withdrawal, sensitivity or toxicity to an investigational product should be reported as an AE.  If 
an overdose is associated with an AE, the overdose and adverse event should be reported as 
separate terms.  See Section 8.8 for the definition of overdose.
In the event of overdose, the subject should be monitored as appropriate and should receive 
supportive measures as necessary. There is no known specific antidote for nab-paclitaxel or 
CC-486 overdose. Actual treatment should depend on the severity of the clinical situation and 
the judgment and experience of the treating physician.
All subjects will be monitored for AEs during the study. Assessments may include monitoring of 
any or all of the following parameters: the subject’s clinical symptoms, laboratory, pathological, 
radiological or surgical findings, physical examination findings, or findings from other 
appropriate tests and procedures.
All AEs will be recorded by the investigator from the time the subject signs informed consent to
28 days after the last dose of IP, and those SAEs made known to the investigator at any time 
thereafter that are suspected of being related to IP. AEs and serious adverse events (SAEs) will 
be recorded on the AE page of the eCRF and in the subject’s source documents. All SAEs must 
be reported to Celgene Drug Safety within 24 hours of the investigator’s knowledge of the event 
by facsimile, or other appropriate method, using the SAE Report Form, or approved equivalent 
form.
11.2.
Evaluation of Adverse Events
A qualified investigator will evaluate all adverse events as to: 
11.2.1.
Seriousness 
A serious adverse event (SAE) is any AE occurring at any dose that:
!
Results in death;
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Celgene Corporation
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!
Is life-threatening (ie, in the opinion of the investigator, the subject is at immediate 
risk of death from the AE);
!
Requires inpatient hospitalization or prolongation of existing hospitalization 
(hospitalization is defined as an inpatient admission, regardless of length of stay);
!
Results in persistent or significant disability/incapacity (a substantial disruption of the 
subject’s ability to conduct normal life functions);
!
Is a congenital anomaly/birth defect;
!
Constitutes an important medical event.
Important medical events are defined as those occurrences that may not be immediately life 
threatening or result in death, hospitalization, or disability, but may jeopardize the subject or 
require medical or surgical intervention to prevent one of the other outcomes listed above.
Medical and scientific judgment should be exercised in deciding whether such an AE should be 
considered serious.
Events not considered to be SAEs are hospitalizations for:
!
A standard procedure for protocol therapy administration. However, hospitalization 
or prolonged hospitalization for a complication of therapy administration will be 
reported as an SAE. 
!
Routine treatment or monitoring of the studied indication not associated with any 
deterioration in condition.
!
The administration of blood or platelet transfusion as routine treatment of studied 
indication. However, hospitalization or prolonged hospitalization for a complication 
of such transfusion remains a reportable SAE.
!
A procedure for protocol/disease-related investigations (eg, surgery, scans, 
endoscopy, sampling for laboratory tests, bone marrow sampling). However, 
hospitalization or prolonged hospitalization for a complication of such procedures 
remains a reportable SAE.
!
Hospitalization or prolongation of hospitalization for technical, practical, or social 
reasons, in absence of an AE.
!
A procedure that is planned (ie, planned prior to starting of treatment on study); must 
be documented in the source document and the eCRF. Hospitalization or prolonged 
hospitalization for a complication remains a reportable SAE.
!
An elective treatment of or an elective procedure for a pre-existing condition 
unrelated to the studied indication. 
!
Emergency outpatient treatment or observation that does not result in admission, 
unless fulfilling other seriousness criteria above.
If an AE is considered serious, both the AE page/screen of the eCRF and the SAE Report Form 
must be completed.
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
59
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
For each SAE, the investigator will provide information on severity, start and stop dates, 
relationship to IP, action taken regarding IP, and outcome.
11.2.2.
Severity / Intensity
For both AEs and SAEs, the investigator must assess the severity/intensity of the event. 
The severity/intensity of AEs will be graded based upon the subject’s symptoms according to the 
current active minor version of NCI CTCAE, Version 4.0
http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm#ctc_40.
Adverse events that are not defined in the NCI CTCAE should be evaluated for severity/intensity 
according to the following scale:
!
Grade 1 = Mild – transient or mild discomfort; no limitation in activity; no medical 
intervention/therapy required
!
Grade 2 = Moderate – mild to moderate limitation in activity, some assistance may be 
needed; no or minimal medical intervention/therapy required
!
Grade 3 = Severe – marked limitation in activity, some assistance usually required; 
medical intervention/therapy required, hospitalization is possible
!
Grade 4 = Life threatening – extreme limitation in activity, significant assistance 
required; significant medical intervention/therapy required, hospitalization or hospice 
care probable
!
Grade 5 = Death – the event results in death
The term “severe” is often used to describe the intensity of a specific event (as in mild, moderate 
or severe myocardial infarction); the event itself, however, may be of relatively minor medical 
significance (such as severe headache). This criterion is not the same as “serious” which is based 
on subject/event outcome or action criteria associated with events that pose a threat to a subject’s 
life or functioning.
Seriousness, not severity, serves as a guide for defining regulatory obligations.
11.2.3.
Causality 
The investigator must determine the relationship between the administration of IP and the 
occurrence of an AE/SAE as Not Suspected or Suspected as defined below:
Not suspected:
Means a causal relationship of the adverse event to IP
administration is unlikely or remote, or other medications, 
therapeutic interventions, or underlying conditions provide a 
sufficient explanation for the observed event.
Suspected:
Means there is a reasonable possibility that the administration 
of IP caused the adverse event.  ‘Reasonable possibility’ means 
there is evidence to suggest a causal relationship between the IP
and the adverse event.
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
60
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
Causality should be assessed and provided for every AE/SAE based on currently available 
information.  Causality is to be reassessed and provided as additional information becomes 
available.
If an event is assessed as suspected of being related to a comparator, ancillary or additional IP
that has not been manufactured or provided by Celgene, please provide the name of the 
manufacturer when reporting the event.
11.2.4.
Duration
For both AEs and SAEs, the investigator will provide a record of the start and stop dates of the 
event.
11.2.5.
Action Taken
The investigator will report the action taken with IP as a result of an AE or SAE, as applicable 
(eg, discontinuation or reduction of IP, as appropriate) and report if concomitant and/or 
additional treatments were given for the event. 
11.2.6.
Outcome
The investigator will report the outcome of the event for both AEs and SAEs. All SAEs that have 
not resolved upon discontinuation of the subject’s participation in the study must be followed 
until recovered, recovered with sequelae, not recovered or death (due to the SAE). 
11.3.
Abnormal Laboratory Values
An abnormal laboratory value is considered to be an AE if the abnormality:
!
results in discontinuation from the study;
!
requires treatment, modification/ interruption of IP dose, or any other therapeutic 
intervention; or
!
is judged to be of significant clinical importance.
Regardless of severity grade, only laboratory abnormalities that fulfill a seriousness criterion 
need to be documented as a serious adverse event.
If a laboratory abnormality is one component of a diagnosis or syndrome, then only the diagnosis 
or syndrome should be recorded on the AE page/screen of the eCRF. If the abnormality was not 
a part of a diagnosis or syndrome, then the laboratory abnormality should be recorded as the AE.
If possible, the laboratory abnormality should be recorded as a medical term and not simply as an 
abnormal laboratory result (eg, record thrombocytopenia rather than decreased platelets).
11.4.
Pregnancy
All pregnancies or suspected pregnancies occurring in either a female subject or partner of a 
male subject are immediately reportable events.
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nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
61
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
11.4.1.
Females of Childbearing Potential
Pregnancies and suspected pregnancies (including a positive pregnancy test regardless of age or 
disease state) of a female subject occurring while the subject is on IP, or within 3 months of the 
subject’s last dose of IP, are considered immediately reportable events. IP is to be discontinued 
immediately. The pregnancy, suspected pregnancy, or positive pregnancy test must be reported 
to Celgene Drug Safety immediately by facsimile, or other appropriate method, using the 
Pregnancy Initial Report Form, or approved equivalent form. The female subject should be 
referred to an obstetrician-gynecologist or another appropriate healthcare professional for further 
evaluation.
The investigator will follow the female subject until completion of the pregnancy, and must 
notify Celgene Drug Safety immediately about the outcome of the pregnancy (either normal or 
abnormal outcome) using the Pregnancy Follow-up Report Form, or approved equivalent form.
If the outcome of the pregnancy was abnormal (eg, spontaneous abortion), the investigator
should report the abnormal outcome as an AE. If the abnormal outcome meets any of the serious 
criteria, it must be reported as an SAE to Celgene Drug Safety by facsimile, or other appropriate 
method, within 24 hours of the investigator’s knowledge of the event using the SAE Report 
Form, or approved equivalent form.
All neonatal deaths that occur within 28 days of birth should be reported, without regard to 
causality, as SAEs. In addition, any infant death after 28 days that the investigator suspects is 
related to the in utero exposure to the IP should also be reported to Celgene Drug Safety by 
facsimile, or other appropriate method, within 24 hours of the investigator’s knowledge of the 
event using the SAE Report Form, or approved equivalent form.
11.4.2.
Male Subjects
If a female partner of a male subject becomes pregnant while the subject is receiving IP or within 
6 months of the last dose of IP, the male subject taking IP should notify the investigator, and the 
pregnant female partner should be advised to call her healthcare provider immediately. If the 
male subject is receiving IP, the IP may need to be discontinued in the male subject, but may be 
resumed later at the discretion of the investigator and medical monitor.
11.5.
Reporting of Serious Adverse Events
Any AE that meets any criterion for an SAE requires the completion of an SAE Report Form in 
addition to being recorded on the AE page/screen of the eCRF. All SAEs must be reported to 
Celgene Drug Safety within 24 hours of the investigator’s knowledge of the event by facsimile, 
or other appropriate method, using the SAE Report Form, or approved equivalent form. This 
instruction pertains to initial SAE reports as well as any follow-up reports.
The investigator is required to ensure that the data on these forms are accurate and consistent.
This requirement applies to all SAEs (regardless of relationship to IP) that occur during the study 
(from the time the subject signs informed consent to at least 28 days after the last dose of IP) and 
those made known to the investigator at anytime thereafter that are suspected of being related to 
IP. SAEs occurring prior to treatment (after signing the ICF) will be captured.
The SAE report should provide a detailed description of the SAE and include a concise summary
of hospital records and other relevant documents. If a subject died and an autopsy has been 
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
62
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
performed, copies of the autopsy report and death certificate are to be sent to Celgene Drug 
Safety as soon as these become available. Any follow-up data will be detailed in a subsequent 
SAE Report Form, or approved equivalent form, and sent to Celgene Drug Safety.
Where required by local legislation, the investigator is responsible for informing the Independent 
Review Board/Ethics Committee (IRB/EC) of the SAE and providing them with all relevant 
initial and follow-up information about the event. The investigator must keep copies of all SAE 
information on file including correspondence with Celgene and the IRB/EC.
11.5.1.
Safety Queries
Queries pertaining to SAEs will be communicated from Celgene Drug Safety to the site via 
facsimile or electronic mail. The response time is expected to be no more than five (5) business 
days. Urgent queries (eg, missing causality assessment) may be handled by phone.
11.6.
Expedited Reporting of Adverse Events
For the purpose of regulatory reporting, Celgene Drug Safety will determine the expectedness of 
events suspected of being related to nab-paclitaxel and CC-486 based on the Investigator
Brochures.
In the United States, all suspected unexpected serious adverse reactions (SUSARs) will be 
reported in an expedited manner in accordance with 21 CFR 312.32.
For countries within the European Economic Area (EEA), Celgene or its authorized 
representative will report in an expedited manner to Regulatory Authorities and Ethics 
Committees concerned, suspected unexpected serious adverse reactions (SUSARs) in accordance 
with Directive 2001/20/EC and the Detailed Guidance on collection, verification and 
presentation of adverse reaction reports arising from clinical trials on investigational products for 
human use (ENTR/CT3) and also in accordance with country-specific requirements.
Celgene or its authorized representative shall notify the investigator of the following 
information: 
!
Any AE suspected of being related to the use of IP in this study or in other studies
that is both serious and unexpected (ie, SUSAR);
!
Any finding from tests in laboratory animals that suggests a significant risk for 
human subjects including reports of mutagenicity, teratogenicity, or carcinogenicity.
Where required by local legislation, the investigator shall notify his/her IRB/EC promptly of 
these new serious and unexpected AE(s) or significant risks to subjects.
The investigator must keep copies of all pertinent safety information on file including 
correspondence with Celgene and the IRB/EC. (See Section 15.3 for record retention 
information).
Celgene Drug Safety Contact Information:
For Celgene Drug Safety contact information, please refer to the Serious Adverse Event Report 
Form/Completion Guidelines or to the Pregnancy Report Form/Completion Guidelines.
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Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
63
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
12.
DISCONTINUATIONS
12.1.
Study Treatment Discontinuation
The following events are considered sufficient reasons for discontinuing a subject from the IP:
!
Adverse Event(s)
!
Disease progression
!
Withdrawal of consent
!
Death
!
Lost to follow-up
!
Protocol violation
The reason for discontinuation should be recorded in the eCRF and in the source documents.
The decision to discontinue a subject remains the responsibility of the treating physician, which
will not be delayed or refused by the sponsor. However, prior to discontinuing a subject, the
investigator may contact the Medical Monitor and forward appropriate supporting documents for 
review and discussion.
All subjects discontinued from IP for any reason will have a treatment discontinuation visit at the 
time of discontinuation and should undergo treatment discontinuation procedures.
All subjects discontinued from IP will be followed for a period of 28 days after last dose of IP
for the collection of AEs.
Additionally subjects who withdraw from or discontinue treatment should be followed for 
progressive disease (if applicable), survival and any new anticancer therapy given.
12.2.
Study Discontinuation
The following events are considered sufficient reasons for discontinuing a subject from the 
study:
!
Withdrawal of consent
!
Death
!
Lost to follow-up
The following events may be considered sufficient reasons for discontinuing a subject from the 
study:
!
Adverse events(s)
!
Protocol violation
The reason for study discontinuation should be recorded in the eCRF and in the source 
documents. The investigator must notify the Medical Monitor immediately when a subject has 
been discontinued/withdrawn due to an AE (any unacceptable toxicity). All subjects who are 
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Celgene Corporation
Confidential and Proprietary
64
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
withdrawn from the study should complete all protocol-required evaluations scheduled for early 
termination at the time of withdrawal.
Since follow-up of subjects who discontinue prematurely is of particular importance, every 
attempt should be made to collect all survival information and NSCLC treatment/therapy, unless 
the subject has specifically withdrawn consent from further follow-up. The investigator must 
make every effort to obtain minimal information regarding the subject’s survival status before 
determining that the subject is lost to follow-up.
12.3.
Subject Replacement
Subjects who discontinue will not be replaced.
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Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
65
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
13.
EMERGENCY PROCEDURES
13.1.
Emergency Contact
In emergency situations, the investigator should contact the responsible Clinical Research
Physician/Medical Monitor or designee by telephone at the number(s) listed on the Emergency 
Contact Information page of the protocol (after title page).
In the unlikely event that the Clinical Research Physician/Medical Monitor or designee cannot be 
reached, please contact the global Emergency Call Center by telephone at the number listed on 
the Emergency Contact Information page of the protocol (after title page). This global 
Emergency Call Center is available 24 hours a day and 7 days a week. The representatives are 
responsible for obtaining your call-back information and contacting the on call Celgene/Contract 
Research Organization (CRO) Medical Monitor, who will then contact you promptly.
Note: The back-up 24-hour global emergency contact call center should only be used if you are 
not able to reach the Clinical Research Physician(s) or Medical Monitor or designee for 
emergency calls. 
13.2.
Emergency Identification of Investigational Products
This is an open-label study; therefore, IP will be indentified on the package labeling. 
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
66
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
14.
REGULATORY CONSIDERATIONS
14.1.
Good Clinical Practice
The procedures set out in this study protocol pertaining to the conduct, evaluation, and 
documentation of this study are designed to ensure that Celgene, its authorized representative,
and investigator abide by Good Clinical Practice (GCP), as described in International Conference 
on Harmonization (ICH) Guideline E6 and in accordance with the general ethical principles 
outlined in the Declaration of Helsinki. The study will receive approval from an IRB/EC prior to 
commencement. The investigator will conduct all aspects of this study in accordance with 
applicable national, state, and local laws of the pertinent regulatory authorities.
14.2.
Investigator Responsibilities
Investigator responsibilities are set out in the ICH Guideline for Good Clinical Practice and in 
the local regulations. Celgene staff or an authorized representative will evaluate and approve all 
investigators who in turn will select their staff.
The investigator should ensure that all persons assisting with the study are adequately informed 
about the protocol, amendments, study treatments, as well as study-related duties and functions. 
The investigator should maintain a list of sub-investigators and other appropriately qualified 
persons to whom he or she has delegated significant study-related duties.
The investigator is responsible for keeping a record of all subjects who sign an ICF and are 
screened for entry into the study. Subjects who fail screening must have the reason(s) recorded in 
the subject’s source documents.
The investigator, or a designated member of the investigator’s staff, must be available during 
monitoring visits to review data, resolve queries and allow direct access to subject records (eg, 
medical records, office charts, hospital charts, and study-related charts) for source data 
verification. The investigator must ensure timely and accurate completion of eCRFs and queries.
14.3.
Subject Information and Informed Consent
The investigator must obtain informed consent of the subject and/or the subject’s legal 
representative prior to any study-related procedures.
Documentation that informed consent occurred prior to the subject’s entry into the study and of 
the informed consent process should be recorded in the subject’s source documents including the 
date. The original ICF signed and dated by the subject and by the person consenting the subject
prior to the subject’s entry into the study, must be maintained in the investigator’s study files and 
a copy given to the subject. In addition, if a protocol is amended and it impacts the content of the 
informed consent, the ICF must be revised. Subjects participating in the study when the amended 
protocol is implemented must be re-consented with the revised version of the ICF. The revised 
ICF signed and dated by the subject and by the person consenting the subject must be maintained 
in the investigator’s study files and a copy given to the subject.
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('06'RF1XPEHU
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Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
67
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
14.4.
Confidentiality
Celgene affirms the subject's right to protection against invasion of privacy and to be in 
compliance with ICH and other local regulations (whichever is most stringent). Celgene requires 
the investigator to permit Celgene's representatives and, when necessary, representatives from 
regulatory authorities, to review and/or copy any medical records relevant to the study in 
accordance with local laws.
Should direct access to medical records require a waiver or authorization separate from the 
subject’s signed ICF, it is the responsibility of the investigator to obtain such permission in 
writing from the appropriate individual.
14.5.
Protocol Amendments
Any amendment to this protocol must be approved by the Celgene Clinical Research 
Physician/Medical Monitor. Amendments will be submitted to the IRB/EC for written approval.
Written approval must be obtained before implementation of the amended version occurs. The
written signed approval from the IRB/EC should specifically reference the investigator name, 
protocol number, study title and amendment number(s) that is applicable. Amendments that are 
administrative in nature do not require IRB/IEC approval but will be submitted to the IRB/IEC 
for information purposes.
14.6.
Institutional Review Board/Independent Ethics Committee Review 
and Approval
Before the start of the study, the study protocol, ICF, and any other appropriate documents will 
be submitted to the IRB/EC with a cover letter or a form listing the documents submitted, their 
dates of issue, and the site (or region or area of jurisdiction, as applicable) for which approval is 
sought. If applicable, the documents will also be submitted to the authorities in accordance with 
local legal requirements.
IP can only be supplied to an Investigator by Celgene or its authorized representative after 
documentation on all ethical and legal requirements for starting the study has been received by 
Celgene or its authorized representative. This documentation must also include a list of the 
members of the IRB/EC and their occupation and qualifications. If the IRB/EC will not disclose 
the names, occupations and qualifications of the committee members, it should be asked to issue 
a statement confirming that the composition of the committee is in accordance with GCP. For 
example, the IRB General Assurance Number may be accepted as a substitute for this list. 
Formal approval by the IRB/EC should mention the protocol title, number, amendment number 
(if applicable), study site (or region or area of jurisdiction, as applicable), and any other 
documents reviewed. It must mention the date on which the decision was made and must be 
officially signed by a committee member. Before the first subject is enrolled in the study, all 
ethical and legal requirements must be met.
The IRB/EC and, if applicable, the authorities, must be informed of all subsequent protocol 
amendments in accordance with local legal requirements. Amendments must be evaluated to 
determine whether formal approval must be sought and whether the ICF should also be revised.
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arch
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Protocol ABI-007-NSCL-006
Celgene Corporation
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68
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
The investigator must keep a record of all communication with the IRB/EC and, if applicable, 
between a Coordinating investigator and the IRB/EC. This statement also applies to any 
communication between the investigator (or coordinating investigator, if applicable) and 
regulatory authorities.
Any advertisements used to recruit subjects for the study must be reviewed by Celgene and the 
IRB/EC prior to use.
14.7.
Ongoing Information for Institutional Review Board / Ethics 
Committee
If required by legislation or the IRB/EC, the investigator must submit to the IRB/EC:
!
Information on serious or unexpected adverse events as soon as possible; 
!
Periodic reports on the progress of the study;
!
Deviations from the protocol or anything that may involve added risk to subjects.
14.8.
Closure of the Study
Celgene reserves the right to terminate this study at any time for reasonable medical or 
administrative reasons. Any premature discontinuation will be appropriately documented 
according to local requirements (eg, IRB/EC, regulatory authorities, etc).
In addition, the investigator or Celgene has the right to discontinue a single site at any time 
during the study for medical or administrative reasons such as:
!
Unsatisfactory enrollment;
!
GCP noncompliance;
!
Inaccurate or incomplete data collection;
!
Falsification of records;
!
Failure to adhere to the study protocol.
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ed risk to su
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nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
69
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
15.
DATA HANDLING AND RECORDKEEPING 
15.1.
Data/Documents
The investigator must ensure that the records and documents pertaining to the conduct of the 
study and distribution of the IP are complete, accurate, filed and retained. Examples of source 
documents include: hospital records; clinic and office charts; laboratory notes; memoranda; 
subject’s diaries or evaluation checklists; dispensing records; recorded data from automated 
instruments; copies or transcriptions certified after verification as being accurate copies; 
microfiche; x-ray film and reports; and records kept at the pharmacy and the laboratories, as well 
as copies of CRFs or CD-ROM.
15.2.
Data Management
Data will be collected via eCRF and entered into the clinical database per Celgene Standard 
Operating Procedures (SOPs). This data will be electronically verified through use of 
programmed edit checks specified by the clinical team. Discrepancies in the data will be brought 
to the attention of the clinical team, and investigational site personnel, if necessary. Resolutions 
to these issues will be reflected in the database. An audit trail within the system will track all 
changes made to the data.
15.3.
Record Retention
Essential documents must be retained by the investigator for a minimum of 2 years after the last 
approval of a marketing application in an ICH region and until there are no pending or 
contemplated marketing applications in an ICH region, or at least 2 years have elapsed since the 
formal discontinuation of clinical development of the IP. The investigator must retain these 
documents for the time period described above or according to local laws or requirements, 
whichever is longer. Essential documents include, but are not limited to, the following:
!
Signed ICFs for all subjects;
!
Subject identification code list, screening log (if applicable), and enrollment log;
!
Record of all communications between the investigator and the IRB/EC;
!
Composition of the IRB/EC;
!
Record of all communications between the investigator, Celgene, and their authorized 
representative(s);
!
List of sub-investigators and other appropriately qualified persons to whom the 
Investigator has delegated significant study-related duties, together with their roles in 
the study, curriculum vitae, and their signatures;
!
Copies of CRFs (if paper) and of documentation of corrections for all subjects;
!
IP accountability records;
!
Record of any body fluids or tissue samples retained;
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Celgene Sta
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nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
70
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
!
All other source documents (subject records, hospital records, laboratory records, 
etc.); 
!
All other documents as listed in Section 8 of the ICH consolidated guideline on GCP 
(Essential Documents for the Conduct of a Clinical Trial).
The investigator must notify Celgene if he/she wishes to assign the essential documents to 
someone else, remove them to another location or is unable to retain them for a specified period.
The investigator must obtain approval in writing from Celgene prior to destruction of any 
records. If the investigator is unable to meet this obligation, the investigator must ask Celgene 
for permission to make alternative arrangements. Details of these arrangements should be 
documented. 
All study documents should be made available if required by relevant health authorities. 
Investigator/Institution should take measures to prevent accidental or premature destruction of 
these documents.
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e
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destruction
destruction

('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
71
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
16.
QUALITY CONTROL AND QUALITY ASSURANCE
All aspects of the study will be carefully monitored by Celgene or its authorized representative
for compliance with applicable government regulations with respect to current GCP and standard 
operating procedures.
16.1.
Study Monitoring and Source Data Verification
Celgene ensures that appropriate monitoring procedures are performed before, during and after 
the study. All aspects of the study are reviewed with the investigator and the staff at a study 
initiation visit and/or at an investigator meeting. Prior to enrolling subjects into the study, a 
Celgene representative or designee will review the protocol, eCRFs, procedures for obtaining 
informed consent, record keeping, and reporting of AEs/SAEs with the investigator. Monitoring 
will include on-site visits with the investigator and his/her staff as well as any appropriate 
communications by mail, email, fax, or telephone. During monitoring visits, the facilities, IP 
storage area, eCRFs, subject’s source documents, and all other study documentation will be
inspected/reviewed by the Celgene representative in accordance with the Study Monitoring Plan.
Accuracy will be checked by performing source data verification that is a direct comparison of 
the entries made onto the eCRFs against the appropriate source documentation. Any resulting 
discrepancies will be reviewed with the investigator and/or his/her staff. Any necessary 
corrections will be made directly to the eCRFs or via queries by the investigator and/or his/her 
staff. Monitoring procedures require that informed consents, adherence to inclusion/exclusion 
criteria and documentation of SAEs and their proper recording be verified. Additional 
monitoring activities may be outlined in a study-specific monitoring plan.
16.2.
Audits and Inspections
In addition to the routine monitoring procedures, a Good Clinical Practice Quality Assurance 
unit exists within Celgene. Representatives of this unit will conduct audits of clinical research 
activities in accordance with Celgene SOPs to evaluate compliance with Good Clinical Practice 
guidelines and regulations.
The investigator is required to permit direct access to the facilities where the study took place, 
source documents, eCRFs and applicable supporting records of subject participation for audits 
and inspections by IRB/IECs, regulatory authorities (eg, FDA, European Medicines Agency 
[EMA], Health Canada) and company authorized representatives. The investigator should make 
every effort to be available for the audits and/or inspections. If the investigator is contacted by 
any regulatory authority regarding an inspection, he/she should contact Celgene immediately.
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nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
72
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
17.
PUBLICATIONS
The results of this study may be published in a medical publication, journal, or may be used for 
teaching purposes. Additionally, this study and its results may be submitted for inclusion in all 
appropriate health authority study registries, as well as publication on health authority study 
registry websites, as required by local health authority regulations. Selection of first authorship 
will be based on several considerations, including, but not limited to study participation, 
contribution to the protocol development, and analysis and input into the manuscript, related 
abstracts, and presentations in a study.
&(/*(1(35235,(7$5<,1)250$7,21

('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
73
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
18.
REFERENCES
Azzoli CG, Baker Jr. S, Temin S, Pao W, Aliff T, Brahmer J, et al. American Society of Clinical 
Oncology clinical practice guideline update on chemotherapy for Stage IV non–small-cell lung 
cancer. J Clin Oncol 2009;27:6251-66.
Belani CP, Ramalingam S, Perry MC, LaRocca RV, Rinaldi D, Gable PS, et al. Randomized, 
phase III study of weekly paclitaxel in combination with carboplatin versus standard 
every-3-weeks administration of carboplatin and paclitaxel for patients with previously untreated 
advanced non-small-cell lung cancer. J Clin Onc 2008;26:468-73.
Benson AB 3rd, Ajani JA, Catalano RB, Engelking C, Kornblau SM, Martenson JA Jr, et al.
Recommended guidelines for the treatment of cancer treatment-induced diarrhea. J Clin Oncol
2004 Jul 15;22(14):2918-2926.
Buccheri G, Ferrigno D. Second-line weekly paclitaxel in patients with inoperable non-small cell 
lung cancer who fail combination chemotherapy with cisplatin. Lung Cancer 2004;45:227–36.
Ceresoli GL, Gregorc V, Cordio S, Bencardino KB, Schipani S, Cozzarini C, et al. Phase II study 
of weekly paclitaxel as second-line therapy in patients with advanced non-small cell lung cancer. 
Lung Cancer 2004;44:231–9.
Desai N, Trieu V, Yao Z, Louie L, Ci S, Yang A, et al. Increased antitumor activity, intratumor 
paclitaxel concentrations, and endothelial cell transport of cremophor-free, albumin-bound 
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2006;12(4):1317-24.
Dumlao TL, Butler TW, Dyess DL, Khong HT. A phase I/II study of the hypomethylating agent 
azacitidine with the nanoparticle albumin bound paclitaxel in the treatment of patients with 
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Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, et al. New 
response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J 
Cancer 2009 Jan;45(2):228-47. 
Garcia-Manero G, Gore SD, Cogle C, Ward R, Shi T, Macbeth KJ, et al. Phase I study of oral
azacitidine in myelodysplastic syndromes, chronic myelomonocytic leukemia, and acute myeloid 
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Gardner ER, Dahut WL, Scripture CD, Jones J, Aragon-Ching JB, Desai N, et al. Randomized 
crossover pharmacokinetic study of solvent-based paclitaxel and nab-paclitaxel. Clin Cancer Res 
2008;14(13):4200-5. 
Gerber DE, Schiller JH. Maintenance chemotherapy for advanced non-small-cell lung cancer: 
new life for an old idea. J Clin Oncol 2013 Mar 10;31(8):1009-20.
Gordian E, Ramachandran K, Singal R. Methylation mediated silencing of TMSl in breast cancer 
and its potential contribution to docetaxel cytotoxicity. Anticancer Res 2009 Aug;29(8):3207-10.
eated 
ated
Jr, et al.
r, et al.
Clin Onco
Clin Onc
perable non
perable no
ancer 2004;
cer 20
zzarini C,
arini C, e
nced non
ed non-sm
reased anti
ased ant
of 
of crem
cremop
op
ed paclitaxe
ed paclita
HT. A phase
HT. A phase
bound pacl
bound pacl
Clin Onco
lin Oncol
gaerts J, Sch
gaerts J, Sc
n so
solid tum
lid tum
-47. 
47. 
re SD, Cog
e SD, Cog
odysplast
odysplasticic
Onco
Oncol 201
20
, Dahut WL
, Dahut WL
r pharmaco
harmaco
14(13):4200
4(13):4200
rber DE
ber DE, S
new life fo
new life fo
ordi
ordi

('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
74
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
Hanna N, Shepherd FA, Fossella FV, Pereira JR, De Marinis F, von Pawel J, et al. Randomized 
Phase III Trial of Pemetrexed Versus Docetaxel in Patients With Non–Small-Cell Lung Cancer 
Previously Treated With Chemotherapy. J Clin Oncol 2004;22:1589-97.
Jones PA, Baylin SB. The epigenomics of cancer. Cell 2007 Feb;128(4):683-92.
Juan O, Albert A, Ordono F, Casany R, Caranana V, Campos JM, et al. Low-dose weekly 
paclitaxel as second-line treatment for advanced non-small cell lung cancer: a phase II study. Jpn 
J Clin Oncol 2002;32:449–54.
Juergens RA, Wrangle J, Vendetti FP, Murphy SC, Zhao M, Coleman B, et al. Combination 
epigenetic therapy has efficacy in patients with refractory advanced non-small cell lung cancer. 
Cancer Discov 2011 Dec;1(7):598-607.
Kaminskas E, Farrell AT, Wang YC, Sridhara R, Pazdur R. FDA Drug Approval Summary: 
Azacitidine (5-azacytidine, Vidaza™) for Injectable Suspension. The Oncologist 2005 
Mar;10(3):176-82.
Li Y, Hu W, Shen DY, Kavanagh JJ, Fu S. Azacitidine enhances sensitivity of platinum-resistant 
ovarian cancer cells to carboplatin through induction of apoptosis. Am J Obstet Gynecol 2009 
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National Institute for Health & Clinical Excellence: The Diagnosis and Treatment of Lung 
Cancer: Methods, Evidence & Guidance, 2011.
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response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 1982;5(6):649-
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Rizvi NA, Riely GJ, Azzoli CG, Miller VA, Ng KK, Fiore J, et al. Phase I/II trial of weekly 
intravenous 130-nm albumin-bound paclitaxel as initial chemotherapy in patients with Stage IV 
non-small-cell lung cancer. J Clin Oncol 2008;26(4):639-43.
Schiller JH, Gandara DR, Goss GD, Vokes EE.  Non-small-cell lung cancer: then and now. 
J Clin Oncol 2013;31(8):981-3.
Sculier JP, Berghmans T, Lafitte JJ, Richez M, Recloux P, Van Cutsem O, et al. A phase II study 
testing paclitaxel as second-line single agent treatment for patients with advanced non-small cell 
lung cancer failing after a first-line chemotherapy. Lung Cancer 2002;37:73–7.
Socinski MA, Manikhas GM, Stroyakovsky DL, Makhson AN, Cheporov SV, Orlov SV, et al. A 
dose finding study of weekly and every-3-week nab-paclitaxel followed by carboplatin as 
first-line therapy in patients with advanced non-small cell lung cancer. J Thorac Oncol 
2010;5(6):852-61.
Socinski MA, Schell MJ, Bakri K, Peterman A, Lee JH, Unger P, et al. Second-line, low-dose, 
weekly paclitaxel in patients with stage IIIB/IV nonsmall cell lung carcinoma who fail first-line 
chemotherapy with carboplatin plus paclitaxel. Cancer 2002;95:1265–73. 
Socinski MA, Steagall A, Gillenwater H. Second-line chemotherapy with 96-hour infusional 
paclitaxel in refractory non-small cell lung cancer: report of a phase II trial. Cancer Invest
1999;17:181–8. 
&(/*(1(35235,(7$5<,1)250$7,21
ancer.
ancer.
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ummary:
t 2005
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nosis and T
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E, McFadd
E, McFad
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gy Group. A
Group
y
Ng KK, Fio
Ng KK, Fio
axel as init
axel as init
ol 2008;26(
 2008;26
, Vo
V kes EE
kes E
afitte JJ, Ri
afitte JJ, R
nd
nd-line sing
ine 
er a first
r a first-lini
nikhas GM
nikhas GM
udy
udy of
of
y
week
w
f
rapy in pat
rapy in pat
):852
52-61.
-61.
nski MA, S
nski MA, 
eekly paclit
eekly paclit
chemother
hemother
ocins
cins

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Celgene Corporation
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75
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
Socinski MA, Bondarenko I, Karaseva NA, Makhson AM, Vynnychenko I, Okamoto I, et al. 
Weekly nab-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus 
carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: final 
results of a phase III trial. J Clin Oncol 2012 Jun 10;30(17):2055-62.
Yasuda K, Igishi T, Kawasaki Y, Kato K, Matsumoto S, Katayama S, et al. Phase II study of 
weekly paclitaxel in patients with non-small cell lung cancer who have failed previous 
treatments. Oncology 2004;66:347–52.
&(/*(1(35235,(7$5<,1)250$7,21

('06'RF1XPEHU
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Celgene Corporation
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76
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
19.
APPENDICES
Appendix A: ECOG Performance Status Score
Grade
ECOG
0
Fully active, able to carry on all pre-disease performance without restriction
1
Restricted in physically strenuous activity but ambulatory and able to carry out work of a light 
or sedentary nature, eg, light house work, office work
2
Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and 
about more than 50% of waking hours
3
Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours
4
Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair
5
Dead
Oken, 1982.
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('06'RF1XPEHU
nab-paclitaxel
Protocol ABI-007-NSCL-006
Celgene Corporation
Confidential and Proprietary
77
ABI-007-NSCL-006 Amendment 2.0 Final: 18 Jul 2014
Appendix B: Recommendations for Management of Treatment-Induced 
Diarrhea
The following published guidelines (Benson, 2004) were modified in order to be consistent with 
the clinical study protocol.
&(/*(1(35235,(7$5<,1)250$7,21

('06'RF1XPEHU
Celgene Signing Page
This is a representation of an electronic record that was signed electronically in Livelink.
This page is the manifestation of the electronic signature(s) used in compliance with
the organizations electronic signature policies and procedures.
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