Clinical Trials Register

Summary
EudraCT Number:	2013-001142-34
Sponsor's Protocol Code Number:	GO28753
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-08-14
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

Spain - AEMPS

A.2

EudraCT number

2013-001142-34

A.3

Full title of the trial

A PHASE II, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF MPDL3280A (ANTI-PD-L1 ANTIBODY) COMPARED WITH DOCETAXEL IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AFTER PLATINUM FAILURE

Estudio de fase II, abierto, multicéntrico y aleatorizado para investigar la eficacia y seguridad de MPDL3280A (anticuerpo anti-PD-L1) en comparación con docetaxel en pacientes con cáncer de pulmón no microcítico tras fracasar un tratamiento con platinos

A.3.1

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

Clinical trial to test the efficacy and the safety of MPDL3280A compared with Docetaxel in patients with non-small cell lung cancer.

Ensayo clínico para probar la eficacia y la seguridad de MPDL3280A en comparación con docetaxel en pacientes con cáncer de pulmón de células no microcíticas.

A.4.1

Sponsor's protocol code number

GO28753

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	F. Hoffmann-La Roche. Ltd.
B.1.3.4	Country	Switzerland
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	F. Hoffman-La Roche Ltd.
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	F. Hoffmann-La Roche Ltd.
B.5.2	Functional name of contact point	Trial Information Support Line-TSIL
B.5.3	Address:
B.5.3.1	Street Address	Grenzacherstrasse 124
B.5.3.2	Town/ city	Basel
B.5.3.3	Post code	4070
B.5.3.4	Country	Switzerland
B.5.6	E-mail	global.rochegenentechtrials@roche.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	No
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	Not Applicable
D.3.2	Product code	MPDL3280A-RO5541267
D.3.4	Pharmaceutical form	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	Not Applicable
D.3.9.2	Current sponsor code	MPDL3280A
D.3.9.3	Other descriptive name	RO5541267
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	125
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.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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	Docetaxel
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	Concentrate and solvent for 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	-
D.3.9.1	CAS number	-
D.3.9.2	Current sponsor code	-
D.3.9.3	Other descriptive name	DOCETAXEL
D.3.9.4	EV Substance Code	SUB12492MIG
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	20
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

NON-SMALL CELL LUNG CANCER AFTER PLATINUM FAILURE

Cancer de pulmón no microcítico tras fallo a platino

E.1.1.1

Medical condition in easily understood language

NON-SMALL CELL LUNG CANCER AFTER PLATINUM FAILURE.

Cancer de pulmón no microcítico tras fallo a platino

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	16.0
E.1.2	Level	LLT
E.1.2	Classification code	10029514
E.1.2	Term	Non-small cell lung cancer NOS
E.1.2	System Organ Class	100000004864

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 estimate the efficacy of MPDL3280A compared with docetaxel as measured by OS
?To evaluate the safety and tolerability of MPDL3280A compared with docetaxel

?Estimar la eficacia de MPDL3280A en comparación con docetaxel, determinada mediante la supervivencia global (SG).
?Evaluar la seguridad y tolerabilidad de MPDL3280A en comparación con docetaxel

E.2.2

Secondary objectives of the trial

?To evaluate the efficacy of MPDL3280A compared with docetaxel with respect to anti-tumor effects measured by overall response, DOR, and PFS per RECIST v1.1
?To evaluate the efficacy of MPDL3280A with respect to anti-tumor effects measured by overall response, DOR, and PFS per modified RECIST

?Evaluar la eficacia de MPDL3280A en comparación con docetaxel con respecto a los efectos antitumorales medidos mediante la respuesta global, la duración de la respuesta (DR) y la supervivencia libre sin progresión (SLSP) según RECIST v1.1.
?Evaluar la eficacia de MPDL3280A con respecto a los efectos antitumorales medidos mediante la respuesta global, la DR y la SLSP según los criterios RECIST modificados.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

?patients must have failed a prior platinum-containing regimen.
?Histologically or cytologically documented locally advanced or metastatic (i.e., Stage IIIB not eligible for definitive chemoradiotherapy, Stage IV, or recurrent) NSCLC (per the UICC/AJCC staging system, 7th edition; Detterbeck et al. 2009); pathological characterization must be sufficient to define patients as having either squamous or non-squamous histology.
?Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (preferred) or at least 15 unstained slides, with an associated pathology report, for central testing and determined to be evaluable for tumor PD-L1 expression prior to study enrollment; patients with fewer than 15 unstained slides available at baseline (but no fewer than 10) may be eligible following discussion with Medical Monitor.
? Measurable disease, as defined by RECIST v1.1
? ECOG performance status of 0 or 1
? Life expectancy > 12 weeks

-pacientes qeu hayan fallado previamente a regimen conteniendo platino
?CPNM localmente avanzado o metastásico confirmado mediante histología o citología (es decir, estadio IIIB no susceptible de quimiorradioterapia definitiva, estadio IV o recurrente) (según el sistema de estadificación de la Unión Internacional Contra el Cáncer/American Joint Committee on Cancer [UICC/AJCC]); la caracterización anatomopatológica deberá ser suficiente para definir a los pacientes como con histología escamosa o no escamosa.
?Muestras tumorales fijadas en formol e incluidas en parafina (FFIP) representativas en bloques de parafina (preferible) o al menos 15 extensiones sin teñir, junto con el informe anatomopatológico correspondiente, para evaluación centralizada y que se consideren evaluables para determinar la expresión tumoral de PD-L1 antes de la inclusión en el estudio; los pacientes con menos de 15 extensiones sin teñir disponibles en el momento basal (pero no menos de 10) podrán participar en el estudio tras comentarlo con el monitor médico.
?Enfermedad medible, definida según los criterios RECIST v1.1.
?Estado funcional del ECOG de 0 o 1.
?Esperanza de vida de 12 semanas como mínimo.

E.4

Principal exclusion criteria

? Known active or untreated central nervous system (CNS) metastases.
? Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for > 2 weeks prior to randomization
? Leptomeningeal disease
? Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
? Uncontrolled tumor-related pain

Metástasis en el sistema nervioso central (SNC) activas o no tratadas.
Compresión medular no tratada definitivamente mediante cirugía o radioterapia o compresión medular diagnosticada y tratada con anterioridad sin datos de que la enfermedad se haya mantenido clínicamente estable durante al menos 2 semanas antes de la aleatorización.
Afectación leptomeníngea.
Derrame pleural, derrame pericárdico o ascitis no controlados que requieran procedimientos de drenaje recurrentes.
Dolor no controlado relacionado con el tumor.

E.5 End points

E.5.1

Primary end point(s)

? OS, defined as the time from randomization to death from any cause

Supervivencia global, definicda como el tiempo desde randomización hasta muerte por cualquier causa

E.5.1.1

Timepoint(s) of evaluation of this end point

See E.5.1

Ver E.5:1

E.5.2

Secondary end point(s)

? Overall response (partial response plus complete response), as determined by investigator using RECIST v1.1 criteria
? PFS, defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator using RECIST v1.1 criteria, or death from any cause

La respuesta global (respuesta parcial más respuesta completa), según lo determinado por el investigador con criterios RECIST v1.1
?SLSP, definido como el tiempo desde la aleatorización hasta la primera aparición de progresión de la enfermedad, según lo determinado por el investigador usando los criterios RECIST v1.1, o muerte por cualquier causa

E.5.2.1

Timepoint(s) of evaluation of this end point

See E.5.2

Ver E.5.2

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

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

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)

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

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

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.8.2.4

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

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

Belgium

Canada

France

Germany

Hungary

Italy

Poland

Spain

Sweden

United Kingdom

United States

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

The end of the study is defined as the date when all patients have one of the following:
?Experienced an OS event
?Been lost to follow-up
?Permanently discontinued study drug or become ineligible for re-treatment and have been followed for at least 18 months from randomization

El final del estudio se define como la fecha en la que todos los pacientes presenten una de las circunstancias siguientes:
?Aparición de un episodio de SG.
?Pérdida para el seguimiento.
?Discontinuación permanente del fármaco del estudio o no ser elegible para recibir retratamiento y se le haya hecho seguimiento durante al menos 18 meses después de la aleatorización.

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:

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

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

F.4.2.2

In the whole clinical trial

180

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)

The Sponsor does not have any plans to provide MPDL3280A or other study interventions to patients after the conclusion of the study or at any earlier patient withdrawal.

El promotor no tiene planes de proporcionar MPDL3280A uotras intervenciones de estudio a los pacientes después de la finalización del estudio o en abondono previo del paciente .

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

2013-08-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-07-02

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-08-31

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