Clinical Trials Register

Summary
EudraCT Number:	2012-002647-18
Sponsor's Protocol Code Number:	IFCT-1102
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-09-04
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

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A. Protocol Information

A.1

Member State Concerned

France - ANSM

A.2

EudraCT number

2012-002647-18

A.3

Full title of the trial

phase II study evaluating the interest of the re-introduction of pemetrexed and platinum (cisplatin or carboplatin) with prolonged angiogenic blocking by bevacizumab in non squamous non small cell lung cancer of advanced stage.

Etude de phase II évaluant l’intérêt de la ré-introduction du pemetrexed et du platine (cisplatine ou carboplatine) avec blocage angiogénique prolongé par bevacizumab dans les Cancers BronchoPulmonaires Non à Petites Cellules (CBNPC) non épidermoïdes avancés.

A.3.1

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

phase II study evaluating the interest of re-introduction of pemetrexed and platinum (cisplatin or carboplatin) with maintenance by bevacizumab in non squamous non small cell lung cancer of advanced stage.

Etude de phase II évaluant l’intérêt de la réintroduction du pemetrexed et du platine (cisplatine ou carboplatine) avec maintien par bevacizumab dans les Cancers BronchoPulmonaires Non à Petites Cellules (CBNPC) non épidermoïdes avancés.

A.3.2

Name or abbreviated title of the trial where available

BUCIL

A.4.1

Sponsor's protocol code number

IFCT-1102

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	IFCT
B.1.3.4	Country	France
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	IFCT
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	IFCT
B.5.2	Functional name of contact point	Clinical trial informations
B.5.3	Address:
B.5.3.1	Street Address	10 rue de la Grange-Batelière
B.5.3.2	Town/ city	Paris
B.5.3.3	Post code	75009
B.5.3.4	Country	France
B.5.4	Telephone number	3315681045
B.5.5	Fax number	33144830151
B.5.6	E-mail	contact@ifct.fr

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	Avastin
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche
D.2.1.2	Country which granted the Marketing Authorisation	France
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	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	BEVACIZUMAB
D.3.9.1	CAS number	216974-75-3
D.3.9.4	EV Substance Code	SUB16402MIG
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	25
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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

Advanced stage non squamous non small cell lung cancer

E.1.1.1

Medical condition in easily understood language

Lung cancer

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	15.0
E.1.2	Level	LLT
E.1.2	Classification code	10025062
E.1.2	Term	Lung cancer stage IV
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

Feasibility

E.2.2

Secondary objectives of the trial

Disease control rate of sequence 2
Obejctive response rate of sequence 1
Progression free survival of sequence 1
Progression free survival of sequence 2
Disease control duration
Overall survival
Safety
Quality of life

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Bio-IFCT-1103, 31/05/2012, 1.0
Objectives :
Test of three biomarkers :
• biomarkers of sensibility or resistance to pemetrexed and bevacizumab de sensibilité : TS (thymidilate synthétase) and folate trabsporters for pemetrexed ;
• biomarkers of sensibility or resistance to platinum : MSH2

E.3

Principal inclusion criteria

Non squamous non small cell lung cancer histologically or cytologically confirmed with no EGFR mutation.
Stage IV NSCLC. Patient with cerebral metastasis are eligible if the metastasis is asymptomatic.
Measurable disease (recist criteria)
Age ≥18 years
PS0 or 1

E.4

Principal exclusion criteria

Mixed cancer small cells and non small cells or squamous lung cancer . EGFR mutated cancer
History of malignant tumour excepted cervical and basocelullar cancer and cancer cured for at least 5 years.
Tumor invaded the big vessels or the proximal visible in TDM.
HIstory of adjuvant or neoadjuvant chemotherapy

E.5 End points

E.5.1

Primary end point(s)

Proportions of patients receiving 3 cycles of chemotherapy with platinum in the 2nd sequence ot the study.

E.5.1.1

Timepoint(s) of evaluation of this end point

after 3 cycles of chemotherapy of sequence 2

E.5.2

Secondary end point(s)

Measurement of target lesions (recist criteria)
Time between inclusion and first progression
Time between first progression and second progression
Time between inclusion and death
Toxicities (NCI CTCAE version 4 scale)
LCSS questionnary

E.5.2.1

Timepoint(s) of evaluation of this end point

After three cycles and later
Until first progression
Until second progression
6, 9, 12 and 18 months
During all study duration
After sequence 1 and sequence 2

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

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

Yes

E.6.13.1

Other scope of the trial description

Feasability

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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

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

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

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

18 months after inclusion of the last patient. Justification LVLS will not permit to access the overall survival.

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

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:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

108

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)

None

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

2012-07-31

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-10-13

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-10-13

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