Clinical Trials Register

Summary
EudraCT Number:	2015-003605-42
Sponsor's Protocol Code Number:	GO29438
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2016-02-08
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

2015-003605-42

A.3

Full title of the trial

A PHASE III, OPEN-LABEL, RANDOMIZED STUDY OF ATEZOLIZUMAB (MPDL3280A, ANTI?PD-L1 ANTIBODY) IN COMBINATION WITH CARBOPLATIN OR CISPLATIN+PEMETREXED COMPARED WITH CARBOPLATIN OR CISPLATIN+PEMETREXED IN PATIENTS WHO ARE CHEMOTHERAPY-NAIVE AND HAVE STAGE IV NON-SQUAMOUS NON?SMALL CELL LUNG CANCER

ESTUDIO DE FASE III, ABIERTO Y ALEATORIZADO DE ATEZOLIZUMAB (MPDL3280A, ANTICUERPO ANTI-PDL1) EN COMBINACIÓN CON CARBOPLATINO O CISPLATINO Y PEMETREXED EN COMPARACIÓN CON CARBOPLATINO O CISPLATINO Y PEMETREXED EN PACIENTES CON CÁNCER DE PULMÓN NO MICROCÍTICO NO EPIDERMOIDE EN ESTADIO IV QUE NUNCA HAN RECIBIDO QUIMIOTERAPIA

A.3.1

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

A Study of Atezolizumab (MPDL3280A, Anti-Pd-L1 Antibody) in Combination with Carboplatin or Cisplatin + Pemetrexed Compared with Carboplatin or Cisplatin + Pemetrexed in Patients who are Chemotherapy-Naive and have Stage IV Non-Squamous Non-Small Cell Lung Cancer

Un estudio de Atezolizumab (MPDL3280A, anticuerpo anti-PDL1) en combinación con Carboplatino o Cisplatino + Pemetrexed comparado con Carboplatino o Cisplatino + Pemetrexed en pacientes con cáncer de pulmón no microcítico no epidermoide en estadio IV que nunca han recibido quimioterapia.

A.4.1

Sponsor's protocol code number

GO29438

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. 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	F.Hoffmann-La Roche Ltd
B.5.2	Functional name of contact point	Trial Information Support Line-TISL
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	+34 91 325 73 00
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	Atezolizumab
D.3.2	Product code	Ro 554-1267/F03-01
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	Atezolizumab
D.3.9.2	Current sponsor code	RO5541267
D.3.9.3	Other descriptive name	MPDL3280A
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	Yes
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	Alimta
D.2.1.1.2	Name of the Marketing Authorisation holder	Eli Lilly Nederland B.V.
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	ALIMTA
D.3.2	Product code	Ro 498-7074
D.3.4	Pharmaceutical form	Powder 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	PEMETREXED
D.3.9.1	CAS number	137281-23-3
D.3.9.4	EV Substance Code	SUB09655MIG
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	500
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	Yes
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

Metastatic non-squamous non-small cell lung cancer

Cáncer de pulmón no microcítico no epidermoide

E.1.1.1

Medical condition in easily understood language

Non-small cell lung cancer is a disease in which malignant (cancer) cells form in the tissues of the lung

Cáncer de pulmón no microcítico no epidermoide es una enfermedad en la que se forman células malignas (cáncer) en los tejidos del pulmón.

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	18.1
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

?To evaluate the efficacy of atezolizumab in the programmed death?ligand 1 (PD-L1)?selected population as measured by investigator-assessed progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in atezolizumab + carboplatin + pemetrexed versus carboplatin + pemetrexed
?To evaluate the efficacy of atezolizumab in the intent-to-treat (ITT) population as measured by investigator-assessed PFS according to RECIST v1.1 in atezolizumab + carboplatin + pemetrexed versus carboplatin + pemetrexed
?To evaluate the efficacy of atezolizumab in the PD-L1?selected population as measured by investigator-assessed PFS according to RECIST v1.1 in atezolizumab + carboplatin or cisplatin + pemetrexed versus carboplatin or cisplatin (pooled) + pemetrexed

Evaluar la eficacia de atezolizumab en la población seleccionada por el ligando 1 del receptor de muerte programada (PD-L1),determinada mediante la supervivencia sin progresión(SSP) valorada por el investigador conforme a los Criterios de evaluación de la respuesta en tumores sólidos,versión 1.1(RECIST v1.1),al administrar atezolizumab,carboplatino y pemetrexed en comparación con carboplatino y pemetrexed.-Evaluar la eficacia de atezolizumab en la población por intención de tratamiento(IT),determinada mediante la SSP valorada por el investigador conforme a los criterios RECISTv1.1 al administrar atezolizumab,carboplatino y pemetrexed en comparación con carboplatino y pemetrexed.-Evaluar la eficacia de atezolizumab en la población seleccionada por el PD-L1,determinada mediante la SSP valorada por el investigador conforme a los criterios RECIST v1.1, al administrar atezolizumab, carboplatino o cisplatino y pemetrexed en comparación con carboplatino o cisplatino (agrupados) y pemetrexed.

E.2.2

Secondary objectives of the trial

? To evaluate the efficacy of atezolizumab as measured by progression-free survival, objective response rate, overall survival, duration of response, time to response, and time to deterioration
? To evaluate the safety and tolerability of atezolizumab
? To characterize the pharmacokinetics of atezolizumab, carboplatin, cisplatin, and pemetrexed

- Evaluar la eficacia de atezolizumab determinada mediante la SSP, la tasa de respuestas objetivas, la supervivencia global, la duración de la respuesta, el tiempo transcurrido hasta la respuesta, tiempo transcurrido hasta el deterioro.
- Evaluar la seguridad y tolerabilidad de atezolizumab
- Definir la farmacocinética de atezolizumab, carboplatino, cisplatino y pemetrexed.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Male or female, 18 years of age or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically or cytologically confirmed, Stage IV non-squamous NSCLC
- No prior treatment for Stage IV non-squamous NSCLC
- Patients who have received prior neo-adjuvant, adjuvant chemotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 6 months from randomization since the last chemotherapy or completion of chemoradiotherapy
- Known PD-L1 tumor status as determined by an immunohistochemistry (IHC) assay performed by a central laboratory on previously obtained archival tumor tissue or tissue obtained from a biopsy at screening
- Measurable disease, as defined by RECIST v1.1
- Adequate hematologic and end organ function
- For women of childbearing potential: agreement to remain abstinent or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 90 days after the last dose of study treatment
- For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm

- Varones o mujeres de 18 años o más de edad.
- Estado funcional del ECOG de 0 o 1.
- CPNM no epidermoide, confirmado mediante histología o citología, en estadio IV
- Ausencia de tratamiento previo para el CPNM no epidermoide en estadio IV.
- Los pacientes que hayan recibido quimioterapia neoadyuvante o adyuvante previa o quimiorradioterapia con intención curativa por enfermedad no metastásica tendrán que haber presentado un intervalo sin tratamiento de al menos 6 meses con respecto a la aleatorización desde la última quimioterapia o la finalización de la quimiorradioterapia.
- Presencia de PD-L1 en el tumor, determinada mediante un análisis de IHQ realizado en un laboratorio central en tejido tumoral de archivo obtenido anteriormente o en tejido obtenido a partir de una biopsia practicada en la visita de selección.
- Enfermedad mensurable, definida conforme a los criterios RECIST v1.1.
- Función hematológica y de órganos efectores adecuada.
- Mujeres en edad fértil: compromiso de practicar abstinencia sexual (ausencia de relaciones heterosexuales) o utilizar métodos anticonceptivos con una tasa de fracasos < 1% anual durante el período de tratamiento y hasta al menos 90 días después de la última dosis del tratamiento del estudio.
- Varones: compromiso de practicar abstinencia sexual (ausencia de relaciones heterosexuales) o uso de métodos anticonceptivos y compromiso de abstenerse de donar semen.

E.4

Principal exclusion criteria

Cancer-Specific Exclusions
- Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
- 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 tumor-related pain
- Uncontrolled or symptomatic hypercalcemia (> 1.5 millimole/Liter ionized calcium or calcium > 12 milligram/deciliter or corrected serum calcium > upper limit of normal)
- Malignancies other than non?small cell lung cancer (NSCLC) within 5 years prior to randomization
- Known tumor PD-L1 expression status from other clinical studies (e.g., patients whose PD-L1 expression status was determined during screening for entry into a study with anti-PD-1 or anti?PD L1 antibodies but were not eligible are excluded)
General Medical Exclusions:
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- History of certain autoimmune disease
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis
- Severe infections within 4 weeks prior to randomization
- Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 3 months prior to randomization, unstable arrhythmias, or unstable angina

Exclusion Criteria Related to Medications and Chemotherapy:
- Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti?PD-1, and anti?PD-L1 therapeutic antibodies
- Treatment with systemic immunostimulatory agents within 4 weeks prior to randomization
- Treatment with systemic immunosuppressive medications

Exclusion Criteria Related to Chemotherapy:
- History of allergic reactions to cisplatin, carboplatin, or other platinum-containing compounds
- Patients with hearing impairment (cisplatin)
- Grade >= 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 criteria (cisplatin)
- Creatinine clearance (CRCL) =< 60 milliliter (mL)/minute (min) for cisplatin or < 45 mL/min for carboplatin

Criterios de exclusión específicos del cáncer
- Metástasis en el SNC activas o no tratadas, determinadas mediante TC o resonancia magnética (RM) durante las evaluaciones radiológicas de selección y precedentes.
- Compresión medular no tratada de forma definitiva con cirugía o radioterapia o compresión medular ya diagnosticada y tratada sin indicios de que la enfermedad haya permanecido clínicamente estable durante >= 2 semanas antes de la aleatorización.
- Afectación leptomeníngea.
- Dolor no controlado relacionado con el tumor.
- Hipercalcemia sintomática o no controlada (calcio ionizado > 1,5 mmol/l, calcio > 12 mg/dl o calcemia corregida > LSN).
- Tumores malignos distintos del CPNM en los 5 años previos a la aleatorización.
- Expresión tumoral conocida de PD-L1, determinada mediante un análisis de IHQ, a partir de otros ensayos clínicos (por ejemplo, quedarán excluidos los pacientes en que se determinó la expresión de PD-L1 durante la selección para participar en un ensayo con anticuerpos anti-PD-1 o anti-PD-L1, pero que no fueron aptos finalmente).

Criterios de exclusión médicos generales
- Antecedentes de reacciones alérgicas, anafilácticas o de hipersensibilidad intensas a proteínas de fusión o anticuerpos humanizados o quiméricos.
- Antecedentes de enfermedad autoinmunitaria.
- Antecedentes de fibrosis pulmonar idiopática, neumonía organizada, neumonitis medicamentosa, neumonitis idiopática o signos de neumonitis activa.
- Infecciones graves en las 4 semanas previas a la aleatorización.
- Enfermedad cardiovascular importante, como cardiopatía en clase II o superior según la New York Heart Association, infarto de miocardio en los 3 meses previos a la aleatorización, arritmias inestables o angina de pecho inestable.

Criterios de exclusión relacionados con medicamentos
- Cualquier tratamiento antineoplásico aprobado, incluida quimioterapia, o tratamiento hormonal en las tres semanas previas al comienzo del tratamiento del estudio.
- Tratamiento previo con agonistas de CD137, terapias de bloqueo de puntos de control inmunológico y anticuerpos terapéuticos anti-PD-1 y anti-PD-L1.
- Tratamiento con fármacos inmunoestimuladores sistémicos en las 4 semanas previas a la aleatorización.
- Tratamiento con inmunodepresores sistémicos.

Criterios de exclusión relacionados con quimioterapia
- Antecedentes de reacciones alérgicas a cisplatino, carboplatino u otros compuestos que contengan platino.
- Pacientes con deterioro auditivo (cisplatino).
- Neuropatía periférica de grado >= 2, según se define en los criterios CTCAE del NCI, versión 4.0 (cisplatino).
- CrCl =< 60 ml/min en el caso de cisplatino o < 45 ml/min en el de carboplatino.

E.5 End points

E.5.1

Primary end point(s)

Progression free survival as assessed by the investigator

Supervivencia sin progresión valorada por el investigador.

E.5.1.1

Timepoint(s) of evaluation of this end point

Up to 44 months

Hasta 44 meses.

E.5.2

Secondary end point(s)

1. Overall Survival
2. Objective Response Rate
3. Duration of Response
4. Time to Response
5. Progression free survival as determined by the Independent Review Facility
6. Landmark analysis on Overall Survival
7. Time to deterioration in patient-reported lung cancer symptoms using each of the EORTC QLQ-C30 and EORTC QLQ-LC13 symptom subscales
8. Time to deterioration in patient-reported lung cancer symptoms (cough, dyspnea, or chest pain, whichever occurs first) with use of the SILC scale symptom score
9. Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.0
10. Maximum observed serum atezolizumab concentration (Cmax) after infusion (Arm A)
11. Minimum observed serum atezolizumab concentration (Cmin) prior to infusion (Arm A)
12. Plasma concentrations for carboplatin or cisplatin (Arm A)
13. Plasma concentrations for pemetrexed (Arm A)

1. Supervivencia Global.
2. Tasa de respuestas objetivas
3. Duración de la respuesta.
4. Tiempo transcurrido hasta la respuesta.
5. Supervivencia sin progresión valorada por Comité de vigilancia de los datos independiente.
6. Análisis Landmark de Supervivencia Global.
7. Tiempo transcurrido hasta el deterioro (THD) de los síntomas del cáncer de pulmón comunicados por el paciente utilizando para ello el Cuestionario de calidad de vida-básico (QLQ-C30) y el módulo de cáncer de pulmón (QLQ-LC13).
8. Tiempo transcurrido hasta el deterioro (THD) de los síntomas del cáncer de pulmón (tos, disnea, dolor torácico, lo que ocurra primero) utilizando para ello la Escala de síntomas del cáncer de pulmón (SILC).
9. Incidencia, naturaleza y gravedad de los acontecimientos adversos clasificados según NCI CTCAE v4.0.
10. Concentración sérica máxima observada (Cmax) después de la infusión (Grupo A).
11. Concentración sñerica mínima observada (Cmin) antes de infusión (Grupo A).
12. Concentraciones plasmáticas de carboplatino o cisplatino (Grupo A).
13. Concentraciones plasmáticas de pemetrexed (Grupo A)

E.5.2.1

Timepoint(s) of evaluation of this end point

1-5. Up to 44 months
6. 1, 2, and 3 years
7-9. Up to 44 months
10-11. C1D1, C2D1, C3D1, C4D1, C8D1, C16D1, after C16 every eighth cycle D1, at treatment discontinuation, 120 (+/-30) days after last dose of atezolizumab
12-13. C1D1, C3D1

1-5. Hasta 44 meses.
6. 1, 2 y 3 años.
7-9. Hasta 44 meses.
10-11. C1D1, C2D1, C3D1, C4D1, C8D1, C16D1, tras C16 en el D1 de cada ocho ciclos, en visita de discontinuación de tratamiento, 120 (+/-30) días tras la última dosis de atezolizumab.
12-13. C1D1, C3D1.

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

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)

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

138

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

Argentina

Australia

Austria

Belgium

Bulgaria

Canada

Chile

France

Hong Kong

Hungary

Israel

Italy

Latvia

Lithuania

Malaysia

Netherlands

New Zealand

Peru

Poland

Portugal

Romania

Russian Federation

Singapore

Slovakia

Spain

Taiwan

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

The end of this study is defined as the date when the last patient, last visit (LPLV) occurs
or the date at which the last data point required for statistical analysis (i.e., final OS
analysis) or safety follow-up is received from the last patient, whichever occurs later.

El final del estudio se define como la fecha en que tenga lugar la última visita del último paciente (UVUP) o la fecha en que se reciba el último punto de datos necesario para el análisis estadístico (es decir, análisis final de la SG) o el seguimiento de seguridad del último paciente, lo que suceda más tarde.

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:

374

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

306

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

290

F.4.2.2

In the whole clinical trial

680

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 atezolizumab to
patients assigned to this treatment after evaluating the primary and secondary efficacy
outcome measures and safety data gathered in the study

El promotor evaluará la conveniencia de seguir proporcionando atezolizumab a los pacientes asignados a este tratamiento tras evaluarlos criterios de valoración principales y secundarios de la eficacia y los datos sobre seguridad recogidos en el 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

2016-04-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-04-12

P. End of Trial
P.	End of Trial Status	Ongoing

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IMP with orphan designation in the indication
Orphan Designation Number:
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