Clinical Trials Register

Summary
EudraCT Number:	2021-002695-40
Sponsor's Protocol Code Number:	MO43156
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:	2021-10-06
Trial 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

2021-002695-40

A.3

Full title of the trial

A PHASE II, SINGLE-ARM STUDY OF ATEZOLIZUMAB IN PATIENTS WITH LOCALLY ADVANCED, UNRESECTABLE STAGE III NON-SMALL CELL LUNG CANCER WHO HAVE NOT PROGRESSED AFTER PLATINUM-BASED CONCURRENT CHEMORADIATION.

ESTUDIO FASE II CON UN SOLO GRUPO DE ATEZOLIZUMAB EN PACIENTES CON CÁNCER DE PULMÓN NO MICROCÍTICO EN ESTADIO III LOCALMENTE AVANZADO E IRRESECABLE QUE NO HAN PROGRESADO DESPUÉS DE LA QUIMIORRADIOTERAPIA CON PLATINO CONCOMITANTE

A.3.1

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

A Study of Atezolizumab in Patients with Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer who have already received chemotherapy and radiotherapy.

Estudio de Atezolizumab En Pacientes Con Cáncer De Pulmón No Microcítico En Estadio III Localmente Avanzado E Irresecable Que No Han Progresado Después De La Quimioterapia y radioterapia

A.4.1

Sponsor's protocol code number

MO43156

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. U. que realiza el ensayo en España y que actúa como representante 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	+34913257300
B.5.5	Fax number	+34913248196
B.5.6	E-mail	spain.start_up_unit@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	Yes
D.2.1.1.1	Trade name	TECNETRIQ®
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration 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.3.4	Pharmaceutical form	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	Atezolizumab
D.3.9.1	CAS number	1380723-44-3
D.3.9.2	Current sponsor code	RO5541267
D.3.9.4	EV Substance Code	SUB178312
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	840
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

Non-Small Cell Lung Cancer (NSCLC)

Cáncer de pulmón no microcítico (CPNM)

E.1.1.1

Medical condition in easily understood language

NSCLC is a disease in which malignant (cancer) cells form in the tissues of the lung. Smoking is the major risk factor for NSCLC.

El CPNM es una enfermedad en la que se forman células malignas (cancerosas) en los tejidos del pulmón. El tabaquismo es el principal factor de riesgo del CPNM.

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	21.1
E.1.2	Level	PT
E.1.2	Classification code	10029519
E.1.2	Term	Non-small cell lung cancer stage III
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 the efficacy of atezolizumab in patients with locally advanced unresectable Stage III NSCLC who have not progressed after at least two cycles of platinum-based concurrent chemoradiation therapy (cCRT) based on 12-month progression-free survival (PFS) rate.

Evaluar la eficacia de atezolizumab en pacientes con CPNM en estadio III localmente avanzado e irresecable que no hayan presentado progresión después de al menos dos ciclos de QRTc con platino

E.2.2

Secondary objectives of the trial

• To evaluate the efficacy of atezolizumab in patients with locally advanced unresectable Stage III NSCLC who have not progressed after at least two cycles of platinum-based cCRT based on independent Review Facility (IRF) and investigator-assessed PFS, overall survival (OS), confirmed objective response rate (ORR), duration of response (DOR), PFS rate, OS rate, and time to death or distant metastasis (TTDM)
• To evaluate the safety of atezolizumab in patients with locally advanced unresectable Stage III NSCLC who have not progressed after platinum-based cCRT.

Evaluar la eficacia de atezolizumab en pacientes con CPNM en estadio III localmente avanzado e irresecable que no hayan presentado progresión después de al menos dos ciclos de QRTc con platino.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Age >=18 years at time of signing the Informed Consent Form
• Histologically or cytologically documented NSCLC with locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology
• Whole-body positron emission tomography–computed tomography (PET-CT) scan (from the base of skull to mid-thighs) for the purposes of staging, performed prior and within 42 days of the first dose of cCRT
• At least two prior cycles of platinum-based chemotherapy administered cCRT completed within 1 to 42 days prior to baseline (one cycle of cCRT is defined as 21 or 28 days)
• The radiotherapy (RT) component in the cCRT must have been at a total radiation dose of 60 (±10%) gray (Gy) (54 Gy to 66 Gy), administered either as intensity-modulated radiotherapy (IMRT) or by 3D-conforming technique
• No progression during or following platinum-based cCRT
• Tumor Programmed Cell Death 1–Ligand 1 (PD-L1) expression, as determined by the investigational Ventana PD-L1 (SP263) CDx Assay and documented by means of central testing of a representative tumor tissue sample, in either a previously obtained archival tumor tissue sample or a fresh tissue sample obtained from a biopsy collected prior to the first dose of cCRT
• Submission of representative formalin-fixed, paraffin-embedded (FFPE) tumor specimens in blocks (preferred) or at least 10 unstained serial slides, along with an associated pathology report to a central laboratory for PD-L1 testing
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Life expectancy >=12 weeks
• Adequate hematologic and end-organ function.

• Edad ≥18 años en el momento de la firma del DCI.
• CPNM confirmado histológica o citológicamente en estadio III localmente avanzado e irresecable de histología epidermoide o no epidermoide.
• Tomografía por emisión de positrones-tomografía computarizada (PET-TC) de cuerpo entero (desde la base del cráneo hasta la mitad de los muslos) con fines de estadificación, realizada en los 42 días previos a la primera dosis de QRTc.
• Al menos dos ciclos previos de quimioterapia con platino concomitante a la radioterapia (QRTc) completados entre 1 y 42 días antes del inicio (un ciclo de QRTc se define como 21 o 28 días).
• El componente de RT de la QRTc deberá consistir en una dosis total de radiación de 60 (±10 %) Gy (54 a 66 Gy), administrada como radioterapia de intensidad modulada (RTMI) (preferible) o mediante una técnica conformada en 3D.
• Ausencia de progresión durante o después de la QRTc con platino.
• Expresión tumoral de PD-L1, determinada mediante el ensayo en investigación Ventana PD-L1 (SP263) CDx (Apéndice 9) y documentada mediante análisis centralizado de una muestra de tejido tumoral representativa, en una muestra de tejido tumoral de archivo obtenida previamente o en una muestra de tejido tumoral reciente obtenida de una biopsia antes de la primera dosis de QRTc.
• Envío de muestras tumorales representativas fijadas en formol e incluidas en parafina (FFIP) en bloques (preferible) o al menos 10 cortes seriados sin teñir, junto con un informe anatomopatológico asociado, a un laboratorio central para el análisis de PD-L1.
• Estado funcional del ECOG de 0 o 1.
• Esperanza de vida ≥12 semanas.
• Función hematológica y de órganos efectores adecuada

E.4

Principal exclusion criteria

• Any history of prior NSCLC and/or any history of prior treatment for NSCLC (patients must be newly diagnosed with unresectable Stage III disease)
• NSCLC known to have a mutation in the epidermal growth factor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene
• Any evidence of Stage IV disease
• Treatment with sequential CRT for locally advanced NSCLC
• Patients with locally advanced NSCLC who have progressed during or after definitive cCRT prior to baseline
• Any Grade > 2 unresolved toxicity from previous cCRT
• Grade ≥ 2 pneumonitis from prior cCRT
• Concurrent enrolment in another clinical study, unless it is an observational clinical study or the follow-up period of an interventional study
• Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer
• Active or history of autoimmune disease or immune deficiency
• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on the screening chest CT scan
• History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
• Severe infection within 4 weeks prior to initiation of study treatment
• Treatment with therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to initiation of study treatment
• Prior allogeneic stem cell or solid organ transplantation
• Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
• Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during study treatment or within 5 months after the final dose of study treatment
• Current treatment with anti-viral therapy for HBV or HCV
• Treatment with investigational therapy within 28 days prior to initiation of study treatment
• Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte–associated protein 4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
• Treatment with systemic immunostimulatory agents (including, but not limited to, IFN and IL-2) within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment
• Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor–�� [anti-TNF–�� agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment.

• Antecedentes de CPNM previo o de tratamiento previo para el CPNM (los pacientes deben haber sido diagnosticados recientemente de cáncer en estadio III irresecable)
• CPNM con una mutación conocida en el gen EGFR o un oncogén de fusión ALK
• Cualquier indicio de enfermedad en estadio IV
• Tratamiento con quimiorradioterapia secuencial para el CPNM localmente avanzado
• Pacientes con CPNM localmente avanzado que hayan presentado progresión durante o después de la QRTc definitiva antes del inicio del estudio
• Cualquier toxicidad de grado >2 no resuelta debida a la QRTc previa
• Neumonitis de grado ≥2 debida a la QRTc previa
• Participación simultánea en otro estudio clínico, a menos que se trate de un estudio clínico observacional (no intervencionista) o del periodo de seguimiento de un estudio intervencionista
• Cualquier quimioterapia, inmunoterapia, tratamiento biológico u hormonal concomitante para el cáncer
• Antecedentes o presencia activa de enfermedades autoinmunitarias o inmunodeficiencias
• Antecedentes de fibrosis pulmonar idiopática, neumonía organizada (p. ej., bronquiolitis obliterante), neumonitis por fármacos, neumonitis idiopática o signos de neumonitis activa en la TC de tórax de selección
• Antecedentes de neoplasias malignas distintas del CPNM en los 5 años previos a la selección, exceptuando aquellas con un riesgo insignificante de metástasis o muerte
• Infección grave en las 4 semanas previas al inicio del tratamiento del estudio
• Tratamiento con antibióticos terapéuticos por vía oral o i.v. en las dos semanas previas al comienzo del tratamiento del estudio
• Alotrasplante de precursores hematopoyéticos o trasplante de órgano sólido previo
• Cualquier otra enfermedad, disfunción metabólica, signo en la exploración física o resultado analítico que contraindique el uso de un fármaco experimental, pueda afectar a la interpretación de los resultados o pueda hacer que el paciente tenga un riesgo elevado de complicaciones por el tratamiento
• Tratamiento con una vacuna de microorganismos vivos atenuados en las 4 semanas previas al comienzo del tratamiento del estudio o previsión de que se vaya a necesitar una vacuna de este tipo durante el tratamiento del estudio o en los 5 meses posteriores a la dosis final del tratamiento del estudio
• Tratamiento actual con antivíricos frente al VHB o VHC
• Uso de un tratamiento experimental en los 28 días previos al comienzo del tratamiento del estudio
• Tratamiento previo con agonistas de CD137 o terapias de bloqueo de puntos de control inmunológico, como anticuerpos terapéuticos antiproteína 4 asociada a los linfocitos T citotóxicos, anti-TIGIT, anti-PD-1 y anti-PD-L1
• Tratamiento con inmunoestimuladores sistémicos (entre ellos, interferón [IFN] e interleucina 2) en las 4 semanas previas o el equivalente a 5 semividas de eliminación del fármaco (lo que suponga más tiempo) antes del comienzo del tratamiento del estudio
• Tratamiento con inmunodepresores sistémicos (entre otros, corticosteroides, ciclofosfamida, azatioprina, metotrexato, talidomida y antagonistas del factor de necrosis tumoral �� [TNF-��]) en las 2 semanas previas al comienzo del tratamiento del estudio o previsión de que vayan a necesitarse durante el transcurso del estudio

E.5 End points

E.5.1

Primary end point(s)

12-month PFS rate, defined as the proportion of patients who have not experienced disease progression, as determined by an IRF according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), or death from any cause, at 12 months.

Tasa de supervivencia sin progresión (SSP) a los 12 meses, definida como la proporción de pacientes que no hayan presentado progresión del cáncer, según lo determinado por un centro de revisión independiente (CRI) conforme a los Criterios de evaluación de la respuesta en tumores sólidos, versión 1.1 (RECIST v1.1), o la muerte por cualquier causa a los 12 meses.

E.5.1.1

Timepoint(s) of evaluation of this end point

At 12 months

A los 12 meses

E.5.2

Secondary end point(s)

1. IRF-assessed PFS, defined as the time from initiation of study treatment to the first occurrence of disease progression, as determined by the IRF according to RECIST v1.1, or death from any cause, whichever occurs first
2. Investigator-assessed PFS, defined as the time from initiation of study treatment to the first occurrence of disease progression, as determined by the Investigator according to RECIST v1.1, or death from any cause, whichever occurs first
3. OS, defined as the time from initiation of study treatment to death from any cause
4. Confirmed ORR, defined as the proportion of patients with a confirmed objective response (i.e., complete response [CR] or partial response [PR] on two consecutive occasions ≥ 4 weeks apart), as determined by the IRF and investigator according to RECIST v1.1
5. DOR, in patients with confirmed ORR, defined as the time from the first occurrence of a documented objective response to disease progression as determined by the IRF and investigator according to RECIST v1.1 or death from any cause, whichever occurs first
6. PFS rate at 18 months and 24 months, defined as the proportion of patients who have not experienced disease progression, as determined by the IRF and investigator according to RECIST v1.1, or death from any cause at 18 months and 24 months, respectively
7. OS rate at 12 months, 24 months and 36 months, defined as the proportion of patients who have not died from any cause at 12 months, 24 months and 36 months, respectively
8. TTDM, defined as the time from initiation of study treatment until the first date of distant metastasis or death in the absence of distant metastasis
9. Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0).

1. SSP evaluada por el CRI, definida como el tiempo transcurrido entre el inicio del tratamiento del estudio y el primer episodio de progresión del cáncer, según lo determinado por el CRI conforme a los criterios RECIST, versión 1.1, o la muerte por cualquier causa, lo que ocurra antes
2. SSP evaluada por el investigador, definida como el tiempo transcurrido entre el inicio del tratamiento del estudio y el primer episodio de progresión del cáncer, según lo determinado por el investigador conforme a los criterios RECIST v1.1, o la muerte por cualquier causa, lo que ocurra antes.
3. Supervivencia global (SG), definida como el tiempo transcurrido entre el inicio del tratamiento del estudio y la muerte por cualquier causa
4. Tasa de respuesta objetiva (TRO) confirmada, definida como la proporción de pacientes con una respuesta objetiva confirmada (es decir, respuesta completa [RC] o respuesta parcial [RP] en dos ocasiones consecutivas con ≥4 semanas de diferencia), según lo determinado por el investigador conforme a los criterios RECIST v1.1
5. Duración de la respuesta (DR) en los pacientes con TRO confirmada, definida como el tiempo transcurrido entre la primera aparición de una respuesta objetiva documentada y la progresión del cáncer, según lo determinado por el CRI y el investigador conforme a los criterios RECIST v1.1, o la muerte por cualquier causa, lo que ocurra antes.
6. Tasa de SSP a los 18 y a los 24 meses, definida como la proporción de pacientes que no hayan presentado progresión del cáncer, según lo determinado por el CRI y el investigador conforme a los criterios RECIST v1.1, o que no hayan fallecido por cualquier causa a los 18 y a los 24 meses, respectivamente.
7. Tasa de SG a los 12, 24 y 36 meses, definida como la proporción de pacientes que no hayan fallecido, con independencia de la causa, a los 12, 24 y 36 meses, respectivamente.
8. Tiempo hasta la muerte o la aparición de metástasis a distancia (THMD), definido como el tiempo transcurrido entre el inicio del tratamiento del estudio y la primera fecha de metástasis a distancia o la muerte en ausencia de metástasis a distancia.
9. Incidencia e intensidad de los acontecimientos adversos, determinando la intensidad conforme a los Criterios terminológicos comunes para acontecimientos adversos del National Cancer Institute, versión 5.0 (CTCAE del NCI v5.0)

E.5.2.1

Timepoint(s) of evaluation of this end point

1-2. From initiation of study treatment to the first occurrence of disease progression
3. From initiation of study treatment to death from any cause
4. Up to approximately 4 years
5. From the first occurrence of a documented objective response to disease progression
6. At 18 months and 24 months
7. At 12 months, 24 months and 36 months
8. From initiation of study treatment until the first date of distant metastasis or death
9. Up to approximately 4 years.

1-2. Del inicio de tratamiento del estudio a la aparición del primer episodio de progresión.
3. Del inicio de tratamiento del estudio a la muerte por cualquier causa
4. Hasta aproximadamente 4 años
5. Desde la primera aparición de una respuesta objetiva documentada y la progresión del cáncer
6. A los 18 meses y 24 meses
7. A los 12 meses, 24 meses y 36 meses
8. Del inicio de tratamiento del estudio hasta la muerte o la aparición de metástasis a distancia
9. Hasta aproximadamente 4 años

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Immunogenicity and Exploratory Biomarker

Inmunogenicidad y exploratorio de biomarcadores

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the 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

Brazil

Chile

China

Costa Rica

Kuwait

Saudi Arabia

Vietnam

Romania

Slovakia

Slovenia

Spain

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

The end of study will occur at the time of the primary analysis, which will take place when approximately 78 PFS events have occurred or the last treated patient has been followed for at least 36 months, whichever occurs first. In addition, the Sponsor may decide to terminate the study at any time. If the Sponsor decides to terminate the study, patients who are still receiving study treatment or undergoing survival follow-up may be enrolled in an extension study.

El final del estudio coincidirá con el análisis ppal, que tendrá lugar cuando se hayan producido aprox 78 eventos de SSP o cuando el último pt tratado haya sido objeto de seguimiento durante al menos 36 meses, lo que ocurra antes. Además, el promotor podrá dar por finalizado el estudio en cualquier momento. Si el promotor decide cancelar el estudio, los pt que todavía estén recibiendo el tto del estudio o en fase de seguimiento de supervivencia podrán incorporarse a un estudio de extensión.

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)

Currently, the Sponsor does not have any plans to provide Roche IMP (atezolizumab) or any other study treatments to patients who have completed the study. The Sponsor may evaluate whether to continue providing atezolizumab in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product, available at the following website:
http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf

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

2021-12-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-12-20

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

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Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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