Clinical Trials Register

Summary
EudraCT Number:	2014-003804-66
Sponsor's Protocol Code Number:	ABI-007-NSCL-003
National Competent Authority:	UK - MHRA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2016-02-09
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

UK - MHRA

A.2

EudraCT number

2014-003804-66

A.3

Full title of the trial

A PHASE III, RANDOMIZED, OPEN-LABEL, MULTICENTER, 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)

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A clinical trial to look into safety and efficacy of Abraxane as maintenance treatment after initial treatment with Abraxane and carboplatin in patients with a type of lung cancer named squamous cell non-small cell lung cancer

A.4.1

Sponsor's protocol code number

ABI-007-NSCL-003

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02027428

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Celgene Corporation
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Celgene Corporation
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Celgene Corporation
B.5.2	Functional name of contact point	ClinicalTrialDisclosure
B.5.3	Address:
B.5.3.1	Street Address	9225 Indian Creek Parkway, Suite 900
B.5.3.2	Town/ city	Overland Park, Kansas
B.5.3.3	Post code	66210
B.5.3.4	Country	United States
B.5.4	Telephone number	+18882601599
B.5.5	Fax number	+19132660394
B.5.6	E-mail	ClinicalTrialDisclosure@celgene.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Abraxane
D.2.1.1.2	Name of the Marketing Authorisation holder	Celgene Europe Limited
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Powder for suspension for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PACLITAXEL
D.3.9.1	CAS number	33069-62-4
D.3.9.2	Current sponsor code	ABI-007
D.3.9.4	EV Substance Code	SUB09583MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	The IMP contains an excipient of biological origin, albumin, a non-active stabilising agent. It is derived from human blood subject to approved donor screening and product manufacturing processes.
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Carboplatin
D.3.2	Product code	L01X A02
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Carboplatin
D.3.9.1	CAS number	41575-94-4
D.3.9.3	Other descriptive name	CARBOPLATIN
D.3.9.4	EV Substance Code	SUB06614MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Squamous Cell Non-small cell lung cancer

E.1.1.1

Medical condition in easily understood language

A type of lung cancer involving a type of cells called squamous cells

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10061873
E.1.2	Term	Non-small cell lung cancer
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

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.

E.2.2

Secondary objectives of the trial

- 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

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

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.
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 nabpaclitaxel
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.

E.4

Principal exclusion criteria

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
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 that 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.

E.5 End points

E.5.1

Primary end point(s)

Progression free survival from randomization into the Maintenance part of the study.

E.5.1.1

Timepoint(s) of evaluation of this end point

PFS, will be based on investigator’s assessment of response using RECIST 1.1 guidelines at baseline, end of cycle 2 and end of cycle 4 in Induction part, every 42 days during the Maintenance part of the study, and at end of treatment. 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.)

E.5.2

Secondary end point(s)

Key secondary efficacy endpoints include OS, ORR, PFS and Disease Control Rate; safety parameters; time and duration of response; exploratory endpoints (please refer to these are outlined in the protocol on page 25)

E.5.2.1

Timepoint(s) of evaluation of this end point

Key secondary efficacy endpoints include Overall Survival from randomization into the Maintenance part of the study. Overall Response Rate during the Induction and Maintenance part 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.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

BSC

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Germany

Italy

Spain

United Kingdom

United States

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

Last Subject Last Visit

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

194

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

256

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

125

F.4.2.2

In the whole clinical trial

450

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Best clinical care at investigator's discretion

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2016-05-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-07-18

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-08-01

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials