Clinical Trials Register

Summary
EudraCT Number:	2013-003331-30
Sponsor's Protocol Code Number:	GO28915
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:	2014-03-07
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

2013-003331-30

A.3

Full title of the trial

A PHASE III, 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 WITH
PLATINUM-CONTAINING CHEMOTHERAPY

ESTUDIO DE FASE III MULTICÉNTRICO, ABIERTO, RANDOMIZADO, PARA INVESTIGAR LA EFICACIA Y LA SEGURIDAD DE MPDL3280A (ANTICUERPO ANTI-PD-L1) COMPARADO CON DOCETAXEL, EN PACIENTES CON CÁNCER DE PULMÓN NO MICROCÍTICO, TRAS FRACASO DE QUIMIOTERAPIA BASADA EN PLATINO

A.3.1

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

A study comparing the clinical benefit and side effects of MPDL3280A to docetaxel in patients with lung cancer who have not benefited from platinum-containing cancer drugs.

Estudio de comparación del beneficio clínico y efectos colaterales de MPDL3280A con docetaxel en paciente con cancer de pulmón que no han recibido medicación con platino para el cancer.

A.4.1

Sponsor's protocol code number

GO28915

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	Roche Farma, S.A. en nombre de 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. Hoffmann 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	Genentech Inc. c/o F. Hoffmann La Roche Ltd.
B.5.2	Functional name of contact point	Trial Info. Support - Marta Maislan
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.5.4	Telephone number	913257300
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.3.2	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	-
D.3.9.1	CAS number	-
D.3.9.2	Current sponsor code	MPDL3280A
D.3.9.3	Other descriptive name	RO5541267
D.3.9.4	EV Substance Code	SUB126162
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	60
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.2.1.1.2	Name of the Marketing Authorisation holder	Accord Healthcare Limited, UK
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	RO-0647746
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 no microcitico de pulmón tras fallo a platinos

E.1.1.1

Medical condition in easily understood language

NON-SMALL CELL LUNG CANCER AFTER PLATINUM FAILURE

cancer no microcitico de pulmón tras fallo a platinos

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	16.1
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

The primary objective of this study is to determine if MPDL3280A treatment results in superior OS compared with docetaxel treatment in patients with locally advanced or metastatic NSCLC who have progressed during or following a platinum-containing regimen

Determinar si el tratamiento con MPDL3280A mejora la supervivencia global (SG) en
comparación con el tratamiento con docetaxel, en pacientes con cáncer de pulmón no microcítico (CPNM) localmente avanzado o metastásico que han manifestado progresión
de la enfermedad durante o después de la administración de un régimen de tratamiento basado en platino.

E.2.2

Secondary objectives of the trial

The secondary efficacy objectives of this study are:
- To evaluate the efficacy of MPDL3280A compared with docetaxel with respect to antitumor effects as measured by ORR per investigator using RECIST v1.1
- To evaluate the efficacy of MPDL3280A compared with docetaxel with respect to antitumor effects as measured by PFS per investigator using RECIST v1.1

Evaluar la eficacia de MPDL3280A en comparación con docetaxel con respecto a los efectos antitumorales, basándose en el índice de respuesta objetiva (IRO) evaluado por el
investigador de acuerdo con los Criterios de Evaluación de la Respuesta en Tumores Sólidos, Versión 1.1 (RECIST v1.1)
· Evaluar la eficacia de MPDL3280A en comparación con docetaxel con respecto a los efectos antitumorales, basándose en la supervivencia libre de progresión (SLP) evaluada por el investigador de acuerdo con los criterios RECIST v1.1

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

?Histologically or cytologically documented locally advanced or metastatic (i.e., Stage IIIB not eligible for definitive chemoradiotherapy, Stage IV, or recurrent) NSCLC
?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
?Disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant regimen
?Measurable disease, as defined by RECIST v1.1
?ECOG performance status of 0 or 1
?Life expectancy > 12 weeks

??CPNM localmente avanzado o metastásico (es decir, en estadio IIIB no apto para ser tratado con quimiorradioterapia definitiva, en estadio IV o recurrente documentado
histológica o citológicamente; la caracterización histopatológica debe ser suficiente para definir a los pacientes en función de que los tumores sean de histología escamosa o no escamosa.
-Disponibilidad de muestras de tumor representativas fijadas en formalina e incluidas en
parafina (FFPE), en bloques de parafina (opción preferida), o un mínimo de 15 secciones
no teñidas, con el correspondiente informe de histopatología, para el análisis en el laboratorio central, y que se determine que son evaluables para la expresión de PD-L1 en
el tumor antes de la inclusión en el estudio
-Progresión de la enfermedad durante o después de un tratamiento previo con un régimen
de quimioterapia basada en platino para CPNM localmente avanzado, no
resecable/inoperable o metastásico, o recurrencia de la enfermedad dentro de los 6 meses de tratamiento adyuvante/neoadyuvante basado en platino
-Enfermedad medible, definida de acuerdo con los criterios RECIST v1.1
??Estado funcional ECOG 0 o 1
??Esperanza de vida ³?12 semanas

E.4

Principal exclusion criteria

?Received therapeutic oral or IV antibiotics within 2 weeks prior to randomization
?Major surgical procedure within 4 weeks prior to randomization or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis
?Administration of a live, attenuated vaccine within 4 weeks prior to randomization or anticipation that such a live attenuated vaccine will be required during the study
?Positive test for HIV

-Administración de antibióticos orales o IV con fines terapéuticos en las 2 semanas previas
a la randomización
Procedimientos de cirugía mayor en las 4 semanas previas a la randomización o que previsiblemente sean necesarios en el transcurso del estudio, excepto los que se realicen
con fines diagnósticos
- Pacientes que han recibido vacunas vivas atenuadas en las 4 semanas previas a la
randomización o que previsiblemente requerirán dichas vacunas durante el estudio
- Resultado positivo en la prueba del VIH

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy outcome measure is OS, defined as the time from randomization to death from any cause.

La primera medida de resultado de eficacia es la supervivencia global definida como el tiempo transcurrido desde la randomización hasta el fallecimiento por cualquier causa

E.5.1.1

Timepoint(s) of evaluation of this end point

Please refer to section E.5.1

Ver sección E.5.1

E.5.2

Secondary end point(s)

?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.

Supervivencia libre de progresión , definida como el tiempo transcurrido desde la randomización al primer indicio de progresión de la enfermedad, determinado por el investigador según criterios del RECIST v1.1, o fallecimiento por cualquier causa

E.5.2.1

Timepoint(s) of evaluation of this end point

Please refer to section E.5.2.

Ver sección 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

Yes

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

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)

Yes

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

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

Canada

France

Greece

Italy

Japan

Austria

Netherlands

New Zealand

Norway

Portugal

Sweden

Argentina

Brazil

Chile

Finland

Germany

Guatemala

Hungary

Korea, Republic of

Spain

Thailand

Mexico

Panama

Poland

Russian Federation

Serbia

Switzerland

Taiwan

Turkey

Ukraine

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 patient, last visit would be four years after the last patient is enrolled.

La ultima visita del ultimo paciente debera ser 4 años tras la inclusión del ultimo paciente

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

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:

750

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

100

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

347

F.4.2.2

In the whole clinical trial

850

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 will evaluate the appropriateness of continuing to provide MPDL3280A to patients assigned to this treatment after evaluating the primary efficacy outcome measure and safety data gathered in the study. These analyses may be conducted prior to completion of the study.

El promotor evaluará la pertinencia de continuar administrando MPDL3280A a pacientes asignados a este tratamiento tras evaluar los resultados preliminares de los datos de eficacia y seguridad extraidos del estudio. Estos anailis pueden realizarse con antelación a la finalización del estudio.

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

2014-04-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-04-09

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-01-09

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