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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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
1
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
TITLE PAGE
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)
INVESTIGATIONAL PRODUCT (IP):
nab-Paclitaxel (Abraxane®)
PROTOCOL NUMBER:
ABI-007-NSCL-003
ORIGINAL DATE FINAL:
27 Sep 2013
AMENDMENT 1 DATE FINAL:
28 Oct 2014
AMENDMENT 2 DATE FINAL:
07 May 2015
AMENDMENT 3 DATE FINAL:
13 Mar 2017
EudraCT NUMBER:
2014-003804-66
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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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
2
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
MEDICAL MONITOR / EMERGENCY CONTACT INFORMATION 
Contact Information:
Name:
Title:
Address: 
Celgene Corporation
86 Morris Avenue
Summit, NJ 07901
Phone:
 
E-mail:
Contact Information:
Name:
Title:
Address: 
Celgene Corporation
86 Morris Avenue
Summit, NJ 07901
Phone:
E-mail:
Note: The back-up 24 hour global emergency contact call center should only be used if you 
are not able to reach the Clinical Research Physician(s) or Medical Monitor or designee for 
emergency calls.
Back-up 24 Hour Global Emergency Contact Call Center: 
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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
3
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
4
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
5
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
6
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
PROTOCOL SUMMARY
Study Title
A Phase III, randomized, open-label, multi-center, safety and efficacy study to evaluate nab®-
paclitaxel1 (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 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, 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 450 subjects
with stage IIIB or IV squamous cell NSCLC will be enrolled in the Induction part of the 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
                                               
1 nab® is a registered trademark of Celgene Corporation.
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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
7
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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 216 subjects will be evaluable for the primary endpoint of 
PFS in maintenance.
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 450 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.
Follow-up Period 
All subjects who discontinue from the Maintenance part 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 
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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
8
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
approximately 136 PFS events in which a total of 147 deaths are expected to be observed for the 
final OS analysis.
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 450 subjects. Based on results from the nab-Paclitaxel Phase 3 NSCLC 
development study (Protocol CA031) it is estimated that approximately 216 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 216 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, and Follow-up is estimated to last approximately 5 years.
Study Treatments
Induction 
The nab-paclitaxel and carboplatin treatments will not be supplied by Celgene during Induction 
in those countries where nab-paclitaxel plus carboplatin is available for the treatment of NSCLC. 
Investigative sites will use standard of care (commercially available) product via prescription in 
these countries.
In those countries where nab-paclitaxel plus carboplatin is not available for the treatment of 
NSCLC, or is available but designated as investigational product (IP) as per local regulations, 
both agents will be packaged and supplied by Celgene.  
Maintenance 
Subjects will be randomized to receive open-label nab-paclitaxel plus BSC or BSC during the 
Maintenance part of the study. The nab-paclitaxel used in the Maintenance part of the study will 
be packaged and supplied by Celgene Corporation.
Please see local prescribing information for Abraxane for detailed instructions on the
reconstitution, storage conditions, and IV administration of nab-paclitaxel.
Statistical Methods
Approximately 450 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 216 subjects are expected to be randomized in the Maintenance part of 
the study.
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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
9
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
Similarly, the percentage of subjects manifesting a PFS event in the Maintenance part will be 
tracked on an ongoing basis.
Induction Part
Efficacy Analyses
All efficacy endpoints will be analyzed based on the intent-to-treat (ITT) population for the 
Induction part, which includes all enrolled subjects who received at least one dose of study 
treatment regardless of whether they 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 at 
the end of Cycle 2 and 4. 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 v1.1 (Eisenhauer, 2009) 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 v1.1 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 along with appropriate point estimates
and 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 
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 216 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.
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 
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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
10
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
before administration of induction therapy (IIIB vs. IV). Tumor response to Induction part 
chemotherapy for stratification is the response assessed at the last CT scan before randomization. 
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.
Analysis of Progression Free Survival (PFS)
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 80% 
power for a two-sided test conducted at a 5% level of significance. This hazard ratio of 0.60 
assumes an underlying exponential distribution for both treatment groups with a median time to 
PFS of 2 months for the BSC alone group and a median time to PFS of 3.33 months for the nab-
paclitaxel plus BSC group. Hence, the final analysis will be conducted after 136 PFS events (ie, 
events of disease progression or deaths from any cause) have occurred.
One non-binding interim analysis will be used to assess futility using the PFS endpoint only, and
is planned when approximately a total of 91 events have been observed. The study may be 
stopped early for futility only if the conditional power for PFS is < 10% under the assumed 
hazard ratio of 0.60, but there is no allowance to stop the study early to declare superior efficacy.
Analysis of Overall Survival (OS)
There will be two analyses for the OS endpoint, one of which involves an interim analysis that 
corresponds to the final analysis of PFS (approximately 136 PFS total events). However, OS 
collection may continue until 1.5 years after the final analysis of PFS with an expected number 
of total deaths of 147. The interim analysis for the OS endpoint will utilize a Lan-DeMets alpha-
spending function to account for the exact timing of the interim based upon the actual number of 
observed events with an O’Brien-Fleming boundary in order to perform an appropriate group-
sequential hypothesis testing procedure for a two-sided test conducted at a 5% level of 
significance.  
A step-down procedure from the PFS final analysis to this group sequential testing approach for 
OS will be used to address multiplicity of testing. 
OS analysis, the study may be stopped if the conditional power is below the threshold specified 
in the SAP.  
General Considerations for the Efficacy Analyses of PFS, OS, and ORR
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 for the Maintenance part, which includes all randomized subjects regardless of 
whether they receive any IP or have any efficacy assessments collected. 
For the primary efficacy endpoint, PFS, the progressive disease component of this endpoint will 
be based on the 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 (PFS) will be defined from the date of randomization to the 
start date of disease progression or date of subject death due to any cause, whichever occurs first.
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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
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ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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 distributions will be summarized using a graphical display of the 
Kaplan-Meier product limit estimates by treatment group, median PFS time estimates (including 
two-sided 95% CI) by each treatment group, and with an estimated hazard ratio (including two-
sided 95% CI) from an unstratified Cox regression model. The hypothesis test of a hazard ratio 
of 1 with respect to the PFS distributions, as shown above, will be evaluated using a stratified 
log-rank test with the 3 baseline and prognostic factors described under the randomization 
scheme in Section 4.1.2. In addition to the stratified log-rank test, a stratified Cox regression 
model will be employed to evaluate the strength of the treatment effect using the estimated 
hazard ratio and corresponding 95% confidence interval.
The 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 a stratified Cochran-Mantel-Haenszel test at a nominal 5% level of significance.
If there exists unacceptable sparseness in some stratum cells (ie, a stratum cell that has less than 
5 BSC subject counts in the ITT population of the Maintenance part of the study), then an 
algorithm for collapsing some full strata will be employed until there are at least 5 BSC subjects 
in any given revised stratum cell. The initial stratum cells for the BSC treatment group will start 
out as 8 cells that represent all possible permutations of the 3 strata (baseline 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]). Hence, the 8 cells representing all possible 
permutations among the strata may be reduced down to either 4 cells (all possible permutations 
of just 2 relatively large strata), 2 cells (just 1 large stratum); or no strata at all when 
implementing the algorithm for the BSC group, the smallest treatment group based on the 2:1 
randomization. However, it is extremely unlikely that the algorithm will result in no stratum.
Once the revised strata have been determined through the algorithm, then it will be used 
consistently for all stratified analyses.
Safety Analyses
The safety population includes all randomized subjects. 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 
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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
12
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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.
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.
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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
13
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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.
Follow-up Period....................................................................................................27
4.2.
Study Design Rationale ..........................................................................................27
4.3.
Study Duration .......................................................................................................29
4.4.
End of Trial ............................................................................................................29
5.
TABLE OF EVENTS.............................................................................................30
6.
PROCEDURES......................................................................................................35
6.1.
Medical History......................................................................................................35
6.2.
Prior Medications/Procedures .................................................................................35
6.3.
Pregnancy Testing ..................................................................................................35
6.4.
Complete Chest Computed Tomography (CT) Scan (including adrenal 
gland) With and Without Contrast ..........................................................................36
20
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23
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TABLE 
TABLE 
PRO
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M
6.2.
6.2

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Celgene Corporation
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ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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........................................................................................37
6.11.
Lung Cancer Symptom Scale Questionnaire and EQ5D..........................................37
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..............................................................................................................38
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.................................................................................................44
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
8.8.
Overdose ................................................................................................................47
9.
CONCOMITANT MEDICATIONS AND PROCEDURES....................................49
&(/*(1(35235,(7$5<,1)250$7,21
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8.6.
.6

EDMS Doc. Number: 
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Protocol ABI-007-NSCL-003
Celgene Corporation
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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.................................................................................................51
10.1.6.
Efficacy Analysis....................................................................................................51
10.1.6.1.
Primary Purpose .....................................................................................................51
10.1.6.2.
Secondary Endpoints ..............................................................................................51
10.1.7.
Safety Analysis.......................................................................................................52
10.1.7.1.
Adverse Events.......................................................................................................52
10.1.7.2.
Laboratory Assessments .........................................................................................52
10.1.8.
Study Treatment Termination .................................................................................52
10.1.9.
Deaths ....................................................................................................................53
10.1.10.
Interim Analysis (Quality of Life Questionnaire and Biomarker Data)....................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.................................................................................................55
10.2.6.
Efficacy Analysis....................................................................................................55
10.2.6.1.
Primary Endpoint....................................................................................................56
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10.2.4.
0.2.4.

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Celgene Corporation
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ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
10.2.6.2.
Secondary Endpoints ..............................................................................................57
10.2.6.3.
Exploratory Endpoints............................................................................................59
10.2.7.
Safety Analysis.......................................................................................................59
10.2.7.1.
Adverse Events.......................................................................................................59
10.2.7.2.
Laboratory Assessments .........................................................................................59
10.2.8.
Study Therapy Termination ....................................................................................60
10.2.9.
Deaths ....................................................................................................................60
10.2.10.
Interim Analysis .....................................................................................................60
10.3.
Data Monitoring Committee ...................................................................................61
10.4.
Scientific Steering Committee ................................................................................61
11.
ADVERSE EVENTS..............................................................................................62
11.1.
Monitoring, Recording and Reporting of Adverse Events .......................................62
11.2.
Evaluation of Adverse Events.................................................................................62
11.2.1.
Seriousness.............................................................................................................63
11.2.2.
Severity / Intensity..................................................................................................64
11.2.3.
Causality ................................................................................................................64
11.2.4.
Duration .................................................................................................................65
11.2.5.
Action Taken..........................................................................................................65
11.2.6.
Outcome.................................................................................................................65
11.3.
Abnormal Laboratory Values..................................................................................65
11.4.
Pregnancy...............................................................................................................65
11.4.1.
Females of Childbearing Potential ..........................................................................66
11.4.2.
Male Subjects.........................................................................................................66
11.5.
Reporting of Serious Adverse Events......................................................................66
11.5.1.
Safety Queries ........................................................................................................67
11.6.
Expedited Reporting of Adverse Events..................................................................67
12.
DISCONTINUATIONS .........................................................................................68
12.1.
Study Treatment Discontinuation............................................................................68
12.2.
Study Discontinuation ............................................................................................68
12.3.
Subject Replacement ..............................................................................................69
13.
EMERGENCY PROCEDURES.............................................................................70
13.1.
Emergency Contact.................................................................................................70
14.
REGULATORY CONSIDERATIONS...................................................................71
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EDMS Doc. Number: 
nab-paclitaxel
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ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
14.1.
Good Clinical Practice............................................................................................71
14.2.
Investigator Responsibilities ...................................................................................71
14.3.
Subject Information and Informed Consent.............................................................71
14.4.
Confidentiality........................................................................................................72
14.5.
Protocol Amendments.............................................................................................72
14.6.
Institutional Review Board/Independent Ethics Committee Review and 
Approval ................................................................................................................72
14.7.
Ongoing Information for Institutional Review Board / Ethics Committee................73
14.8.
Closure of the Study ...............................................................................................73
15.
DATA HANDLING AND RECORDKEEPING.....................................................74
15.1.
Data/Documents.....................................................................................................74
15.2.
Data Management...................................................................................................74
15.3.
Record Retention....................................................................................................74
16.
QUALITY CONTROL AND QUALITY ASSURANCE........................................76
16.1.
Study Monitoring and Source Data Verification......................................................76
16.2.
Audits and Inspections............................................................................................76
17.
PUBLICATIONS ...................................................................................................77
18.
REFERENCES.......................................................................................................78
19.
APPENDICES........................................................................................................80
Appendix A:
ECOG Performance Status Score.......................................................................80
&(/*(1(35235,(7$5<,1)250$7,21
..72
72
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73
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tus Score
us Score

EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
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ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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....................................................................................30
Table 4:
Table of Events – Maintenance...............................................................................33
Table 5:
Permanent Dose Reductions for Hematologic and Non-Hematologic 
Toxicities on the Study ...........................................................................................46
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3
........
.......46
46

EDMS Doc. Number: 
nab-paclitaxel
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ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
LIST OF FIGURES
Figure 1:
Overall Study Design..............................................................................................28
&(/*(1(35235,(7$5<,1)250$7,21

EDMS Doc. Number: 
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ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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 
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.
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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
21
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
nab-Paclitaxel for Injectable Suspension is approved under the trade name of ABRAXANE in 
the first-line setting in combination with carboplatin for patients with non-small cell lung cancer 
who are not candidates for curative surgery or radiation therapy in several countries (eg, US, 
Japan, Argentina, Australia, New Zealand, Ecuador, Chile and Guatemala). 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. nab-Paclitaxel is also 
approved for the treatment of patients with metastatic breast cancer and for the first-line 
treatment of metastatic adenocarcinoma of the pancreas.
The 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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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
22
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
23
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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 (Grades 1-4 [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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there is st
here is stil

EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
24
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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 assess healthcare resource utilization during the Maintenance part of the study.
!
To assess the LCSS and EQ5D.
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atment 
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thth squamo
squam
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 treatment
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which pred
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uction pa
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ilizati
d EQ5D
d EQ5D.

EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
25
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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.
!
PFS from Day 1 Cycle 1.
!
OS from Day 1 Cycle 1.
!
ORR in Maintenance Part beyond response in Induction Part.
!
Disease control rate during the Induction Part and over the entire study.
!
Time to response during the Induction Part and over the entire study, with and 
without the requirement of confirmation of response.
!
Duration of response over the entire study, with and without the requirement of 
confirmation of response.
3.3.
Exploratory Endpoints
!
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 association between DNA nucleotide polymorphisms in subject’s germ line DNA 
and association with treatment efficacy and or 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.
&(/*(1(35235,(7$5<,1)250$7,21
study
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 of the stud
of the st
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over the 
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of response
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study, wi
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pretreatm
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treatm
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en
en
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to therapy
nance.
ance.
associa
associatit o
and associa
nd associa
!
Heal
Health
th
l
ques
que
v

EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
26
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
4.
OVERALL STUDY DESIGN
4.1.
Study Design
This is a Phase III, randomized, open-label, 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 450 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 216 subjects will be evaluable for the primary 
endpoint of PFS in maintenance.
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 450 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 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 216) 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 
starting dose for the Maintenance part of the study if the subject had dose reduced 
during the Induction part of the study)
OR
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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
27
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
!
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.
Follow-up Period 
All subjects who discontinue from the Maintenance part 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 approximately 1.5 years after final analysis of 
approximately 136 PFS events in which a total of 147 deaths are expected to be observed for the 
final OS analysis.
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).
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.
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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
28
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
Figure 1:
Overall Study Design
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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
29
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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, 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

EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
30
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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)
At the end 
of Cycles 2 
and 4 
(-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-hCGa
X
X
-
-
X
-
-
-
X
-
Complete Chest CT Scan (including 
adrenal gland) and any other studies 
required for tumor imagingb
X
-
-
-
-
-
X
X
Xc
Weight
X
X
X
X
X
X
X
-
X
Xc
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
-
-
-
-
-
-
-
-
Xc
ECOG status
X
X
-
-
X
-
-
-
X
Xc
Concomitant Medication/Procedures
X
X
X
X
X
X
X
-
X
Xc
Peripheral Neuropathy Assessmente
X
X
X
X
X
X
X
-
X
Xc
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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
31
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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)
At the end 
of Cycle 2 
and 4 (-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
-
Xc
X
Adverse Event Evaluation
X
X
X
X
X
X
X
-
X
Xc
nab-paclitaxel Administration
-
X
X
X
X
X
X
-
-
-
Carboplatin Administration
-
X
-
-
X
-
-
-
-
-
LCSS and EQ5D
-
X
-
-
X
-
-
-
X
-
Electrocardiogram (ECG)
X
-
-
-
-
-
-
-
-
Xc
CT Scan of Head or Brain 
Magnetic Resonance 
Imaging (MRI) g
X
-
-
-
-
-
-
-
-
Xc
Bone Scan (X-rays if 
needed)g
X
Xc
Physical Examination
X
-
-
-
-
-
-
-
X
Xc
Vital Signs
X
-
-
-
-
-
-
-
X
Xc
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 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.
b All subjects must have a radiographically documented measurable tumor(s) by RECIST v1.1 criteria. Complete chest CT scan (including adrenal gland) is performed at
Screening, at the end of Cycles 2 and 4 during Induction part, 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. A CT scan with (if not contraindicated) and without contrast is preferred throughout the study. A CT scan with 
contrast only could be performed if not contraindicated per local site standard of practice, if the presence of liver metastasis can be assessed accurately. Scans will be archived as 
per institution standards.
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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
32
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
c If clinically indicated.
d BSA calculated at baseline and recalculated if body weight changes by more than 10% since baseline or since the previous visit when BSA was recalculated.
e The occurrence of peripheral neuropathy should be reported by the investigator as an AE or SAE.
f Laboratory assessments will be done prior to each treatment by local laboratories and as clinically indicated. The results from laboratory assessments will be captured as per 
Section 6.18.
g At Screening, if lesions are suspected.
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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
33
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
Table 4:
Table of Events – Maintenance
EVERY CYCLE
(21-day)
Assessment
Screening/ 
Baseline
(up to 14
days)
Day 1
(±2 days, 
except 1st
cycle)
Day 8a
(±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-hCG b
X
X
-
-
X
-
-
-
Complete Chest CT Scan (including adrenal 
gland) and any other studies required for 
tumor imaging c
Xd
-
-
X
X
-
-
Xe
Weight
X
X
X
-
X
X
-
Xe
Plasma for Biomarker Analyses
-
-
-
X
-
-
-
Body Surface Area (BSA) Calculation and 
Heightf
X
-
-
-
-
-
-
Xe
ECOG status
Xg
X
-
-
X
-
-
Xe
Concomitant Medication/Procedures
X
X
X
X
X
X
X
Xe
Peripheral Neuropathy Assessment h
X
X
X
-
X
X
-
Xe
Hematology and Serum Chemistry i
X
X
X
-
X
X
-
Xe
Adverse Event Evaluation
X
X
X
X
X
X
-
Xe
nab-paclitaxel Administration
-
X
X
-
-
-
-
Survival phone call 
-
-
-
-
-
-
X
-
Healthcare Resource Utilization 
Questionnaire
-
X
-
-
X
-
-
-
LCSS and EQ5D
-
X
-
-
X
-
-
-
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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
34
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
Table 4:
Table of Events – Maintenance (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 Adherence to Day 1 and 8 visits during Maintenance part is preferred and strongly encouraged. Per local standard of care assessment of Day 8 visit may be done over the phone 
for subjects randomized to BSC arm if there are no safety concerns.
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) 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.
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. A CT scan with (if not contraindicated) and without contrast is preferred throughout the study. A CT scan with contrast only could be performed if not contraindicated 
per local site standard of practice if the presence of liver metastasis can be assessed accurately. Scans will be archived as per institution standards.
d Induction End of Cycle 4 information may serve as baseline for Maintenance.
e If clinically indicated.
f BSA calculated at baseline and recalculated if body weight changes by more than 10% since baseline or since the previous visit when BSA was recalculated.
g The ECOG performance status must be 0 or 1 for subjects to start maintenance treatment.
h The occurrence of peripheral neuropathy should be reported by the investigator as an AE or SAE.
i 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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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
35
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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).
A CT scan with (if not contraindicated) and without the contrast is preferred throughout the 
study.
Chemistry assessments or CT scans performed in accordance with the local standard of care 
within 28 days before the first dose of study drug, even if they took place prior to signing of the 
ICF, can be used for the screening assessment (in this instance if only the CT scan with contrast 
is available, a CT scan without the contrast should be performed).
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, smoking 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 and Maintenance. 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).
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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
36
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
6.4.
Complete Chest Computed Tomography (CT) Scan (including 
adrenal gland) With and Without Contrast
Complete Chest CT Scan (including adrenal gland) and any other studies required for tumor 
imaging will be done at Screening, at the end of Cycles 2 and 4, and at Early Treatment 
Discontinuation during the Induction part of the study. During the Maintenance part 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 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. A CT scan with (if not contraindicated) and without contrast is preferred
throughout the study. A CT scan with contrast only could be performed if not contraindicated per 
local site standard of practice, if the presence of liver metastasis can be assessed accurately. All 
scans and reports will be archived as per institution standards.
6.5.
Weight
Weight will be collected at every visit during the Induction and Maintenance 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 and Maintenance 
parts of the study. BSA may be recalculated if body weight changes by more than 10% since 
baseline or since the previous visit when BSA was recalculated.
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 part 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. 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. Additional peripheral neuropathy assessments may be done at any 
time during the study as needed.
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phe
i
gr

EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
37
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
6.10.
Adverse Event Reporting
All subjects will have AEs recorded from time of signature on the ICF until 28 days after the last 
dose of study drug, including any unscheduled visits. See Section 11 for details. 
6.11.
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 
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 part 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 part of 
the study.
6.13.
Electrocardiogram 
An Electrocardiogram (ECG) will be performed at screening and as clinically indicated;
however, normal and non-clinically significant results will not be collected in the eCRFs. If 
results are abnormal and clinically significant at Screening, they will be recorded as medical 
history. 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 performed at screening if lesions are suspected and as 
clinically indicated during the study; however, results will not be collected in the eCRFs. If scans 
show progression of disease, this information will be collected on the eCRF.
6.15.
Bone Scans and X-rays
Bone scans and x-rays will be performed at screening if lesions are suspected and as clinically 
indicated during the study; however, results will not be collected in the eCRFs. If scans show 
progression of disease, this information will be collected on the eCRF.
6.16.
Physical Examinations
Physical examinations will be performed at screening and treatment discontinuation and any 
other time as clinically indicated/per the institutional practice. However, results will not be 
routinely collected on the eCRFs.  If the findings are abnormal and clinically significant at 
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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
38
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
screening, they will be recorded as medical history, and if findings are abnormal and clinically 
significant after screening, they will be recorded as an AE or SAE.
6.17.
Vital Signs
Vital signs will be measured at screening, treatment discontinuation, and any other time as 
clinically indicated / standard of care for the institution. However, results will not be routinely 
collected on the eCRFs.  If the findings are abnormal and clinically significant at screening, they 
will be recorded as medical history, and if findings are abnormal and clinically significant after 
screening, they will be recorded as an AE or SAE.
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 will 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 part 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.
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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
39
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
Types of techniques planned to be used for tumor and blood analyses include:
!
Gene expression by RNA sequencing
!
Immunohistochemistry 
!
DNA sequencing
Details regarding the collection, storage, and shipment of the samples are given in the Laboratory 
Manual.
6.20.
Survival
After discontinuation from the Maintenance part of the study, the subjects will be followed for 
survival by phone approximately every 90 days for up to 1.5 years after final analysis of 
approximately 136 PFS events in which a total of 147 deaths are expected to be observed for the 
final OS analysis. The subjects will also be asked questions of other medications they may be 
taking for their NSCLC. 
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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
40
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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 450 subjects. Based on results from the nab-Paclitaxel Phase 3 NSCLC 
development study (Protocol CA031) it is estimated that approximately 216 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 216 subjects are randomized into the Maintenance part of the study. The 
study will be conducted at approximately 120 sites in the United States and European Union 
(EU).
7.2.
Inclusion Criteria
Subjects must satisfy the following criteria to be enrolled in the Induction and Maintenance 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 other current active malignancy requiring anticancer therapy.
6. Radiographically documented measurable disease at study entry (as defined by the 
RECIST v1.1 criteria).
7. No prior chemotherapy for the treatment of metastatic NSCLC at study entry. Adjuvant, 
neo-adjuvant chemotherapy or chemoradiotherapy with curative intent for non-metastatic 
disease is permitted providing it 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.
12. Total bilirubin ≤ 1.5 × ULN except in cases of Gilbert’s disease and liver metastases. 
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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
41
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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.
agree to take a pregnancy test prior to starting study medication and throughout the 
study participation.
b. commit to complete abstinence from heterosexual contact, or agree to use medical 
doctor-approved contraception throughout the study without interruption, and while 
receiving study medication or for a longer period if required by local regulations.
Male subjects must:
c.
agree to complete abstinence from heterosexual contact or use a condom during 
sexual contact with a female of child bearing potential while receiving study 
medication and within 6 months after last dose of study medication, even if he has 
undergone a successful vasectomy.
7.3.
Exclusion Criteria
The presence of any of the following will exclude a subject from enrollment into the Induction
and Maintenance parts of the study (except if specified at study entry only):
1. Evidence of active brain metastases, including leptomeningeal involvement (prior 
evidence of brain metastasis are permitted only if treated and stable and off therapy for
≥4 weeks prior to first dose of study drug).
2. Only evidence of disease is non-measurable at study entry.
3. Preexisting peripheral neuropathy of Grade 2, 3, or 4 (per CTCAE v4.0). For the 
Maintenance part of the study subjects with peripheral neuropathy of Grade 3 and higher 
are excluded.
4. Venous thromboembolism (VTE) within 1 month prior to signing ICF. If the subject has 
a history of VTE earlier than 1 month prior to signing the ICF the event should be 
resolved, stable and without clinically significant bleeding, such as hematuria, 
gastrointestinal bleeding or hemoptysis.
5. Current congestive heart failure (New York Heart Association class II-IV).
6. History of the following within 6 months prior to first administration of a study drug: a 
myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass 
graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled 
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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
42
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
hypertension, clinically significant cardiac dysrhythmia or clinically significant ECG 
abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder.
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. Subject has any other malignancy within 5 years prior to randomization. Exceptions are 
malignancies with a negligible risk of metastasis or death (eg, expected 5-year OS
> 90%) that were treated with an expected curative outcome such as squamous cell 
carcinoma of the skin, in-situ carcinoma of the cervix, uteri, non-melanomatous skin 
cancer, carcinoma in situ of the breast, or incidental histological finding of prostate 
cancer (TNM stage of T1a or T1b) — all treatments should have been completed 6 
months prior to signing ICF.
12. Subject has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 
weeks prior to starting IP, and/or from whom ≥ 30% of the bone marrow was irradiated. 
Prior radiation therapy to a target lesion is permitted only if there has been clear 
progression of the lesion since radiation was completed.
13. Any condition, including the presence of laboratory abnormalities, that places the subject 
at unacceptable risk if he/she were to participate in the study.
14. Any condition that confounds the ability to interpret data from the study.
15. Pregnant and nursing females.
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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
43
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
8.
DESCRIPTION OF STUDY TREATMENTS
8.1.
Description of Investigational Product(s)
Induction 
The nab-paclitaxel and carboplatin treatments will not be supplied by Celgene during induction 
in those countries where nab-paclitaxel plus carboplatin is available for the treatment of NSCLC.  
Investigative sites will use standard of care (commercially available) product via prescription in 
these countries.
In those countries where nab-paclitaxel plus carboplatin is not available for the treatment of 
NSCLC, or is available but designated as investigational product (IP) as per local regulations
both agents will be packaged and supplied by Celgene.
Maintenance 
Subjects will be randomized to receive open-label nab-paclitaxel plus BSC or BSC during the 
Maintenance part of the study. The nab-paclitaxel used in the Maintenance part of the study is
designated as IP and will be packaged and supplied by Celgene Corporation. 
The preparation for IV administration procedures for IP should be followed as per Prescribing 
Information.
8.1.1.
nab-Paclitaxel
nab-Paclitaxel will be supplied by the Sponsor, Celgene Corporation, for the Maintenance part in 
all countries and for the Induction part if either not available or designated as IP in a country.
nab-Paclitaxel will be supplied 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.
Please see local prescribing information for Abraxane for detailed instructions on the
reconstitution, storage conditions and IV administration of nab-paclitaxel.
Unreconstituted nab-paclitaxel should be stored in accordance with the product label. 
Reconstituted nab-paclitaxel should be used immediately. 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 IP 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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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
44
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
8.2.
Treatment Administration and Schedule
Following administration of nab-paclitaxel, the intravenous line should be flushed with sodium 
chloride 9 mg/mL (0.9%) solution for injection to ensure administration of the complete dose, 
according to local practice.
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 450 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 216
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.
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.
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 and Maintenance 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 part of the study.
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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
45
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
!
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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pathy
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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
46
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
Table 5:
Permanent Dose Reductions for Hematologic and Non-Hematologic Toxicities on the Study
Adverse Drug Reaction
Occurrence
nab-Paclitaxel 
Dose (mg/m2)
Carboplatin Dose 
(mg*min/mL)
Starting Dose Maintenance:
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
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Induction and ANC > 1500/mm3, will 
start at 100, 100 or 75 respectively 
during Maintenance
Second
50
3.0
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
Second
Discontinue Treatment*
Peripheral 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
Second
50
3.0
Third
Discontinue Treatment*
Grade 2 or 3 cutaneous toxicity
Grade 3 diarrhea
Grade 3 mucositis
Any other Grade 3 or 4 nonhematologic toxicity 
First
75
4.5
If subject at 100, 75 or 50 at end of
Induction and < a Grade 2 or none of 
the noted events, will start at 100, 100
or 75 respectively during Maintenance
Second
50
3.0
Third
Discontinue Treatment*
Grade 4 cutaneous toxicity, diarrhea or mucositis
First
Discontinue Treatment*
ANC: Absolute Neutrophil Count.
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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
47
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
8.4.
Method of Treatment Assignment
The Induction and Maintenance 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 and completely used vials should be destroyed according 
to local guidelines, and disposition should be recorded on the Investigational Drug 
Accountability Record Form.
The investigator, 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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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
48
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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. For nab-paclitaxel, an infusion completed in less than 25 minutes may increase Cmax by 
approximately 20%; therefore, a nab-paclitaxel infusion completed in less than 25 minutes will 
meet the infusion rate criterion for an overdose.
Complete data about drug administration, including any overdose, regardless of whether the 
overdose was accidental or intentional, should be reported in the case report form. See 
Section 11.1 for the reporting of adverse events associated with overdose.
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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
49
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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

EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
50
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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 detail in the SAP.
10.1.
Induction Part
10.1.1.
Overview
This is an 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 at the end of Cycle 2 and Cycle 4. 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 who received at least one dose of study treatment regardless of whether they 
have 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 up to 450 subjects will be enrolled in the Induction part of the study. This sample 
size would provide approximately 216 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 
5 and beyond. It is assumed that approximately 50% (225/450) of the subjects in the Induction 
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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
51
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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 225 subjects will not meet 
the other inclusion/exclusion criteria for the Maintenance part, yielding a total of approximately 
216 subjects entering the Maintenance part of the study.
The actual number of subjects enrolling into the Induction part, and then being randomized in the 
Maintenance part of the study will be monitored on an ongoing basis and adjusted accordingly to 
ensure that the targeted number of required PFS events for the Maintenance part is attained.
Enrollment of the Induction part, therefore, could be discontinued early or extended beyond the 
planned number of 450 subjects.
The sample size in the Induction part of the study does not support any pre-defined hypothesis 
and hence power is not relevant for this part of the study. Sample sizes for this part of the study 
are based on the pragmatic requirements for achieving the necessary PFS events in the 
Maintenance part of the study. (See Section 10.2.3). 
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.
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 inferential testing
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.
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he p

EDMS Doc. Number: 
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Protocol ABI-007-NSCL-003
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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 adverse events of 
special 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.
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 until 28 days after the 
last dose of study drug for those who do not randomize in the Maintenance part. In addition, any 
serious AE with an onset date more than 28 days after the last dose of study drug that is assessed
by the investigator as related to study drug will be considered a TEAE.
Adverse events will be 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.
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Celgene Corporation
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ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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.
10.1.10.
Interim Analysis (Quality of Life Questionnaire and Biomarker Data)
For administrative purposes (eg, planning of new studies, publication of data) the LCSS, EQ-5D 
measurements and biomarker data collected during the Induction part will be summarized using 
descriptive statistics when approximately 50, 100, 200 and all subjects, respectively, have either 
discontinued during or completed the Induction part of the study.
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 216 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.
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).
Tumor response to Induction part chemotherapy for stratification is the response assessed at the 
last CT scan before randomization.
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.
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EDMS Doc. Number: 
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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 or on BSC arm 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 and 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.  
One non-binding interim analysis for PFS with early stopping rule for futility only will be 
conducted when approximately 91 events are observed. The study may be stopped for futility 
only if conditional power is < 10% under the assumed design hazard ratio of 0.60, but there is no 
allowance to stop the study early to declare superior efficacy.
The final analysis of the primary endpoint will be performed when approximately 136 PFS 
events have been observed. A total of approximately 216 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 month dropout rate.
Analysis of Progression Free Survival (PFS)
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. There is an 
80% power to detect a hazard ratio of 0.60 using a two-sided test conducted at the 5% level of 
significance. This hazard ratio of 0.60 assumes an underlying exponential distribution for both 
treatment groups with a median time to PFS of 2 months for the BSC alone group and a median 
time to PFS of 3.33 months for the nab-paclitaxel plus BSC group. Hence, the final analysis will 
be conducted after 136 PFS events (ie, events of disease progression or deaths from any cause) 
have occurred.
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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
55
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
The required number of PFS events and power calculation were obtained from 
 
Analysis of Overall Survival (OS)
There will be two analyses for the OS endpoint, one of which involves an interim analysis that 
corresponds to the final analysis of PFS (approximately 136 PFS total events with a 
corresponding total of 92 deaths). However, OS collection may continue until 1.5 years after the 
final analysis of PFS in which a total of 147 total deaths are expected to be observed. The interim 
analysis for the OS endpoint will utilize a Lan-DeMets alpha-spending function to account for 
the exact timing of the interim based upon the actual number of observed events with an 
O’Brien-Fleming boundary in order to perform an appropriate group-sequential hypothesis 
testing procedure at the 5% level of significance (two-sided).  
Assuming an underlying exponential distribution for both treatment groups with median OS 
times of 7.2 and 10.3 months for the BSC alone and nab-paclitaxel plus BSC regimens, 
respectively, there is 53% power to detect a hazard ratio of 0.70 using this two-sided group 
sequential testing procedure at an overall 5% level of significance, provided that the study has an 
opportunity to continue up to 147 observed events.
A step-down procedure from the PFS final analysis to this group sequential testing approach for 
OS will be used to address multiplicity of testing.
OS analysis, the study may be stopped if the conditional power is below the threshold specified 
in the SAP.  
The required number of OS events and power calculation were obtained from 
 
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. 
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 some efficacy analyses are described in this section, additional analyses may be specified 
in the SAP.
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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
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ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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 distributions will be summarized using a graphical display of the 
Kaplan-Meier product limit estimates by treatment group, median PFS time estimates (including 
two-sided 95% CI) by each treatment group, and with an estimated hazard ratio (including two-
sided 95% CI) from an unstratified Cox regression model. The hypothesis test of a hazard ratio 
of 1 with respect to the PFS distributions, as shown above, will be evaluated using a stratified 
log-rank test with the 3 baseline and prognostic factors described under the randomization 
scheme in Section 4.1.2. In addition to the stratified log-rank test, a stratified Cox regression 
model will be employed to evaluate the strength of the treatment effect using the estimated 
hazard ratio and corresponding 95% confidence interval.
Pooling of Sparse Strata
If there exists unacceptable sparseness in some stratum cells (ie, a stratum cell that has less than 
5 BSC subject counts in the ITT population of the Maintenance part of the study), then an 
algorithm for collapsing some full strata will be employed until there are at least 5 BSC subjects 
in any given revised stratum cell. The initial stratum cells for the BSC treatment group will start 
out as 8 cells that represent all possible permutations of the 3 strata (baseline 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]). Hence, the 8 cells representing all possible 
permutations among the strata may be reduced down to either 4 cells (all possible permutations 
of just 2 relatively large strata), 2 cells (just 1 large stratum); or no strata at all when 
implementing the algorithm for the BSC group, the smallest treatment group based on the 2:1 
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EDMS Doc. Number: 
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Protocol ABI-007-NSCL-003
Celgene Corporation
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57
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
randomization. However, it is extremely unlikely that the algorithm will result in no stratum. 
Once the revised strata have been determined through the algorithm, then it will be used 
consistently for all stratified analyses.  
Sensitivity and Supplemental Analyses
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, sensitivity analyses will be performed to 
further assess the impact of missed radiologic assessments. An additional analysis of PFS, where 
new treatment will be considered as an event, will be conducted to address the impact of second 
line therapy. 
10.2.6.2.
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 in the same manner as PFS (primary endpoint), including the 
stratification variables.
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. Relative response rates between 
treatment regimens will be tested using a stratified Cochran-Mantel-Haenszel chi-square test at a 
two-sided 5% significance level.  The stratification variables for the analysis will be the same as 
the PFS analysis (primary endpoint).
10.2.6.2.3. 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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EDMS Doc. Number: 
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10.2.6.2.4. Progression Free Survival From Day 1 Cycle 1
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.
10.2.6.2.5. Overall Survival from Day 1 Cycle 1
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.
10.2.6.2.6. Overall Response Rate in Maintenance Part Beyond Response in Induction 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 (ie, 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.
10.2.6.2.7. Time to Response During the Induction Part and Over the Entire Study, With 
and Without the Requirement of Confirmation of Response
Time to response is defined as the time from Day 1 Cycle 1 to the first occurrence of confirmed 
response (CR or PR). Time to response will be summarized with descriptive statistics. Only 
subjects with a CR or PR as a best overall confirmed response during induction will be included 
in this analysis.
The same analysis will be performed for time to response without confirmation of response.
10.2.6.2.8. Duration of Response Over the Entire Study, With and Without the 
Requirement of Confirmation of Response
For subjects who had a confirmed CR or PR, the duration of overall response is measured from 
the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first 
date that recurrent or progressive disease is radiologically documented (taking as reference for 
progressive disease the smallest measurements recorded on study).
Subjects who are non-responders (ie, do not achieve at least a PR) will be excluded from this 
analysis. Subjects who do not have PD after the response will be censored on the date of last 
tumor assessment. If a subject died before PD, then the subject will be censored on the date of 
death.
The duration of response will be analyzed using the Kaplan-Meier method. The median time 
(including 2-sided 95% CI) will be summarized for each treatment arm; the associated hazard 
ratio with two-sided 95% confidence interval will be estimated using a stratified Cox 
proportional hazard model. For this analysis, the stratification factors will be the same as those 
used in the primary efficacy analysis, if stratum sizes are sufficient.
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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
59
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The same analysis will be performed for duration of response without confirmation of response.
10.2.6.3.
Exploratory Endpoints
10.2.6.3.1. 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.
10.2.6.3.2. 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
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 adverse events of special 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. 
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 date of randomization through 28 days after the last administration of the study 
regimen. 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).
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 
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ca

EDMS Doc. Number: 
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Celgene Corporation
Confidential and Proprietary
60
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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
Progression Free Survival (PFS)
One non-binding interim analysis will be used to assess futility using the PFS endpoint only, and 
is planned when approximately a total of 91 events have been observed. The study may be 
stopped early for futility only if the conditional power for PFS is < 10% under the assumed 
design hazard ratio of 0.60, but there is no allowance to stop the study early to declare superior 
efficacy.
The final analysis of PFS will be performed when approximately 136 PFS events have been 
observed, provided the study is not terminated early due to futility or other administrative 
reasons.
An observed hazard ratio at the interim of greater than or equal to 0.94 corresponds to the 
conditional power boundary of less than or equal to 10%. These boundaries were calculated 
using 
Overall Survival (OS)
The interim analysis for the OS endpoint will utilize a Lan-DeMets alpha-spending function to 
account for the exact timing of the interim based upon the actual number of observed events with 
an O’Brien-Fleming boundary in order to perform an appropriate group-sequential hypothesis 
testing procedure at the 5% level of significance (two-sided). 
Assuming an underlying exponential distribution for both treatment groups with median OS 
times of 7.2 and 10.3 months for the BSC alone and nab-paclitaxel plus BSC regimens, 
respectively, there is 53% power to detect a hazard ratio of 0.70 using this two-sided group 
sequential testing procedure at an overall 5% level of significance, provided that study has an 
opportunity to continue up to 147 observed events.
The two-sided nominal value p-value stopping boundary for first interim analysis is 0.009, while 
the final two-sided nominal p-value stopping boundary is 0.047. These stopping boundaries and 
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ial
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35

EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
61
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
previous power calculation for the OS endpoint were calculated using 
 
OS analysis, the study may be stopped if the conditional power is below the threshold specified 
in the SAP.
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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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
62
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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. However, signs and symptoms (events) related to disease 
progression may be reported as adverse events. If reported, events of disease progression for 
squamous cell NSCLC disease under the study (including deaths due to disease progression for 
indications that are considered to be fatal) will be assessed as expected AEs and will not be 
expedited safety reports to regulatory authorities.
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 Treatment 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: 
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E
A quali
A qual

EDMS Doc. Number: 
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Celgene Corporation
Confidential and Proprietary
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ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
11.2.1.
Seriousness 
A serious adverse event (SAE) is any AE occurring at any dose that:
!
Results in death;
!
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.
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be
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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
64
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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.
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.
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Not su

EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
65
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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.
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.
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4

EDMS Doc. Number:
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
66
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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 28 days of the 
subject’s last dose of IP, are considered immediately reportable events. IP is to be discontinued 
immediately. The pregnancy, suspected pregnancy, or positive pregnancy test must be reported 
to Celgene Drug Safety immediately by facsimile, or other appropriate method, using the 
Pregnancy Initial Report Form, or approved equivalent form. The female subject should be 
referred to an obstetrician-gynecologist, 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
6 months of the last dose of IP, the male subject taking IP should notify the Investigator, and the 
pregnant female partner should be advised to call her healthcare provider immediately. 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 Treatment Visit, whichever is later) and those made known to the Investigator at 
any time thereafter that are suspected of being related to IP. SAEs occurring prior to treatment 
will be captured.
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EDMS Doc. Number: 
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Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
67
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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.
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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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
68
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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.
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.
The decision to discontinue a subject remains the responsibility of the treating physician, which 
will not be delayed or refused by the Sponsor. However, prior to discontinuing a subject, the 
Investigator may contact the Medical Monitor and forward appropriate supporting documents for 
review and discussion.
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 
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EDMS Doc. Number: 
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Celgene Corporation
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ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
withdrawn from the study should complete all protocol-required evaluations scheduled for early 
termination at the time of withdrawal.
Since follow-up of subjects who discontinue prematurely is of particular importance, every 
attempt should be made to collect all survival information and NSCLC treatment/therapy, unless 
the subject has specifically withdrawn consent from further follow-up. The investigator must 
make every effort to obtain minimal information regarding the subject’s survival status before 
determining the subject lost to follow-up.
12.3.
Subject Replacement
Subjects who discontinue will not be replaced.
&(/*(1(35235,(7$5<,1)250$7,21

EDMS Doc. Number: 
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Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
70
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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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EDMS Doc. Number: 
nab-paclitaxel
Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
71
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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 Council for
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 the subject and/or the subject’s legal
representative prior to any study-related procedures.
Documentation that informed consent occurred prior to the subject’s entry into the study and of 
the informed consent process should be recorded in the subject’s source documents including the 
date. The original ICF signed and dated by the subject and by the person consenting the subject
prior to the subject’s entry into the study, must be maintained in the Investigator’s study files and 
a copy given to the subject. In addition, if a protocol is amended and it impacts the content of the 
informed consent, the ICF must be revised. Subjects participating in the study when the amended 
protocol is implemented must be re-consented with the revised version of the ICF. The revised 
ICF signed and dated by the subject and by the person consenting the subject must be maintained 
in the Investigator’s study files and a copy given to the subject.
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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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EDMS Doc. Number: 
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Protocol ABI-007-NSCL-003
Celgene Corporation
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ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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;
!
All other source documents (subject records, hospital records, laboratory records, 
etc.); 
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EDMS Doc. Number: 
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Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
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ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
!
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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tion of 
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EDMS Doc. Number: 
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Celgene Corporation
Confidential and Proprietary
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ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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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EDMS Doc. Number: 
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Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
77
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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.
&(/*(1(35235,(7$5<,1)250$7,21

EDMS Doc. Number: 
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Protocol ABI-007-NSCL-003
Celgene Corporation
Confidential and Proprietary
78
ABI-007-NSCL-003 Amendment 3 Final: 13 Mar 2017
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.
Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, et al. New response 
evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 
Jan;45(2):228-47.
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.
&(/*(1(35235,(7$5<,1)250$7,21
ponse
onse
ncer. 2009
cer. 2009
backs and 
acks and
(13)
(13):1590
:1590
Cremophor
emoph
Agents Act
gents Acti
ite.
te.
i
nessss. Acces
Acce
e Diag
iagnosi
nos
ntenance
enance er
827
827-1832.
-1832.
ting proced
ting proced
, DC,
, DC, et ala
Am J Clin
Am J Clin
Dediu M, e
ediu M, 
placebo plu
placebo pl
anced non
anced non
se 3, rando
se 3, rando
ely GJ, Azz
ely GJ, Az
ound paclit
und paclit
J Clin Onc
J Clin Onc
ell MJ,
ell MJ, Pet
Pet
continuous 
ontinuous 
lung can
ung ca

EDMS Doc. Number: 
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Protocol ABI-007-NSCL-003
Celgene Corporation
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Stinchcombe TE, Socinski MA. Current treatments for advanced stage non-small cell lung 
cancer. Proc Am Thorac Soc. 2009;6(2):233-241.
Weiss RB, Donehower RC, Wiernik PH, et al. Hypersensitivity reactions from Taxol. J Clin 
Oncol. 1990;8(7):1263-1268.

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Celgene Corporation
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19.
APPENDICES
Appendix A:
ECOG Performance Status Score
Grade
ECOG
0
Fully active, able to carry on all pre-disease performance without restriction
1
Restricted in physically strenuous activity but ambulatory and able to carry out work of a light 
or sedentary nature, eg, light house work, office work
2
Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and 
about more than 50% of waking hours
3
Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours
4
Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair
5
Dead
Oken, 1982.
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EDMS Doc. Number: 
Celgene Signing Page
This is a representation of an electronic record that was signed electronically in Livelink.
This page is the manifestation of the electronic signature(s) used in compliance with
the organizations electronic signature policies and procedures.
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