Clinical Trials Register

Summary
EudraCT Number:	2021-001930-20
Sponsor's Protocol Code Number:	GO43104
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:	2021-12-28
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

2021-001930-20

A.3

Full title of the trial

A PHASE III, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY OF LURBINECTEDIN IN COMBINATION WITH ATEZOLIZUMAB COMPARED WITH ATEZOLIZUMAB AS MAINTENANCE THERAPY IN PARTICIPANTS WITH EXTENSIVE-STAGE SMALL-CELL LUNG CANCER (ES-SCLC) FOLLOWING FIRST-LINE INDUCTION THERAPY WITH CARBOPLATIN, ETOPOSIDE AND ATEZOLIZUMAB

ESTUDIO DE FASE III, ALEATORIZADO, ABIERTO Y MULTICÉNTRICO DE LURBINECTEDINA EN COMBINACIÓN CON ATEZOLIZUMAB, EN COMPARACIÓN CON ATEZOLIZUMAB, COMO TRATAMIENTO DE MANTENIMIENTO EN PACIENTES CON CÁNCER DE PULMÓN MICROCÍTICO EN ENFERMEDAD EXTENSA (CPM-EE) DESPUÉS DE TRATAMIENTO DE INDUCCIÓN DE PRIMERA LÍNEA CON CARBOPLATINO, ETOPÓSIDO Y ATEZOLIZUMAB

A.3.1

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

A study of lurbinectedin in combination with atezolizumab compared with atezolizumab as maintenance therapy in participants with extensive-stage small-cell lung cancer (ES-SCLC) following first-line induction therapy with carboplatin, etoposide and atezolizumab

Estudio de lurbinectedina en combinación con atezolizumab, en comparación con atezolizumab, como tratamiento de mantenimiento en pacientes con cáncer de pulmón microcítico en enfermedad extensa (CPM-EE) después de tratamiento de inducción de primera línea con carboplatino, etopósido y atezolizumab

A.4.1

Sponsor's protocol code number

GO43104

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. 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. Hoffman-La Roche Ltd.
B.4.2	Country	Switzerland
B.4.1	Name of organisation providing support	JazzPharma
B.4.2	Country	United States
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	4047
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	ZEPZELCA
D.2.1.1.2	Name of the Marketing Authorisation holder	Jazz Pharmaceuticals
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	Lurbinectedin
D.3.2	Product code	RO7508182
D.3.4	Pharmaceutical form	Lyophilisate 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	LURBINECTEDIN
D.3.9.2	Current sponsor code	RO7508182
D.3.9.3	Other descriptive name	PM01183 or PM1183
D.3.9.4	EV Substance Code	SUB190540
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	4
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	Yes
D.2.1.1.1	Trade name	Tecentriq
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.3.1	Product name	Atezolizumab
D.3.2	Product code	RO5541267
D.3.4	Pharmaceutical form	Concentrate for solution for injection/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.3.9.4	EV Substance Code	SUB178312
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.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

Small-Cell Lung Cancer

Cáncer de pulmón microcítico

E.1.1.1

Medical condition in easily understood language

Small cell lung cancer is a disease in which malignant rapidly dividing cancer cells form in the tissues of the lung

El cáncer de pulmón microcítico es una enfermedad en la que se forman células cancerosas malignas que se dividen rápidamente 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	21.1
E.1.2	Level	PT
E.1.2	Classification code	10041068
E.1.2	Term	Small cell lung cancer extensive stage
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 lurbinectedin in combination with atezolizumab compared with atezolizumab based on Independent Review Facility (IRF)-assessed progression-free survival (PFS) and overall survival (OS)

• Evaluar la eficacia de lurbinectedina en combinación con atezolizumab, en comparación con atezolizumab basándose en supervivencia sin progresión (SSP) y supervivencia global (SG) según el centro de evaluación independiente (CEI).

E.2.2

Secondary objectives of the trial

• To evaluate the efficacy of lurbinectedin in combination with atezolizumab compared with atezolizumab based on Investigator-assessed PFS, Confirmed objective response rate (ORR), duration of response (DOR), PFS rates at 6 months and 12 months, and overall survival (OS) rates at 12 months and 24 months
• To evaluate the safety of lurbinectedin in combination with atezolizumab compared with atezolizumab based on incidence and severity of adverse events
• To evaluate the immunogenicity of atezolizumab with and without lurbinectedin based on the prevalence of anti-drug antibodies (ADA) to atezolizumab throughout treatment
• To evaluate the health-related quality of life of participants treated with lurbinectedin in combination with atezolizumab compared with atezolizumab

Evaluar la eficacia de lurbinectedina en combinación con atezolizumab, en comparación con atezolizumab basándose en SSP según el investigador, tasa de respuestas objetivas (TRO) confirmadas, duración de la respuesta (DR), tasa de SSP a los 6 y 12 meses y tasa de SG a los 12 y 24 meses.
• Evaluar la seguridad de lurbinectedina en combinación con atezolizumab, en comparación con atezolizumab basándose en la incidencia e intensidad de los acontecimientos adversos.
• Evaluar la inmunogenicidad de atezolizumab con y sin lurbinectedina basándose en la prevalencia de ACF dirigidos contra atezolizumab.
• Evaluar la calidad de vida relacionada con la salud de los participantes tratados con lurbinectedina en combinación con atezolizumab, en comparación con atezolizumab

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Age >= 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
• Histologically or cytologically confirmed ES-SCLC (per the modified VALG staging system)
• No prior systemic treatment for ES-SCLC
• Adequate hematologic and end-organ function to receive 4 cycles of induction treatment with carboplatin, etoposide and atezolizumab
• Measurable disease, as defined by RECIST v1.1
• Submission of pre-induction therapy tumor sample for exploratory biomarker research
• Negative HIV test and no evidence of active Hepatitis B or Hepatitis C at screening
• Remain abstinent or use contraception and refrain from donating eggs (women) or donating sperm (men)

Inclusion Criteria for the Maintenance Phase
• ECOG performance status (PS) of 0 or 1
• Ongoing response or stable disease per RECIST v1.1 after completion of the induction therapy
• Randomized within 5 weeks (35 days) from last dose of induction therapy, or if receiving PCI, randomized within 9 weeks (63 days) from last dose of induction therapy
• Toxicities attributed to prior induction anti-cancer therapy or PCI resolved to Grade <=1Adequate hematologic and end-organ function
• For participants not receiving therapeutic anticoagulation: INR and aPTT <= 1.5 x ULN

• Edad >= 18 años
• Estado funcional según la escala del Eastern Cooperative Oncology Group (ECOG) de 0 o 1
• Presencia de un CPM-EE confirmado histológica o citológicamente (según el sistema de estadificación del VALG modificado).
• No prior systemic treatment for ES-SCLC
• Función hematológica y orgánica adecuada para recibir 4 ciclos de tratamiento de inducción con carboplatino, etopósido y atezolizumab
• Enfermedad mensurable, definida conforme a los criterios RECIST v1.1.
• Envío de una muestra tumoral previa al tratamiento de inducción para la investigación de biomarcadores exploratorios.
• Resultado negativo en la prueba del VIH o no evidencia de no hay evidencia de hepatitis B activa o hepatitis C en la fase de selección.
• Compromiso de practicar abstinencia sexual o de utilizar métodos anticonceptivos y de no donar óvulos (mujeres) o no donar semen (verones)

Criterios de inclusión de la fase de mantenimiento
• Estado funcional según la escala del ECOG de 0 o 1.
• Respuesta o EE en curso conforme a los criterios RECIST v1.1 después de finalizar el tratamiento de inducción.
• Aleatorización en las 5 semanas (35 días) siguientes al día de administración de la última dosis del tratamiento de inducción o 9 semanas (63 días) siguientes a la última dosis del tratamiento de inducción si ha recibido ICP.
• La toxicidad atribuida al tratamiento de inducción previo o a ICP deberá haberse resuelto a un grado<=1 .Función hematológica y orgánica adecuada.
• Participantes que no reciban anticoagulación terapéutica: INR y TTPa <=1,5 veces el LSN.

E.4

Principal exclusion criteria

• Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 6 months after the final dose of study treatment
• CNS metastases
• Planned consolidative chest radiation
• Uncontrolled tumor-related pain
• Lesions requiring palliative radiotherapy
• Uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent drainage procedures
• Active or history of autoimmune disease or deficiency
• Clinically significant liver disease
• History of malignancies other than SCLC within 5 years prior to enrollment
• Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, or lurbinectedin or trabectedin
• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
• Treatment with investigational therapy within 28 days prior to enrollment

Exclusion Criteria for the Maintenance Phase
• CNS metastases
• Receiving consolidative chest radiation
• Lesions that require palliative radiotherapy
• Severe infection within 2 weeks prior to randomization into maintenance phase
• Major surgical procedure, other than for diagnosis, within 4 weeks prior to randomization
• Treatment with therapeutic oral or IV antibiotics at the time of randomization

• Mujeres embarazadas, en período de lactancia o con intención de quedarse embarazadas durante el estudio o en los 6 meses siguientes a la última dosis del tratamiento del estudio.
• Metástasis en el SNC.
• Previsión de recibir radioterapia torácica de consolidación.
• Dolor no controlado relacionado con el tumor.
• Lesiones que precisen radioterapia paliativa.
• Derrame pleural, derrame pericárdico o ascitis no controlados que precisen procedimientos de drenaje repetidos
• Presencia o antecedentes de enfermedad autoinmunitaria o inmunodeficiencia
• Hepatopatía clínicamente significativa
• Antecedentes de neoplasias malignas distintas del CPM en los 5 años previos a la inclusión
• Tratamiento previo con agonistas de CD137 o tratamientos de bloqueo de puntos de control inmunológico, como anticuerpos terapéuticos anti-CTLA-4, antiPD-1 y anti-PD-L1 o con lurbinectedina or trabectedina
• Antecedentes de fibrosis pulmonar idiopática, neumonía organizada, neumonitis medicamentosa o neumonitis idiopática o signos de neumonitis activa en la TC de tórax de selección.
• Recepción de un tratamiento experimental en los 28 días previos a la inclusión.

Criterios de exclusión de la fase de mantenimiento
• Metástasis en el SNC
• Recepción de radioterapia torácica de consolidación.
• Lesiones que precisen radioterapia paliativa.
• Infección grave en las 2 semanas previas a la aleatorización en la fase de mantenimiento
• Intervención de cirugía mayor, excepto con fines diagnósticos, en las 4 semanas previas a la aleatorización
• Recepción de antibióticos terapéuticos por vía oral o IV en el momento de la aleatorización.

E.5 End points

E.5.1

Primary end point(s)

1. IRF-assessed progression-free survival (PFS) defined as the time from randomization to the first occurrence of disease progression according to RECIST v1.1, or death from any cause (whichever occurs first)
2. Overall Survival defined as the time from randomization to death from any cause

1. Supervivencia sin progresión (SSP) según el CEI, definida como el tiempo transcurrido entre la aleatorización y el primer episodio de progresión de la enfermedad conforme a los criterios RECIST v1.1, o la muerte por cualquier causa, lo que ocurra antes.
2. Supervivencia global (SG), definida como el tiempo transcurrido entre la aleatorización y la muerte por cualquier causa.

E.5.1.1

Timepoint(s) of evaluation of this end point

1-2. Up to 52 months

1-2. Hasta los 52 meses

E.5.2

Secondary end point(s)

1. Investigator-assessed progression-free survival (PFS)
2. Confirmed objective response rate (ORR)
3. Duration of response (DOR)
4. PFS rates at 6 months and 12 months
5. OS rates at 12 months and 24 months
6. Incidence and severity of adverse events, including serious adverse events and adverse events of special interest in randomized participants, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
7. Prevalence of anti-drug antibodies (ADAs) to atezolizumab at induction phase baseline and incidence of ADAs to atezolizumab after drug administration by treatment group
8. Time to confirmed deterioration (TTCD) from maintenance baseline in participant reported physical functioning and global health status as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

1. Supervivencia sin progresión (SSP) según el investigador
2. Tasa de respuestas objetivas (TRO) confirmadas
3. Duración de la respuesta (DR)
4 Tasa de SSP a los 6 y 12 meses
5. Tasa de SG a los 12 y 24 meses
6. Incidencia e intensidad de los acontecimientos adversos, incluidos los acontecimientos adversos graves y los acontecimientos adversos de interés especial en los participantes aleatorizados, determinándose la intensidad conforme a los criterios CTCAE del NCI, v5.0.
7. Prevalencia de ACF dirigidos contra atezolizumab en el momento basal de la fase de inducción e incidencia de ACF dirigidos contra atezolizumab después de la administración del fármaco según el grupo de tratamiento
8. Tiempo transcurrido hasta el deterioro confirmado (THDC) con respecto al momento basal de la fase de mantenimiento del funcionamiento físico y el estado de salud general comunicados por los participantes, según lo determinado mediante el cuestionario QLQ C30 de la EORTC.

E.5.2.1

Timepoint(s) of evaluation of this end point

1-3. Up to 52 months
4. At 6 months and 12 months after randomization
5. At 12 months and 24 months after randomization
6. Up to 52 months
7. Induction Phase: Day 1 of Cycle 1-4; Maintenance Phase: Day 1 of Cycle 1-4, 8, 12, and 16, </= 30 days after treatment discontinuation
8. Induction Phase: Day 1 of Cycle 1-4; Maintenance Phase: Day 1 of Cycle 1, <=30 Days after the
last dose of study treatment, at treatment discontinuation visit, post treatment follow up visit

1-3. Hasta los 52 meses
4. A los 6 y 12 meses de la aleatorización
5. A los 12 y 24 meses de la aleatorización
6. Hasta los 52 meses
7. Fase de inducción: Día 1 del ciclo 1-4; Fase de mantenimiento: Día 1 del ciclo 1-4,8,12, y 16</= 30 días de la discontinuación del tratamiento
8. Fase de inducción: Día 1 del ciclo 1-4; Fase de mantenimiento: Día 1 del ciclo 1, <=30 días de la última dosis del tratamiento del estudio, en la visita de discontinuación de tratamiento, en la visita de seguimiento tras tratamiento

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

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

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Belgium

Germany

Greece

Hungary

Italy

Korea, Republic of

Poland

Russian Federation

Spain

Taiwan

Ukraine

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

last participant, last visit (LPLV) 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 participant, whichever occurs later.

El último participante, última visita (UPUV) o la fecha en la que se reciben los últimos datos requeridos para el análisis estadístico (es decir, el análisis final de la SG) o se recibe el seguimiento de seguridad del último participante, lo que ocurra 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

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:

310

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

380

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

160

F.4.2.2

In the whole clinical trial

690

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)

A participant will be eligible to receive atezolizumab and/or lurbinectedin after completing the study if all of the following conditions are met:
*The participant has a life-threatening or severe medical condition and requires continued treatment with atezo and/or lurbi for his or her well-being
*There are no appropriate alternative treatments available to the participant
*The participant and his or her doctor comply with and satisfy any legal or regulatory requirements that apply to them

Un participante será elegible para recibir atezolizumab y/o lurbinectedina después de completar el estudio si se cumplen todas las condiciones siguientes:
* El participante tiene una condición médica grave o potencialmente mortal y requiere tratamiento continuo con atezo y/o lurbi para su bienestar
* No hay tratamientos alternativos apropiados disponibles para el participante.
* El participante y su médico cumplen y satisfacen los requisitos legales o reglamentarios que les correspondan.

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	Clinical Research Alliance
G.4.3.4	Network Country	United States
G.4 Investigator Network to be involved in the Trial: 2
G.4.1	Name of Organisation	Sarah Cannon and HCA Research Institute
G.4.3.4	Network Country	United States

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2021-12-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-12-22

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

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IMP with orphan designation in the indication
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