A Phase III, Randomized, Open-Label, Multi-Center, Safety and Efficacy Study to Evaluate Nab-Paclitaxel (Abraxane®) as Maintenance Treatment After Induction With Nab-Paclitaxel Plus Carboplatin in Subjects With Squamous Cell Non-Small Cell Lung Cancer (NSCLC)
Phase: PHASE3
Conditions: Squamous Cell Carcinoma, Non-Small-Cell Lung
Sponsor: Celgene

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nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
1
ABI-007-NSCL-003 Final: 27 Sep 2013
TITLE PAGE
A PHASE III, RANDOMIZED, OPEN-LABEL, CROSS-
OVER, MULTI-CENTER, SAFETY AND EFFICACY 
STUDY TO EVALUATE NAB-PACLITAXEL 
(ABRAXANE®) AS MAINTENANCE TREATMENT 
AFTER INDUCTION WITH NAB-PACLITAXEL PLUS 
CARBOPLATIN IN SUBJECTS WITH SQUAMOUS 
CELL NON-SMALL CELL LUNG CANCER (NSCLC)
INVESTIGATIONAL PRODUCT (IP):
nab-Paclitaxel (Abraxane®)
PROTOCOL NUMBER:
ABI-007-NSCL-003
DATE FINAL:
27 Sep 2013
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-003
Celgene Corporation
Confidential and Proprietary
2
ABI-007-NSCL-003 Final: 27 Sep 2013
MEDICAL MONITOR / EMERGENCY CONTACT INFORMATION 
Contact Information:
Name:
Title:
Address: 
Celgene Corporation
86 Summit Avenue
Summit, NJ 07901
Phone:
 
E-mail:
Contact Information:
Name:
Title:
Address: 
Celgene Corporation
86 Summit 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-003
Celgene Corporation
Confidential and Proprietary
3
ABI-007-NSCL-003 Final: 27 Sep 2013
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-003
Celgene Corporation
Confidential and Proprietary
4
ABI-007-NSCL-003 Final: 27 Sep 2013
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-003
Celgene Corporation
Confidential and Proprietary
5
ABI-007-NSCL-003 Final: 27 Sep 2013
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-003
Celgene Corporation
Confidential and Proprietary
6
ABI-007-NSCL-003 Final: 27 Sep 2013
PROTOCOL SUMMARY
Study Title
A Phase III, randomized, open-label, cross-over, multi-center, safety and efficacy study to 
evaluate nab-paclitaxel (Abraxane) as maintenance treatment after induction with nab-paclitaxel
plus carboplatin in subjects with squamous cell non-small cell lung cancer (NSCLC).
Indication
Maintenance treatment of squamous cell NSCLC.
Objectives
Primary
!
To evaluate progression free survival (PFS) with nab-paclitaxel as maintenance 
treatment after response or stable disease (SD) with nab-paclitaxel plus carboplatin in 
subjects with squamous cell NSCLC.
Secondary 
!
To evaluate the safety and tolerability of nab-paclitaxel as maintenance treatment 
after response or SD with nab-paclitaxel plus carboplatin in subjects with squamous 
cell NSCLC.
!
To further assess the efficacy with nab-paclitaxel as maintenance treatment after
response or SD with nab-paclitaxel plus carboplatin in subjects with squamous cell 
NSCLC, as measured by secondary efficacy endpoints.
Exploratory 
!
To determine baseline tumor characteristics which predict response and resistance to 
nab-paclitaxel/carboplatin during the Induction part of the study. 
!
To determine what changes in peripheral tumor characteristics during treatment are 
associated with acquisition of resistance in the subjects who had initial clinical 
benefit.
!
To evaluate the safety and efficacy of nab-paclitaxel as Cross-over treatment after 
progression during the Maintenance part of the study in subjects with squamous cell 
NSCLC. 
!
To assess healthcare resource utilization during the Maintenance part of the study.
!
To assess the Lung Cancer Symptom Scale (LCSS) and EuroQol Group 5-Dimension 
Self-Report Questionnaire score (EQ5D).
Study Design
This is a Phase III, randomized, open-label, cross-over, multi-center study of nab-paclitaxel or 
best supportive care (BSC) as maintenance treatment after response or SD with nab-paclitaxel
plus carboplatin as induction in subjects with squamous cell NSCLC. Approximately 540
subjects with stage IIIB or IV squamous cell NSCLC will be enrolled in the Induction part of the 
maintenan
maintenan
xel
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nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
7
ABI-007-NSCL-003 Final: 27 Sep 2013
study to receive nab-paclitaxel plus carboplatin for 4 cycles. If after the 4 cycles, the subject has 
a complete response (CR), partial response (PR), or SD, they will be randomized (2:1) in the 
Maintenance part of the study to receive nab-paclitaxel plus BSC or BSC alone. BSC is defined 
as the best palliative care per investigator (including but not limited to: antibiotics, analgesics, 
antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and/or focal 
external-beam radiation for control of pain, cough, dyspnea, or hemoptysis), excluding
antineoplastic agents. Approximately 260 subjects will be evaluable for the primary endpoint of 
PFS in maintenance. Once a subject in the BSC arm during the Maintenance part of the study 
experiences radiologic progression of disease, they will be eligible to cross-over to receive nab-
paclitaxel.
Induction Part
The main purpose of the Induction part is to identify those subjects who are eligible for 
randomization in the Maintenance part of the study. Approximately 540 subjects eligible for 
standard treatment with nab-paclitaxel plus carboplatin for 4 cycles will be enrolled, provided if 
all inclusion/exclusion criteria are met within a 28-day screening period prior to Cycle 1 Day 1.
Induction treatment will commence on Day 1: 
!
nab-Paclitaxel 100 mg/m2 intravenous (IV) infusion over 30 minutes on Days 1, 8, 
and 15 of each 21-day cycle
!
Carboplatin AUC = 6 mg*min/mL IV on Day 1 of each 21-day cycle after completion 
of nab-paclitaxel infusion
Once 4 cycles have been completed for Induction, if the subject has a radiologically assessed
CR, PR, or SD, and has met all eligibility criteria, they will continue on to the Maintenance part 
of the study. If the subject has radiological or clinical PD, they will be discontinued from the 
study and will not be followed.
Maintenance Part
Once 4 cycles have been completed for Induction, if the subject has a radiologically assessed
CR, PR, or SD without clinical progression, and has met all eligibility criteria, they will be 
randomized 2:1 to receive:
!
nab-Paclitaxel 100 mg/m2 IV infusion over 30 minutes on Days 1 and 8 of each 21-
day cycle plus BSC until disease progression or unacceptable toxicity (see Section 8.3
for guidelines on starting dose for the Maintenance part of the study if the subject had 
dose reduced during the Induction part of the study)
OR
!
BSC until disease progression
Maintenance therapy should start at the time of randomization. If this is not possible, a maximum 
of 7 days will be allowed from the date of randomization to the start date of Maintenance 
therapy. Subjects must start Maintenance therapy no earlier than 21 days and no later than 35
days from Day 1 of the fourth cycle of Induction therapy.
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nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
8
ABI-007-NSCL-003 Final: 27 Sep 2013
Cross-over 
A subject in the BSC alone arm during the Maintenance part of the study who experiences 
radiological progression of disease, will be eligible to cross-over to receive nab-paclitaxel
100 mg/m2 IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle until unacceptable 
toxicity or discontinuation for any other reason, if the benefit : risk is considered appropriate by 
the treating investigator (see Section 8.3 for guidelines on starting dose for the Cross-over part of 
the study if the subject had dose reduced during the Induction part of the study, and Sections 7.2
and 7.3 for eligibility criteria).
Follow-up Period 
All subjects who discontinue from the Maintenance or Cross-over parts of the study for any 
reason other than withdrawal of consent, lost to follow-up, or death, will enter the Follow-up 
period that will have a visit 28 days after progression or discontinuation.   Those subjects 
entering the follow up period without documented progression will continue to have CT scan in 
accordance with standard of care until documented progression of disease.  Additionally, 
subjects will be followed for overall survival (OS) by phone approximately every 90 days for up 
to 1.5 years after final analysis of approximately 182 PFS events or approximately 218 deaths 
have been observed for the final OS analysis, whichever is earlier.
Study Population
Subjects with squamous cell NSCLC stage IIIB or IV with no prior chemotherapy for metastatic 
disease and ≥ 18 years old will be eligible for this study. The Induction part of the study will 
enroll approximately 540 subjects. Based on results from the nab-Paclitaxel Phase 3 NSCLC 
development study (Protocol CA031) it is estimated that approximately 260 subjects with CR, 
PR, or SD from the Induction part of the study will be randomized to the Maintenance part of the 
study. Enrollment into the Induction part of the study will be monitored and adjusted to ensure 
that approximately 260 subjects are randomized into the Maintenance part of the study.
Length of Study
The Induction part of the study will last approximately 36 months to enroll sufficient subjects for 
the Maintenance part of the study. The total length of this Phase III study with Induction, 
Maintenance, Cross-over, and Follow-up is estimated to last approximately 5 years.
Study Treatments
Induction 
The nab-paclitaxel and carboplatin treatments are designated as non-investigational products
during induction and will not be supplied by Celgene. Investigative sites will use standard of care 
(commercially available) product via prescription.
Maintenance and Cross-over
Subjects will be randomized to receive open-label nab-paclitaxel plus BSC or BSC during the 
Maintenance part of the study. Subjects will receive open-label nab-paclitaxel during the Cross-
over part of the study. The nab-paclitaxel used in the Maintenance and Cross-over parts of the 
study is designated as investigational product (IP) and will be packaged and supplied by Celgene 
Corporation.
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nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
9
ABI-007-NSCL-003 Final: 27 Sep 2013
The preparation for IV administration procedures for IP should be followed as per package 
insert.
Statistical Methods
Approximately 540 subjects will be enrolled in the open-label Induction part of the study. All 
subjects will receive nab-paclitaxel 100 mg/m2 administered weekly followed by carboplatin
AUC = 6 mg*min/mL on Day 1 of each cycle, repeated every 21 days, for 4 cycles.
At the end of Cycle 4, subjects who achieve a radiologically assessed complete response (CR), 
partial response (PR), or stable disease (SD) without clinical progression based on the 
Investigator’s evaluation using the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 
guidelines will be further evaluated for their eligibility to participate in the Maintenance part of 
the study.  Approximately 260 subjects are expected to be randomized in the Maintenance part of 
the study.
The actual number of subjects that will be enrolled in the Induction part will be monitored and 
adjusted to ensure that the target number of subjects for the Maintenance part is attained.
Similarly, the percentage of subjects manifesting a PFS event in the Maintenance part will be 
tracked on an ongoing basis. If the observed percentage of subjects with a PFS event is trending 
lower than the assumed 70%, the number of subjects enrolled in the Induction and Maintenance 
parts will be increased to ensure that at least 182 PFS events will be observed within the 
anticipated duration of the study.
Induction Part
Efficacy Analyses
All efficacy endpoints will be analyzed based on the intent-to-treat (ITT) population, which 
includes all subjects who are enrolled regardless of whether the subjects receive any nab-
paclitaxel or have any efficacy assessments collected.
The main purpose of the Induction part is to identify those subjects who are eligible for 
randomization in the Maintenance part of the study. Subjects will have CT scans performed 
every 42 days (-3/+7 days). Subjects who attain a radiologically assessed CR, PR, or SD without 
clinical progression according to the investigator’s assessment of the scan performed at the end 
of Cycle 4, based on RECIST 1.1 guidelines, and satisfy eligibility criteria will be eligible to be 
randomized in the Maintenance part.
The secondary objective of the Induction part is to estimate the Overall Response Rate (ORR, 
percent of subjects who have a CR or PR according to RECIST 1.1 guidelines as determined by 
the investigator and confirmed by repeat assessments performed no less than 28 days after the 
criteria for response were first met). Descriptive statistics (point estimate and the associated two-
sided 95% confidence interval) will be calculated for this endpoint.
Safety Analyses
The safety population, includes all subjects enrolled who received at least 1 dose of study 
treatment, will be the analysis population for all safety analyses. Adverse events will be 
summarized by worst severity grade. Adverse events (AEs), as well as treatment-emergent AEs, 
will be summarized by system organ class, and preferred term. Adverse event severity/grade will 
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nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
10
ABI-007-NSCL-003 Final: 27 Sep 2013
be summarized by National Cancer Institute (NCI) Common Terminology Criteria for Adverse 
Events (CTCAE) v4.0. 
Laboratory test results will not be collected in the eCRFs unless they are determined to be 
clinically significant laboratory abnormalities. Abnormal and clinically significant laboratory 
assessments at Screening will be recorded as medical history, and after Screening, as AE or 
serious adverse event (SAE). If a clinically significant laboratory abnormality is captured as 
medical history, AE, or SAE, the specific laboratory parameter(s) should be recorded on the 
laboratory assessments CRF.
Maintenance Part
Approximately 260 subjects will be randomized in the Maintenance part of the study. These 
subjects will be randomized in a 2:1 ratio to the nab-paclitaxel plus BSC and BSC alone groups, 
respectively. The nab-paclitaxel group will receive nab-paclitaxel 100 mg/m2 on Day 1 and 8 of 
each 21-day cycle plus BSC (the actual starting dose may be adjusted as specified in Section 
8.3), while the BSC group will receive the standard BSC regimen. All subjects will receive the 
assigned regimen until disease progression or unacceptable toxicity. Subjects in the BSC alone 
group who have radiologic progression will be eligible to crossover and receive the nab-
paclitaxel regimen until unacceptable toxicity or discontinuation for any other reason, if the 
benefit:risk is considered appropriate by the treating investigator.
Randomization will be stratified by the following 3 baseline and prognostic stratification factors:
Eastern Cooperative Oncology Group (ECOG) performance status at the end of the Induction 
part (0 vs. 1), tumor response to induction chemotherapy (CR/PR vs. SD), and disease stage 
before administration of induction therapy (IIIB vs. IV). It is postulated that subjects will benefit 
from maintenance therapy with nab-paclitaxel, therefore a randomization ratio of 2:1 will reduce 
subject exposure to treatment with BSC alone while providing sufficient data for testing the 
treatment difference with respect to the primary endpoint, progression free survival.
The Maintenance part of the study is designed to detect a hazard ratio (HR) of 0.60 for PFS 
improvement with the nab-paclitaxel plus BSC regimen over the BSC alone regimen with 90% 
power and an overall type-I error rate of 5% (two-sided). The final analysis will be conducted 
after approximately 182 PFS events (ie, events of disease progression or deaths from any cause) 
have occurred. Assuming an exponential distribution with a median time to PFS of 2 months for 
the BSC alone group and proportional hazards, a hazard ratio of 0.60 constitutes a 1.33 months 
improvement for the nab-paclitaxel plus BSC group over that of the BSC alone group.
A non-binding interim analysis for futility with PFS will be planned at approximately 91 events.
The stopping rules and the final marginal significance level are determined based on O'Brien-
Fleming type boundaries (O’Brien, 1979). The study may be stopped early for futility if the 
conditional power is < 10%.
There will be 2 analyses for the OS endpoint. The interim analysis (non-binding) of OS will be 
conducted based on the number of deaths observed at the time of the final PFS analysis.
However, all subjects will continue to be followed for OS up to 1.5 years after final analysis of
approximately 182 PFS events or approximately 218 deaths have been observed for the final OS
analysis, whichever is earlier. The marginal significance levels for OS are determined based on 
O'Brien-Fleming type boundaries and will be adjusted based on the actual number of deaths 
observed at each stage.  
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A Step-down procedure from PFS to OS will be used to control the family-wise two-sided Type-
I error rate to 5%.
Efficacy Analyses
The Maintenance part of the study starts on the date the subject is randomized to either of the 
treatment arms. All efficacy analyses in the Maintenance part will be based on the ITT 
population, which includes all randomized subjects regardless of whether they receive any IP or 
have any efficacy assessments collected. 
The primary efficacy endpoint is PFS based on investigator’s assessment of the subject’s 
radiologic response using RECIST 1.1 guidelines. Baseline tumor measurements will be 
determined by the computed tomography (CT)-scan performed less than 28 days before the first 
dose of nab-paclitaxel in the Induction part of the study. Progression-free survival will be 
counted from the date of randomization 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.
The null (Ho) and alternative (Ha) hypotheses for the primary efficacy endpoint are: 
Ho: HR nab-paclitaxel plus best supportive care / best supportive care = 1
Ha: HR nab-paclitaxel plus best supportive care / best supportive care ≠1
Progression-free survival will be summarized using the Kaplan-Meier method and by median 
PFS time (including two-sided 95% CI) for each treatment regimen along with the hazard ratio 
(including two-sided 95% CI). The Kaplan-Meier curve for PFS will be presented graphically for 
each treatment regimen and differences in the curves will be tested using a stratified log-rank test 
with the 3 baseline and prognostic factors described above.
Secondary efficacy endpoints include OS and ORR (percent of subjects who attain a CR or PR 
according to RECIST 1.1 guidelines as determined by the investigator and confirmed by repeat 
assessments performed no less than 28 days after the criteria for response are first met). Overall 
survival will be analyzed by the same method described for PFS, while ORR will be analyzed by 
chi-square test.
Safety Analyses
The safety population includes all randomized subjects in the BSC alone arm and those who
receive at least one dose of nab-paclitaxel in the nab-paclitaxel plus BSC arm in the Maintenance 
part of the study. Adverse events will be summarized by worst severity grade. AEs, as well as 
treatment-emergent AEs, will be summarized by system organ class, and preferred term. Adverse 
event severity/grade will be summarized by NCI CTCAE v4.0.
Laboratory test results will not be collected in the eCRFs unless they are determined to be 
clinically significant laboratory abnormalities. Abnormal and clinically significant laboratory 
assessments at Screening will be recorded as medical history, and after Screening, as AE or 
serious adverse event (SAE). If a clinically significant laboratory abnormality is captured as 
medical history, AE, or SAE, the specific laboratory parameter(s) should be recorded on the 
laboratory assessments CRF.
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Data Monitoring Committee
An independent Data Monitoring Committee (DMC) will be established with the responsibilities 
for safeguarding the interests of study participants and monitoring the overall conduct of the 
study. Final recommendations of the DMC will reflect the judgment of the DMC members and 
will be considered advisory in nature to the Sponsor. The decision to implement the 
recommendations of the DMC will be made by the Sponsor, following consultation with the trial 
Coordinating Principal Investigator and Steering Committee. A DMC charter will be established.
&(/*(1(35235,(7$5<,1)250$7,21

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TABLE OF CONTENTS
TITLE PAGE..............................................................................................................................1
PROTOCOL SUMMARY ..........................................................................................................6
1.
INTRODUCTION..................................................................................................20
1.1.
Non-small Cell Lung Cancer (NSCLC)...................................................................20
1.2.
nab-Paclitaxel.........................................................................................................20
1.3.
Rationale for Development of nab-Paclitaxel as Maintenance Treatment in 
Squamous Cell NSCLC ..........................................................................................23
2.
STUDY OBJECTIVES...........................................................................................24
2.1.
Primary Objective...................................................................................................24
2.2.
Secondary Objectives .............................................................................................24
2.3.
Exploratory Objectives ...........................................................................................24
3.
STUDY ENDPOINTS............................................................................................25
3.1.
Primary Endpoint....................................................................................................25
3.2.
Secondary Endpoints ..............................................................................................25
3.2.1.
Safety.....................................................................................................................25
3.2.2.
Efficacy..................................................................................................................25
3.3.
Exploratory Endpoints............................................................................................25
4.
OVERALL STUDY DESIGN ................................................................................26
4.1.
Study Design ..........................................................................................................26
4.1.1.
Induction Part.........................................................................................................26
4.1.2.
Maintenance Part....................................................................................................26
4.1.3.
Cross-over..............................................................................................................27
4.1.4.
Follow-up Period....................................................................................................27
4.2.
Study Design Rationale ..........................................................................................27
4.3.
Study Duration .......................................................................................................30
4.4.
End of Trial ............................................................................................................30
5.
TABLE OF EVENTS.............................................................................................31
6.
PROCEDURES......................................................................................................35
6.1.
Medical History......................................................................................................35
6.2.
Prior Medications/Procedures .................................................................................35
6.3.
Pregnancy Testing ..................................................................................................35
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6.1.
6.1

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6.4.
Complete Chest Computed Tomography (CT) Scan (including adrenal 
gland) With and Without Contrast ..........................................................................35
6.5.
Weight....................................................................................................................36
6.6.
Body Surface Area (BSA) Calculation and Height..................................................36
6.7.
ECOG Performance Score ......................................................................................36
6.8.
Concomitant Medications/Procedures.....................................................................36
6.9.
Peripheral Neuropathy Assessment.........................................................................36
6.10.
Adverse Event Reporting........................................................................................36
6.11.
Lung Cancer Symptom Scale Questionnaire and EQ5D..........................................36
6.12.
Healthcare Resource Utilization Questionnaire .......................................................37
6.13.
Electrocardiogram ..................................................................................................37
6.14.
CT Scan of Head or Brain Magnetic Resonance Imaging (MRI).............................37
6.15.
Bone Scans and X-rays...........................................................................................37
6.16.
Physical Examinations............................................................................................37
6.17.
Vital Signs..............................................................................................................37
6.18.
Laboratory Assessments .........................................................................................38
6.19.
Tumor Tissue Sample Collection and Peripheral Blood Collection 
(Exploratory Assessments) .....................................................................................38
6.20.
Survival..................................................................................................................39
7.
STUDY POPULATION.........................................................................................40
7.1.
Number of Subjects and Sites .................................................................................40
7.2.
Inclusion Criteria....................................................................................................40
7.3.
Exclusion Criteria...................................................................................................41
8.
DESCRIPTION OF STUDY TREATMENTS........................................................43
8.1.
Description of Investigational Product(s)................................................................43
8.1.1.
nab-Paclitaxel.........................................................................................................43
8.1.2.
Carboplatin.............................................................................................................43
8.2.
Treatment Administration and Schedule .................................................................44
8.3.
Dose Modifications.................................................................................................45
8.4.
Method of Treatment Assignment...........................................................................47
8.5.
Packaging and Labeling..........................................................................................47
8.6.
Investigational Product Accountability and Disposal ..............................................47
8.7.
Investigational Product Compliance........................................................................47
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8.8.
Overdose ................................................................................................................47
9.
CONCOMITANT MEDICATIONS AND PROCEDURES....................................49
9.1.
Permitted Concomitant Medications and Procedures...............................................49
9.2.
Prohibited Concomitant Medications and Procedures..............................................49
9.3.
Required Concomitant Medications and Procedures................................................49
10.
STATISTICAL ANALYSES..................................................................................50
10.1.
Induction Part.........................................................................................................50
10.1.1.
Overview................................................................................................................50
10.1.2.
Study Population Definitions ..................................................................................50
10.1.2.1.
Intent-to-Treat Population.......................................................................................50
10.1.2.2.
Safety Population....................................................................................................50
10.1.3.
Sample Size and Power Considerations...................................................................50
10.1.4.
Background and Demographic Characteristics........................................................51
10.1.5.
Subject Disposition.................................................................................................52
10.1.6.
Efficacy Analysis....................................................................................................52
10.1.6.1.
Primary Purpose .....................................................................................................52
10.1.6.2.
Secondary Endpoints ..............................................................................................52
10.1.7.
Safety Analysis.......................................................................................................52
10.1.7.1.
Adverse Events.......................................................................................................53
10.1.7.2.
Laboratory Assessments .........................................................................................53
10.1.8.
Study Treatment Termination .................................................................................53
10.1.9.
Deaths ....................................................................................................................53
10.2.
Maintenance Part....................................................................................................53
10.2.1.
Overview................................................................................................................53
10.2.2.
Study Population Definitions ..................................................................................54
10.2.2.1.
Intent-to-Treat Population.......................................................................................54
10.2.2.2.
Response Evaluable Population ..............................................................................54
10.2.2.3.
Per-protocol (PP) Population ..................................................................................54
10.2.2.4.
Safety Population....................................................................................................54
10.2.3.
Sample Size and Power Considerations...................................................................54
10.2.4.
Background and Demographic Characteristics........................................................55
10.2.5.
Subject Disposition.................................................................................................56
10.2.6.
Efficacy Analysis....................................................................................................56
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0.2.3.

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10.2.6.1.
Primary Endpoint....................................................................................................56
10.2.6.2.
Key Secondary Endpoints.......................................................................................57
10.2.6.3.
Other Secondary Efficacy Endpoints.......................................................................57
10.2.6.4.
Exploratory Endpoints............................................................................................58
10.2.7.
Safety Analysis.......................................................................................................58
10.2.7.1.
Adverse Events.......................................................................................................59
10.2.7.2.
Laboratory Assessments .........................................................................................59
10.2.8.
Study Therapy Termination ....................................................................................59
10.2.9.
Deaths ....................................................................................................................59
10.2.10.
Interim Analysis .....................................................................................................59
10.3.
Data Monitoring Committee ...................................................................................60
10.4.
Scientific Steering Committee ................................................................................60
11.
ADVERSE EVENTS..............................................................................................61
11.1.
Monitoring, Recording and Reporting of Adverse Events .......................................61
11.2.
Evaluation of Adverse Events.................................................................................61
11.2.1.
Seriousness.............................................................................................................61
11.2.2.
Severity / Intensity..................................................................................................63
11.2.3.
Causality ................................................................................................................63
11.2.4.
Duration .................................................................................................................64
11.2.5.
Action Taken..........................................................................................................64
11.2.6.
Outcome.................................................................................................................64
11.3.
Abnormal Laboratory Values..................................................................................64
11.4.
Pregnancy...............................................................................................................64
11.4.1.
Females of Childbearing Potential: .........................................................................64
11.4.2.
Male Subjects.........................................................................................................65
11.5.
Reporting of Serious Adverse Events......................................................................65
11.5.1.
Safety Queries ........................................................................................................66
11.6.
Expedited Reporting of Adverse Events..................................................................66
12.
DISCONTINUATIONS .........................................................................................67
12.1.
Study Treatment Discontinuation............................................................................67
12.2.
Study Discontinuation ............................................................................................67
12.3.
Subject Replacement ..............................................................................................68
13.
EMERGENCY PROCEDURES.............................................................................69
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2.1.

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13.1.
Emergency Contact.................................................................................................69
14.
REGULATORY CONSIDERATIONS...................................................................70
14.1.
Good Clinical Practice............................................................................................70
14.2.
Investigator Responsibilities ...................................................................................70
14.3.
Subject Information and Informed Consent.............................................................70
14.4.
Confidentiality........................................................................................................71
14.5.
Protocol Amendments.............................................................................................71
14.6.
Institutional Review Board/Independent Ethics Committee Review and 
Approval ................................................................................................................71
14.7.
Ongoing Information for Institutional Review Board / Ethics Committee................72
14.8.
Closure of the Study ...............................................................................................72
15.
DATA HANDLING AND RECORDKEEPING.....................................................73
15.1.
Data/Documents .....................................................................................................73
15.2.
Data Management...................................................................................................73
15.3.
Record Retention....................................................................................................73
16.
QUALITY CONTROL AND QUALITY ASSURANCE........................................75
16.1.
Study Monitoring and Source Data Verification......................................................75
16.2.
Audits and Inspections............................................................................................75
17.
PUBLICATIONS ...................................................................................................76
18.
REFERENCES.......................................................................................................77
19.
APPENDICES........................................................................................................79
Appendix A: Response Evaluation Criteria in Solid Tumors (RECIST 1.1)...............................79
Appendix B: ECOG Performance Status Score..........................................................................83
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LIST OF TABLES
Table 1:
Blinded Radiology Assessment of Overall Response Rate  (ITT Population) ..........22
Table 2:
Blinded Radiology Assessment of Response Rate for Patients with 
Squamous or Non-squamous Histologies (ITT Subgroups).....................................22
Table 3:
Table of Events – Induction....................................................................................31
Table 4:
Table of Events – Maintenance and Cross-over.......................................................33
Table 5:
Permanent Dose Reductions for Hematologic and Neurologic Adverse 
Events and Dosing for Maintenance and Cross-over Parts of the Study...................46
Table 6:
Precision of the Estimate for a Proportion Given a Sample Size of 540...................51
Table 7:
Evaluation of Target Lesions ..................................................................................81
Table 8:
Evaluation of Non-target Lesions............................................................................81
3
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LIST OF FIGURES
Figure 1:
Overall Study Design..............................................................................................29
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1.
INTRODUCTION
1.1.
Non-small Cell Lung Cancer (NSCLC)
Lung cancer is the leading cause of cancer-related deaths (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 recent advances in identifying optimal chemotherapy regimens, patients with 
advanced NSCLC continue to have a poor prognosis (especially those without identifiable 
biomarkers), with only 10% to 15% of those treated still alive after 2 years of diagnosis.
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 vs 
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). 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).
1.2.
nab-Paclitaxel
nab-Paclitaxel has been developed to reduce the toxicities associated with Taxol and the 
Cremophor EL/ethanol vehicle while maintaining or improving the chemotherapeutic effect of 
the drug. The Cremophor EL-free medium enables nab-paclitaxelto be given in a shorter 
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ABI-007-NSCL-003 Final: 27 Sep 2013
duration without the need for premedication to prevent solvent-related hypersensitivity reactions.
In addition, standard tubing and 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, pancreatic cancer and NSCLC. For NSCLC in the US, nab-Paclitaxel is approved for the 
treatment of patients with locally advanced or metastatic NSCLC, as first-line treatment in 
combination with carboplatin, in patients 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.
The Food and Drug Administration (FDA) approval of nab-paclitaxel was based on the 
evaluation of Phase I and II data (Rizvi, 2008; Socinski, 2010; Belani, 2008), as well as the 
pivotal Phase III study: A multicenter, randomized, open-label study was conducted in 1052 
chemonaive patients 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 or development of an unacceptable toxicity. The primary efficacy outcome measure 
was overall response rate 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 adenocarcinoma, 43% had 
squamous cell lung cancer, 76% were ECOG PS 1, and 73% were current or former smokers. 
Patients received a median of 6 cycles of treatment in both study arms. Patients in 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]. There 
was no statistically significant difference in the secondary endpoint OS between the two study 
arms.
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fference in

nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
22
ABI-007-NSCL-003 Final: 27 Sep 2013
Table 1:
Blinded Radiology Assessment of Overall Response Rate 
(ITT Population)
Variable
Category/Statistic
ABI-007/
carboplatin
(N=521)
Taxol/
carboplatin
(N=531)
Response Rate 
Ratio
(pA/pT)
P-value
Patients with Confirmed Complete or Partial Overall Response
n (%)
170 (33%)
132 (25%)
1.313
0.005*
Confidence Interval (CI) a
28.6, 36.7
21.2, 28.5
1.082, 1.593
Complete Response
0
1 (< 1%)
Partial Response
170 (33%)
131 (25%)
Source Data on File
a 95% CI of response rate and 95.1% CI of response rate ratio.
Note: P-value is based on a chi-square test.
* Indicates p-value < 0.049
Per protocol, patients were stratified by NSCLC histology (squamous cell carcinoma vs
adenocarcinoma vs other histology). Subgroup analyses were performed to assess the influence 
of squamous vs non-squamous histology on the primary efficacy endpoint of overall response 
rate (the percentage of patients who achieved an objective confirmed CR or PR based on the 
blinded radiological review using RECIST response guidelines, Version 1.0). The proportion of 
patients with squamous cell carcinoma who responded was significantly higher for the 
ABI-007/carboplatin regimen relative to the Taxol/carboplatin regimen (41% vs 24%: pA/pT: 
1.680; p < 0.001). The proportion of patients with non-squamous cell carcinoma with a 
confirmed complete or partial overall response was comparable between the ABI-007 and 
Taxol/carboplatin arms (26% vs 25%: pA/pT: 1.034; p = 0.808).
Table 2:
Blinded Radiology Assessment of Response Rate for Patients with Squamous 
or Non-squamous Histologies (ITT Subgroups)
Prognostic Factor
Category/Statistic/N
ABI-007/
carboplatin
Taxol/
carboplatin
Response Rate 
Ratio (pA/pT)
P-value
Patients with Confirmed Complete 
or Partial Overall Response
Squamous cell carcinoma
94/229 (41%)
54/221 (24%)
1.680
< 0.001*
95% Confidence Interval
1.271, 2.221
Non-squamous cell carcinoma
76/292 (26%)
78/310 (25%)
1.034
0.808
95% Confidence Interval
0.788, 1.358
Abbreviations: ITT = intent-to-treat
Note: P value is based on a chi-square test.
* Indicates p-value < 0.05.
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nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
23
ABI-007-NSCL-003 Final: 27 Sep 2013
Adverse reactions were assessed in 514 nab-paclitaxel/carboplatin-treated patients and 524 
paclitaxel injection/carboplatin-treated patients. Patients in both treatment arms received a 
median of 6 cycles of treatment. The following common (≥ 10% incidence) adverse reactions 
were observed at a similar incidence in nab-paclitaxel plus carboplatin-treated and paclitaxel 
injection plus carboplatin-treated patients: 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).
Laboratory-detected abnormalities which occurred with a difference ≥5% for nab-paclitaxel plus 
carboplatin vs paclitaxel injection plus carboplatin (Grades1-4 [and G3-4]) are: anemia (98% vs 
91% [28% vs 7%]), neutropenia (85% vs 83% [47% vs 58%]) and thrombocytopenia (68% vs 
55% [18% vs 9%]).  
1.3.
Rationale for Development of nab-Paclitaxel as Maintenance 
Treatment in Squamous Cell NSCLC
Although significant advances have been made in the treatment options and outcomes of patients 
with non-squamous NSCLC, progress for patients with squamous cell NSCLC has been 
disappointing. Furthermore, the data of maintenance therapy that resulted in the FDA approval of 
pemetrexed (Alimta) and erlotinib (Tarceva), seems to confer benefit (and choice) primarily for 
non-squamous NSCLC patients.
Both Alimta studies as well as the Tarceva study demonstrated an overall survival benefit with 
maintenance vs. placebo (Paz-Arez, 2012; Tarceva package insert). However, both of the Alimta 
maintenance studies showed benefit in non-squamous patients only. Whereas Tarceva showed
significant benefit in the non-squamous cell NSCLC patients, only modest improvement was 
observed in squamous cell NSCLC patients (Neal, 2010).
To date there have been no randomized studies showing benefit of maintenance therapy in 
squamous NSCLC patients. Therefore, there is still an unmet medical need for maintenance 
treatment in squamous cell NSCLC. 
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dies show
there is st
here is stil

nab-paclitaxel
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ABI-007-NSCL-003 Final: 27 Sep 2013
2.
STUDY OBJECTIVES
2.1.
Primary Objective
The primary objective of the study is to evaluate PFS with nab-paclitaxel as maintenance 
treatment after response or SD with nab-paclitaxel plus carboplatin in subjects with squamous 
cell NSCLC.
2.2.
Secondary Objectives 
The secondary objectives of the study are:
!
To evaluate the safety and tolerability of nab-paclitaxel as maintenance treatment 
after response or SD with nab-paclitaxel plus carboplatin in subjects with squamous 
cell NSCLC.
!
To further assess the efficacy with nab-paclitaxel as maintenance treatment after 
response or SD with nab-paclitaxel plus carboplatin in subjects with squamous cell 
NSCLC, as measured by secondary efficacy endpoints.
2.3.
Exploratory Objectives
The exploratory objectives of the study are:
!
To determine baseline tumor characteristics which predict response and resistance to 
nab-paclitaxel/carboplatin during the Induction part of the study. 
!
To determine what changes in peripheral tumor characteristics during treatment are 
associated with acquisition of resistance in the subjects who had initial clinical 
benefit.
!
To evaluate the safety and efficacy of nab-paclitaxel as cross-over (re-induction)
treatment after progression during the Maintenance part of the study in subjects with 
squamous cell NSCLC. 
!
To assess healthcare resource utilization during the Maintenance part of the study.
!
To assess the LCSS and EQ5D.
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treatment 
treatmen
s with
with squa
squ
ance treatm
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bjects with 
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ics
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which
Induct
nduction p
n p
ripheral
ripheral tum
tum
resistance i
resistance 
and efficacy
and efficacy
ression dur
ession dur
SCLC
SCLC. 
ltlthcare
hcare res
r
s the LCSS
the LCSS

nab-paclitaxel
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3.
STUDY ENDPOINTS
3.1.
Primary Endpoint
Progression free survival from randomization into the Maintenance part of the study.
3.2.
Secondary Endpoints
3.2.1.
Safety
Safety parameters including AEs and SAEs.
3.2.2.
Efficacy
!
Overall survival from randomization into the Maintenance part of the study.
!
Overall response rate during the Induction and Maintenance parts of the study.
3.3.
Exploratory Endpoints
!
Overall response rate and disease control rate of subjects in the Cross-over part of the 
study.
!
The correlation between pretreatment tumor characteristics and response and 
resistance to the study treatment determined using next-generation sequencing 
methods, immunohistochemistry, or other analysis methods.
!
The association between the changes in tumor characteristics and the acquisition of 
resistance to therapy from plasma samples taken at treatment failure during 
Maintenance.
!
The relationships between variants in subject pharmacogenomics, such as 
polymorphisms in enzymes involved in drug metabolism, and treatment efficacy and 
toxicity. 
!
Healthcare resource utilization during the Maintenance part of the study using a 
questionnaire including hospitalizations, emergency room visits, doctor or nurse 
visits, procedures, and/or additional medication.
!
Change in the LCSS and EQ5D.
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the study
the study
parts of the 
arts of 
bjects
bjects in the
i
characteri
character
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her analy
ges in tumo
ges in tumo
ma samples
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en variants
n variant
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zymes invo
ource
ource utu ili
irere includin
includin
rocedures, 
rocedures, 
ange in the 
nge in th

nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
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ABI-007-NSCL-003 Final: 27 Sep 2013
4.
OVERALL STUDY DESIGN
4.1.
Study Design
This is a Phase III, randomized, open-label, cross-over, multi-center study of nab-paclitaxel plus 
BSC or BSC alone as maintenance treatment after response or SD with nab-paclitaxel plus 
carboplatin as induction in subjects with squamous cell NSCLC. Approximately 540 subjects 
with Stage IIIB/IV squamous cell NSCLC eligible to receive standard treatment of nab-paclitaxel
plus carboplatin for 4 cycles will be enrolled in the Induction part of the study. If after the 4 
cycles, the subject has a radiologically assessed CR, PR, or SD without clinical progression, they 
will be randomized (2:1) in the Maintenance part of the study to receive nab-paclitaxel plus BSC 
or BSC alone. BSC is defined as the best palliative care per investigator (including but not 
limited to: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, 
nutritional support, and/or focal external-beam radiation for control of pain, cough, dyspnea, or 
hemoptysis) excluding antineoplastic agents. Approximately 260 subjects will be evaluable for 
the primary endpoint of PFS in maintenance. Once a subject in the BSC arm during the 
Maintenance part of the study experiences radiologic progression of disease, they will be eligible 
to cross-over to receive nab-paclitaxel.
4.1.1.
Induction Part
The main purpose of the Induction part is to identify those subjects who are eligible for 
randomization in the Maintenance part of the study. Approximately 540 subjects eligible for 
standard treatment with nab-paclitaxel plus carboplatin for 4 cycles will be enrolled, provided if 
all inclusion/exclusion criteria are complied within a 28-day screening period prior to Cycle 1 
Day 1.
Induction treatment will commence on Cycle 1 Day 1: 
!
nab-Paclitaxel 100 mg/m2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 
21-day cycle
!
Carboplatin AUC = 6 mg*min/mL IV on Day 1 of each 21-day cycle after completion 
of nab-paclitaxel infusion
Once 4 cycles have been completed for Induction, if the subject has a radiologically assessed
CR, PR, or SD, and has met all eligibility criteria, they will continue on to the Maintenance part 
of the study. If the subject has radiological or clinical PD, they will be discontinued from the 
study and will not be followed.
4.1.2.
Maintenance Part
Once 4 cycles have been completed for Induction, if the subject has a radiologically assessed
CR, PR, or SD without clinical progression, they will be screened for eligibility over a 7-day 
period. Subjects (approximately 260) who satisfy all inclusion/exclusion criteria, will be 
randomized 2:1 to receive either:
!
nab-Paclitaxel 100 mg/m2 IV infusion over 30 minutes on Days 1 and 8 of each 21-
day cycle plus BSC until disease progression (see Section 8.3 for guidelines on 
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nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
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ABI-007-NSCL-003 Final: 27 Sep 2013
starting dose for the Maintenance part of the study if the subject had dose reduced 
during the Induction part of the study)
OR
!
BSC until disease progression
Maintenance therapy should start at the time of randomization. If this is not possible, a maximum 
of 7 days will be allowed from the date of randomization to the start date of Maintenance 
therapy. Subjects must start Maintenance therapy no earlier than 21 days and no later than 35
days from Day 1 of the fourth cycle of Induction therapy. 
Randomization will be stratified by disease stage (IIIB vs IV), response in induction (CR/PR vs 
SD), and performance status (0 vs 1).
4.1.3.
Cross-over 
A subject in the BSC arm during the Maintenance part of the study who experiences radiological 
progression of disease, will be eligible to cross-over to receive nab-paclitaxel 100 mg/m2 IV 
infusion over 30 minutes on Days 1 and 8 of each 21-day cycle until unacceptable toxicity or 
discontinuation for any other reason, if the benefit : risk is considered appropriate by the treating 
investigator (see Section 8.3 for guidelines on starting dose for the Cross-over part of the study if 
the subject had dose reduced during the Induction part of the study, and Sections 7.2 and 7.3 for 
eligibility). 
4.1.4.
Follow-up Period 
All subjects who discontinue from the Maintenance or Cross-over parts of the study for any 
reason other than withdrawal of consent, lost to follow-up, or death, will enter the Follow-up 
period that will have a visit 28 days after progression or discontinuation. Those subjects entering 
the follow up period without documented progression will continue to have CT scans in 
accordance with standard of care until documented progression of disease. Additionally, subjects 
will be followed for OS by phone approximately every 90 days for up to 1.5 year after final 
analysis of approximately 182 PFS events or approximately 218 deaths have been observed for 
the final OS analysis, whichever is earlier.
4.2.
Study Design Rationale
The results of promising activity with nab-paclitaxel in NSCLC, especially in squamous cell 
NSCLC, underscore the hypothesis for this Phase III study as a superiority trial to compare nab-
paclitaxel/BSC vs BSC as maintenance therapy in subjects with squamous cell NSCLC
(randomizing subjects with CR/PR/SD after Induction treatment with nab-paclitaxel/
carboplatin). The nab-paclitaxel regimen used for Induction will be in accordance with the FDA 
approved label, 100 mg/m2 administered once per week on Days 1, 8 and 15 of each 21-day
cycle with no break combined with carboplatin AUC = 6 mg*min/mL administered on Day 1 
every 21 days. Four cycles of doublet-chemotherapy is chosen as the cut-off, based on observed 
risk:benefit results that additional cycles of doublet chemotherapy did not confer significant 
advantages (Socinski, 2002); furthermore, 4 cycles of doublet-chemotherapy represents general 
trends of practice (Stinchcombe, 2009).
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nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
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ABI-007-NSCL-003 Final: 27 Sep 2013
The nab-paclitaxel regimen used for Maintenance will be 100 mg/m2 administered on Days 1 and 
8 of each 21-day cycle until progression (the actual starting dose may be adjusted as specified in 
Section 8.3). The nab-paclitaxel dosing regimen was reduced to Days 1 and 8 of each 21-day 
cycle in the Maintenance part of the study to decrease potential toxicity and possibly optimize 
tolerability of treatment and drug exposure in subjects. Sufficient subjects will be enrolled to 
provide adequate power to compare PFS. The safety and tolerability of nab-paclitaxel will be 
assessed.
&(/*(1(35235,(7$5<,1)250$7,21

nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
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ABI-007-NSCL-003 Final: 27 Sep 2013
Figure 1:
Overall Study Design
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nab-paclitaxel
Protocol ABI-007-NSCL-003
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Confidential and Proprietary
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4.3.
Study Duration 
The Induction part of the study will last approximately 36 months to randomize sufficient 
subjects for the Maintenance part of the study. The total length of this Phase III study with 
Induction, Maintenance, Cross-over, and Follow-up is estimated to last approximately 5 years.
4.4.
End of Trial
The End of Trial is defined as either the date of the last visit of the last subject to complete the 
study, or the date of receipt of the last data point from the last subject that is required for 
primary, secondary and/or exploratory analysis, as pre-specified in the protocol and/or the 
Statistical Analysis Plan (SAP), whichever is the later date.
&(/*(1(35235,(7$5<,1)250$7,21
e

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5.
TABLE OF EVENTS
Table 3:
Table of Events – Induction
CYCLE 1 and 3 (21-day)
CYCLE 2 and 4 (21-day)
Assessment
Screening/
Baseline
(up to 28 
days)
Day 1
(C3: ±2 
days)
Day 8
(±2 days)
Day 15
(±2 days)
Day 1
(±2 days)
Day 8
(±2 days)
Day 15
(±2 days)
Every 42 
days
(-3/+7 days)
Early
Treat-
ment 
Discon-
tinuation /
End of 4 
Cycles
Unsched-
uled
Informed Consent
X
-
-
-
-
-
-
-
-
-
Medical History
X
-
-
-
-
-
-
-
-
-
Prior Medication and Procedures
X
-
-
-
-
-
-
-
-
-
Serum β-hCGb
X
X
-
-
X
-
-
-
X
-
Complete Chest CT Scan (including 
adrenal gland) with contrast and any 
other studies required for tumor 
imagingc
X
-
-
-
-
-
X
X
Xa
Weight
X
X
X
X
X
X
X
-
X
Xa
Archived Tumor Tissue Sample for 
Biomarker (biopsy, surgical specimen, 
or other diagnostic tumor sample)
-
X (C1D1 
only)
-
-
-
-
-
-
-
-
Plasma for Biomarker Analyses 
-
X (C1D1 
only)
-
-
-
-
-
-
X
-
Blood for Pharmacogenomic Analyses
-
X (C1D1 
only)
-
-
-
-
-
-
-
-
Body Surface Area (BSA) Calculation 
and Heightd
X
-
-
-
-
-
-
-
-
Xa
ECOG status
X
X
-
-
X
-
-
-
X
Xa
Concomitant Medication/Procedures
X
X
X
X
X
X
X
X
X
Xa
Peripheral Neuropathy Assessmente
X
X
X
X
X
X
X
-
X
Xa
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nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
32
ABI-007-NSCL-003 Final: 27 Sep 2013
Table 3:
Table of Events – Induction (Continued)
CYCLE 1 and 3 (21-day)
CYCLE 2 and 4 (21-day)
Assessment
Screening/
Baseline 
(up to 28 
days)
Day 1
(C3: ±2 
days)
Day 8
(±2 days)
Day 15
(±2 days)
Day 1
(±2 days)
Day 8
(±2 days)
Day 15
(±2 days)
Every 42 
days
(-3/+7 days)
Early 
Treat-
ment 
Discon-
tinuation / 
End of 4 
Cycles
Unsched-
uled
Hematology and Serum Chemistry f
X
X
X
X
X
X
X
-
Xa
X
Adverse Event Evaluation
X
X
X
X
X
X
X
X
X
Xa
nab-paclitaxel Administration
-
X
X
X
X
X
X
-
-
-
Carboplatin Administration
-
X
-
-
X
-
-
-
-
-
LCSS and EQ5D
-
X
-
-
X
-
-
-
X
-
Electrocardiogram (ECG)
Will be done as per standard of care during the study and as clinically indicated, however results will not 
be routinely collected in the eCRFs, However if abnormal and clinically significant results, will be collected as AE or SAE and if scans 
show documented progression of disease will be collected on eCRF.
CT Scan of Head or Brain Magnetic 
Resonance Imaging (MRI)
Bone Scan (X-rays if needed)
Physical Examination
Vital Signs
C3: Cycle 3, eCRF: electronic Case Report Form, C1D1: Cycle 1 Day 1, AE: Adverse Event, SAE: Serious Adverse Event, ECOG: Eastern Cooperative Oncology Group, CT: Computed Tomography, 
b-HCG: beta human chorionic gonadotropin, RECIST: Response Evaluation Criteria in Solid Tumors, LCSS: Lung Cancer Symptom Scale, EQ5D: EuroQol 5D
a If clinically indicated.
b A pregnancy test is required for women of child-bearing potential only. For women of child-bearing potential a Serum β-hCG pregnancy test must be performed to assess
eligibility at Screening/Baseline and within 72 hours of the first administration of study drug before beginning each new cycle. Note: the screening serum pregnancy test can be 
used as the test prior to Day 1 study therapy if it is performed within the 72-hour timeframe.
c All subjects must have a radiographically documented measurable tumor(s) by RECIST criteria: Complete chest CT scan (including adrenal gland) with and without contrast are
performed at Screening, every 42 days (-3/+7 days) while on-treatment (schedule based on calendar, not start of cycle), early termination, and if clinically indicated while on-
treatment. The methods of assessment chosen at baseline to follow tumors are to remain consistent throughout study duration. Scans will be archived as per institution standards.
d BSA calculated at baseline and recalculated if body weight changes by more than 10% from baseline.
e The occurrence of peripheral neuropathy should be reported by the investigator per protocol as an AE or SAE.
f Laboratory assessments will be done prior to each nab-paclitaxel treatment by local laboratories as per standard of care during the study and as clinically indicated. The results 
from laboratory assessments will be captured as per Section 6.18.
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nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
33
ABI-007-NSCL-003 Final: 27 Sep 2013
Table 4:
Table of Events – Maintenance and Cross-over
EVERY CYCLE
(21-day)
Assessment
Screening/ 
Baseline
(up to 14
days)
Day 1
(±2 days, 
except 1st
cycle)
Day 8
(±2 days)
Every 42 
days
(-3/+7 days)
Early 
Treatment 
Discon-
tinuation /
Disease
Progression
28-day 
Follow-up 
visit
Survival 
(every 90 
days) up 
to as 
specified 
in Section 
6.20
Unsched-
uled
Serum β-hCGb
X
X
-
-
X
-
-
-
Complete Chest CT Scan (including adrenal 
gland) with contrast and any other studies 
required for tumor imaging c
Xg
-
-
X
X
-
-
Xa
Weight
X
X
X
-
X
X
-
Xa
Plasma for Biomarker Analyses
-
-
-
X
-
-
-
Body Surface Area (BSA) Calculation and 
Heightd
X
-
-
-
-
-
-
Xa
ECOG status
Xf
X
-
-
X
-
-
Xa
Concomitant Medication/Procedures
X
X
X
X
X
X
X
Xa
Peripheral Neuropathy Assessmente
X
X
X
-
X
X
-
Xa
Hematology and Serum Chemistry h
X
X
X
-
X
X
-
Xa
Adverse Event Evaluation
X
X
X
X
X
X
-
Xa
nab-paclitaxel Administration
-
X
X
-
-
-
-
Survival phone call 
-
-
-
-
-
-
X
-
Healthcare Resource Utilization 
Questionnaire
-
X
-
-
X
-
-
-
LCSS and EQ5D
-
X
-
-
X
-
-
-
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nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
34
ABI-007-NSCL-003 Final: 27 Sep 2013
Table 4:
Table of Events – Maintenance and Cross-over (Continued)
EVERY CYCLE
(21-day)
Assessment
Screening/ 
Baseline
(up to 14
days)
Day 1
(±2 days, 
except 1st
cycle)
Day 8
(±2 days)
Every 42 
days
(-3/+7 days)
Early 
Treatment 
Discon-
tinuation / 
Disease 
Progression
28-day 
Follow-up 
visit
Survival 
(every 90 
days) up 
to as 
specified 
in Section 
6.20
Unsched-
uled
Electrocardiogram (ECG)
Will be done as per standard of care during the study and as clinically indicated, however results will not 
be routinely collected in the eCRFs, However if abnormal and clinically significant results, will be collected as AE or SAE and if 
scans show documented progression of disease will be collected on eCRF.
CT Scan of Head or Brain Magnetic 
Resonance Imaging (MRI)
Bone Scan (X-rays if needed)
Physical Examination
Vital Signs
C1: Cycle 1, eCRF: electronic Case Report Form, AE: Adverse Event, SAE: Serious Adverse Event, ECOG: Eastern Cooperative Oncology Group, CT: Computed Tomography, b-HCG: beta human 
chorionic gonadotropin, LCSS: Lung Cancer Symptom Scale, EQ5D: EuroQol 5D 
a If clinically indicated.
b A pregnancy test is required for women of child-bearing potential only. For women of child-bearing potential a Serum β-hCG pregnancy test must be performed to assess subject
eligibility at Screening/Baseline and within 72 hours of the first administration of study drug before beginning each new cycle. Note; the screening serum pregnancy test can be 
used as the test prior to Day 1 study therapy if it is performed within the 72-hour timeframe.
c Complete chest CT scan (including adrenal gland) with and without contrast is performed at baseline, every 42 days (-3/+7 days) while on-treatment (schedule based on calendar, 
not start of cycle), early termination, and if clinically indicated while on-treatment. The methods of assessment chosen at baseline to follow tumors are to remain consistent 
throughout study duration. Scans will be archived as per institution standards. Those subjects entering the follow up period without documented progression will continue to 
have CT scans in accordance with standard of care until documented progression of disease.
d BSA calculated at baseline and recalculated if body weight changes by more than 10% from baseline.
e The occurrence of peripheral neuropathy should be reported by the investigator per protocol as an AE or SAE.
f The ECOG performance status must be 0 or 1 for subjects to start maintenance treatment.
g Induction End of Cycle 4 information may serve as baseline for Maintenance.
h Laboratory assessments will be done prior to each nab-paclitaxel treatment by local laboratories as per standard of care during the study and as clinically indicated. The results 
from laboratory assessments will be captured as per Section 6.18.
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nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
35
ABI-007-NSCL-003 Final: 27 Sep 2013
6.
PROCEDURES
Subjects will be provided with a written informed consent form (ICF), given the opportunity to 
ask any questions concerning the study, and will sign an ICF prior to participating in any study 
procedures. After giving written informed consent, subjects will undergo a screening period to be 
assessed for eligibility. All subjects who sign an ICF must be screened into the Interactive Voice 
Response System (IVRS) immediately upon signature on the document. Subjects who do not 
meet the inclusion/exclusion criteria will be considered screening failures and will not be eligible 
for the study. Subjects that have satisfied all eligibility criteria after the screening period will be 
eligible to be enrolled. Subjects who screen fail may re-screen up to 3 times and an ICF will need 
to be signed at each re-screen, 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).
6.1.
Medical History
A complete medical history including, but not limited to, evaluation for past (up to 5 years) or 
present cardiovascular, respiratory, gastrointestinal, renal, hepatic, neurological, endocrine, 
lymphatic, hematological, immunologic, dermatological, psychiatric, genitourinary, obstetrical, 
surgical history or any other diseases or disorders will be performed at Screening. 
6.2.
Prior Medications/Procedures
All prior medications/procedures within 28 days of time of signature on the ICF should be 
recorded. All NSCLC-related prior medications/procedures should be recorded regardless of 
time.
6.3.
Pregnancy Testing
Serum pregnancy test with sensitivity of at least 25 mIU/mL is to be obtained in females of 
childbearing potential (FCBP) at Screening for Induction, Maintenance and Cross-over. A serum 
pregnancy test must be done within 72 hours prior to Cycle 1 Day 1 of starting study therapy, 
repeated before beginning each new cycle, and at discontinuation or end of treatment. The 
subject may not receive treatment until the investigator has verified that the result of the 
pregnancy test is negative. See inclusion criteria for pregnancy testing requirements. Any 
pregnancies that occur in women who have received study drug must be immediately reported to 
Celgene Drug Safety (See Section 11.4).
6.4.
Complete Chest Computed Tomography (CT) Scan (including 
adrenal gland) With and Without Contrast
Complete Chest CT Scan (including adrenal gland) with and without contrast and any other 
studies required for tumor imaging will be done at Screening, every 42 days (-3/+7 days) 
(schedule for scans will be based on calendar, not start of cycle), and at Early Treatment 
Discontinuation/End of Cycle 4 during the Induction part of the study. During the Maintenance 
and Cross-over parts of the study scans will be done every 42 days (-3/+7 days) (schedule for 
scans will be based on calendar, not start of cycle) and at Early Treatment 
Discontinuation/Disease Progression. Additional CTs may be done at any time during the study 
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nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
36
ABI-007-NSCL-003 Final: 27 Sep 2013
if clinically indicated. CT scans are preferred, however MRI would be acceptable. The same 
scanning modality for lesion assessment should be used throughout the study. All scans and 
reports should be archived as per institution standards.
6.5.
Weight
Weight will be collected at every visit during the Induction, Maintenance, and Cross-over parts 
of the study. Additional weights may be collected at any time during the study as needed.
6.6.
Body Surface Area (BSA) Calculation and Height
BSA and height will be collected and calculated at Screening during Induction, Maintenance, 
and Cross-over parts of the study. BSA may be recalculated if body weight changes by more 
than 10% from baseline.
6.7.
ECOG Performance Score
ECOG performance score will be collected at Screening, Day 1 of every cycle and at Early 
Treatment Discontinuation/End of Cycle 4 during the Induction part of the study. During the 
Maintenance and Cross-over parts of the study, ECOG performance score will be collected at 
Screening, Day 1 of every cycle, and at Early Treatment Discontinuation/Disease Progression. 
Additional ECOG may be collected at any time during the study as needed.
6.8.
Concomitant Medications/Procedures
All subjects will have concomitant medications and procedures recorded from the time of 
signature on the ICF until progression during the Induction part of the study or the 28-day 
follow-up visit during the Maintenance part of the study or after Cross-over. Only NSCLC 
associated concomitant medications/procedures will be recorded, including BSC. During 
survival follow-up, anti-cancer treatment information will be collected, if available.
6.9.
Peripheral Neuropathy Assessment
Peripheral neuropathy assessment will be done from the time of signature on the ICF until 
progression during the Induction part of the study or the 28-day follow-up visit during the 
Maintenance part of the study or after Cross-over. Additional peripheral neuropathy assessments 
may be done at any time during the study as needed.
6.10.
Adverse Event Reporting
All subjects will have AEs recorded from time of signature on the ICF until progression during 
the Induction part of the study or the 28 days after the last dose of study drug during the 
Maintenance part of the study or after Cross-over, including any unscheduled visits. See 
Section 11 for details. 
6.11.
Lung Cancer Symptom Scale Questionnaire and EQ5D
The Lung Cancer Symptom Scale (LCSS) and (EQ-5D) questionnaires will be used to measure 
quality of life (QoL) for subjects in the trial. The LCSS is a 9 question analysis the subject
completes using a visual analogue scale (VAS) to denote intensity of a symptom. The EQ-5D 
ance
nce, , 
by more
by more
y cycle
ycle and 
an
of the study
of the stud
ce score wi
e score w
ntinuat
inua ion/D
tudy
udy as nee
as nee
y
res
re
nd procedur
nd procedur
he Induct
Inductioio
of the study
of the stud
edures
edures will
will
nt informa
t informa
opathy As
opathy A
ment will b
ment w
duct
ductioion par
n 
e study
e stud or r
y
time d
me durin
urin
d
dverse Ev
verse E
cts will hav
will hav
duction part
duction part
ntenance p
ntenance p
ecti
ection
on 11
11 f
11.
11

nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
37
ABI-007-NSCL-003 Final: 27 Sep 2013
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 cycle, and 
at Early Treatment Discontinuation/End of Cycle 4 during the Induction part of the study. During 
the Maintenance and Cross-over parts of the study, at Day 1 of every cycle, and at progression of 
disease. The quality of life data generated from these questionnaires will be analyzed per the 
description in the SAP.
6.12.
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 cycle, and at progression of disease during the Maintenance and 
Cross-over parts of the study.
6.13.
Electrocardiogram 
Electrocardiograms (ECGs) will be done as per standard of care during the study and as 
clinically indicated, however results will not be collected in the eCRFs (if results are abnormal 
and clinically significant at Screening, they will be recorded as medical history, and if results are 
abnormal and clinically significant after Screening, they will be recorded as AE or SAE).
6.14.
CT Scan of Head or Brain Magnetic Resonance Imaging (MRI)
CT scan of head or brain MRI will be done as per standard of care during the study and as 
clinically indicated, however results will not be collected in the eCRFs. If scans show  
progression of disease, this information will be collected on eCRF.
6.15.
Bone Scans and X-rays
Bone scans and x-rays will be done as per standard of care during the study and as clinically 
indicated, however results will not be collected in the eCRFs. If scans show progression of 
disease, this information will be collected on eCRF.
6.16.
Physical Examinations
Physical examinations will be done as per standard of care during the study and as clinically 
indicated, however results will not be collected in the eCRFs (if results are abnormal and 
clinically significant at Screening, they will be recorded as medical history, and if results are 
abnormal and clinically significant after Screening, they will be recorded as AE or SAE).
6.17.
Vital Signs
Vital signs will be done as per standard of care during the study and as clinically indicated, 
however results will not be collected in the eCRFs (if results are abnormal and clinically 
significant at Screening, they will be recorded as medical history, and if results are abnormal and 
clinically significant after Screening, they will be recorded as AE or SAE). 
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nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
38
ABI-007-NSCL-003 Final: 27 Sep 2013
6.18.
Laboratory Assessments
Laboratory assessments will be done prior to each nab-paclitaxel treatments by local laboratories 
as per standard of care during the study and as clinically indicated, however results will not be 
collected in the eCRFs unless they are determined to be clinically significant laboratory 
abnormalities. 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. Abnormal and 
clinically significant laboratory assessments at Screening will be recorded as medical history, 
and after Screening, as AE or SAE (clinically significant laboratory abnormalities at Screening 
may result in a subject being ineligible for the study and should not be captured as an AE). If a 
clinically significant laboratory abnormality is captured as medical history, AE, or SAE, the 
specific laboratory parameter(s) should be recorded on the laboratory assessments CRF. Any 
abnormal values that persist should be followed at the discretion of the Investigator. The 
Investigator should file all copies of the reports, including faxes with the subject’s medical chart.
6.19.
Tumor Tissue Sample Collection and Peripheral Blood Collection 
(Exploratory Assessments) 
If archival tumor biopsy blocks or (preferably) surgical specimens from subjects with prior 
resections are available, 10 or more slides of at least 4 um thickness will be collected at Cycle 1 
Day 1 of Induction. Additionally a core of an area representing viable tumor epithelium be 
collected from the block. If the amount of tumor tissue available is not sufficient, fewer slides 
may be collected. 
If a fine needle aspirate (FNA) specimen is available, slides of at least 4 um thickness will be 
collected with the goal of obtaining at least 100,000 cells (preferably more) of material. If 
sufficient material cannot be collected, fewer slides/cells may be collected.
If only other types of diagnostic samples such as endoscopies, lavage, or sputum are available, 
this material should be optionally collected when possible, and collection is strongly encouraged 
when tissue such as endoscopy samples with multiple needle passes exists in quantities 
comparable to a core biopsy. In this instance, 10 slides and a core sample of tumor tissue should 
be collected as per biopsy and surgical samples above. 
Plasma for biomarker analyses will be collected on Day 1 of Cycle 1 during Induction and at 
progression during the Maintenance and Cross-over parts of the study. When progression occurs 
during Induction and before Cycle 4, a plasma sample will be collected at the time of study 
withdrawal.
Peripheral blood will be collected for pharmacogenomic analyses on Cycle 1 Day 1 of Induction.
This sample will be collected in a CPT tube and shipped on dry ice to the central lab for 
processing to Peripheral Blood Mononuclear Cells (PBMC) and stored as a frozen pellet.
Types of techniques planned to be used for tumor and blood analyses include:
!
Gene expression by RNA sequencing
!
Immunohistochemistry 
!
DNA sequencing
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nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
39
ABI-007-NSCL-003 Final: 27 Sep 2013
Details regarding the collection, storage, and shipment of the samples are given in the Laboratory 
Manual.
6.20.
Survival
After discontinuation from the Maintenance or Cross-over part of the study, the subjects will be 
followed for survival by phone approximately every 90 days for up to 1.5 year after final 
analysis of approximately 182 PFS events, or approximately 218 deaths have been observed for 
the final OS analysis, whichever is earlier. The subjects will also be asked questions of other 
medications they may be taking for their NSCLC. 
&(/*(1(35235,(7$5<,1)250$7,21

nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
40
ABI-007-NSCL-003 Final: 27 Sep 2013
7.
STUDY POPULATION
7.1.
Number of Subjects and Sites
Subjects with squamous cell NSCLC stage IIIB or IV with no prior chemotherapy for metastatic 
disease who are ≥ 18 years old will be eligible for this study. The Induction part of the study will 
enroll approximately 540 subjects. Based on results from the nab-Paclitaxel Phase 3 NSCLC 
development study (Protocol CA031) it is estimated that approximately 260 subjects with CR, 
PR, or SD from the Induction part of the study will be randomized to the Maintenance part of the 
study. Enrollment into the Induction part of the study will be monitored and adjusted to ensure 
that approximately 260 subjects are randomized into the Maintenance part of the study. The 
study will be conducted at approximately 120 sites in the United States.
7.2.
Inclusion Criteria
Subjects must satisfy the following criteria to be enrolled in the Induction, Maintenance, and 
Cross-over parts of the study (except if specified at study entry only):
General and Demographics
1. Age ≥ 18 years of age at the time of signing the ICF.
2. Understand and voluntarily provide written consent to the ICF prior to conducting any 
study related assessments/procedures. 
3. Able to adhere to the study visit schedule and other protocol requirements
Disease Specific
4. Histologically or cytologically confirmed Stage IIIB or IV squamous cell NSCLC at 
study entry.
5. No prior history of other malignancies, except basal cell carcinoma of the skin, squamous 
cell carcinoma of the skin, or carcinoma in situ of the cervix.
6. Radiographically documented measurable disease at study entry (as defined in Appendix 
A; lesions in previously irradiated areas [or areas with local therapy] should not be 
selected as target lesions, unless there has been demonstrated progression in the lesion).
7. No prior chemotherapy for the treatment of metastatic disease at study entry. Adjuvant
chemotherapy is permitted providing cytotoxic chemotherapy was completed 12 months 
prior to starting the study and without disease recurrence.
8. Absolute neutrophil count (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.
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12. Total bilirubin ≤ 1.5 × ULN except in cases of Gilbert’s disease and liver metastases. 
13. Creatinine ≤ 1.5 mg/dL.
14. Expected survival of > 12 weeks for the Induction part of the study.
15. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
16. For Maintenance part of the study, subjects must have received at least one dose of nab-
paclitaxel in each of the 4 cycles during Induction 
Pregnancy 
17. Females of childbearing potential [defined as a sexually mature woman who (1) have not 
undergone hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy 
(the surgical removal of both ovaries) or (2) have not been naturally postmenopausal for 
at least 24 consecutive months (ie, has had menses at any time during the preceding 24 
consecutive months)] must:
a.
Have a negative pregnancy test as verified by the study doctor prior to starting study 
therapy. She must agree to ongoing pregnancy testing during the course of the study, 
and after end of study therapy. This applies even if the subject practices true 
abstinence* from heterosexual contact.
b. Either commit to true abstinence* from heterosexual contact (which must be reviewed 
on a monthly basis) or agree to use, and be able to comply with, effective 
contraception without interruption, 28 days prior to starting study drug, during the 
study therapy (including dose interruptions), and for 3 months after discontinuation of 
study therapy. 
Male subjects must:
c.
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 3 months following study drug 
discontinuation, even if he has undergone a successful vasectomy. 
* 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].
18. Females must abstain from breastfeeding during study participation and 3 months after IP 
discontinuation.
7.3.
Exclusion Criteria
The presence of any of the following will exclude a subject from enrollment into the Induction, 
Maintenance, or Cross-over parts of the study (except if specified at study entry only):
1. Evidence of active brain metastases, including leptomeningeal involvement (prior 
evidence of brain metastasis are permitted only if treated and stable and off therapy for ≥
42 days prior to signing ICF).
2. Only evidence of disease is non-measurable at study entry.
3. Preexisting peripheral neuropathy of Grade 2, 3, or 4 (per CTCAE v4.0).
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4. Venous thromboembolism within 6 months prior to signing ICF.
5. Current congestive heart failure (New York Heart Association class II-IV).
6. Myocardial infarction (MI) within 6 months prior to signing ICF.
7. Treatment with any investigational product within 28 days prior to signing ICF.
8. History of allergy or hypersensitivity to nab-paclitaxel or carboplatin.
9. Currently enrolled in any other clinical protocol or investigational trial that involved 
administration of experimental therapy and/or therapeutic devices.
10. Any other clinically significant medical condition and/or organ dysfunction that will 
interfere with the administration of the therapy according to this protocol.
11. Any condition including the presence of laboratory abnormalities, which places the 
subject at unacceptable risk if he/she were to participate in the study.
12. Any condition that confounds the ability to interpret data from the study.
13. Pregnant and nursing females.
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8.
DESCRIPTION OF STUDY TREATMENTS
8.1.
Description of Investigational Product(s)
Induction 
Subjects will receive open-label nab-paclitaxel and carboplatin during the Induction part of the 
study as non-investigational products and will not be supplied by Celgene. Investigative sites 
will use standard of care (commercially available) product via prescription.
Maintenance and Cross-over
Subjects will be randomized to receive nab-paclitaxel plus BSC or BSC alone during the 
Maintenance part of the study. Once a subject in the BSC alone arm during the Maintenance part 
of the study experiences radiologic progression of disease, they will be eligible to cross-over to 
receive nab-paclitaxel. The nab-paclitaxel used in the Maintenance and Cross-over parts of the 
study is designated as IP and will be packaged and supplied by Celgene Corporation. 
The preparation for IV administration procedures should be followed as per package insert.
8.1.1.
nab-Paclitaxel
nab-Paclitaxel will be supplied by the Sponsor, Celgene Corporation, for the Maintenance and 
Cross-over parts of the study in single-use vials in single count cartons. Each single-use 50 mL 
vial will contain 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, the time of reconstitution should be recorded to 
ensure compliance with the 8 hour requirement. Both forms should be stored in an area free of 
environmental extremes and must 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-cyclobutanedicarboxylato
(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. 
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8.2.
Treatment Administration and Schedule
Induction
The main purpose of the Induction part is to identify those subjects who are eligible for 
randomization in the Maintenance part of the study. Approximately 540 subjects will be treated 
with nab-paclitaxel plus carboplatin for 4 cycles.
Induction treatment will commence on Day 1, in accordance with standard of care of 1st line 
treatment of metastatic NSCLC: 
!
nab-Paclitaxel 100 mg/m2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 
21-day cycle
!
Carboplatin AUC = 6 mg*min/mL IV on Day 1 of each 21-day cycle after completion 
of nab-Paclitaxel infusion
Maintenance Part
Once 4 cycles have been completed for Induction, if the subject has a radiologically assessed
CR, PR, or SD without clinical progression, they will be randomized 2:1 (approximately 260
subjects) to receive:
!
nab-Paclitaxel 100 mg/m2 IV infusion over 30 minutes on Days 1 and 8 of each 21-
day cycle plus BSC until disease progression (the actual starting dose may be 
adjusted as specified in Section 8.3)
OR
!
BSC until disease progression
Maintenance therapy should start at the time of randomization. If this is not possible, a maximum 
of 7 days will be allowed from the date of randomization to the start date of Maintenance 
therapy. Subjects must start Maintenance therapy no earlier than 21 days and no later than 35
days from Day 1 of the fourth cycle of Induction therapy.
Cross-over Part
A subject in the BSC arm during the Maintenance part of the study experiences radiologic 
progression of disease, they will be eligible to cross-over to receive nab-paclitaxel 100 mg/m2 IV 
infusion over 30 minutes on Days 1 and 8 of each 21-day cycle until unacceptable toxicity or 
discontinuation for any other reason, if the benefit : risk is considered appropriate by the treating 
investigator (see Section 8.3 for guidelines on starting dose for the Cross-over part of the study if 
the subject had dose reduced during the Induction part of the study, and Sections 7.2 and 7.3 for 
eligibility). 
Subjects may receive BSC as needed per Investigator discretion and should be recorded.
All IP will be administered by the clinical site and administration will be documented in the 
study source record.
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8.3.
Dose Modifications
Subjects will be evaluated for AEs at each visit with the NCI CTCAE v4.0 used as a guide for 
the grading of severity.  The dose of nab-paclitaxel and carboplatin for each subject will be 
modified following toxicity as described in Table 5.
Subjects who experience any of the adverse drug reactions in Table 5 will be dose reduced as per 
Table 5 during the Induction, Maintenance, or Cross-over parts of the study. If a subject is dose 
reduced in the Induction part of the study, please refer to Table 5 for guidelines on dose and 
schedule for the Maintenance and Cross-over parts of the study.
!
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, on Day 1 of any 
cycle, withhold treatment until the ANC recovers to at least 1500 cells/mm3 and the 
platelet count recovers to at least 100,000 cells/mm3. On Days 8 and 15 the ANC 
should recover to at least 500 cells/mm3 and platelet count of at least 50,000 
cells/mm3. When dosing is resumed, the subject should be dosed at the next lower 
dose level of nab-paclitaxel and carboplatin as outlined in Table 5.
!
Withhold nab-paclitaxel for Grade 3 or 4 peripheral neuropathy. Resume nab-
paclitaxel and carboplatin at reduced doses (Table 5) when peripheral neuropathy 
improves to Grade 1 or completely resolves.
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Table 5:
Permanent Dose Reductions for Hematologic and Neurologic Adverse Events and Dosing for Maintenance and 
Cross-over Parts of the Study
Dose Modification During Induction, Maintenance and Cross-over
Starting Dose 
Maintenance
Starting Dose 
Cross-over
Adverse Drug Reaction
Occurrence
Weekly nab-
paclitaxel Dose 
(mg/m2)
Every 21-Days
Carboplatin 
Dose (AUC 
mg•min/mL)
nab-paclitaxel 
Dose (mg/m2) 
Days 1 and 8 of 
each 21-day 
Cycle
nab-paclitaxel 
Dose (mg/m2) 
Days 1 and 8 of 
each 21-day Cycle
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
If subject at 100, 75 or 50 at end of
Induction and ANC > 1500/mm3, will 
start at 100, 100 or 75 respectively
during Maintenance and Cross-over
Second
50
3
Third
Discontinue Treatment
Platelet count < 50,000/mm3
First
75
4.5
If subject at 100 or 75 at end of
Induction and platelet > 100,000/mm3, 
will start at 100 during Maintenance 
and Cross-over 
Second
Discontinue Treatment
Sensory Neuropathy Grade 3 or 4
First
75
4.5
If subject at 100, 75 or 50 at end of
Induction and Grade 1 or no peripheral 
neuropathy, will start at 100, 100 or 75
respectively during Maintenance and 
Cross-over
Second
50
3
Third
Discontinue Treatment
ANC: Absolute Neutrophil Count
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8.4.
Method of Treatment Assignment
The Induction, Maintenance and Cross-over parts of the study are open-label. In the Maintenance 
part of the study, subjects will be randomized 2:1 to nab-paclitaxel plus BSC or BSC alone. 
Enrollment/randomization will occur via IVRS for all parts of the study. 
8.5.
Packaging and Labeling
The label(s) for IP (nab-paclitaxel) will include Sponsor name, address and telephone number, 
the protocol number, IP name, dosage form and strength (where applicable), amount of IP per 
container, lot number, expiry date (where applicable), medication identification/kit number, 
dosing instructions, storage conditions, and required caution statements and/or regulatory 
statements as applicable. Additional information may be included on the label as applicable per 
local regulations.
8.6.
Investigational Product Accountability and Disposal
Celgene (or designee) will review with the Investigator and relevant site personnel the process 
for IP return, disposal, and/or destruction including responsibilities for the site vs. Celgene (or 
designee).
Celgene will instruct the Investigator on the return, disposal and/or destruction of IP and/or 
medical device materials if applicable. Only completely unused IP vials should be retained by 
the site until a representative from Celgene or other Celgene-designated personnel have 
completed an inventory. Partially used an completely used vials should be destroyed according to 
local guidelines, and disposition should be recorded on the Investigational Drug Accountability 
Record Form.
The investigator, or designee, shall record the dispensing of IP to subjects in an IP accountability 
record. The IP record will be made available to Celgene, or other authorized Celgene-designated 
monitoring personnel for the purpose of accounting for the IP supply. Inspections of the IP 
supply for inventory purposes and assurance of proper storage will be conducted as necessary. 
Any significant discrepancy will be recorded and reported to Celgene or their designee and a 
plan for resolution will be documented.
Investigational product will not be loaned or dispensed by the investigator to another investigator 
or site. Under certain circumstances, and with sponsor permission, cooperative groups may 
manage IP between locations within their network as clinical trial agreement and local guidelines 
permit.
8.7.
Investigational Product Compliance
All IP will be administered only by study site personnel and accurate recording of all IP 
administration will be made in the appropriate section of the subject’s eCRF and source 
documents.
8.8.
Overdose
Overdose, as defined for this protocol, refers to nab-paclitaxel or carboplatin dosing only.
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On a per dose basis, an overdose is defined as 10% over the protocol-specified dose of nab-
paclitaxel or carboplatin to a given subject, regardless of any associated adverse events or 
sequelae. 
On a schedule or frequency basis, an overdose is defined as anything more frequent than the 
protocol required schedule or frequency.
On an infusion rate basis, an overdose is defined as any rate faster than the protocol-specified 
rate.
Complete data about drug administration, including any overdose, regardless of whether the 
overdose was accidental or intentional, should be reported in the case report form. See 
Section 11.1 for the reporting of adverse events associated with overdose.
&(/*(1(35235,(7$5<,1)250$7,21

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9.
CONCOMITANT MEDICATIONS AND PROCEDURES
9.1.
Permitted Concomitant Medications and Procedures
All supportive care is permitted. 
9.2.
Prohibited Concomitant Medications and Procedures
Other antineoplastic agents or IP other than what is specified in the protocol is prohibited.
9.3.
Required Concomitant Medications and Procedures
Not applicable.
&(/*(1(35235,(7$5<,1)250$7,21

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10.
STATISTICAL ANALYSES
Statistical analyses for the primary and key secondary endpoints of the Induction and 
Maintenance parts of the study are described below by study part. Although some definitions for 
the efficacy and safety endpoints, and the analysis populations are the same for both parts of the 
study, they are repeated in the respective section to ensure that each part is self-contained.
Furthermore, while key analyses for the primary and key secondary endpoints are described in 
this section, additional analyses of these endpoints as well as exploratory endpoints will be 
described in details in the SAP.
10.1.
Induction Part
10.1.1.
Overview
This is the open-label, single-arm, Induction part of the study. Subjects receiving nab-paclitaxel 
100 mg/m2 administered weekly followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of 
each cycle, repeated every 21 days, for 4 cycles will be enrolled. Subjects will have CT scans 
performed every 42 days (-3/+7 days). At the end of the 4 cycles, subjects who achieve a 
radiologically assessed CR, PR, or SD without clinical progression based on the Investigator’s 
evaluation using RECIST 1.1 guidelines, and meet inclusion/exclusion criteria will be 
randomized in the Maintenance part of the study.
An independent DMC will be established to monitor the study conduct. Details will be provided 
in the DMC charter.
10.1.2.
Study Population Definitions
10.1.2.1.
Intent-to-Treat Population
The primary efficacy analysis will be performed on the ITT population, which includes all 
enrolled subjects regardless of whether the subject receives any dose of nab-paclitaxel or has any 
efficacy assessments collected.
10.1.2.2.
Safety Population
The safety population will be the analysis population for all safety/ tolerability analyses. The 
safety population includes all subjects enrolled who received at least 1 dose of study treatment. 
Only subjects with clear documentation that no study treatment was administered will be 
excluded from the safety population. 
10.1.3.
Sample Size and Power Considerations
Approximately 540 subjects will be enrolled in the Induction part of the study. This sample size 
is expected to provide approximately 260 subjects eligible for randomization in the Maintenance 
part.   
In the nab-Paclitaxel Phase 3 NSCLC development study (Protocol CA031), 42% (13/31) and 
63% (125/198) of the squamous subjects from the North American and ex-North American sites, 
respectively, were progression free after 4 cycles of treatment and remained in the study in Cycle 
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art.

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5 and beyond. To be conservative, it is assumed that approximately 50% (270/540) of the 
subjects in the Induction part of this study will meet the radiologic and clinical progression free 
criteria at the end of Cycle 4. Furthermore, it is expected that approximately 4% of these 270
subjects will not meet the other inclusion/exclusion criteria for the Maintenance part, yielding a 
total of approximately 260 subjects entering the Maintenance part of the study.
The actual number of subjects that will be enrolled in the Induction part will be monitored on an 
ongoing basis and adjusted to ensure that the target number of subjects for the Maintenance part 
is attained. Enrollment of the Induction part, therefore, could be discontinued early or extended 
beyond the planned number of 540 subjects.
The ORR is the secondary endpoint in the Induction part. The point estimate and the associated 
two-sided 95% confidence interval will be calculated for this endpoint. No multiplicity 
adjustment will be made for this endpoint as no formal inferential testing will be performed.
The percentage of subjects with an AE of Grade 3 or higher peripheral neuropathy will be 
captured along with the associated two-sided 95% confidence interval without inferential testing.
Table 6 below demonstrates the precision of the estimate for a proportion that can be attained 
given a sample size of 540. For example, for a hypothetical ORR rate of 40% at the end of Cycle 
4, the half-width of the associated two-sided 95% confidence interval will be 4.1%, and the 
estimated 95% confidence interval will be (35.9%, 44.1%).
Table 6:
Precision of the Estimate for a Proportion Given a Sample Size of 540
Endpoint
Hypothetical Event Rate
Half Widtha of 
95% Confidence 
Interval
two-sided 95% 
Confidence Intervala
Overall Response Rate
35%
4.0%
(31.0% to 39.0%)
40%
4.1%
(35.9% to 44.1%)
45%
4.2%
(40.8% to 49.2%)
Peripheral Neuropathy
≥ Grade 3
5%
1.8%
(3.2% to 6.8%)
10%
2.5%
(7.5% to 12.5%)
15%
3.0%
(12.0% to 18.0%)
a Estimated based on normal approximation.
10.1.4.
Background and Demographic Characteristics
The baseline characteristics of all subjects enrolled 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. Medical 
history data will be summarized using frequency tabulations by system organ class and preferred 
term.
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10.1.5.
Subject Disposition
Subject disposition including the number and percent of subjects enrolled, randomized, treated, 
and the primary reason for discontinuation of therapy will be summarized by study site. Protocol 
deviations will be summarized using frequency tabulations.
10.1.6.
Efficacy Analysis
10.1.6.1.
Primary Purpose
The main purpose of the Induction part is to identify those subjects who are eligible for 
randomization in the Maintenance part of the study. There is no formal statistical analysis 
planned for this purpose. Subjects who attain a radiologically assessed CR, PR, or SD without 
clinical progression according to the investigator’s assessment of the scan performed at the end 
of Cycle 4, based on RECIST 1.1 guidelines, and satisfy the inclusion/exclusion criteria will be 
eligible to be randomized into the Maintenance part of the study.  
10.1.6.2.
Secondary Endpoints
10.1.6.2.1. Overall Response Rate 
The percentage of subjects who achieve an overall complete or partial response (ORR) according 
to RECIST 1.1 guidelines as determined by the investigator and confirmed by repeat assessments 
performed no less than 28 days after the criteria for response were first met will be calculated.
The associated two-sided 95% CI of the ORR will be presented.
Given that the confirmation CT-scan for the ORR could be taken after the start of the 
Maintenance part in which subjects will be receiving either nab-paclitaxel plus BSC or BSC
alone, the ORR will be reported for all subjects enrolled as 1 group, and also by the Maintenance 
treatment regimen, if necessary.
It is important to note that the Induction part is analogous to a 4-cycle fixed duration study with 
all subjects exiting this part prior to or at the end of Cycle 4. Therefore, the analysis results for 
all secondary efficacy endpoints should be interpreted accordingly.
10.1.7.
Safety Analysis
All subjects who take at least 1 dose of nab-paclitaxel will be included in the safety analyses. 
Adverse events will be summarized by worst severity grade. AEs, as well as treatment-emergent 
AEs, will be summarized by system organ class, and preferred term. nab-Paclitaxel-related 
adverse events, adverse events leading to death or to discontinuation from treatment, events 
classified as CTCAE Grade 3 or Grade 4, and serious adverse events, and events of interest will 
be summarized separately.
Cross tabulations will be provided to summarize frequencies of abnormalities.
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.
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10.1.7.1.
Adverse Events
Adverse events will be coded using the Medical Dictionary for Drug Regulatory Activities 
(MedDRA).
Adverse events will be analyzed in terms of treatment emergent adverse events (TEAEs), defined 
as any AEs that began or worsened in grade after the start of nab-paclitaxel to the start of the 
Maintenance part for those who randomize in the Maintenance part, or through end of treatment 
of nab-paclitaxel for those who do not randomize in the Maintenance part. 
Adverse events will be summarized by system organ class, relative and absolute frequency, 
severity/grade based on the NCI CTCAE version 4.0 and relationship to treatment. Study 
medication-related AEs, SAEs, and events leading to discontinuation or death will be listed 
separately.
10.1.7.2.
Laboratory Assessments
Laboratory test results will not be collected in the eCRFs unless they are determined to be 
clinically significant laboratory abnormalities. Abnormal and clinically significant laboratory 
assessments at Screening will be recorded as medical history, and after Screening, as AE or SAE. 
If a clinically significant laboratory abnormality is captured as medical history, AE, or SAE, the 
specific laboratory parameter(s) should be recorded on the laboratory assessments CRF.
10.1.8.
Study Treatment Termination
Reasons for stopping study treatment during the Induction part will be summarized in listings by 
frequency of occurrence and corresponding percentage of occurrence.
10.1.9.
Deaths
Deaths reported during treatment (defined as deaths after the start of nab-paclitaxel to the start of 
the Maintenance part for those who are randomized in the Maintenance part, or through end of 
treatment of nab-paclitaxel for those who are not randomized in the Maintenance part) will be 
summarized by frequency of occurrence and corresponding percentage by cause of death per 
period.
10.2.
Maintenance Part
10.2.1.
Overview
This is the open-label, randomized, Maintenance part of the study for the evaluation of the 
benefit of a maintenance treatment after an initial 4 cycles of Induction treatment for subjects 
with squamous NSCLC.
Approximately 260 radiologic and clinical progression free subjects from the Induction part will 
be randomized in the Maintenance part. These subjects will be randomized in a 2:1 ratio to the 
nab-paclitaxel plus BSC and BSC alone groups, respectively. The nab-paclitaxel group will 
receive nab-paclitaxel 100 mg/m2 on Day 1 and 8 of each 21-day cycle plus BSC (the actual 
starting dose may be adjusted as specified in Section 8.3), while the BSC group will receive the 
standard BSC. All subjects will receive the assigned regimen until disease progression or 
unacceptable toxicity. Subjects in the BSC alone group who have radiologic progression will be 
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eligible to crossover and receive the nab-paclitaxel regimen until unacceptable toxicity or 
discontinuation for any other reason.
A permuted-block randomization method and an Interactive Voice Response System (IVRS) will 
be utilized to ensure a central randomization. The randomization will be stratified based on 
following 3 baseline and prognostic factors:
!
ECOG performance status at the end of the Induction part (0 vs. 1)
!
Tumor response to induction chemotherapy (CR or PR vs. SD), and 
!
Disease stage before administration of induction therapy (IIIB vs. IV).
It is hypothesized that subjects will benefit from maintenance treatment with nab-paclitaxel. A
randomization ratio of 2:1 will, therefore, minimize subject exposure to treatment with BSC only 
while providing sufficient data for testing the treatment difference with respect to the primary 
endpoint, PFS, in the Maintenance part of the study. 
A DMC will be used to monitor the study conduct. Details will be provided in the DMC charter.
10.2.2.
Study Population Definitions
10.2.2.1.
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 IP or has any efficacy 
assessments collected. 
10.2.2.2.
Response Evaluable Population
Response evaluable population includes all randomized subjects who meet eligibility criteria, 
take at least one dose of IP or on BSC and have at least one baseline and post baseline efficacy 
assessment. The response evaluable population may be used for additional analyses which will 
be described in the SAP.
10.2.2.3.
Per-protocol (PP) Population
The PP population is defined as all subjects randomized in the Maintenance part who receive at 
least one dose of the study therapy and do not have any known major protocol deviations and 
fulfill the study enrollment criteria. The PP population may be used for additional analyses 
which will be described in the SAP.
10.2.2.4.
Safety Population
The safety population includes all randomized subjects in the BSC alone arm and those who
receive at least one dose of nab-paclitaxel in the nab-paclitaxel plus BSC arm in the Maintenance 
part of the study. The safety population will be the population for all safety analyses.
10.2.3.
Sample Size and Power Considerations
Progression free survival is the primary endpoint while OS and ORR are the secondary endpoints 
in this part of the study.  
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0 2 3

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One non-binding interim analysis for PFS with early stopping rule for futility will be conducted 
when approximately 91 events are observed. The study may be stopped for futility if conditional 
power is < 10%.
The final analysis of the primary endpoint will be performed when approximately 182 PFS 
events have been observed. A total of approximately 260 subjects will need to be randomized 
assuming an approximate 36 months accrual period and an approximate 2 months follow-up and 
an approximate 9% per year dropout rate.
This study is designed to provide approximately 90% power to detect a HR of 0.60 for PFS 
improvement with nab-paclitaxel plus BSC over BSC alone with a two-sided 5% significance 
level. Assuming an exponential distribution with a median time to PFS of 2 months for the BSC 
alone and proportional hazard, a hazard ratio of 0.60 constitutes an approximate 1.33 months 
increase in median PFS or a 40% hazard risk reduction by the nab-paclitaxel plus BSC regimen 
over that of the BSC alone.
There will be 2 analyses for the OS endpoint. The interim analysis (non-binding) of OS will be 
conducted based on the number of deaths observed at the time of the final PFS analysis. 
However, all subjects will continue to be followed for OS up to 1.5 years after final analysis of 
approximately 182 PFS events or approximately 218 deaths have been observed for the final OS 
analysis, whichever is earlier. The marginal significance levels for OS will be adjusted according 
to O’Brien-Fleming type boundary based on the actual number of deaths observed at each stage.
For example, if 163 and 218 deaths (~75% information) are observed by the time of the interim 
and final analyses of OS, respectively, the marginal critical values will be p ≤0.01106 and p ≤
0.04794, correspondingly.
Assuming an exponential distribution, proportional hazards, and median OS times of 7.2 and 
10.30 months for the BSC alone and nab-paclitaxel plus BSC regimens, respectively, this design 
provides 70% marginal power to detect a hazard ratio of 0.70 between the 2 maintenance 
regimens with an overall two-sided 5% significance level.
A step-down procedure from PFS to OS will be used to control family-wise Type-I error rate to 
5%. That is, OS will be tested only if the nab-paclitaxel plus BSC regimen demonstrates 
superiority over the BSC alone with PFS. 
As an illustration for timeline projection, assuming an exponential distribution for PFS, a 36-
month recruitment period for 260 subjects, and a median PFS of approximately 2.0 months for 
the BSC alone, it will take approximately 23 months from the first subject randomized to observe 
91 PFS events for the interim analysis. The final analysis of PFS (with 182 events) is estimated 
to take place at approximately 15 months after that, which is approximately 2 months after the 
last subject randomized.  
Assuming an exponential distribution for OS and a median OS of 7.2 months for the BSC arm, it 
will take approximately an additional 1.5 years follow-up after the final analysis of PFS to 
observe a total of 218 death events in the entire Maintenance part.
10.2.4.
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. 
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2

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Medical history data will be summarized using frequency tabulations by system organ class and 
preferred term.
10.2.5.
Subject Disposition
Subject disposition (analysis population allocation, entered, discontinued, along with primary 
reason for discontinuation) will be summarized using frequency and percent for both treatments 
and follow-up parts. A summary of subjects enrolled by site will be provided. Protocol 
deviations will be summarized using frequency tabulations.
10.2.6.
Efficacy Analysis
While key analyses are described in this section, additional analyses will be specified in the SAP.
10.2.6.1.
Primary Endpoint 
The primary endpoint, PFS, will be based on investigator’s assessment of response using 
RECIST 1.1 guidelines. Baseline tumor measurements will be determined from the radiology 
evaluation performed within 28 days of the start of Induction therapy. Time to Progression will 
be calculated from the date of randomization (start of Maintenance part) to the first date of 
progressive disease or death from any cause.  
Progression-free survival will be summarized using Kaplan-Meier methods. 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. In the event 
that a new anticancer treatment occurs prior to documented progression, the subject will be 
censored at the time 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 time 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 time of the last radiologic 
assessment where the subject was documented to be progression-free prior to the first of the two 
missing visits.
The null (Ho) and alternative (Ha) hypotheses for testing the primary efficacy endpoint are: 
Ho: HR nab-paclitaxel plus best supportive care/ best supportive care = 1
Ha: HR nab-paclitaxel plus best supportive care/ best supportive care ≠1 
Progression-free survival will be summarized by median PFS time (including two-sided 95% CI) 
for each treatment regimen 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 regimen and differences in the curves will be tested using the 
stratified log-rank test, where the strata include ECOG performance status at the end of the 
Induction part (0 vs.1), tumor response to induction chemotherapy (CR or PR vs. SD), and 
disease stage before administration of induction therapy (IIIB vs. IV), if the number of events in 
each cell is adequate. Other factors may be included if indicated by the actual population 
enrolled.
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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 regimen. 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. 
Additional analyses of PFS calculated from the date of the first dose of Induction therapy will be 
conducted using the same statistical methods described for PFS measured from the date of 
randomization above.
10.2.6.2.
Key Secondary Endpoints
Key secondary efficacy endpoints include OS and ORR (percent of subjects who had a 
radiologic complete or partial response according to RECIST 1.1 guidelines determined by the 
investigator and confirmed by repeat assessments performed no less than 28 days after the 
criteria for response were first met). 
10.2.6.2.1. 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 trial or who are withdrawn from the trial 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 cut-off date. 
Overall survival will be analyzed similarly as PFS.
Additional analyses of OS calculated from the date of the first dose of induction therapy will be 
conducted using the same statistical methods described for OS calculated from the date of 
randomization above.
10.2.6.2.2. Overall Response Rate 
The percentage of randomized subjects having an overall confirmed CR or PR based on the 
investigator’s assessment using RECIST 1.1 guidelines over the entire study (Induction and 
Maintenance) will be calculated (scans will be performed every 42 days [-3/+7 days] and 
confirmation scan will be performed no less than 4 weeks after the criteria for response were first 
met). Baseline tumor measurements will be determined from the radiology evaluation performed 
within 28 days of the start of Induction therapy.
The two-sided 95% CI of the response rates will be presented. Differences in response rates 
between treatment regimens will be tested using chi-square test at a two-sided 5% significance 
level.  
10.2.6.3.
Other Secondary Efficacy Endpoints
10.2.6.3.1. Disease Control Rate
Disease Control rate (ie, SD for ≥ 6 weeks or confirmed CR or PR) over the entire study will be 
analyzed in the same manner as overall response rate. Baseline tumor measurements will be 
determined from the radiology evaluation performed within 28 days of the start of Induction 
therapy.
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.6.3.
Ot
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10.2.6.3
0.2.6.

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10.2.6.4.
Exploratory Endpoints
10.2.6.4.1. Overall Response Rate in Maintenance Part 
Tumor reductions during maintenance treatment beyond the response to induction therapy will 
be explored by the percentage of randomized subjects achieving an overall confirmed CR or PR
compared with the radiologic assessment before randomization (i.e, using end of cycle 4 CT-
scan as the baseline measurement) according to the investigator’s evaluation using RECIST 1.1 
guidelines.  
The two-sided 95% CI of the response rates will be presented. Differences in response rates 
between treatment regimens may be tested using chi-square test at a two-sided 5% significance 
level.
10.2.6.4.2. Response Rate Subsequent to Cross-over to nab-Paclitaxel Regimen
The number and percentage of subjects from the BSC group who cross over to the nab-paclitaxel 
plus BSC regimen after radiologic disease progression, who subsequently achieve CR or PR will 
be estimated with the associated two-sided 95% confidence interval.
For this endpoint, baseline tumor measurements will be determined from the radiologic 
evaluation that renders the subject as having progressive disease by the investigator prior to 
crossing over to receive the nab-paclitaxel plus BSC regimen.
10.2.6.4.3. Health Care Utilization and Quality of Life Questionnaire
The analysis of health care utilization and quality of life questionnaire will be described in detail 
in the SAP.
10.2.6.4.4. Biomarkers and Pharmacogenomic Data
Statistical analysis of the biomarkers and pharmacogenomic data collected from the plasma and 
blood samples will be covered under a separate SAP from that mentioned above.
10.2.7.
Safety Analysis
All subjects in the BSC arm and all subjects who take at least 1 dose of nab-paclitaxel in the nab-
paclitaxel plus BSC in the Maintenance part will be included in the safety analyses. Adverse 
events will be summarized by worst severity grade. AEs, as well as treatment-emergent AEs, 
will be summarized by system organ class, and preferred term. IP-related adverse events, adverse 
events leading to death or to discontinuation from treatment, events classified as CTCAE Grade 
3 or Grade 4 (or moderate/severe if other rating scale is used), and serious adverse events, and 
events of interest will be summarized separately.
Cross tabulations will be provided to summarize frequencies of abnormalities.
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. 
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10.2.7.1.
Adverse Events
Adverse events will be analyzed in terms of TEAEs, defined as any AE occurring or worsening 
on or after the first treatment of the study regimen of the Maintenance part through 28 days after 
the last dose of study regimen administration. In addition, any AE with an onset date more than 
28 days after the last dose of IP that is assessed by the investigator as related to study drug will 
be considered a TEAE. They will be summarized by system organ class, relative and absolute 
frequency, severity grade based on the NCI CTCAE version 4.0 and relationship to treatment. 
Study medication-related AEs, SAEs, and events leading to discontinuation or death will be 
listed separately. 
AEs will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA, 
Version 16.0). 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.
Since laboratory test data will not be collected routinely in the eCRFs, this will not be analyzed.
10.2.7.2.
Laboratory Assessments
Laboratory tests will be performed weekly prior to nab-paclitaxel administration, as per standard 
of care during the study and as clinically indicated. Laboratory test results will not be collected 
in the eCRFs unless they are determined to be clinically significant laboratory abnormalities.
Abnormal and clinically significant laboratory assessments at Screening will be recorded as 
medical history, and after Screening, as AE or SAE. If a clinically significant laboratory 
abnormality is captured as medical history, AE, or SAE, the specific laboratory parameter(s) 
should be recorded on the laboratory assessments CRF.
10.2.8.
Study Therapy Termination
Reasons for stopping study therapy will be summarized in listings by frequency of occurrence 
and corresponding percentage of occurrence per study part (Induction and Maintenance) and 
combined.
10.2.9.
Deaths
Deaths reported during treatment (defined as deaths from the first administration of the study 
Maintenance regimen through 28 days after the last dose of the study Maintenance regimen) 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).
Deaths occurring during the entire study (Induction and Maintenance parts) will also be 
summarized similarly.
10.2.10.
Interim Analysis
There will be one non-binding interim analysis for futility for the primary endpoint, PFS, when 
approximately 91 events (50% information) have been observed. Futility may be declared and 
the study discontinued if the conditional power at the interim analysis is < 10%.  The final 
analysis of PFS will be performed when approximately 182 PFS events have been observed.
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There will be two analyses for the secondary OS endpoint. The interim analysis of OS (for 
efficacy) will be conducted based on the number of deaths observed up to the time of the final 
PFS analysis. The final OS analysis will be performed after approximately 218 deaths have been 
observed, if applicable.  
A Step-down procedure from PFS to OS will be used to control the family-wise two-sided Type-
I error rate to 5%.
The marginal significance level for OS will be adjusted according to O'Brien-Fleming type of 
boundary. The nominal two-sided p-values for declaring superiority will be calculated using the 
statistical software 
. The analysis and boundaries will be adjusted 
based on the actual number of deaths observed.
10.3.
Data Monitoring Committee
An independent DMC will be established with the responsibilities for safeguarding the interests 
of study participants and monitoring the overall conduct of the study. Final recommendations of 
the DMC will reflect the judgment of the DMC members and will be considered advisory in 
nature to the Sponsor. The decision to implement the recommendations of the DMC will be 
made by the Sponsor, following consultation with the coordinating PI and Steering Committee.
A DMC charter will be established.
10.4.
Scientific Steering Committee
The conduct of this trial will be overseen by a Steering Committee. The Steering Committee will 
serve in an advisory capacity to the Sponsor. 
Note: the Steering Committee is separate from the Data Monitoring Committee described in 
Section 10.3.
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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 CRF rather than the individual signs or symptoms of 
the diagnosis or syndrome. 
For the purposes of this study, progressive disease (PD) of squamous cell NSCLC will not 
require reporting as an adverse event.
An overdose, accidental or intentional, whether or not it is associated with an AE, or abuse, 
withdrawal, sensitivity or toxicity to an IP 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 other appropriate tests and 
procedures.
All AEs will be recorded by the Investigator from the time the subject signs informed consent to
28 days after the last dose of IP or the End of Study Visit, whichever is longer, and those SAEs 
made known to the investigator at any time thereafter that are suspected of being related to IP.
AEs and serious adverse events (SAEs) will be recorded on the AE page of the CRF and in the 
subject’s source documents. All SAEs must be reported to Celgene Drug Safety within 24 hours 
of the Investigator’s knowledge of the event by facsimile, or other appropriate method, using the 
SAE Report Form, or approved equivalent form.
11.2.
Evaluation of Adverse Events
A qualified Investigator will evaluate all adverse events as to: 
11.2.1.
Seriousness 
A serious adverse event (SAE) is any AE occurring at any dose that:
!
Results in death;
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ser

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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 CRF. Hospitalization or prolonged 
hospitalization for a complication remains a reportable SAE.
!
An elective treatment of 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.
For each SAE, the Investigator will provide information on severity, start and stop dates, 
relationship to IP, action taken regarding IP, and outcome.
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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 IP and the 
occurrence of an AE/SAE as Not Suspected or Suspected as defined below:
Not suspected:
The temporal relationship of the adverse event to IP 
administration makes a causal relationship unlikely or 
remote, or other medications, therapeutic interventions, or 
underlying conditions provide a sufficient explanation for the 
observed event.
Suspected:
The temporal relationship of the adverse event to IP 
administration makes a causal relationship possible, and other 
medications, therapeutic interventions, or underlying conditions 
do not provide a sufficient explanation for the observed event.
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If an event is assessed as suspected of being related to a comparator, ancillary or additional IP 
that has not been manufactured or provided by Celgene, please provide the name of the 
manufacturer when reporting the event.
11.2.4.
Duration
For both AEs and SAEs, the Investigator will provide a record of the start and stop dates of the 
event.
11.2.5.
Action Taken
The Investigator will report the action taken with IP as a result of an AE or SAE, as applicable 
(eg, discontinuation or reduction of IP, as appropriate) and report if concomitant and/or 
additional treatments were given for the event. 
11.2.6.
Outcome
The investigator will report the outcome of the event for both AEs and SAEs. All SAEs that have 
not resolved upon discontinuation of the subject’s participation in the study must be followed 
until recovered, recovered with sequelae, not recovered (death due to another cause) or death 
(due to the SAE). 
11.3.
Abnormal Laboratory Values
An abnormal laboratory value is considered to be an AE if the abnormality:
!
results in discontinuation from the study;
!
requires treatment, modification/ interruption of IP dose, or any other therapeutic 
intervention; or
!
is judged to be of significant clinical importance.
Regardless of severity grade, only laboratory abnormalities that fulfill a seriousness criterion 
need to be documented as a serious adverse event.
If a laboratory abnormality is one component of a diagnosis or syndrome, then only the diagnosis 
or syndrome should be recorded on the AE page/screen of the CRF. 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.
11.4.1.
Females of Childbearing Potential:
Pregnancies and suspected pregnancies (including a positive pregnancy test regardless of age or 
disease state) of a female subject occurring while the subject is on IP, or within 3 months of the 
subject’s last dose of IP, are considered immediately reportable events. IP is to be discontinued 
immediately. The pregnancy, suspected pregnancy, or positive pregnancy test must be reported 
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11.4.1.
1.4.1.

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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, preferably one experienced in reproductive toxicity for 
further evaluation and counseling.
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 or therapeutic abortion), the 
Investigator should report the abnormal outcome as an AE. If the abnormal outcome meets any 
of the serious criteria, it must be reported as an SAE to Celgene Drug Safety by facsimile, or 
other appropriate method, within 24 hours of the Investigator’s knowledge of the event using the 
SAE Report Form, or approved equivalent form.
All neonatal deaths that occur within 28 days of birth should be reported, without regard to 
causality, as SAEs. In addition, any infant death after 28 days that the Investigator suspects is 
related to the in utero exposure to the IP should also be reported to Celgene Drug Safety by 
facsimile, or other appropriate method, within 24 hours of the Investigator’s knowledge of the 
event using the SAE Report Form, or approved equivalent form.
11.4.2.
Male Subjects
If a female partner of a male subject becomes pregnant while the subject is receiving IP or within 
3 months of the last dose of IP, the male subject taking IP should notify the Investigator, and the 
pregnant female partner should be advised to call her healthcare provider immediately. The IP 
may need to be discontinued in the male subject, but may be resumed later at the discretion of 
the Investigator and medical monitor.
11.5.
Reporting of Serious Adverse Events
Any AE that meets any criterion for an SAE requires the completion of an SAE Report Form in 
addition to being recorded on the AE page/screen of the eCRF. All SAEs must be reported to 
Celgene Drug Safety within 24 hours of the Investigator’s knowledge of the event by facsimile, 
or other appropriate method, using the SAE Report Form, or approved equivalent form. This 
instruction pertains to initial SAE reports as well as any follow-up reports.
The Investigator is required to ensure that the data on these forms is accurate and consistent. This 
requirement applies to all SAEs (regardless of relationship to IP) that occur during the study 
(from the time the subject signs informed consent to at least 28 days after the last dose of IP or 
End of Study Visit, whichever is later) and those made known to the Investigator at anytime 
thereafter that are suspected of being related to IP. SAEs occurring prior to treatment will be 
captured.
The SAE report should provide a detailed description of the SAE and include summaries 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.
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Where required by local legislation, the Investigator is responsible for informing the 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 Abraxane and Investigator 
Brochure. For the purpose of regulatory reporting in the EEA, Celgene Drug Safety will 
determine the expectedness of events suspected of being related to the other IP, carboplatin,
based on the EU Summary of Product Characteristics (SmPC). 
For countries within the European Economic Area (EEA), Celgene or its authorized 
representative will report in an expedited manner to Regulatory Authorities and Ethics 
Committees concerned, suspected unexpected serious adverse reactions (SUSARs) in accordance 
with Directive 2001/20/EC and the Detailed Guidance on collection, verification and 
presentation of adverse reaction reports arising from clinical trials on IP for human use 
(ENTR/CT3) and also in accordance with country-specific requirements.
Celgene or its authorized representative shall notify the Investigator of the following 
information: 
!
Any AE suspected of being related to the use of IP in this study or in other studies 
that is both serious and unexpected (ie, SUSAR);
!
Any finding from tests in laboratory animals that suggests a significant risk for 
human subjects including reports of mutagenicity, teratogenicity, or carcinogenicity.
Where required by local legislation, the Investigator shall notify his/her IRB/EC promptly of 
these new serious and unexpected AE(s) or significant risks to subjects.
The Investigator must keep copies of all pertinent safety information on file including 
correspondence with Celgene and the IRB/EC. (See Section 15.3 for record retention 
information).
Celgene Drug Safety Contact Information:
For Celgene Drug Safety contact information, please refer to the Serious Adverse Event Report 
Form/Completion Guidelines or to the Pregnancy Report Form/Completion Guidelines.
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12.
DISCONTINUATIONS
12.1.
Study Treatment Discontinuation
The following events are considered sufficient reasons for discontinuing a subject from the IP:
!
Adverse Event(s)
!
Disease progression
!
Withdrawal of consent
!
Death
!
Lost to follow-up
!
Protocol violation
All subjects discontinued from nab-paclitaxel for any reason will have a treatment 
discontinuation visit at the time of nab-paclitaxel discontinuation and should undergo early 
termination procedures.
All subjects discontinued from nab-paclitaxel will be followed for a period of 28 days after PFS 
or early discontinuation, or until the date of the last study visit (whichever is longer) for the 
collection of AEs.
Additionally subjects who withdraw from or complete treatment should not be withdrawn from 
the study (unless specifically requested) and should be followed up for progressive disease, 
survival and any new therapy given.
The reason for treatment discontinuation should be recorded in the eCRF and in the source 
documents.
12.2.
Study Discontinuation
The following are considered sufficient reasons for discontinuing a subject from the study:
!
Withdrawal of consent (decision form the subject not to provide follow-up 
information)
!
Death
!
Lost to follow-up
The following may be considered a sufficient reason for discontinuing a subject from the study:
!
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 
withdrawn from the study should complete all protocol-required evaluations scheduled for early 
termination at the time of withdrawal.
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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 the subject 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 CRFs 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.
IP can only be supplied to an Investigator by Celgene or its authorized representative after 
documentation on all ethical and legal requirements for starting the study has been received by 
Celgene or its authorized representative. This documentation must also include a list of the 
members of the IRB/EC and their occupation and qualifications. If the IRB/EC will not disclose 
the names, occupations and qualifications of the committee members, it should be asked to issue 
a statement confirming that the composition of the committee is in accordance with GCP. For 
example, the IRB General Assurance Number may be accepted as a substitute for this list. 
Formal approval by the IRB/EC should mention the protocol title, number, amendment number 
(if applicable), study site (or region or area of jurisdiction, as applicable), and any other 
documents reviewed. It must mention the date on which the decision was made and must be 
officially signed by a committee member. Before the first subject is enrolled in the study, all 
ethical and legal requirements must be met.
The IRB/EC and, if applicable, the authorities, must be informed of all subsequent protocol 
amendments in accordance with local legal requirements. Amendments must be evaluated to 
determine whether formal approval must be sought and whether the ICF should also be revised.
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The Investigator must keep a record of all communication with the IRB/EC and, if applicable, 
between a Coordinating Investigator and the IRB/EC. This statement also applies to any 
communication between the Investigator (or Coordinating Investigator, if applicable) and 
regulatory authorities.
Any advertisements used to recruit subjects for the study must be reviewed by Celgene and the 
IRB/EC prior to use.
14.7.
Ongoing Information for Institutional Review Board / Ethics 
Committee
If required by legislation or the IRB/EC, the Investigator must submit to the IRB/EC:
!
Information on serious or unexpected adverse events as soon as possible; 
!
Periodic reports on the progress of the study;
!
Deviations from the protocol or anything that may involve added risk to subjects.
14.8.
Closure of the Study
Celgene reserves the right to terminate this study at any time for reasonable medical or 
administrative reasons. Any premature discontinuation will be appropriately documented 
according to local requirements (eg, IRB/EC, regulatory authorities, etc).
In addition, the Investigator or Celgene has the right to discontinue a single site at any time 
during the study for medical or administrative reasons such as:
!
Unsatisfactory enrollment;
!
GCP noncompliance;
!
Inaccurate or incomplete data collection;
!
Falsification of records;
!
Failure to adhere to the study protocol.
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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 the distribution of the IP are complete, accurate, filed and retained. Examples of source 
documents include: hospital records; clinic and office charts; laboratory notes; memoranda; 
subject’s diaries or evaluation checklists; dispensing records; recorded data from automated 
instruments; copies or transcriptions certified after verification as being accurate copies; 
microfiche; x-ray film and reports; and records kept at the pharmacy, and the laboratories, as 
well as copies of CRFs or CD-ROM.
15.2.
Data Management
Data will be entered into the clinical database per Celgene Standard Operating Procedures 
(SOPs). This data will be electronically verified through use of programmed edit checks 
specified by the clinical team. Discrepancies in the data will be brought to the attention of the 
clinical team, and investigational site personnel, if necessary. Resolutions to these issues will be 
reflected in the database. An audit trail within the system will track all changes made to the data.
15.3.
Record Retention
Essential documents must be retained by the Investigator for a minimum of 2 years after the last 
approval of a marketing application in an ICH region and until there are no pending or 
contemplated marketing applications in an ICH region, or at least 2 years have elapsed since the 
formal discontinuation of clinical development of the IP. The investigator must retain these 
documents for the time period described above or according to local laws or requirements, 
whichever is longer. Essential documents include, but are not limited to, the following:
!
Signed ICFs for all subjects;
!
Subject identification code list, screening log (if applicable), and enrollment log;
!
Record of all communications between the Investigator and the IRB/EC;
!
Composition of the IRB/EC;
!
Record of all communications between the Investigator, Celgene, and their authorized 
representative(s);
!
List of Sub-investigators and other appropriately qualified persons to whom the 
Investigator has delegated significant study-related duties, together with their roles in 
the study, curriculum vitae, and their signatures;
!
Copies of CRFs (if paper) and of documentation of corrections for all subjects;
!
IP accountability records;
!
Record of any body fluids or tissue samples retained;
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!
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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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, CRFs, procedures for obtaining informed 
consent, record keeping, and reporting of AEs/SAEs with the Investigator. Monitoring will 
include on-site visits with the Investigator and his/her staff as well as any appropriate 
communications by mail, email, fax, or telephone. During monitoring visits, the facilities, IP
storage area, CRFs, 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 CRFs 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 CRFs 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, CRFs 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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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 and order of  
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 the study.
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18.
REFERENCES
Azzoli CG, Baker Jr. S, Temin S, 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, et al. Randomized, phase III study of weekly paclitaxel in 
combination with carboplatin versus standard every-3-weeks administration of carboplatin and 
paclitaxel for patients with previously untreated advanced non-small-cell lung cancer. J Clin 
Onc. 2008;26:468-473.
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):1590-1598.
Lorenz W, Reimann HJ, Schmal A, et al. Histamine release in dogs by Cremophor El and its 
derivatives: oxethylated oleic acid is the most effective constituent. Agents Actions 
1997;7:63-67.
Lung Cancer Awareness. Global Lung Cancer Coalition Website. 
http://www.lungcancercoalition.org/en/pages/about/awareness. Accessed July 12, 2013.
National Institute for Health & Clinical Excellence: The Diagnosis and Treatment of Lung 
Cancer: Methods, Evidence & Guidance, 2011.
Neal, JW. The SATURN trial: the value of maintenance erlotinib in patients with non-small-cell
lung cancer. Future Oncol. 2010 Dec;6(12):1827-1832.
O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979 
Sep;35(3):549-556.
Oken, MM, Creech, RH, Tormey, DC, et al. Toxicity And Response Criteria Of The Eastern 
Cooperative Oncology Group. Am J Clin Oncol 5:649-655, 1982.
Paz-Ares L, de Marinis F, Dediu M, et al. Maintenance therapy with pemetrexed plus best 
supportive care versus placebo plus best supportive care after induction therapy with pemetrexed 
plus cisplatin for advanced non-squamous non-small-cell lung cancer (PARAMOUNT): a 
double-blind, phase 3, randomised controlled trial. Lancet Oncol. 2012 Mar;13(3):247-55.
Rizvi NA, Riely GJ, Azzoli CG, 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):639-643.
Schell MJ, Peterman A, et al. Phase III trial comparing a defined duration of therapy versus 
continuous therapy followed by second-line therapy in advanced-stage IIIB/IV non-small-cell 
lung cancer. J Clin Oncol. 2002;20(5):1335-1343.
Socinski M, Manikhas GM, Stroyakovsky DL, 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):852-861.
Stinchcombe TE, Socinski MA. Current treatments for advanced stage non-small cell lung 
cancer. Proc Am Thorac Soc. 2009;6(2):233-241.
&(/*(1(35235,(7$5<,1)250$7,21
and 
nd 
590
90-1598.
1598
phor El
hor El and
an
Act
Actioions
ns
ccessed Ju
cessed Ju
gnosis and 
nosis and
ce
ce erl
erlotinib
otinib
832.
32
ocedure for
cedure fo
t al
t al. Toxi
Tox c
Clin Oncol
Clin On
M, et al.
M, et al. M
o plus best 
o plus best
non
non-squam
squam
andomised 
andomise
, Azzo
Azzoli CG
li CG
paclitaxel as
aclitaxel a
Onc
Oncol
ol. 200
20
J, Peterm
Peterman
an
uous therap
uous therap
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g cancer. J C
J
Socinski M
Socinski M
week na
week n

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Weiss RB, Donehower RC, Wiernik PH, et al. Hypersensitivity reactions from Taxol. J Clin 
Oncol. 1990;8(7):1263-1268.
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19.
APPENDICES
Appendix A: Response Evaluation Criteria in Solid Tumors (RECIST 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 longest diameter # 20 mm using conventional techniques or # 10 
mm with spiral CT scan.
∀
Non-measurable lesions - all other lesions, including small lesions (longest 
diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan), 
ie, bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusion, 
inflammatory breast disease, lymphangitis cutis/pulmonis, cystic lesions, and also 
abdominal masses that are not confirmed and followed by 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 five lesions per organ and 10 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 7:
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 the LD of target lesions, taking as 
reference the smallest sum LD recorded since the treatment started 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 LD since the treatment 
started
Table 8:
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 lesions
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
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nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
82
ABI-007-NSCL-003 Final: 27 Sep 2013
!
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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nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
83
ABI-007-NSCL-003 Final: 27 Sep 2013
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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