Clinical Trials Register

Summary
EudraCT Number:	2011-001814-33
Sponsor's Protocol Code Number:	1200.123
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:	2011-10-25
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

2011-001814-33

A.3

Full title of the trial

LUX-Lung 7: A randomised, open-label Phase IIb Trial of afatinib versus gefitinib as first-line treatment of patients with EGFR mutation positive advanced adenocarcinoma of the lung

LUX-Lung 7: Ensayo clínico de fase IIb, abierto, aleatorizado de afatinib versus gefitinib en primera línea de tratamiento en pacientes con adenocarcinoma de pulmón avanzado con mutaciones del EGFR

A.3.1

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

Afatinib vs. gefitinib in 1st line EGFR mutation +ve adenocarcinoma of the lung

afatinib versus gefitinib en primera línea de tratamiento en pacientes con adenocarcinoma de pulmón avanzado con mutaciones del EGFR

A.3.2

Name or abbreviated title of the trial where available

LUX-Lung 7

A.4.1

Sponsor's protocol code number

1200.123

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	+18002430127
B.5.5	Fax number	+18008217119
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	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.3.9.2	Current sponsor code	BIBW 2992
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	50
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: 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	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	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.3.9.2	Current sponsor code	BIBW 2992
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.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	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	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.3.9.2	Current sponsor code	BIBW 2992
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)	Yes
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	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	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.3.9.2	Current sponsor code	BIBW 2992
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: 5
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	IRESSA 250 mg film-coated tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca AB
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	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	Gefitinib
D.3.9.1	CAS number	184475-35-2
D.3.9.4	EV Substance Code	SUB08856MIG
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	250
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

Recurrent, advanced or metastatic non-small cell lung cancer harbouring activating EGFR mutations with adnocarcinomatous histology

Cáncer de pulmón no microcítico avanzado, recurrente o metastásico con mutación activadora del EGFR y con histología adenocarcinomatosa.

E.1.1.1

Medical condition in easily understood language

Advanced lung cancer with EGFR mutation positive

Cáncer de pulmón avanzado con mutación EGFR positiva

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	14.0
E.1.2	Level	LLT
E.1.2	Classification code	10025054
E.1.2	Term	Lung cancer non-small cell stage IIIB
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	14.0
E.1.2	Level	LLT
E.1.2	Classification code	10025048
E.1.2	Term	Lung cancer non-small cell recurrent
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	14.0
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.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To compare the progression-free survival (PFS) and disease control rate (at 12 months) of afatinib with gefitinib among patients with adenocarcinoma of the lung harbouring activating EGFR mutations who have no prior systemic chemotherapy in advanced setting (stage IIIB or IV)

Comparar la supervivencia libre de progresión (SLP) y la tasa de control de la enfermedad (a los 12 meses) de afatinib y gefitinib en pacientes con adenocarcinoma de pulmón portadores de mutaciones activadoras del EGFR que no han recibido quimioterapia sistémica previa en estadios avanzados (estadios IIIB ó IV).

E.2.2

Secondary objectives of the trial

To compare afatinib with gefitinib in terms of:
Overall survival (OS),
Objective response rate (ORR),
Disease control rate (DCR) at 6 and 9 months,
Time to objective response,
- Duration of objective response,
- Duration of disease control,
- Tumour shrinkage
- Time to treatment failure
- Health-related Quality of Life (HRQoL) and
- The assessment of safety

Comparar afatinib y gefitinib en cuanto a:
- Supervivencia global (SG),
- Tasa de respuesta objetiva (TRO),
- Tasa de control de la enfermedad (TCE) a los 6 y a los 9 meses,
- Tiempo hasta la respuesta objetiva,
- Duración de la respuesta objetiva,
- Duración del control de la enfermedad,
- Disminución del tumor,
- Tiempo hasta el fracaso del tratamiento,
- Calidad de vida relacionada con la salud (HRQoL),
- Evaluación de la seguridad

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Pathologically confirmed diagnosis of Stage IIIB (not amenable for curative intent local radiotherapy)/IV (recurrent or metastatic) adenocarcinoma of the lung.
2.Documented activating EGFR mutation (Del 19 and/or L858R) with tumour tissues.
3.At least one measurable lesion according to RECIST 1.1
4.Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
5.Age ≥ 18 years.
6.Adequate organ function as defined by the following criteria:
• Serum aspartate transaminase (AST) and serum alanine transaminase
(ALT) ≦3 x upper limit of normal (ULN), or AST and ALT ≦5 x
ULN if liver function abnormalities are due to underlying malignancy
• Total serum bilirubin ≦1.5 x ULN
• Absolute neutrophil count (ANC) ≧1.5 x 109/L
• Platelets ≧75 x 109/L
• Creatinine clearance > 45ml / min.
7.Written informed consent that is consistent with ICH-GCP guidelines.

1. Diagnóstico confirmado de adenocarcinoma de pulmón en estadío IIIB (no susceptible de ser tratado con radioterapia local con intención curativa) o estadio IV (recurrente o metastásico).
2. Mutación activadora del EGFR documentada (Del 19 y/o L858R) en tejido tumoral.
3. Al menos una lesión medible según los criterios RECIST 1.1.
4. Estado funcional 0 ó 1 según la escala del Eastern Cooperative Oncology Group (ECOG).
5. Edad ≥ 18 años.
6. Función orgánica adecuada según los criterios siguientes:
• Aspartato aminotransferasa sérica (AST) y alanina aminotransferasa sérica (ALT) ≦3 x límite superior de la normalidad (LSN), o AST y ALT ≦5 x
LSN si la alteración de la función hepática se debe al cáncer subyacente
• Bilirrubina sérica total ≦1,5 x LSN
• Recuento absoluto de neutrófilos (ANC) ≧1,5 x 109/l
• Plaquetas ≧75 x 109/l
• Aclaramiento de creatinina > 45 ml / min.
7. Consentimiento informado por escrito conforme a las normas de BPC de la ICH.

E.4

Principal exclusion criteria

1.Prior systemic chemotherapy for stage IIIB or IV NSCLC. Neo-/adjuvant chemotherapy, chemoradiation or radiotherapy is permitted if at least 12 months has elapsed prior to disease progression, except palliative, limited field radiation to non-target metastatic lesions.
2.Prior treatment with EGFR targeting small molecules or antibodies.
3.Major surgery within 4 weeks of study randomisation. At least 7 days should elapse since minor surgical procedure including placement of an access device or fine needle aspiration and at least 14 days for diagnostic or palliative video-assisted thoracoscopic surgery (VATS) should elapse.
4.Active brain metastases except for the followings:
- Asymptomatic brain metastases incidentally found during screening process which does not require local treatment in the opinion of the investigator.
- Asymptomatic brain metastases for which local treatment has been given: At least 1 week off corticosteroids and/or anti-convulsants treatment before study randomisation.
5. Meningeal carcinomatosis.
6.Previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured in the opinion of investigator.
7.Known pre-existing interstitial lung disease.
8.Any history or presence of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug in the opinion of investigator
9.Clinically relevant cardiovascular abnormalities as judged by the investigator
10.Cardiac left ventricular function with resting ejection fraction of less than institutional lower limit of normal (if no lower limit of normal is defined in the institution the lower limit is 50%).
11.Women of child-bearing potential (WOCBP) and men who are able to father a child, unwilling to be abstinent or use adequate contraception prior to study entry, for the duration of study participation and for at least 2 months after treatment has ended. 12.Pregnancy or breast-feeding.
13.Active hepatitis B infection, active hepatitis C infection and/or known HIV carrier.
14.Use of any investigational drug within 4 weeks of randomisation

1. Quimioterapia sistémica previa para el CPNM en estadío IIIB ó IV. Se permite la quimioterapia, la quimiorradioterapia o la radioterapia neoadyuvante/adyuvante si han transcurrido al menos 12 meses hasta la progresión de la enfermedad, excepto la radioterapia paliativa de campo limitado de lesiones metastásicas no diana.
2. Tratamiento previo con moléculas de pequeño tamaño o anticuerpos dirigidos al EGFR.
3. Cirugía mayor en las 4 semanas anteriores a la aleatorización del estudio. Deben haber transcurrido al menos 7 días desde un procedimiento quirúrgico menor, incluida la colocación de una vía de acceso o una aspiración con aguja fina, y al menos 14 días desde una toracoscopia videoasistida (VATS) diagnóstica o paliativa.
4. Metástasis cerebrales activas, excepto en los siguientes casos:
• Metástasis cerebrales asintomáticas halladas casualmente durante el proceso de selección y que a juicio del investigador no requieren tratamiento local.
• Metástasis cerebrales asintomáticas tratadas localmente: debe haber transcurrido al menos una semana desde la última administración de corticosteroides y/o anticonvulsionantes antes de la aleatorización en el estudio.
5. Carcinomatosis meníngea.
6. Cáncer previo o concomitante en otras localizaciones, excepto cánceres cutáneos distintos al melanoma tratados eficazmente, carcinoma cervical in situ, carcinoma ductal in situ o un cáncer tratado eficazmente que ha estado en remisión durante más de 3 años y que en opinión del investigador se puede considerar curado.
7. Antecedentes de neumopatía intersticial.
8. Antecedentes o presencia de trastornos gastrointestinales mal controlados que en opinión del investigador pudieran afectar la absorción del fármaco del estudio.
9. Alteraciones cardiovasculares clínicamente significativas en opinión del investigador.
10. Función ventricular izquierda con una fracción de eyección en reposo inferior al límite inferior normal vigente en la institución (si en la institución no se ha definido un límite inferior de la normalidad, dicho límite es del 50%).
11. Mujeres en edad fértil y hombres con capacidad para engendrar que no estén dispuestos a guardar abstinencia o utilizar un método anticonceptivo adecuado antes de la inclusión en el ensayo, durante su participación en el ensayo y al menos 2 meses después de haber finalizado el tratamiento.
12. Embarazo o lactancia.
13. Hepatitis B activa, hepatitis C activa y/o ser portador conocido del VIH.
14. Uso de cualquier fármaco en fase de investigación en las 4 semanas anteriores a la aleatorización

E.5 End points

E.5.1

Primary end point(s)

Progression-free survival (PFS) and disease control rate at 12 months

Supervivencia libre de progresión (SLP) y tasa de control de la enfermedad a los 12 meses.

E.5.1.1

Timepoint(s) of evaluation of this end point

After 175 randomized patients have progressed or died or after disease control rate at 12 months is evaluable for all patients, whatever is later.

Una vez 175 pacientes aleatorizados hayan experimentado una progresión de su enfermedad o hayan fallecido o se haya podido evaluar la tasa de control de la enfermedad a los 12 meses en todos los pacientes, lo que se produzca más tarde.

E.5.2

Secondary end point(s)

Overall survival (OS),
Objective response rate (ORR),
Disease control rate (DCR) at 6 and 9 months,
Time to objective response,
Duration of objective response,
Duration of disease control,
Tumour shrinkage
Time to treatment failure (TTF)
Health-related Quality of Life (HRQoL)
Intensity and incidence of adverse events, graded according to US NCI CTCAE Version 3.0

-Supervivencia global (SG),
-Tasa de respuesta objetiva (TRO),
-Tasa de control de la enfermedad (TCE) a los 6 y a los 9 meses,
-Tiempo hasta la respuesta objetiva,
-Duración de la respuesta objetiva,
-Duración del control de la enfermedad,
-Disminución del tumor,
-Tiempo hasta el fracaso del tratamiento,
-Calidad de vida relacionada con la salud (HRQoL),
-Evaluación de la seguridad

E.5.2.1

Timepoint(s) of evaluation of this end point

After "last patient out" the analysis will be performed.

Después del análisis del último paciente en salir.

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

Yes

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

Yes

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

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Gefitinib

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

Australia

Canada

China

France

Germany

Hong Kong

Ireland

Korea, Republic of

Norway

Singapore

Spain

Sweden

Taiwan

United Kingdom

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

LSLV

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:

200

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

264

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)

Patient will stay in trial for as long as benefiting from treatment or until unacceptable side effects from medication. Once patient completes treatment/follow up they will go back to normal treatment of condition but patient will be followed for survival unless they withdraw consent.

Los pacientes permanecerán en el ensayo mientras se beneficien del tratamiento o hasta que aparezcan efectos adversos inaceptables debidos a la medicación. Una vez el paciente haya completado el tratamiento/seguimiento volverá al tratamiento normal de la enfermedad pero se le realizará un seguimiento de supervivencia a menos que retire el consentimiento.

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

2011-12-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-12-13

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-04-12

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