Safety and Efficacy of Nab-paclitaxel (Abraxane) in Combination With Carboplatin as First Line Treatment in Elderly Subjects With Advance Non-Small Cell Lung Cancer (NSCLC): A Phase IV, Randomized, Open-Label, Multicenter Study (Abound.70+)
Phase: PHASE4
Conditions: Non-Small Cell Lung Cancer, Carcinoma, Squamous Cell Carcinoma, Adenocarcinoma, Carcinoma, Large Cell, Lung Neoplasm
Sponsor: Celgene

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nab-paclitaxel
Protocol ABI-007-NSCL-005
Celgene Corporation
Confidential and Proprietary
1
ABI-007-NSCL-005 Final: 06 Mar 2014
TITLE PAGE
SAFETY AND EFFICACY OF nab-PACLITAXEL 
(ABRAXANE®) IN COMBINATION WITH 
CARBOPLATIN AS FIRST LINE TREATMENT IN 
ELDERLY SUBJECTS WITH ADVANCED NON-SMALL 
CELL LUNG CANCER (NSCLC): A PHASE IV, 
RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY
(ABOUND.70+)
STUDY DRUG
nab-Paclitaxel (Abraxane®)
PROTOCOL NUMBER:
ABI-007-NSCL-005
DATE FINAL:
06 Mar 2014
EudraCT NUMBER:
Not applicable
IND NUMBER:
114882
SPONSOR NAME / ADDRESS:
Celgene Corporation
86 Morris Avenue
Summit, NJ 07901
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-005
Celgene Corporation
Confidential and Proprietary
2
ABI-007-NSCL-005 Final: 06 Mar 2014
MEDICAL MONITOR / EMERGENCY CONTACT INFORMATION 
Contact Information:
Name:
Title:
Address: 
Celgene Corporation
86 Morris Avenue
Summit, NJ 07901
Phone:
E-mail:
Contact Information:
Name:
Title:
Address: 
Celgene Corporation
86 Morris Avenue
Summit, NJ 07901
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-005
Celgene Corporation
Confidential and Proprietary
3
ABI-007-NSCL-005 Final: 06 Mar 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-005
Celgene Corporation
Confidential and Proprietary
4
ABI-007-NSCL-005 Final: 06 Mar 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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nab-paclitaxel
Protocol ABI-007-NSCL-005
Celgene Corporation
Confidential and Proprietary
5
ABI-007-NSCL-005 Final: 06 Mar 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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nab-paclitaxel
Protocol ABI-007-NSCL-005
Celgene Corporation
Confidential and Proprietary
6
ABI-007-NSCL-005 Final: 06 Mar 2014
PROTOCOL SUMMARY
Study Title
Safety and efficacy of nab-paclitaxel (Abraxane) in combination with carboplatin as first line 
treatment in elderly subjects with advanced non-small cell lung cancer (NSCLC): A Phase IV, 
randomized, open-label, multicenter study (Abound.70+).
Indication
First-line treatment of advanced NSCLC in elderly subjects.
Objectives
Primary
!
To assess the safety and tolerability of continuous weekly versus weekly times three 
with one-week break nab-paclitaxel (Abraxane) in combination with carboplatin as 
first-line treatment for advanced NSCLC in elderly subjects (≥ 70 years old).
Secondary 
!
To evaluate the efficacy of nab-paclitaxel in combination with carboplatin in elderly 
subjects with advanced NSCLC.
Exploratory 
!
To assess healthcare resource utilization for the two nab-paclitaxel treatment arms.
!
To assess the Lung Cancer Symptom Scale (LCSS) and EuroQol Group 5-Dimension 
Self-Report Questionnaire score (EQ-5D) for the two nab-paclitaxel treatment arms.
!
 
 
!
 
Study Design
This is a Phase IV, randomized, open-label, multicenter study of continuous weekly versus 
weekly times three with one-week break nab-paclitaxel in combination with carboplatin as first-
line treatment in elderly subjects (≥ 70 years old) with advanced NSCLC who are not candidates 
for curative surgery or radiation therapy. Approximately 284 subjects with locally advanced or 
metastatic NSCLC will be randomized in this study to receive nab-paclitaxel in combination 
with carboplatin and will be randomized 1:1 into one of the two treatment arms prior to starting 
first dose of study drug. Randomization will be centralized and stratified by Eastern Cooperative 
Oncology Group (ECOG) performance status (0 versus 1) and histology (squamous cell 
carcinoma versus non-squamous cell carcinoma).
The study will consist of a 28-day Screening Period, a Treatment Period and a Follow-up Period.  
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352

nab-paclitaxel
Protocol ABI-007-NSCL-005
Celgene Corporation
Confidential and Proprietary
7
ABI-007-NSCL-005 Final: 06 Mar 2014
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 study drug.
The Treatment Period begins with the first dose of study drug as described in Section 8.  Subjects 
will receive one of the following treatments based on the randomization assignment:
Arm A (21-day treatment cycle):
!
nab-Paclitaxel 100 mg/m2 intravenous (IV) infusion over 30 minutes on Days 1, 8, 
and 15 of each 21-day treatment cycle,
!
Carboplatin area under the curve (AUC) = 6 mg*min/mL IV on Day 1 of each 21-day 
treatment cycle after completion of nab-paclitaxel infusion.
Arm B (21-day treatment followed by one-week break cycle, 28-day duration):
!
nab-Paclitaxel 100 mg/m2 intravenous (IV) infusion over 30 minutes on Days 1, 8, 
and 15 of each 21-day treatment  followed by one-week break cycle (ie, every 28 
days),
!
Carboplatin AUC = 6 mg*min/mL IV on Day 1 of each 21-day treatment followed by 
one-week break cycle (ie, every 28 days), after completion of nab-paclitaxel infusion. 
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, or withdrawal of 
consent, in accordance with local standard of care.
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
(v1.1).
Local laboratory test data for absolute neutrophil count (ANC), platelet count, hemoglobin and 
serum creatinine will be collected in the electronic case report forms (eCRFs). All other 
laboratory test data, except those mentioned above, will not be collected routinely in the eCRF. 
All abnormal and clinically significant laboratory test results will be reported as adverse events 
(AEs) or serious adverse events (SAEs), and the specific associated laboratory parameter(s) 
should be recorded on the laboratory assessments eCRF. Local safety laboratory data will also be 
the primary guide for eligibility and subject management. 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 locally for routine diagnosis.  
All subjects who discontinue from treatment for any reason other than withdrawal of consent or 
lost to follow-up will enter the Follow-up Period. It will consist of a visit 28 days after treatment 
discontinuation. Thereafter, subjects will be followed for survival approximately every 90 days 
(or when they are seen for routine care) by phone call or chart review for documentation of last 
contact for up to 6 months after the last subject is randomized or 192 progression-free survival 
(PFS) events have been observed, whichever comes later.
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nab-paclitaxel
Protocol ABI-007-NSCL-005
Celgene Corporation
Confidential and Proprietary
8
ABI-007-NSCL-005 Final: 06 Mar 2014
Those subjects entering the Follow-up Period without documented progression will continue to 
have computed tomography (CT) scans in accordance with standard of care (at least every 90 
days) until documented progression of disease, withdrawal of consent, lost to follow-up, death or 
study closure. 
Study Population
Male and female subjects ≥ 70 years of age, with locally advanced or metastatic NSCLC who 
have not received chemotherapy for their advanced disease and are not candidates for curative 
surgery or radiation therapy, will be eligible for this study.
Length of Study
The enrollment of 284 subjects on this study will take approximately 24 months. The total length 
of this Phase IV study with follow-up is estimated to be approximately 3 years.  
Study Treatments
nab-Paclitaxel and carboplatin are designated as non-investigational products and investigative 
sites will use standard of care (commercially available) product via routine prescription.
The preparation for IV administration procedures for nab-paclitaxel and carboplatin should be 
followed in accordance with the approved Prescribing Information for each drug.
Statistical Methods
Approximately 284 subjects will be randomized in a 1:1 ratio to one of two treatment arms 
(approximately 142 per arm).  Arm A will receive nab-paclitaxel 100 mg/m2 administered on 
Days 1, 8 and 15 in combination with carboplatin AUC = 6 mg*min/mL on Day 1 of each 21-
day treatment cycle, and Arm B will receive the same treatment in the same schedule as that of 
Arm A during the first 21 days, followed by a one-week break prior to the start of the next cycle
(28-day duration).  
Randomization will be stratified by ECOG performance status (0 versus 1) and histology 
(squamous cell carcinoma versus non-squamous cell carcinoma).
The primary objective of this study is to assess the safety and tolerability of the two treatment 
arms for first-line treatment of locally advanced or metastatic NSCLC in elderly subjects ( ≥ 70 
years old).  The primary study endpoint, correspondingly, is the percentage of subjects with 
either peripheral neuropathy of Grade ≥2 or myelosuppression AEs Grade ≥3 based on the local
laboratory values for ANC, platelet count, and hemoglobin, assessed using National Cancer 
Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4.0). 
The peripheral neuropathy events will be identified from the clinical AE dataset using the 
Standardised MedDRA Queries (SMQs). For the purpose of this protocol, this endpoint will be 
referred to as the percentage of subjects with Grade ≥2 peripheral neuropathy or Grade ≥3 
myelosuppression laboratory adverse events.  
The study is designed to detect a difference of 16 percentage points between the 2 treatment arms
with respect to the primary safety endpoint with 80% power and a Type-I error rate of 5% (two-
sided), assuming 139 of the 142 randomized subjects per arm will receive at least one dose of 
study drug and the percentage of the treated subjects with the AEs specified above is 73% for 
Arm A.
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nab-paclitaxel
Protocol ABI-007-NSCL-005
Celgene Corporation
Confidential and Proprietary
9
ABI-007-NSCL-005 Final: 06 Mar 2014
A non-binding interim analysis for futility with the primary safety endpoint will be conducted 
when approximately a total of 139 treated subjects have either completed 6 months of study 
treatment or discontinued from the study due to progression, adverse events, deaths, lost to 
follow up, or other reasons. The study may be stopped early for futility if the treatment 
difference is between ± 0.4%, given the interim analysis is performed at 50% information 
fraction. 
Overview of Safety Assessment
The treated population, which includes all randomized subjects who received at least one dose of 
study drug, will be the analysis population for all safety analyses.  
The primary study endpoint (a composite safety endpoint) will be the percentage of subjects with 
Grade ≥2 peripheral neuropathy or Grade ≥3 myelosuppression laboratory adverse events.  
The null (Ho) and alternative (Ha) hypotheses for this endpoint are as follows, where P is the rate 
of the AEs described for the primary safety endpoint: 
Ho:  P Arm B = P Arm A
Ha:  P Arm B ≠ P Arm A
The AE rate of the primary study endpoint will be summarized within each treatment arm by 
descriptive statistics.  The treatment difference in the AE rate will be analyzed using a Mantel-
Haenszel Chi-square test with ECOG performance status (0 versus 1) and histology (squamous 
cell carcinoma versus non-squamous cell carcinoma) as the stratification factors.  The ratio of the 
AE rates will be summarized along with the two-sided 95% confidence interval (CI). 
Adverse events will be analyzed in terms of treatment-emergent adverse events (TEAEs), 
defined as any AE or SAE that begins or worsens in grade on or after the start of the study drug
through 28 days after the last dose of the study drug. Additionally, any SAE that occurs beyond 
this period of observation and is assessed by the investigator as related to the study drug, will be 
reported and analyzed.  
Treatment-emergent adverse events will be summarized by treatment arm by system organ class
and preferred term. Grade 3 or higher TEAEs, SAEs, TEAEs leading to dose modification 
(reduction, delay not given, and interruption), TEAEs leading to treatment discontinuation, and 
TEAEs with an outcome of death will be summarized by treatment arm. Adverse events of 
special interest of the nab-paclitaxel and carboplatin combination identified in previous studies
in a similar population will be summarized in the same manner.
In order to investigate the maximal degree of myelosuppression, ANC, platelet count, and 
hemoglobin will be summarized by the most severe grade in each treatment cycle and by the 
most severe grade during the study using NCI CTCAE v4.0. 
Overview of Efficacy Assessment
All efficacy analyses will be based on the intent-to-treat (ITT) population, which includes all
randomized subjects regardless of whether they receive any study drugs or have any efficacy 
assessments performed.  
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nab-paclitaxel
Protocol ABI-007-NSCL-005
Celgene Corporation
Confidential and Proprietary
10
ABI-007-NSCL-005 Final: 06 Mar 2014
Progression-free Survival (PFS) based on investigator’s assessment of the subject’s radiologic 
response using RECIST v1.1 guidelines, Overall Response Rate (ORR), and Overall Survival 
(OS) are the key efficacy endpoints.  Since the primary research interest of this study is to 
evaluate the relative safety and toxicities of the two treatment arms, the sample size was
calculated based on the primary safety endpoint, the percentage of subjects with Grade ≥2
peripheral neuropathy or Grade ≥3 myelosuppression laboratory adverse events.  Consequently, 
a statistically non-significant treatment difference in PFS, ORR or OS could simply be a function 
of the sample size and/or the lack of statistical power. Therefore, the assessments of treatment 
differences in PFS and OS will be based on the hazard ratios and in ORR, the ratio of response 
rates, and the corresponding 95% confidence intervals. P-values for between-group comparisons 
will be provided to indicate the strength of association only.  No multiplicity adjustment with the 
Type-I error rate will be made. 
Progression-free survival is defined as the time from the randomization date to the start of 
disease progression or subject death from any cause, whichever occurs first. Subjects who do not 
have disease progression or have not died as of the data cutoff date for the statistical analysis will 
be censored at the time of the last radiologic assessment prior to the data cutoff date. Rules for 
censoring for missing visits and start of anticancer treatment are provided in Section 10. 
Progression-free survival will be summarized using the Kaplan-Meier method and by median 
PFS time (including two-sided 95% confidence interval [CI]) for each treatment arm along with 
the hazard ratio (including two-sided 95% CI) between treatment arms. The Kaplan-Meier curve 
for PFS will be presented graphically for each treatment arm. To illustrate the strength of 
association, the p-value for treatment difference in the curves will be reported from a stratified 
log-rank test with ECOG performance status (0 versus 1) and histology (squamous versus non-
squamous cell carcinoma) as the stratification factors.  
Of note, if recruitment is complete in 24 months, assuming that approximately 67% of the 284 
subjects randomized will experience a PFS event (approximately 192 PFS events total) within 28
months from first subject randomized, there is 73% power to detect a hazard ratio (HR) of 0.69 
for PFS improvement with Arm B over Arm A and an overall Type-I error rate of 5% (two-
sided).  Assuming an exponential distribution with a median time to PFS of 5.8 months for Arm 
A and proportional hazards, a hazard ratio of 0.69 constitutes a 2.6 months improvement for Arm 
B. 
Overall response rate (percent of subjects who had a radiologic complete or partial response 
according to the investigator’s assessment of response based on RECIST v1.1 guidelines) and 
OS also will be assessed by descriptive statistics with the associated 95% CIs.  P-values from a 
Chi-square test and a stratified log-rank test will be provided to indicate the strength of 
association for the treatment differences in ORR and OS, respectively.  
The analyses of the safety and efficacy endpoints for the clinical study report will be performed 
after ~192 PFS events have been observed.  
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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 Further Study of nab-Paclitaxel as First-line Treatment in 
Elderly Subjects with Advanced NSCLC................................................................20
2.
STUDY OBJECTIVES...........................................................................................22
2.1.
Primary Objectives .................................................................................................22
2.2.
Secondary Objective...............................................................................................22
2.3.
Exploratory Objectives ...........................................................................................22
3.
STUDY ENDPOINTS............................................................................................23
3.1.
Primary Endpoint....................................................................................................23
3.2.
Secondary Endpoints ..............................................................................................23
3.2.1.
Safety.....................................................................................................................23
3.2.2.
Efficacy..................................................................................................................23
3.3.
Exploratory Endpoints............................................................................................23
4.
OVERALL STUDY DESIGN ................................................................................24
4.1.
Study Design ..........................................................................................................24
4.1.1.
Follow-up Period....................................................................................................25
4.2.
Study Design Rationale ..........................................................................................25
4.3.
Study Duration .......................................................................................................27
4.4.
End of Trial ............................................................................................................27
5.
TABLE OF EVENTS.............................................................................................28
6.
PROCEDURES......................................................................................................31
6.1.
Medical History......................................................................................................31
6.2.
Prior and Concomitant Medications/Procedures......................................................31
6.3.
Computed Tomography (CT) Scan of Complete Chest (including base of 
neck and adrenal glands).........................................................................................31
6.4.
Weight....................................................................................................................32
6.5.
Body Surface Area (BSA) Calculation and Height..................................................32
6.6.
ECOG Performance Score ......................................................................................32
9
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6.7.
Peripheral Neuropathy Assessment.........................................................................32
6.8.
Adverse Event Reporting........................................................................................32
6.9.
Lung Cancer Symptom Scale Questionnaire and EQ-5D.........................................32
6.10.
Healthcare Resource Utilization Questionnaire .......................................................32
6.11.
Electrocardiogram ..................................................................................................33
6.12.
CT Scan of the Head or Brain Magnetic Resonance Imaging (MRI) .......................33
6.13.
Bone Scans and X-rays...........................................................................................33
6.14.
Physical Examinations............................................................................................33
6.15.
Vital Signs..............................................................................................................33
6.16.
Laboratory Assessments .........................................................................................33
6.17.
Tumor Tissue Sample Collection and Peripheral Blood Collection 
(Exploratory Assessments) .....................................................................................34
6.18.
Survival..................................................................................................................34
7.
STUDY POPULATION.........................................................................................35
7.1.
Number of Subjects and Sites .................................................................................35
7.2.
Inclusion Criteria....................................................................................................35
7.3.
Exclusion Criteria...................................................................................................36
8.
DESCRIPTION OF STUDY TREATMENTS........................................................38
8.1.
Description of Study Drug(s)..................................................................................38
8.1.1.
nab-Paclitaxel.........................................................................................................38
8.1.2.
Carboplatin.............................................................................................................38
8.2.
Treatment Administration and Schedule .................................................................38
8.3.
Dose Modifications.................................................................................................39
8.4.
Method of Treatment Assignment...........................................................................41
8.5.
Packaging and Labeling..........................................................................................41
8.6.
Study Drug Accountability and Disposal ................................................................41
8.7.
Study Drug Compliance..........................................................................................41
8.8.
Overdose ................................................................................................................41
9.
CONCOMITANT MEDICATIONS AND PROCEDURES....................................42
9.1.
Permitted Concomitant Medications and Procedures...............................................42
9.2.
Prohibited Concomitant Medications and Procedures..............................................42
9.3.
Required Concomitant Medications and Procedures................................................42
10.
STATISTICAL ANALYSES..................................................................................43
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9.1

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10.1.
Overview................................................................................................................43
10.2.
Study Population Definitions ..................................................................................43
10.2.1.
Intent-to-treat Population........................................................................................43
10.2.2.
Per-protocol (PP) Population ..................................................................................43
10.2.3.
Treated Population..................................................................................................43
10.3.
Sample Size and Power Considerations...................................................................43
10.4.
Background and Demographic Characteristics........................................................45
10.5.
Subject Disposition.................................................................................................45
10.6.
Safety Analysis.......................................................................................................45
10.6.1.
Primary Safety Endpoint.........................................................................................45
10.6.2.
Adverse Events.......................................................................................................46
10.6.3.
Laboratory Assessments .........................................................................................46
10.6.4.
Study Drug Exposure..............................................................................................47
10.7.
Efficacy Analysis....................................................................................................47
10.7.1.
Key Efficacy Endpoints..........................................................................................47
10.7.1.1.
Progression-free Survival........................................................................................47
10.7.1.2.
Overall Survival .....................................................................................................48
10.7.1.3.
Overall Response Rate............................................................................................48
10.7.2.
Exploratory Endpoints............................................................................................48
10.7.2.1.
Health Care Utilization and Quality of Life Questionnaire......................................48
10.8.
Study Therapy Termination ....................................................................................48
10.9.
Deaths ....................................................................................................................48
10.10.
Interim Analysis .....................................................................................................49
10.11.
Scientific Steering Committee ................................................................................49
11.
ADVERSE EVENTS..............................................................................................50
11.1.
Monitoring, Recording and Reporting of Adverse Events .......................................50
11.2.
Evaluation of Adverse Events.................................................................................50
11.2.1.
Seriousness.............................................................................................................50
11.2.2.
Severity / Intensity..................................................................................................52
11.2.3.
Causality ................................................................................................................52
11.2.4.
Duration .................................................................................................................53
11.2.5.
Action Taken..........................................................................................................53
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11.2.2.
1.2.2.
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11.2.6.
Outcome.................................................................................................................53
11.3.
Abnormal Laboratory Values..................................................................................53
11.4.
Pregnancy...............................................................................................................53
11.4.1.
Female Subjects......................................................................................................54
11.4.2.
Male Subjects.........................................................................................................54
11.5.
Reporting of Serious Adverse Events......................................................................54
11.5.1.
Safety Queries ........................................................................................................55
11.6.
Expedited Reporting of Adverse Events..................................................................55
12.
DISCONTINUATIONS .........................................................................................56
12.1.
Study Treatment Discontinuation............................................................................56
12.2.
Study Discontinuation ............................................................................................56
12.3.
Subject Replacement ..............................................................................................57
13.
EMERGENCY PROCEDURES.............................................................................58
13.1.
Emergency Contact.................................................................................................58
14.
REGULATORY CONSIDERATIONS...................................................................59
14.1.
Good Clinical Practice............................................................................................59
14.2.
Investigator Responsibilities ...................................................................................59
14.3.
Subject Information and Informed Consent.............................................................59
14.4.
Confidentiality........................................................................................................60
14.5.
Protocol Amendments.............................................................................................60
14.6.
Institutional Review Board/Independent Ethics Committee Review and 
Approval ................................................................................................................60
14.7.
Ongoing Information for Institutional Review Board / Ethics Committee................61
14.8.
Closure of the Study ...............................................................................................61
15.
DATA HANDLING AND RECORDKEEPING.....................................................62
15.1.
Data/Documents .....................................................................................................62
15.2.
Data Management...................................................................................................62
15.3.
Record Retention....................................................................................................62
16.
QUALITY CONTROL AND QUALITY ASSURANCE........................................64
16.1.
Study Monitoring and Source Data Verification......................................................64
16.2.
Audits and Inspections............................................................................................64
17.
PUBLICATIONS ...................................................................................................65
18.
REFERENCES.......................................................................................................66
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19.
APPENDICES........................................................................................................68
Appendix A:
Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 ..............68
Appendix B:
ECOG Performance Status Score.......................................................................72
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LIST OF TABLES
Table 1:
Blinded Radiology Assessment of Overall Response Rate (ITT Population) ...........20
Table 3:
Table of Events.......................................................................................................28
Table 4:
Permanent Dose Reductions for Hematologic and Neurologic Toxicities and 
Dosing on the Study ...............................................................................................40
Table 5:
Evaluation of Target Lesions ..................................................................................70
Table 6:
Evaluation of Non-Target Lesions ..........................................................................70
.40
40
........
.......70
70
.............
.......
7

nab-paclitaxel
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LIST OF FIGURES
Figure 1:
Overall Study Design..............................................................................................26
&(/*(1(35235,(7$5<,1)250$7,21

nab-paclitaxel
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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). A trend that is becoming more 
prevalent is personalized NSCLC treatment based on tumor histology (squamous versus
non-squamous), on molecular characteristics of the tumor, and on the patient’s clinical status 
using agents targeting specific receptors and kinases and pathways (ie, epidermal growth factor 
receptor [EGFR], echinoderm microtubule-associated protein-like 4 [EML4] and anaplastic 
lymphoma kinase [ALK] fusion protein).
In advanced NSCLC, the prevalently used combination of solvent-based paclitaxel/carboplatin 
results in modest response rate, survival, and toxicity. Paclitaxel is currently available in the 
proprietary product Taxol®(paclitaxel) Injection, manufactured by Bristol-Myers Squibb (New 
York, NY) and by several other generic drug manufacturers. Taxol consists of paclitaxel 
dissolved in a proprietary solvent, Cremophor® EL (BASF, Ludwigshafen, Germany), and 
ethanol. While this solvent system addresses the poor water solubility of paclitaxel, the Taxol 
formulation has a number of other limitations. For example, Taxol administration requires 
routine premedication with corticosteroids, diphenhydramine, and H2 antagonists to reduce the 
incidence of hypersensitivity reactions and histamine release caused by a response to the 
formulation vehicle (Gelderblom, 2001; Lorenz, 1997; Weiss, 1990). Furthermore, the solvent 
alters drug pharmacokinetics (PK), leading to highly increased systemic drug exposure, 
decreased drug clearance, nonlinear PK, and lack of dose-dependent antitumor activity 
(Sparreboom, 1999; ten Tije, 2003; van Tellingen, 1999). Also, Taxol must be administered over 
a period of either 3 hours or 24 hours, and requires the use of specialized infusion sets and in-line 
filters that do not contain di[2-ethylhexyl] phthalate (DEHP).
Compared with solvent-based paclitaxel, nab-paclitaxel exhibits 10-fold higher mean Cmax of 
free paclitaxel, delivers 33% higher drug concentration to tumors in preclinical xenograft 
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models, and demonstrates enhanced transport across endothelial cell monolayers (Desai, 2006; 
Gardner, 2008). The Cremophor EL-free medium enables nab-paclitaxelto be given in a shorter
duration without the need for premedication to prevent solvent-related hypersensitivity reactions.
In addition, standard tubing and intravenous (IV) bags may be used for the IV administration of 
nab-paclitaxel. nab-Paclitaxel for Injectable Suspension is approved for the treatment of 
metastatic breast cancer (globally) and for the treatment of adenocarcinoma of the pancreas (US). 
For NSCLC, nab-paclitaxel is approved in the US in combination with carboplatin for first-line 
treatment of patients with locally advanced or metastatic NSCLC who are not candidates for 
curative surgery or radiation therapy. The recommended dose of nab-paclitaxel for the NSCLC 
indication is 100 mg/m2 administered as an intravenous infusion over 30 minutes on Days 1, 8, 
and 15 of each 21-day cycle.
1.2.
nab-Paclitaxel in NSCLC
The Food and Drug Administration (FDA) approval of nab-paclitaxel was based on the 
evaluation of Phase I and II data (Belani, 2008; Rizvi, 2008; Socinski, 2010), as well as the 
pivotal Phase III study (CA031). The pivotal Phase III study was a multicenter, randomized, 
open-label study conducted in 1052 chemo naive subjects with Stage IIIB/IV non-small cell lung 
cancer to compare nab-paclitaxel in combination with carboplatin to paclitaxel injection in 
combination with carboplatin as first-line treatment in patients with advanced non-small cell lung
cancer. nab-Paclitaxel was administered as an intravenous 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 intravenous infusion over 3 hours at a dose of 200 mg/m2, following premedication. In both 
treatment arms carboplatin at a dose of AUC = 6 mg*min/mL was administered intravenously 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 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 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%), see Table 1].
Non-inferiority analysis of overall survival (OS) demonstrated that nab-paclitaxel/carboplatin
(nab-p/C) treatment is not inferior to solvent-based paclitaxel/carboplatin (sb-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).  Toxicities, particularly neuropathy and neutropenia were less 
pronounced using nab-paclitaxel in the dose and schedule employed.
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Table 1:
Blinded Radiology Assessment of Overall Response Rate (ITT Population)
Variable
Category/Statistic
nab-Paclitaxel/
Carboplatin
(N=521)
sb-Paclitaxel/
Carboplatin
(N=531)
Response Rate 
Ratio
(pA/pT)a
p-value
Patients with Confirmed Complete or Partial Overall Response
n (%)
170 (33%)
132 (25%)
1.313
0.005*
Confidence Interval (CI) b
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%)
a PA/PT equals response rate of nab-paclitaxel/response rate of sb paclitaxel.
b 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 were assessed in 514 nab-paclitaxel/carboplatin-treated patients and 524 
paclitaxel injection/carboplatin-treated patients. The following common (≥ 10% incidence) 
adverse events were observed at a similar incidence in nab-paclitaxel and paclitaxel 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).
1.3.
Rationale for Further Study of nab-Paclitaxel as First-line Treatment 
in Elderly Subjects with Advanced NSCLC
The tolerability of doublet chemotherapy in elderly patients with advanced NSCLC is an
important therapeutic consideration, whereby the landmark IFCT 0501 reported that first-line sb-
paclitaxel given weekly three weeks out of four coupled with carboplatin every 4 weeks (ie, 
21days of treatment followed by one-week break) improved efficacy over single-agent 
chemotherapy (either gemcitabine or vinorelbine) in patients 70 years or older with advanced 
NSCLC. The results demonstrated that doublet chemotherapy was feasible in this elderly
population with an acceptable toxicity profile, when sb-paclitaxel/carboplatin was given as 21
days of treatment followed by one-week rest. The combination also resulted in a significant 
improvement in OS (median, 10.3 versus 6.2 months; HR = 0.639, 95% CI:0.52-0.79, p <
0.0001), with 1-year survival rates of 45.1% versus 26.9% for doublet therapy and monotherapy.  
This prospective trial set a standard, against which doublet-regimens must be measured in the 
elderly population with advanced NSCLC.
In the CA031 study of nab-paclitaxel (Abraxane) in combination with carboplatin, patients were 
stratified by age (< 70 years old versus ≥ 70 years old). Fifteen percent of ITT patients were 
elderly (≥70 years: nab-paclitaxel, n = 74: sb-paclitaxel, n = 82). Baseline characteristics were 
generally well balanced between treatment arms in elderly population, and subgroup analyses 
were performed to assess the influence of age on the primary efficacy endpoint of overall 
response rate as well as PFS and OS (Socinski, 2013). 
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nab-paclitaxel
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Of note, the post-hoc analysis of the CA031 trial showed marked improvement in survival in the 
nab-paclitaxel/carboplatin arm. Amongst 156 elderly (≥70 years of age) subjects randomized on 
the study, OS was 19.9 months versus 10.4 months (HR: 0.583, p = 0.009) in favor of the nab-
p/C arm compared to sb-p/C. The proportion of patients who had complete or partial response 
were consistently higher in all age stratum groups for the nab-paclitaxel/carboplatin regimen 
relative to the sb-paclitaxel/carboplatin regimen (in patients ≥ 70 years of age 34% versus 24% 
respectively, ratio of rates 1.385, p = 0.196, 
).
 
 
 
Although it was a statistically significant treatment effect in favor of nab-paclitaxel in the elderly 
subgroup from CA031 trial, 46% of patients in the nab-paclitaxel/carboplatin arm experienced 
dose reductions or dose delays. Approximately 92% of dose modifications and reductions were 
due to AEs. The most common clinical AEs in this subgroup were hematologic Grade ≥ 3 
neutropenia (45%), anemia (22%) and thrombocytopenia (19%). Approximately 18% of the 
elderly population in the CA031 trial had Grade ≥ 2 peripheral neuropathy. Despite that,
approximately 10% more elderly patients in the nab-paclitaxel arm were able to receive second-
line therapy compared to sb-paclitaxel (61% versus 50%, respectively), possibly because they 
may have been in better shape due to a better tolerated first-line regimen with nab-paclitaxel or 
better disease and symptom control as demonstrated as improvement in ORR.
The results from the elderly subset in CA031 trial showed the combination of nab-paclitaxel and 
carboplatin to be particularly promising. We hypothesize that the tolerability can be improved 
further by introducing a one week break at the end of each treatment cycle (similar to the 
schedule advocated by Quoix, 2011) among elderly patients.  Reducing the rate of the most 
common AEs (Grade ≥ 3 myelosuppression toxicities and Grade ≥ 2 peripheral neuropathy) by 
16% will be clinically meaningful as it can potentially improve tolerability, quality of life and 
allow patients to receive treatment for a longer period of time, without necessarily compromising 
efficacy.  
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nab-paclitaxel
Protocol ABI-007-NSCL-005
Celgene Corporation
Confidential and Proprietary
22
ABI-007-NSCL-005 Final: 06 Mar 2014
2.
STUDY OBJECTIVES
2.1.
Primary Objectives 
!
To assess the safety and tolerability of continuous weekly versus weekly times three 
with one-week break nab-paclitaxel (Abraxane) in combination with carboplatin as 
first-line treatment for advanced NSCLC in elderly subjects (≥ 70 years old).
2.2.
Secondary Objective
!
To evaluate the efficacy of nab-paclitaxel in combination with carboplatin in elderly 
subjects with advanced NSCLC.
2.3.
Exploratory Objectives
!
To assess healthcare resource utilization for the two nab-paclitaxel treatment arms.
!
To assess the Lung Cancer Symptom Scale (LCSS) and EuroQol Group 5-Dimension 
Self-Report Questionnaire score (EQ-5D) for the two nab-paclitaxel treatment arms.
!
 
 
!
 
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nab-paclitaxel
Protocol ABI-007-NSCL-005
Celgene Corporation
Confidential and Proprietary
23
ABI-007-NSCL-005 Final: 06 Mar 2014
3.
STUDY ENDPOINTS
3.1.
Primary Endpoint
!
The primary study endpoint is the percentage of subjects with either peripheral 
neuropathy of Grade ≥2 or myelosuppression AEs of Grade ≥3 based on the local
laboratory values for ANC, platelet count, and hemoglobin. All AEs will be graded 
using NCI CTCAE v4.0. 
3.2.
Secondary Endpoints
The secondary endpoints are: 
3.2.1.
Safety
!
The type, frequency, and severity of AEs and SAEs. 
!
Discontinuation rate.
!
Dose intensity administered.
!
The incidence of dose reduction and dose delay.
3.2.2.
Efficacy
!
Progression-free Survival (PFS).
!
Overall response rate (ORR) using RECIST v1.1 guidelines.
!
Overall Survival (OS).
3.3.
Exploratory Endpoints
!
Healthcare resource utilization during the study using a questionnaire.
!
Changes in the LCSS and EQ-5D.
!
 
!
 
 
!
Additional exploratory endpoints may be defined in the statistical analysis plan 
(SAP), if applicable.
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nab-paclitaxel
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Celgene Corporation
Confidential and Proprietary
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ABI-007-NSCL-005 Final: 06 Mar 2014
4.
OVERALL STUDY DESIGN
4.1.
Study Design
This is a Phase IV, randomized, open-label, multicenter study of continuous weekly versus
weekly times three with one-week break nab-paclitaxel in combination with carboplatin as first-
line treatment in elderly subjects (≥ 70 years old) with advanced NSCLC who are not candidates 
for curative surgery or radiation therapy.
Subjects will be randomized 1:1 to receive one of the following treatments:
Arm A (21-day treatment cycle):
!
nab-Paclitaxel 100 mg/m2 intravenous (IV) infusion over 30 minutes on Days 1, 8, 
and 15 of each 21-day treatment cycle
!
Carboplatin AUC = 6 mg*min/mL IV on Day 1 of each 21-day treatment cycle after 
completion of nab-paclitaxel infusion 
Arm B (21-day treatment followed by one-week break cycle, 28-day duration):
!
nab-Paclitaxel 100 mg/m2 intravenous (IV) infusion over 30 minutes on Days 1, 8, 
and 15 of each 21-day treatment  followed by one-week break cycle
!
Carboplatin AUC = 6 mg*min/mL IV on Day 1 of each 21-day treatment followed by 
one-week break cycle, after completion of nab-paclitaxel infusion 
The study will consist of a 28-day Screening Period, a Treatment Period, and a Follow-up
Period.
The Screening Period will start from signing the Informed Consent Form (ICF) until first dose of 
study drug. 
The Treatment Period will start from first dose of study drug until End-of-Treatment Visit 
(which is defined as visit with last dose of study drug).
Follow-up Period will start after End-of-Treatment visit.
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, or withdrawal of 
consent, in accordance with local standard of care.
Tumor evaluations will be assessed locally and response (Complete Response (CR) or Partial 
Response (PR)) will be determined according to RECIST guidelines, Version 1.1. In both 
treatment arms, tumor assessments will be conducted at screening, every 42 days (-3/+7 days) 
(starting from Day 1 Cycle 1) until disease progression (even if treatment has been 
discontinued), withdrawal of consent, lost to follow-up, death or if clinically indicated while on 
treatment.
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nab-paclitaxel
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Celgene Corporation
Confidential and Proprietary
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Local laboratory test data for ANC, platelet count, hemoglobin and serum creatinine will be 
collected in the eCRFs. All other routine laboratory test data except those mentioned above will 
not be collected in the eCRF unless they are determined to be clinically significant laboratory 
abnormalities. A clinically significant laboratory abnormality will be reported as an AE, or SAE,
and the specific associated laboratory parameter(s) should be recorded in the laboratory 
assessments eCRF. Local safety laboratory data will also be the primary guide for eligibility and 
subject management. 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 locally for routine diagnosis.  
4.1.1.
Follow-up Period
All subjects who discontinue from treatment for reasons other than withdrawal of consent or lost 
to follow-up, will enter the Follow-up Period. It will consist of a visit 28 days after treatment 
discontinuation following by follow-up for survival approximately every 90 days (+/- 14 days or 
when they are seen for routine care) by phone call or chart review for documentation of last 
contact for up to 6 months after the last subject is randomized or 192 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 standard of care (at least every 90 days) until documented 
progression of disease, withdrawal of consent, lost to follow-up, death or study closure.
4.2.
Study Design Rationale
The nab-paclitaxel schedule used in Arm A is in accordance with pivotal trial CA031,
ie,100 mg/m2 administered once per week on Days 1, 8 and 15 combined with carboplatin 
AUC = 6 mg*min/mL administered on Day 1 every 21 days, as approved by the FDA.  The nab-
paclitaxel/carboplatin schedule used in Arm B is the same schedule as the current approved nab-
paclitaxel label with introduction of a one-week break following 21 days of treatment. This 
study will determine whether the one-week break can further improve tolerability without 
compromising efficacy (similar to the schedule advocated by Quoix, 2011) among elderly 
patients.  Reducing the rate of the most common AEs (Grade ≥ 3 myelosuppression toxicities 
and Grade ≥ 2 peripheral neuropathy) by 16% will be clinically meaningful as it can potentially 
improve tolerability, quality of life and allow subjects to receive treatment for a longer period of 
time.
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nab-paclitaxel
Protocol ABI-007-NSCL-005
Celgene Corporation
Confidential and Proprietary
26
ABI-007-NSCL-005 Final: 06 Mar 2014
Figure 1:
Overall Study Design
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nab-paclitaxel
Protocol ABI-007-NSCL-005
Celgene Corporation
Confidential and Proprietary
27
ABI-007-NSCL-005 Final: 06 Mar 2014
4.3.
Study Duration 
Recruitment is expected to take approximately 24 months, and the analysis of PFS will be 
performed when approximately 192 PFS events have occurred, estimated as approximately 28
months from first subject randomized. The total length of this Phase IV 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 SAP, 
whichever is the later date.
for 
or
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d/or the S

nab-paclitaxel
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ABI-007-NSCL-005 Final: 06 Mar 2014
5.
TABLE OF EVENTS
Table 3:
Table of Events
Screening
/ Baseline
Treatment Perioda
Every cycle starting with Cycle 1
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) 
(counting from 
Day 1 Cycle 1)
End-of-
Treatment
Visit (last dose 
of study drug)
28-day Follow-up 
Visit (after last 
dose of study 
drug)
Survival Follow-Upb
Every 90 days (+/-
14 days) (after 28-
day follow-up visit)
Informed Consent
X
-
-
-
-
-
-
-
Medical History, Prior Medication and Procedures
X
-
-
-
-
-
-
-
CT Scan of Complete Chest (including base of neck 
and adrenal glands) and any other studies required 
for Tumor Imagingc
X
-
-
-
X c
X c
-
X c
Weight and Heightd
X
X
X
X
-
-
-
-
Body Surface Area (BSA) Calculationd
X
-
-
-
-
-
-
-
ECOG status
X
X
-
-
-
X
X
-
Concomitant Medication/Procedures
-
X
X
X
-
X
X
X
Peripheral Neuropathy Assessmente
X
X
X
X
-
X
X
-
Healthcare Resource Utilization Questionnaire
-
X
-
-
-
X
X
-
Hematologyf (ANC, platelet count, Hgb)
X
X
X
X
-
X
X
-
Serum Chemistryf (serum creatinine)
X
X
-
-
-
X
X
-
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nab-paclitaxel
Protocol ABI-007-NSCL-005
Celgene Corporation
Confidential and Proprietary
29
ABI-007-NSCL-005 Final: 06 Mar 2014
Table 3:
Table of Events (Continued)
Screening
/ Baseline
Treatment Perioda
Every cycle starting with Cycle 1
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
(last dose of 
study drug)
28-day Follow-up 
Visit (after last 
dose of study 
drug)
Survival Follow-Upb
Every 90 days (+/-
14 days) (after 28-
day follow-up visit)
Adverse Event Evaluation
After signing ICF and until 28 days after the last dose of study drug
nab-paclitaxel Administration/accountabilityg
-
X
X
X
-
-
-
-
Carboplatin Administration/accountabilityg
-
X
-
-
-
-
-
-
LCSS and EQ-5D
-
X
-
-
-
X
X
-
Survival phone call (or chart review for 
documentation of last contact or when they are seen 
for routine care
-
-
-
-
-
-
-
Xb
Electrocardiogram (ECG)
Will be done as per standard of care at screening, during the Treatment Period and as clinically indicated; however, results 
will not be routinely collected in the eCRFs. Results will be collected in the eCRFs as AE or SAE only if results are abnormal 
and clinically significant.
CT Scan of the Head or Brain Magnetic Resonance 
Imaging (MRI)
Bone Scan (X-rays if needed)
Physical Examination
Vital Signs
AE = Adverse Event; ANC = absolute neutrophil count; CT = Computed Tomography; ECOG = Eastern Cooperative Oncology Group; eCRF = electronic Case Report Form; EQ-
5D = EuroQol 5D; ICF = informed consent form; LCSS = Lung Cancer Symptom Scale; SAE = Serious Adverse Event.
a Treatment Period:  Arm A: nab-paclitaxel Days 1, 8, and 15 and carboplatin Day 1. Arm B: nab-paclitaxel Days 1, 8, and 15 and carboplatin Day 1 followed by one-week break.
b Every 90 (+/-14) days (from 28-day Follow-up Visit) or when they are seen for routine care for up to 6 months after the last subject is randomized or 192 PFS events have been 
observed, whichever comes later.
c All subjects must have a radiographically documented measurable tumor(s) by RECIST Version 1.1 criteria: CT scan of complete chest (including base of neck and adrenal 
glands) are performed at screening, every 42 days (-3/+7 days) thereafter (counting from Day 1 Cycle 1) until disease progression, withdrawal of consent, lost to follow-up, 
death and if clinically indicated while on treatment. 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 standard of care (at least every 90 days) until 
documented progression of disease, withdrawal of consent, lost to follow-up, death or study closure.
d BSA will be calculated at screening and recalculated if body weight changes by more than 10% from previous assessment. Height will only be obtained at Screening Visit. 
Weight will be obtained at screening and every visit during the Treatment Period before administration of study drug, but will only be collected on the eCRF for the Screening 
Visit.
e The occurrence of peripheral neuropathy will be reported by the investigator per protocol as an AE or SAE.
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nab-paclitaxel
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Celgene Corporation
Confidential and Proprietary
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f Laboratory assessments will be done prior to each nab-paclitaxel treatment as per standard of care during the study and as clinically indicated. ANC, platelet count, hemoglobin
(Hgb) level and serum creatinine results will be collected in the eCRFs (all other routine laboratory test data except those mentioned above will not be collected in the eCRF
unless it is clinically significant, which will then be reported as AEs or SAEs, and the specific associated laboratory parameter(s) should be recorded on the laboratory 
assessments eCRF).
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6.
PROCEDURES
Subjects will be provided with a written 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 Interactive Randomization 
Technology (IRT) system 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 screen fail may re-screen up to 2 times at any time and an ICF will need to 
be re-signed, 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 to be randomized. 
6.1.
Medical History
Only clinically significant or ongoing medical conditions will be recorded at screening on the 
eCRF. 
6.2.
Prior and Concomitant Medications/Procedures
Prior medications are considered any medications stopped prior to the date of the first dose of 
study drug. Only prior medications/procedures (of clinically significant or ongoing medical 
conditions) within 28 days of time of signature on the ICF should be recorded. All NSCLC-
related prior medications/procedures (including radiation therapy) should be recorded regardless 
of time. 
Concomitant medications and procedures are considered any medications or procedures that 
were taken on or after the date of the first dose of study drug. All subjects will have concomitant 
medications and procedures (including radiation therapy) recorded 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.
Computed Tomography (CT) Scan of Complete Chest (including 
base of neck and adrenal glands)
A CT scan of complete chest (including base of neck and adrenal glands) 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) until treatment discontinuation or withdrawal of consent. Those subjects entering 
the Follow-up Period without documented progression will continue to have CT scans in 
accordance with standard of care (at least every 90 days) until documented progression of 
disease, withdrawal of consent, lost to follow-up, death or study closure. 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.
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nab-paclitaxel
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6.4.
Weight
Weight will be obtained at screening and at every visit during the Treatment Period before 
administration of study drug, but will only be collected on the eCRF for the Screening Visit.
Additional weights may be collected per local standards at any time during the study as needed.
6.5.
Body Surface Area (BSA) Calculation and Height
Height will be collected at screening only, and BSA will be calculated at screening of the study.
BSA will be recalculated if body weight changes by more than 10% from previous assessment.
6.6.
ECOG Performance Score
Eastern Cooperative Oncology Group performance 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, 8, 15 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.
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 study drug, including any unscheduled visits. See Section 11 for details. 
6.9.
Lung Cancer Symptom Scale Questionnaire and EQ-5D
The LCSS and EQ-5D 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 comprises 5 questions on 
mobility, self-care, usual activities, pain/discomfort, anxiety/depression and a VAS for overall 
QoL. These questionnaires will be completed at Day 1 of every Treatment Period, 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 at Day 1 of every treatment cycle, at the End-of-Treatment visit and at 28-day Follow-
up Visit. 
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nab-paclitaxel
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ABI-007-NSCL-005 Final: 06 Mar 2014
6.11.
Electrocardiogram
Electrocardiograms (ECGs) will be done per standard of care at screening, 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.
6.12.
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. Results will be collected in 
the eCRFs as an AE or SAE only if the results are abnormal and clinically significant.
6.13.
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 as AE or SAE only if 
results are abnormal and clinically significant.
6.14.
Physical Examinations
Physical examinations 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 as AE or SAE only if 
results are abnormal and clinically significant.
6.15.
Vital Signs
Vital signs 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 as AE or SAE only if results are 
abnormal and clinically significant.
6.16.
Laboratory Assessments
Laboratory assessments will be done as indicated in Table 3 by local laboratories as per standard 
of care during the study and as clinically indicated. Local laboratory test data for ANC, platelet 
count and hemoglobin must be collected at screening, each visit before administration of study 
drug, at the End-of-Treatment visit and at the 28-day Follow-up Visit in the eCRF. Serum 
creatinine must be collected at screening, Day 1 of each cycle, at the End-of-Treatment visit and 
at the 28-day Follow-up Visit in the eCRF. Normal ranges for these selected parameters will be 
collected on the eCRF. All other laboratory test data, except those mentioned above, will not be 
collected routinely in the eCRF. Local safety laboratory data will also be the primary guide for 
eligibility and subject management. It is the responsibility of the investigator to assess the 
clinical significance of all abnormal values as defined by the reference ranges from the local 
laboratory. All clinically significant laboratory abnormalities (Section 11.3) are to be recorded as 
AEs on the AE eCRF, and the specific laboratory parameter(s) as well as the corresponding 
normal ranges should be recorded on the laboratory assessments eCRF. Clinically significant 
laboratory abnormalities at screening may result in subject ineligibility for the study and should 
not be captured as 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.
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6.17.
Tumor Tissue Sample Collection and Peripheral Blood Collection
(Exploratory Assessments) 
Provision of tumor tissue is mandatory for study enrollment, except when no tumor tissue is 
extant and this requirement would necessitate a new procedure such as a biopsy to collect it.  
 
 
 
 
 
 
 
 
 
 
 
 
 
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
locally for routine diagnosis.
 
 
 
 
6.18.
Survival 
After the End-of-Treatment Visit, the subjects will have a 28-day Follow-up Visit followed by a
call or chart review for documentation of last contact approximately every 90 days (or when they 
are seen for routine care) for up to 6 months after the last subject is randomized or 192 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 or their medical records will be 
reviewed to determine a last contact date for routine purposes. Those subjects entering the 
Follow-up Period without documented progression will continue to have CT scans in accordance 
with standard of care (at least every 90 days) until documented progression of disease, 
withdrawal of consent, lost to follow-up, death or study closure.
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nab-paclitaxel
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Celgene Corporation
Confidential and Proprietary
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ABI-007-NSCL-005 Final: 06 Mar 2014
7.
STUDY POPULATION
7.1.
Number of Subjects and Sites
Elderly (≥70 years of age) male and female subjects with locally advanced or metastatic NSCLC 
with no prior chemotherapy for metastatic disease will be eligible for this study. The study will 
enroll approximately 284 subjects. The study will be conducted at approximately 65 sites in the 
United States.
7.2.
Inclusion Criteria
Subjects must satisfy the following criteria to be randomized in the study:
1. Age ≥ 70 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 locally advanced or metastatic NSCLC who are 
not candidates for curative surgery or radiation therapy.
5. No other current active malignancy requiring anticancer therapy.
6. Radiographically documented measurable disease (defined by the presence of 
≥1 radiographically documented measurable lesion) (See Appendix A).
7. No prior chemotherapy for the treatment of metastatic disease. Adjuvant chemotherapy is 
permitted providing cytotoxic chemotherapy was completed 12 months prior to signing 
the ICF and without disease recurrence.
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]), 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 mg/dL (unless there is a known history of Gilberts Syndrome).
13. Creatinine clearance (CrCl) > 40 mL/min calculated using Cockcroft-Gault equation (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 who (1) have undergone hysterectomy (the surgical removal of the uterus) or 
bilateral oophorectomy (the surgical removal of both ovaries) or (2) have been naturally 
postmenopausal for at least 24 consecutive months (ie, has not had menses at any time 
during the preceding 24 consecutive months).
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15.5. F

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Celgene Corporation
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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 28 days following study drug 
discontinuation, even if he has undergone a successful vasectomy. 
7.3.
Exclusion Criteria
The presence of any of the following will exclude a subject from enrollment:
1. Evidence of active brain metastases, including leptomeningeal involvement (prior 
evidence of brain metastasis are permitted only if treated and stable and off therapy for
≥4 weeks prior to signing ICF). MRI of the brain (or CT scan w/contrast) is preferred for 
diagnosis.
2. History of leptomeningeal disease.
3. Only evidence of disease is non-measurable.
4. Preexisting peripheral neuropathy of Grade 2, 3, or 4 (per CTCAE v4.0).
5. Venous thromboembolism within 1 month prior to signing ICF.
6. Current congestive heart failure (New York Heart Association Class II-IV).
7. History of the following within 6 months prior to first administration of a study drug: a 
myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass 
graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled 
hypertension, clinically significant cardiac dysrhythmia or clinically significant ECG 
abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder.
8. Subject has a known infection with hepatitis B or C, or history of human 
immunodeficiency virus (HIV) infection, or subject receiving immunosuppressive or 
myelosuppressive medications that would in the opinion of the investigator, increase the 
risk of serious neutropenic complications.
9. Subject has an 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.
10. History of interstitial lung disease, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, or 
pulmonary hypersensitivity pneumonitis.
11. Treatment with any investigational product within 28 days prior to signing the ICF.
12. History of allergy or hypersensitivity to nab-paclitaxel or carboplatin.
13. Currently enrolled in any other clinical protocol or investigational trial that involves
administration of experimental therapy and/or therapeutic devices.
                                               
* 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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nab-paclitaxel
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Celgene Corporation
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14. 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.
15. Subject has any other malignancy within 5 years prior to randomization. Exceptions 
include the following: squamous cell carcinoma of the skin, in-situ carcinoma of the 
cervix, uteri, non-melanomatous skin cancer, carcinoma in situ of the breast, or incidental 
histological finding of prostate cancer (TNM stage of T1a or T1b). All treatment of 
which should have been completed 6 months prior to signing ICF.
16. Any condition including the presence of laboratory abnormalities, which places the 
subject at unacceptable risk if he/she were to participate in the study.
17. Any medical condition that confounds the ability to interpret data from the study.
18. Females 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).
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8.
DESCRIPTION OF STUDY TREATMENTS
8.1.
Description of Study Drug(s)
Treatment
Subjects will receive open-label nab-paclitaxel and carboplatin during the Treatment Period of 
the study. The nab-paclitaxel and carboplatin are designated as noninvestigational products and 
investigative sites will use standard of care (commercially available) product via prescription.
The preparation for IV administration procedures should be followed as per approved 
Prescribing Information.
8.1.1.
nab-Paclitaxel
Each single-use 50 mL vial contains paclitaxel (100 mg) and approximately 900 mg human 
albumin as a stabilizer.
Unreconstituted nab-paclitaxel should be stored in accordance with the product label. 
Reconstituted nab-paclitaxel should be used immediately. If not used immediately, the vial of 
reconstituted nab-paclitaxel must be placed in its carton and be placed in a refrigerator at 2° to 
8°C (36° to 46°F) for a maximum of 8 hours. Both forms should be stored in an area free of 
environmental extremes and should be 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 study drug storage.
8.1.2.
Carboplatin
Carboplatin is a platinum coordination compound that is used as a cancer chemotherapeutic
agent. The chemical name for carboplatin is platinum diammine [1,1-cyclobutane-
dicarboxylato (2-)-0,0’]-,(SP-4-2). Carboplatin is a crystalline powder with the molecular 
formula of C6Hl2N204Pt and a molecular weight of 371.25. It is soluble in water at a rate of 
approximately 14 mg/mL, and the pH of a 1% solution is 5 to 7. It is virtually insoluble in 
ethanol, acetone, and dimethylacetamide.
For additional information about carboplatin storage, preparation, and administration please refer 
to the package insert. 
8.2.
Treatment Administration and Schedule
Approximately 284 subjects will be treated with nab-paclitaxel plus carboplatin until disease 
progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of 
consent.
Treatment will commence on Day 1, in accordance with standard of care of first-line treatment of 
NSCLC: 
Arm A:
!
nab-Paclitaxel 100 mg/m2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 
21-day treatment cycle,
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NSCLC

nab-paclitaxel
Protocol ABI-007-NSCL-005
Celgene Corporation
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ABI-007-NSCL-005 Final: 06 Mar 2014
!
Carboplatin AUC = 6 mg*min/mL IV on Day 1 of each 21-day treatment cycle, after 
completion of nab-paclitaxel infusion
OR
Arm B:
!
nab-Paclitaxel 100 mg/m2 IV infusion over 30 minutes on Days 1, 8 and 15 of each 
21-day treatment with one-week break cycle (ie, every 28 days),
!
Carboplatin AUC = 6 mg*min/mL IV on Day 1 of each 21-day treatment with one-
week break cycle (ie, every 28 days), after completion of nab-paclitaxel infusion.
8.3.
Dose Modifications
Subjects who experience any of the adverse drug reactions in Table 4 will be dose reduced as per 
Table 4 during treatment. 
!
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 500 cells/mm3 and platelet count of at least 50,000 cells/mm3 on 
Days 8 or 15 of the cycle. Upon resumption of dosing, permanently reduce nab-
paclitaxel and carboplatin doses as outlined in Table 4.
!
Withhold nab-paclitaxel for Grade 3 or 4 peripheral neuropathy. Resume nab-
paclitaxel and carboplatin at reduced doses (Table 4) when peripheral neuropathy 
improves to Grade 1 or completely resolves.
Re-escalation is not permitted at any time. 
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nab-paclitaxel
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Celgene Corporation
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Table 4:
Permanent Dose Reductions for Hematologic and Neurologic Toxicities and Dosing on the Study
Dose Modification During Treatment for A and B arms
Adverse Drug Reaction
Occurrence
nab-Paclitaxel Dose
(mg/m2)
Carboplatin Dose 
(AUC mg*min/mL)
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
4.5
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50
3.0
Third
Discontinue Treatment*
Platelet count < 50,000/mm3
First
75
4.5
Second
Discontinue Treatment*
Sensory Neuropathy Grade 3 or 4
First
75
4.5
Second
50
3.0
Third
Discontinue Treatment*
Grade 2 or 3 cutaneous toxicity
Grade 3 diarrhea
Grade 3 mucositis
Any other Grade 3 or 4 nonhematologic toxicity
First
75
4.5
Second
50
3.0
Third
Discontinue Treatment*
Grade 4 cutaneous toxicity, diarrhea or mucositis
First
Discontinue Treatment*
ANC = Absolute Neutrophil Count; AUC = area under the curve.
* If an adverse event that requires dose reduction recurs after the dose has been reduced twice, 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. Re-Escalation is not 
permitted at anytime.
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8.4.
Method of Treatment Assignment
The Treatment Period of the study is open-label. Enrollment/randomization will occur via IRT 
system for all periods of the study. 
8.5.
Packaging and Labeling
nab-Paclitaxel and carboplatin are designated as noninvestigational products and investigative 
sites will use standard of care (commercially available) product via prescription.
8.6.
Study Drug Accountability and Disposal
nab-Paclitaxel and carboplatin are designated as noninvestigational products and investigative 
sites will use standard of care (commercially available) product via prescription. Procedures for 
proper handling and disposal of anticancer drug must comply with the relevant health, safety and 
environment regulations.
8.7.
Study Drug Compliance
Study drug will be administered only by study site personnel and accurate recording of all study 
drug 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 or carboplatin dosing only.
On a per dose basis, an overdose is defined as 10% over the protocol-specified dose of nab-
paclitaxel or carboplatin given to a 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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nab-paclitaxel
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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 antiemetic medications, white blood cell (WBC)
growth factors, erythrocyte stimulating agents, zolendronic acid, and denosumab) is permitted
and may be administered at the discretion of the investigator, according to local guidelines. 
9.2.
Prohibited Concomitant Medications and Procedures
Other antineoplastic agents or Investigational Product than what is specified in the protocol are 
prohibited.
9.3.
Required Concomitant Medications and Procedures
Not applicable.
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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.
10.1.
Overview
Approximately 284 subjects will be randomized in a 1:1 ratio to two treatment arms (142 
subjects per group).  Arm A will receive nab-paclitaxel 100 mg/m2 administered on Days 1, 8 
and 15 followed by carboplatin AUC = 6 mg*min/mL on Day 1 of each 21-day treatment cycle. 
Arm B will receive the same treatment in the same schedule as that of Arm A during the first 21 
days of treatment, but followed by a one-week break prior to the start of next cycle (28-day 
duration). All subjects will receive the assigned study treatment until disease progression, 
unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance of 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 2 baseline or prognostic factors:
!
ECOG performance status (0 versus 1)
!
Histology (squamous cell carcinoma versus non-squamous cell carcinoma)
10.2.
Study Population Definitions
10.2.1.
Intent-to-treat Population
The primary efficacy analysis will be performed on the ITT population, which includes all 
randomized subjects regardless of whether the subject receives any study drug 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 study drug and have been treated in the arm they were assigned to. Additional analyses 
utilizing the PP population will be described in the SAP.
10.2.3.
Treated Population
The treated population will consist of all randomized subjects who receive at least one dose of 
study drug. The treatment groups for 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 assess the safety and tolerability of nab-paclitaxel in 
combination with carboplatin administered in 21-day treatment cycles continuously or with a 
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one-week break in between cycles for the treatment of locally advanced or metastatic NSCLC in 
elderly subjects (≥ 70 years old). 
The primary study endpoint (also the primary safety endpoint) is the percentage of subjects with 
either peripheral neuropathy of Grade ≥2 or myelosuppression AEs of Grade ≥3 based on the 
local laboratory values for ANC, platelet count, and hemoglobin.  For the purpose of this 
protocol, this endpoint will be referred to as the percentage of subjects with Grade ≥2 peripheral 
neuropathy or Grade ≥3 myelosuppression laboratory adverse events.  
In Protocol CA031, the Phase 3 NSCLC study of the nab-paclitaxel development program, 
approximately 2% of the elderly subjects randomized discontinued from the study prior to 
receiving any study drug.  In addition, approximately 73% of the treated elderly subjects had 
AEs that fell in the category of AEs described above for the primary safety endpoint of the 
current study.  
The study is designed to detect a difference of 16 percentage points between the 2 treatment arms 
with respect to the primary safety endpoint with 80% power and a Type-I error of 5% (two-
sided), assuming the percentage of subjects with the AEs specified above is 73% for Arm A.  
Therefore, the current study is planned to randomize approximately 284 subjects to the 2 
treatment arms in a 1:1 ratio, with the expectation that approximately 278 subjects (139 per 
group) will receive at least one dose of study drug (as observed in CA031) and be included in the 
treated population for the analysis of the primary safety endpoint.
A non-binding interim analysis for futility with the primary safety endpoint will be conducted 
when approximately a total of 139 treated subjects have either completed 6 months of study 
treatment or discontinued from the study due to progression, adverse events, deaths, lost to 
follow up, or other reasons. The stopping rule and the final marginal significance level are 
determined based on the Gamma family spending function with parameter = -7 (Hwang, 1990) to
control the Type-II error rate at 20%. The study may be stopped early for futility if the treatment 
difference is between ± 0.4% (Z-score ± 0.054) given the interim analysis is performed at 50% 
information fraction.  
Progression free survival, OS, and ORR are the key efficacy endpoints of the study.  Since the 
primary research interest of this study is to evaluate the relative safety and toxicities of the 2 
treatment arms, the sample size was calculated based on the primary safety endpoint, the 
percentage of subjects with Grade ≥2 peripheral neuropathy or Grade ≥3 myelosuppression 
laboratory AEs, hence, the study is underpowered for the key efficacy endpoint, PFS, OS and 
ORR.  Consequently, a non-significant treatment difference in PFS, OS or ORR could simply be 
a function of the sample size and/or the lack of statistical power. Therefore, the assessments of 
all efficacy endpoints will be based on the point estimates and the associated 95% confidence 
intervals for the within-group parameters of interest and the between-group differences.  P-
values for between-group comparisons will be provided to indicate the strength of association 
only.  No multiplicity adjustment with the Type-I error rate will be made. 
Of note, based on the data from CA031 it is expected that approximately 67% of the 284
randomized subjects will have a PFS event during the study (ie, approximately 192 PFS events 
total).  With 192 PFS events, there is 73% power to detect a hazard ratio (HR) of 0.69 for PFS 
improvement with Arm B over Arm A and an overall Type-I error of 5% (two-sided).  Assuming 
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an exponential distribution with a median time to PFS of 5.8 months for Arm A and proportional 
hazards, a hazard ratio of 0.69 constitutes a 2.6 months improvement for Arm B.  
As an illustration for timeline projection, assuming an exponential distribution for PFS, a 24-
month recruitment period for 284 subjects, and a median PFS of approximately 5.8 months for 
Arm A, it will take approximately 28 months from the first subject randomized to observe 192 
PFS events.
The analysis of both the safety and efficacy endpoints for the clinical study report will be 
performed when approximately 192 PFS events have been observed.  No adjustment for the 
multiple treatment comparisons among the primary and secondary study endpoints will be made.  
Subjects will be followed for OS for at least 6 months after the last subject is randomized or 192 
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.
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.
Safety Analysis
The treated population, which includes all randomized subjects who received at least one dose of 
study drug, will be the analysis population for all safety analyses.
The safety/tolerability of the two treatment arms will be monitored through continuous reporting 
and evaluated by the primary safety endpoint, adverse events and serious adverse events, 
abnormalities in ANC, platelet count and hemoglobin, and incidence of subjects experiencing 
dose modifications, dose interruptions, and/or premature discontinuation of study drug.
10.6.1.
Primary Safety Endpoint
The primary endpoint for this study is a composite safety endpoint, namely, the percentage of 
subjects who develop either peripheral neuropathy of Grade ≥2 or myelosuppression AEs of 
Grade ≥3 based on the local laboratory values for ANC, platelet count and hemoglobin.  The 
peripheral neuropathy events will be identified from the clinical AE dataset using the 
Standardised MedDRA Queries (SMQs). 
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The null (Ho) and alternative (Ha) hypotheses for this endpoint are as follows, where P is the rate 
of the AEs described for the primary safety endpoint: 
Ho:  P Arm B = P Arm A
Ha:  P Arm B ≠ P Arm A
The rate of the AEs described for the primary endpoint will be summarized within each 
treatment schedule by descriptive statistics. The treatment difference in the AE rate will be 
analyzed using a Mantel-Haenszel Chi-square test with ECOG performance status (0 versus 1)
and histology (squamous cell carcinoma versus non-squamous cell carcinoma) as the
stratification factors.  The ratio of the AE rates will be summarized along with the two-sided 
95% confidence interval (CI). 
10.6.2.
Adverse Events
Adverse events will be analyzed in terms of TEAEs, defined as any AE or SAE occurring or 
worsening on or after the first dose of the study drug through 28 days after the last dose of study 
drug.  In addition, any serious AE with an onset date more than 28 days after the last dose of 
study drug that is assessed by the investigator as related to study drug 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 Common Terminology Criteria 
for Adverse Events (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 plus carboplatin combination identified in 
previous studies in a similar population will be summarized in the same manner.
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.
10.6.3.
Laboratory Assessments
Hematology Parameters:  In order to investigate the maximal degree of myelosuppression, the 
NCI CTCAE v 4.0 grades for ANC, platelet count, and hemoglobin concentration will be 
summarized by the most severe grade in each treatment cycle and by the most severe grade 
anytime during the study for each treatment arm.  
All other laboratory parameters reported on the eCRFs will be summarized by descriptive 
statistics by visit and treatment if the number of subjects with data is adequate. In addition, NCI 
CTCAE v 4.0 grades for the reported parameters will be summarized, if applicable.  
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10.6.4.
Study Drug Exposure
The extent of exposure to the study drugs will be assessed based on the descriptive statistics on 
the number of cycles and study drug doses administered, cumulative dose, average dose 
intensity, and percentage of protocol dose administered.  The incidences of nab-paclitaxel and/or 
carboplatin dose reductions, dose interruptions, and dose delays will be summarized by treatment 
arm. 
10.7.
Efficacy Analysis
10.7.1.
Key Efficacy Endpoints 
10.7.1.1.
Progression-free Survival
Progression-free survival 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 occurred 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, or 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 post-baseline radiologic tumor 
assessment will be censored on the date of randomization.
The null (Ho) and alternative (Ha) hypotheses for testing the PFS endpoint are: 
Ho: HR Arm B / Arm A = 1
Ha: HR Arm B / Arm A ≠ 1
Progression-free survival will be summarized using Kaplan-Meier methods with median PFS 
time (including two-sided 95% CI) for each treatment schedule along with the hazard ratio 
estimated using Cox proportional hazards model (including two-sided 95% CI). The Kaplan-
Meier curve for PFS will be presented graphically for each treatment schedule.  P-value from a
stratified log-rank test will be reported as an indication for the strength of association for the 
difference between the two curves, where the strata include ECOG performance status (0 versus 
1) and histology (squamous versus non-squamous cell carcinoma), if the number of events in 
each cell is adequate.  
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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 schedule. 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 second-line therapy. 
10.7.1.2.
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 similarly as PFS.
10.7.1.3.
Overall Response Rate 
Overall response rate is defined as the percent of subjects who had a radiologic complete or 
partial response according to RECIST Version 1.1 guidelines determined by the investigator and 
confirmed by repeat radiologic assessment performed no less than 28 days after the criteria for 
response were first met.  
Overall response rate for each treatment arm will be presented with the two-sided 95% CI.  
Relative treatment effect will be summarized by the difference in response rate and the 
associated two-sided 95% CI.  P-value from a Chi-square test will be reported to indicate the 
strength of association of the relative treatment effect.  
10.7.2.
Exploratory Endpoints
10.7.2.1.
Health Care Utilization and Quality of Life Questionnaire
The analysis of health care utilization and quality of life questionnaire data will be described in 
detail in the SAP.
 
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 study 
drug through 28 days post last dose of the study drug) and deaths that occur during the Follow-
up Period will be summarized by frequency of occurrence and corresponding percentage by 
cause of death per period (during treatment or follow-up).
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10.10.
Interim Analysis
A non-binding interim analysis for futility with the primary safety endpoint will be conducted 
when approximately a total of 139 treated subjects have either completed 6 months of study 
treatment or discontinued from the study due to progression, adverse events, deaths, lost to 
follow up, or other reasons. The stopping rule and the final marginal significance level are 
determined based on the Gamma family spending function with parameter = -7 (Hwang, 1990) to 
control the Type-II error rate at 20%. The study may be stopped early for futility if the treatment 
difference is between ± 0.4% (Z-score ± 0.054) given the interim analysis is performed at 50% 
information fraction.
10.11.
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. 
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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 a study drug 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 
carboplatin 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 study drug, and those SAEs made known to the investigator at any 
time thereafter that are suspected of being related to study drug. 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:
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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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For each SAE, the investigator will provide information on severity, start and stop dates, 
relationship to study drug, action taken regarding study drug, 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 National Cancer Institute (NCI) Common Terminology Criteria 
for Adverse Events (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 study drug 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 study drug
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 study drug caused the adverse event.  ‘Reasonable 
possibility’ means there is evidence to suggest a causal 
relationship between the study drug and the adverse event.
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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 study 
drug 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 study drug as a result of an AE or SAE, as 
applicable (eg, discontinuation or reduction of study drug, 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 study drug 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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11.4.1.
Female Subjects
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 study drug, or within 3 months 
of the subject’s last dose of study drug, are considered immediately reportable events. Study drug
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 study drug 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 study drug
or within 3 months of the last dose of study drug, the male subject taking study drug should 
notify the investigator, and the pregnant female partner should be advised to call her healthcare 
provider immediately. If the male subject is receiving study drug, the study drug 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 is accurate and consistent. This 
requirement applies to all SAEs (regardless of relationship to study drug) that occur during the 
study (from the time the subject signs informed consent to at least 28 days after the last dose of
study drug) and those made known to the investigator at anytime thereafter that are suspected of 
being related to study drug. SAEs occurring prior to treatment (after signing the ICF) will be 
captured.
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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 
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 based on the Investigator Brochure.
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.
Celgene or its authorized representative shall notify the investigator of the following 
information: 
!
Any AE suspected of being related to the use of study drug 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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12.
DISCONTINUATIONS
12.1.
Study Treatment Discontinuation
The following events are considered sufficient reasons for discontinuing a subject from the study 
drug:
!
Adverse Event(s)
!
Disease progression
!
Withdrawal of consent
!
Death
!
Lost to follow-up
!
Protocol violation
Prior to discontinuing a subject for disease progression, the investigator should contact and 
forward appropriate supporting documents to the Medical Monitor.
All subjects discontinued from study drug for any reason will have a treatment discontinuation 
visit at the time of discontinuation and should undergo treatment discontinuation procedures.
All subjects discontinued from nab-paclitaxel will be followed for a period of 28 days after last
dose of study drug 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.
The reason for treatment discontinuation should be recorded in the eCRF and in the source 
documents.
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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A

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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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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. 
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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 a 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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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.
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.
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.
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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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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 study drug 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 eCRFs or CD-ROM.
15.2.
Data Management
Data will be 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 study drug. 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 eCRFs (if paper) and of documentation of corrections for all subjects;
!
Study drug accountability records;
!
Record of any body fluids or tissue samples retained;
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!
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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ities.
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destruction
destruction

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ABI-007-NSCL-005 Final: 06 Mar 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 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, 
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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Protocol ABI-007-NSCL-005
Celgene Corporation
Confidential and Proprietary
65
ABI-007-NSCL-005 Final: 06 Mar 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.

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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 Oncol. 2008;26:468-73.
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 
paclitaxel, ABI-007, compared with cremophor-based paclitaxel. Clin Cancer Res. 
2006;12(4):1317-24.
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. 
Gelderblom H, Verweij J, Nooter K, Sparreboom A. Cremophor EL: the drawbacks and 
advantages of vehicle selection for drug formulation. Eur J Cancer. 2001;37(13):1590-8.
Hwang IK, Shih WJ, De Cani JS. Group sequential designs using a family of type I error
probability spending functions. Stat Med. 1990;9:1439-1445.
Lorenz W, Reimann HJ, Schmal A, Dormann P, Schwarz B, Neugebauer E, et al. Histamine 
release in dogs by Cremophor El and its derivatives: oxethylated oleic acid is the most effective 
constituent. Agents Actions 1977;7:63-7.
National Institute for Health & Clinical Excellence (NICE): The Diagnosis and Treatment of 
Lung Cancer: Methods, Evidence & Guidance, 2011.
Oken, MM, Creech, RH, Tormey, DC, Horton J, Davis TE, McFadden ET, et al. Toxicity and 
Response Criteria Of The Eastern Cooperative Oncology Group. Am J Clin Oncol. 
1982;5(6):649-55.
Quoix E, Zalcman G, Oster JP, Westeel V, Pichon E, Lavolé A, et al. Intergroupe Francophone 
de Cancérologie Thoracique. Carboplatin and weekly paclitaxel doublet chemotherapy compared 
with monotherapy in elderly patients with advanced non-small-cell lung cancer: IFCT-0501 
randomised, phase 3 trial. Lancet. 2011;378(9796):1079-88. 
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.
Socinski MA, Langer CJ, Okamoto I, Hon JK, Hirsh V, Dakhil SR, et al. Safety and efficacy of 
weekly nab®-paclitaxel in combination with carboplatin as first-line therapy in elderly patients 
with advanced non-small-cell lung cancer. Ann Oncol. 2013;24(2):314-21. 
&(/*(1(35235,(7$5<,1)250$7,21
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ABI-007-NSCL-005 Final: 06 Mar 2014
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.
Sparreboom A, van Zuylen L, Brouwer E, Loos WJ, de Bruijn P, Gelderblom H, et al. 
Cremophor EL-mediated alteration of paclitaxel distribution in human blood: clinical 
pharmacokinetic implications. Cancer Res. 1999;59(7):1454-7.
Ten Tije AJ, Verweij J, Loos WJ, Sparreboom A. Pharmacological effects of formulation 
vehicles: implications for cancer chemotherapy. Clin Pharmacokinet. 2003;42(7):665-85. 
Review.
Van Tellingen O, Beijnen JH, Verweij J, Scherrenburg EJ, Nooijen WJ, Sparreboom A. Rapid 
esterase-sensitive breakdown of polysorbate 80 and its impact on the plasma pharmacokinetics of 
docetaxel and metabolites in mice. Clin Cancer Res. 1999;5(10):2918-24.
Weiss RB, Donehower RC, Wiernik PH, Ohnuma T, Gralla RJ, Trump DL, et al. 
Hypersensitivity reactions from Taxol. J Clin Oncol. 1990;8(7):1263-8.
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ABI-007-NSCL-005 Final: 06 Mar 2014
19.
APPENDICES
Appendix A: Response Evaluation Criteria in Solid Tumors (RECIST), 
Version 1.1
Eligibility
!
Only subjects with measurable disease at baseline should be included in protocols 
where objective tumor response is the primary endpoint. 
∀
Measurable disease - the presence of at least one measurable lesion. If the 
measurable disease is restricted to a solitary lesion, its neoplastic nature should be 
confirmed by cytology/histology. 
∀
Measurable lesions - lesions that can be accurately measured in at least one 
dimension with a minimum size of: 10 mm by CT scan, 10 mm caliper 
measurement by clinical exam, 20 mm by chest X-ray.
∀
Non-measurable lesions - all other lesions, including small lesions (longest 
diameter < 10 mm or pathological lymph nodes with ≥10 mm to < 15 mm short 
axis) as well as truly non-measurable lesions ie, leptomeningeal disease, ascites, 
pleural/pericardial effusion, inflammatory breast disease, lymphangitis
involvement of skin or lung, abdominal masses/abdominal organomegaly 
identified by physical exam that is not measurable by reproducible imaging 
techniques.
!
All measurements should be taken and recorded in metric notation, using a ruler or 
calipers. All baseline evaluations should be performed as closely as possible to the 
beginning of treatment and never more than 28 days before the beginning of the 
treatment. 
!
The same method of assessment and the same technique should be used to 
characterize each identified and reported lesion at baseline and during follow-up. 
!
Clinical lesions will only be considered measurable when they are superficial (eg, 
skin nodules and palpable lymph nodes). For the case of skin lesions, documentation 
by color photography, including a ruler to estimate the size of the lesion, is 
recommended. 
Methods of Measurement 
!
CT and MRI are the best currently available and reproducible methods to measure 
target lesions selected for response assessment. Conventional CT and MRI should be 
performed with cuts of 10 mm or less in slice thickness contiguously. Spiral CT 
should be performed using a 5 mm contiguous reconstruction algorithm. This applies 
to tumors of the chest, abdomen and pelvis. Head and neck tumors and those of 
extremities usually require specific protocols.
!
Lesions on chest X-ray are acceptable as measurable lesions when they are clearly 
defined and surrounded by aerated lung. However, CT is preferable. 
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!
When the primary endpoint of the study is objective response evaluation, ultrasound 
should not be used to measure tumor lesions. It is, however, a possible alternative to 
clinical measurements of superficial palpable lymph nodes, subcutaneous lesions and 
thyroid nodules. Ultrasound might also be useful to confirm the complete 
disappearance of superficial lesions usually assessed by clinical examination.
!
The utilization of endoscopy and laparoscopy for objective tumor evaluation has not 
yet been fully and widely validated. Their uses in this specific context require 
sophisticated equipment and a high level of expertise that may only be available in 
some centers. Therefore, the utilization of such techniques for objective tumor 
response should be restricted to validation purposes in specialized centers. However, 
such techniques can be useful in confirming complete pathological response when 
biopsies are obtained.
!
Tumor markers alone cannot be used to assess response. If markers are initially above 
the upper normal limit, they must normalize for a subject to be considered in 
complete clinical response when all lesions have disappeared.
!
Cytology and histology can be used to differentiate between PR and CR in rare cases 
(eg, after treatment to differentiate between residual benign lesions and residual 
malignant lesions in tumor types such as germ cell tumors).
Baseline Documentation of “Target” and “Nontarget” Lesions
!
All measurable lesions up to a maximum of two lesions per organ and five lesions in 
total, representative of all involved organs should be identified as target lesions and
recorded and measured at baseline. 
!
Target lesions should be selected on the basis of their size (lesions with the longest 
diameter) and their suitability for accurate repeated measurements (either by imaging 
techniques or clinically). 
!
A sum of the longest diameter (LD) for all target lesions will be calculated and 
reported as the baseline sum LD. The baseline sum LD will be used as reference by 
which to characterize the objective tumor.
!
All other lesions (or sites of disease) should be identified as nontarget lesions and 
should also be recorded at baseline. Measurements of these lesions are not required, 
but the presence or absence of each should be noted throughout follow-up.
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Response Criteria
Table 5:
Evaluation of Target Lesions
Response
Criteria
Complete Response (CR):
Disappearance of all target lesions
Partial Response (PR):
At least a 30% decrease in the sum of the LD of target lesions, taking as 
reference the baseline sum LD
Progressive Disease (PD):
At least a 20% increase in the sum of diameters of target lesions, taking as 
reference the smallest sum on study (including baseline), in addition sum 
must demonstrate an absolute increase of at least 5 mm, or the appearance 
of one or more new lesions
Stable Disease (SD):
Neither sufficient shrinkage to qualify for PR nor sufficient increase to 
qualify for PD, taking as reference the smallest sum diameters while on 
study
Table 6:
Evaluation of Non-Target Lesions
Response
Criteria
Complete Response (CR):
Disappearance of all non-target lesions and normalization of tumor marker 
level
Incomplete Response/
Stable Disease (SD): 
Persistence of one or more non-target lesion(s) or/and maintenance of 
tumor marker level above the normal limits
Progressive Disease (PD):
Appearance of one or more new lesions and/or unequivocal progression of 
existing non-target lesionsa
a Although a clear progression of “nontarget” lesions only is exceptional, in such circumstances, the opinion of the 
treating physician should prevail and the progression status should be confirmed later on by the review panel (or 
study chair).
Evaluation of Best Overall Response
The best overall response is the best response recorded from the start of the treatment until 
disease progression/recurrence (taking as reference for PD the smallest measurements recorded 
since the treatment started). In general, the subject's best response assignment will depend on the 
achievement of both measurement and confirmation criteria.
Target Lesions
Non-Target Lesions
New Lesions
Overall Response
CR
CR
No
CR
CR
Incomplete response/SD
No
PR
PR
Non-PD
No
PR
SD
Non-PD
No
SD
PD
Any
Yes or No
PD
Any
PD
Yes or No
PD
Any
Any
Yes
PD
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ABI-007-NSCL-005 Final: 06 Mar 2014
!
Subjects with a global deterioration of health status requiring discontinuation of 
treatment without objective evidence of disease progression at that time should be 
classified as having “symptomatic deterioration”. Every effort should be made to 
document the objective progression even after discontinuation of treatment. 
!
In some circumstances it may be difficult to distinguish residual disease from normal
tissue. When the evaluation of complete response depends on this determination, it is 
recommended that the residual lesion be investigated (fine needle aspirate/biopsy) to 
confirm the complete response status.
Confirmation
!
The main goal of confirmation of objective response is to avoid overestimating the 
response rate observed. In cases where confirmation of response is not feasible, it 
should be made clear when reporting the outcome of such studies that the responses 
are not confirmed.
!
To be assigned a status of PR or CR, changes in tumor measurements must be 
confirmed by repeat assessments that should be performed no less than 28 days after 
the criteria for response are first met. Longer intervals as determined by the study 
protocol may also be appropriate. 
!
In the case of SD, follow-up measurements must have met the SD criteria at least 
once after study entry at a minimum interval (in general, not less than 6-8 weeks) that 
is defined in the study protocol.
Duration of Overall Response
!
The duration of overall response is measured from the time measurement criteria are 
met for CR or PR (whichever status is recorded first) until the first date that 
recurrence or PD is objectively documented, taking as reference for PD the smallest 
measurements recorded since the treatment started.
Duration of Stable Disease
!
SD is measured from the start of the treatment until the criteria for disease 
progression are met, taking as reference the smallest measurements recorded since the 
treatment started. 
!
The clinical relevance of the duration of SD varies for different tumor types and 
grades. Therefore, it is highly recommended that the protocol specify the minimal 
time interval required between two measurements for determination of SD. This time 
interval should take into account the expected clinical benefit that such a status may 
bring to the population under study. 
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Protocol ABI-007-NSCL-005
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Appendix B: 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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