Clinical Trials Register

Summary
EudraCT Number:	2015-001477-41
Sponsor's Protocol Code Number:	1373.1
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:	2015-09-11
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

2015-001477-41

A.3

Full title of the trial

A randomised, double blind phase I/II trial to investigate efficacy, immunogenicity and safety of intradermally administered BI 1361849 (CV9202) plus afatinib versus placebo plus afatinib as first-line treatment for patients with stage IV adenocarcinoma of the lung harbouring common EGFR mutations.

Estudio de fase I/II, aleatorizado y doble ciego que evalúa la eficacia, inmunogenicidad y seguridad de BI 1361849 (CV9202) administrado por vía intradérmica más afatinib frente a placebo en combinación con afatinib, como tratamiento de primera línea en pacientes con adenocarcinoma de pulmón en estadio IV portadores de mutaciones comunes del EGFR .

A.3.1

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

BI 1361849 (CV9202) + afatinib compared with placebo + afatinib in first-line NSCLC harbouring common EGFR mutations

BI 1361849 (CV9202) + afatinib comparado con placebo + afatinib como tratamiento de primera línea en pacientes con NSCLC portadores de mutaciones comunes del EGFR.

A.3.2

Name or abbreviated title of the trial where available

A study of BI 1361849 (CV9202) plus afatinib in 1st line NSCLC pts harbouring common EGFR mutations

Estudio de BI 1361849 (CV9202) más afatinib en primera línea en pacientes con NSCLC portadores de mu

A.4.1

Sponsor's protocol code number

1373.1

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	Boehringer Ingelheim España, S.A.
B.1.3.4	Country	Spain
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	Boehringer Ingelheim España, S.A.
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Boehringer Ingelheim Pharma GmbH & Co. KG
B.5.2	Functional name of contact point	QRPE PSC CT Information Disclosure
B.5.3	Address:
B.5.3.1	Street Address	Binger Strasse 173
B.5.3.2	Town/ city	Ingelheim am Rhein
B.5.3.3	Post code	55216
B.5.3.4	Country	Germany
B.5.4	Telephone number	+34 93 4045100
B.5.5	Fax number	+34 93 4045580
B.5.6	E-mail	clintriage.rdg@boehringer-ingelheim.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	BI 1361849
D.3.2	Product code	BI 1361849
D.3.4	Pharmaceutical form	Powder and solvent for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intradermal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	no INN available
D.3.9.2	Current sponsor code	BI 1361849
D.3.9.3	Other descriptive name	BI 1361849 (CV9202), CV9202
D.3.9.4	EV Substance Code	SUB176625
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	0.8
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)	Yes
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	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	GIOTRIF 20 mg film-coated tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	Boehringer Ingelheim International GmbH
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.3.1	Product name	Afatinib
D.3.2	Product code	BIBW 2992
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Afatinib
D.3.9.1	CAS number	850140-72-6
D.3.9.3	Other descriptive name	AFATINIB
D.3.9.4	EV Substance Code	SUB32268
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	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.IMP: 3
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	GIOTRIF 30 mg film-coated tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	Boehringer Ingelheim International GmbH
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.3.1	Product name	Afatinib
D.3.2	Product code	BIBW 2992
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Afatinib
D.3.9.1	CAS number	850140-72-6
D.3.9.3	Other descriptive name	AFATINIB
D.3.9.4	EV Substance Code	SUB32268
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	30
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.IMP: 4
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	GIOTRIF 40 mg film-coated tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	Boehringer Ingelheim International GmbH
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.3.1	Product name	Afatinib
D.3.2	Product code	BIBW 2992
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Afatinib
D.3.9.1	CAS number	850140-72-6
D.3.9.3	Other descriptive name	AFATINIB
D.3.9.4	EV Substance Code	SUB32268
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	40
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Powder and solvent for solution for injection
D.8.4	Route of administration of the placebo	Intradermal use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Advanced non-small cell lung cancer (adenocarcinoma) stage IV.

Cáncer de pulmón no microcítico metastásico (adenocarcinoma) estadio IV .

E.1.1.1

Medical condition in easily understood language

Advanced lung cancer with metastases.

Cáncer de pulmón avanzado con metástasis.

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	18.0
E.1.2	Level	PT
E.1.2	Classification code	10029522
E.1.2	Term	Non-small cell lung cancer stage IV
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.0
E.1.2	Level	LLT
E.1.2	Classification code	10025055
E.1.2	Term	Lung cancer non-small cell stage IV
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.0
E.1.2	Level	PT
E.1.2	Classification code	10059515
E.1.2	Term	Non-small cell lung cancer metastatic
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 efficacy, immunogenicity and safety of BI 1361849 (CV9202) in combination with afatinib, as first-line treatment for patients with stage IV adenocarcinoma of the lung harbouring common EGFR mutations

Phase I: To confirm feasibility and safety of the combination of BI 1361849 (CV9202) with afatinib, and to assess immunological responses of BI 1361849 (CV9202) in combination with afatinib in comparison to placebo plus afatinib

Phase II (analyses will cover all randomised patients, i.e. will also include all patients randomised during the phase I part of the trial): To assess efficacy, immunogenicity and safety of BI 1361849 (CV9202) in combination with afatinib in comparison to placebo plus afatinib

Evaluar la eficacia, inmunogenicidad y seguridad de BI 1361849 (CV9202) en combinación con afatinib, como tratamiento de primera línea en pacientes con cáncer de pulmón no microcítico metastásico (estadio IV) que presentan mutaciones comunes del EGFR.

Fase I: confirmar la viabilidad y seguridad de la combinación de BI 1361849 (CV9202) con afatinib, y evaluar las respuestas inmunitarias a BI 1361849 (CV9202) en combinación con afatinib en comparación con placebo en combinación con afatinib.

Fase II (los análisis incluirán a todos los pacientes aleatorizados, es decir, también incluirá a todos los pacientes aleatorizados durante la parte de la fase I del ensayo): evaluar la eficacia, inmunogenicidad y seguridad de BI 1361849 (CV9202) en combinación con afatinib en comparación con placebo en combinación con afatinib.

E.2.2

Secondary objectives of the trial

Not applicable

No aplica.

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

Tumour biopsy substudy

Subestudio de biopsia de tumor.

E.3

Principal inclusion criteria

? Pathologically confirmed diagnosis of stage IV adenocarcinoma of the lung
? Documented activating EGFR mutation (Del 19 and/or L858R) determined in tumour tissues
? Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
? Measurable disease according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1)

? Diagnóstico de adenocarcinoma de pulmón en estadio IV confirmado desde el punto de vista anatomopatológico
? Presencia confirmada de mutación activadora del EGFR (Del 19 y/o L858R) determinada en los tejidos tumorales
? Puntuación de 0 o 1 del estado funcional según el Eastern Cooperative Oncology Group (ECOG).
? Enfermedad mensurable según los criterios de evaluación de la respuesta en tumores sólidos (RECIST 1.1)

E.4

Principal exclusion criteria

? Prior systemic chemotherapy for relapsed and/or metastatic NSCLC
? Prior treatment with EGFR targeting small molecules or antibodies
? Known allergy to protamine or fish protein
? Known type I allergy to penicillin or other beta-lactam antibiotics
? Known autoimmune disorder or propensity for severe hypersensitivity reactions

- Quimioterapia sistémica previa en cáncer NSCLC recidivante y/o metastásico.
-Tratamiento previo con moléculas pequeñas o anticuerpos dirigidos contra el EGFR.
-Alergia conocida a protaminass o proteinas de pescado.
-Alergia conocida tipo I a penincilina u otros antibióticos betalactámicos.
-Enfermedad autoinmune conocida o propensión a reacciones de hipersensibilidad grave.

E.5 End points

E.5.1

Primary end point(s)

Progression-free survival (PFS) by central independent review according to RECIST 1.1

Supervivencia sin progresión (PFS, Progression-free survival), evaluada mediante una revisión central independiente basada en los criterios RECIST 1.1.

E.5.1.1

Timepoint(s) of evaluation of this end point

52, 90 and 156 weeks after randomisation of the last patient.

52, 90 y 156 semanas después de la aleatorización del último paciente.

E.5.2

Secondary end point(s)

1. Overall survival (OS)
2. PFS status at 52 weeks after randomisation by central independent review based on RECIST 1.1
3. PFS2, defined as time (days) from randomisation to either death or disease progression by investigator assessment occurring after initiation of 1st subsequent post trial systemic therapy
4. Symptomatic progression, defined as time (days) from randomisation to an increase of at least 10 points from baseline for one or more of cough (Q1, QLQ-LC13), dyspnoea (Q3-5, QLQ-LC13) or chest pain (Q10, QLQ-LC13) based on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung cancer specific supplementary module (EORTC QLQ-LC13)
5. Immune response status which will be determined as a composite of data derived from immunological assessments of blood samples planned to be obtained at week 6 and 13*
6. Discontinuation of vaccination by 13 weeks after randomisation due to an adverse event or patient refusal to continue taking medication*
7. Discontinuation of vaccination by 24 weeks after randomisation due to an adverse event or patient refusal to continue taking medication

*These endpoints in particular will be considered to determine whether to proceed to full recruitment (phase II part).

1. - Supervivencia global (OS, Overall survival).
2.- Estado de la PFS a las 52 semanas de la aleatorización, evaluada mediante revisión central independiente basada en los criterios RECIST 1.1.
3. - PFS2, definida como el tiempo (días) transcurrido desde la aleatorización hasta la muerte o progresión de la enfermedad según la evaluación del investigador realizada después del inicio del primer tratamiento sistémico posterior al estudio.
4.- Progresión sintomática, definida como el tiempo (días) transcurrido desde la aleatorización hasta un aumento de al menos 10 puntos respecto al periodo basal en una o más de los siguientes: tos (Q1, QLQ-LC13), disnea (Q3-5, QLQ-LC13) o dolor torácico (Q10, QLQ-LC13) en el módulo suplementario específico de cáncer de pulmón del cuestionario sobre la calidad de vida de la European Organisation for Research and Treatment of Cancer (EORTC QLQ-LC13).
5. - Estado de la respuesta inmunitaria se determinará como una combinación de los datos derivados de las evaluaciones inmunológicas de las muestras de sangre que está previsto obtener en las semanas 6 y 13*.
6. - Interrupción definitiva del tratamiento a las 13 semanas de la aleatorización debido a un acontecimiento adverso o a la negativa del paciente a continuar recibiendo la medicación*.
7. - Interrupción definitiva del tratamiento a las 24 semanas de la aleatorización debido a un acontecimiento adverso o a la negativa del paciente a continuar recibiendo la medicación.

*Estos criterios de valoración en particular son los que se tendrán en cuenta para determinar si se procede al reclutamiento completo (parte de la fase II).

E.5.2.1

Timepoint(s) of evaluation of this end point

1. 52, 90 and 156 weeks after randomisation of the last patient.
2. At 52 weeks after randomisation of the last patient.
3. 52, 90 and 156 weeks after randomisation of the last patient.
4. 52, 90 and 156 weeks after randomisation of the last patient.
5. 52 weeks after randomisation of the last patient.
6. 52 weeks after randomisation of the last patient.
7. 52 weeks after randomisation of the last patient.

1. A la 52, 90 y 156 semanas de la aleatorización del último paciente.
2. A las 52 semanas de la aleatorización del último paciente.
3. A las 52, 90 y 156 semanas de la aleatorización del último paciente.
4. A las 52, 90 y 156 semanas de la aleatorización del último paciente.
5. A las 52 semanas de la aleatorización del último paciente.
6. A las 52 semanas de la aleatorización del último paciente.
7. A las 52 semanas de la aleatorización del último paciente.

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

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

First use in combination with afatinib.

First use en combinación con afatinib.

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

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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

Yes

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

Denmark

France

Germany

Korea, Republic of

Poland

Portugal

Singapore

Spain

Taiwan

Thailand

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

The end of the trial is defined as 156 weeks (3 years) after the last patient was randomised, with the aim of providing as much information as possible on OS. In case there are still on-treatment patients, the timeline of end of trial can be extended: If 10% or more of randomised patients remain on treatment at 156 weeks after the last patient was randomised then the end of trial will be postponed by 26 weeks (i.e. to 182 weeks [3.5 years] after the last patient was randomised).

Fin del ensayo: a las 156 semanas (3 años) de la aleatorización del último paciente, para obtener la máxima información sobre la supervivencia global (OS). Si todavía hubiera pacientes en tratamiento, el fin del ensayo puede extenderse: si el 10% de los pacientes aleatorizados continuan en tratamiento a las 156 semanas de la aleatorización del último paciente, entonces el fin del ensayo se pospondrá 26 semanas (es decir a las 182 semanas [3,5 años] de la aleatorización del último 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

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

120

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)

If >=10% of patients on treatment at 156 weeks after last patient randomised then end of trial will be postponed by 26 weeks after the last patient was randomised. If at the end of trial any patient still on treatment, patients receiving the verum vaccine in combination with afatinib will be given the option to continue combination therapy or to continue afatinib as monotherapy. Patients receiving placebo and afatinib will be given the option to continue treatment with afatinib as monotherapy.

Si a las 156 semanas de la aleatorización del último paciente hay >=10% de los pacientes en tratamiento, el fin del ensayo se extenderá 26 semanas. Si en el fin del ensayo hay todavía algún paciente con tratamiento, a los pacientes que reciben la vacuna en combinación con afatinib se les ofrecerá la opción de continuar con la combinación o con afatinib como monoterapia. A los pacientes que reciben placebo con afatinib se les ofrecerá la opción de continuar con afatinib como monoterapia.

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

2015-11-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-10-09

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-06-20

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