| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| First-line treatment of metastatic NSCLC |
| Tratamiento de primera línea del CPNM metastásico |
|
| E.1.1.1 | Medical condition in easily understood language |
| Adult participants that have non-small cell lung cancer (NSCLC) that has spread to other parts of the body and have not been treated for this condition |
| Participantes adultos que tienen cáncer de pulmón no microcítico (CPCNP) que se ha extendido a otras partes del cuerpo y no han recibido tratamiento para esta afección. |
|
| 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 | 10059515 |
| E.1.2 | Term | Non-small cell lung cancer metastatic |
| E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
1. To compare MK-7684A in combination with chemotherapy to pembrolizumab in combination with chemotherapy with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR)
2. To compare MK-7684A in combination with chemotherapy to pembrolizumab in combination with chemotherapy with respect to Overall Survival (OS) |
1.Comparar MK-7684A en combinación con quimioterapia y pembrolizumab en combinación con quimioterapia en cuanto a la supervivencia sin progresión (SSP) conforme a los Criterios de evaluación de la respuesta en tumores sólidos (RECIST), versión 1.1, según una revisión central independiente y enmascarada (RCIE).
2.Comparar MK-7684A en combinación con quimioterapia y pembrolizumab en combinación con quimioterapia en cuanto a la supervivencia global (SG). |
|
| E.2.2 | Secondary objectives of the trial |
1. To evaluate MK-7684A in combination with chemotherapy to pembrolizumab in combination with chemotherapy with respect to Objective Response Rate (ORR) per RECIST 1.1 as assessed by BICR
2. To evaluate the mean change from baseline in global health status/quality of life (QoL), physical functioning, dyspnea, cough, and chest pain for MK-7684A in combination with chemotherapy compared to pembrolizumab in combination with chemotherapy
3. To evaluate the Time to True Deterioration (TTD) in global health status/QoL, physical functioning, dyspnea, cough, and chest pain for MK-7684A in combination with chemotherapy compared to pembrolizumab in combination with chemotherapy
4. To evaluate the safety and tolerability of MK-7684A in combination with chemotherapy compared to pembrolizumab in combination with chemotherapy
5. To evaluate DOR per RECIST 1.1 as assessed by BICR for MK-7684A plus chemotherapy compared to pembrolizumab plus chemotherapy |
1.Evaluar MK-7684A en combinación con quimioterapia, frente a pembrolizumab en combinación con quimioterapia, en cuanto a la TRO conforme a los criterios RECIST 1.1, según una RCIE.
2.Evaluar la variación media con respecto al momento basal del estado de salud general/calidad de vida, la función física, la disnea, tos y dolor torácico con MK -7684A combinado con quimioterapia en comparación con pembrolizumab combinado con quimioterapia.
3.Evaluar el tiempo transcurrido hasta un deterioro real (TDR) del estado de salud general/calidad de vida, función física, disnea, tos y dolor torácico con MK-7684A combinado con quimioterapia en comparación con pembrolizumab combinado con quimioterapia.
4. Evaluar la seguridad y la tolerabilidad de MK-7684A combinado con quimioterapia en comparación con pembrolizumab combinado con quimioterapia.
5. Evaluar la DR con MK-7684A más quimioterapia, en comparación con pembrolizumab más quimioterapia, conforme a los criterios RECIST 1.1, según una RCIE. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Has a histologically or cytologically confirmed diagnosis of Stage IV (T any, N any, M1a, M1b, M1c - AJCC eighth Edition) squamous or nonsquamous NSCLC
2. Has measurable disease based on RECIST 1.1, as determined by the local site assessment
3. Has provided tumor tissue (post diagnosis of metastatic disease is preferred) for determination of PD-L1 status before randomization
4. Has confirmation that EGFR-, ALK-, or ROS1-directed therapy is not indicated as primary therapy (documentation of the absence of tumor-activating EGFR mutations [eg, DEL19 or L858R], AND absence of ALK and ROS1 gene rearrangements)
5. Has not received prior systemic treatment for metastatic NSCLC
6. Is male or female, from ≥18 years of age inclusive, at the time of signing the informed consent
7. Has an ECOG PS of 0 or 1 assessed within 7 days before randomization
8. Has a life expectancy of at least 3 months
9. If male, agrees to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is as follows:
• Chemotherapy: at least 95 days from the last dose
• Refrain from donating sperm
PLUS either:
• Abstains from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent
OR
• Uses contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause, documented from the site personnel’s review of the participant’s medical records, medical examination, or medical history interview as detailed below:
- Uses a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant
- Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed
10. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
• Not a WOCBP
OR
• Is a WOCBP and:
- Uses a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. The length of time required to continue contraception for each study intervention is as follows:
◦ MK-7684A/pembrolizumab: 120 days
◦ Chemotherapy: 180 days
- The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed
- Has a negative highly sensitive pregnancy test ( as required by local regulations) within 24 hours for urine or within 72 hours for serum before the first dose of study imtervention. If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive
- Abstains from breastfeeding during the study intervention period and for at least 120 days after the last dose of study intervention
- Medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a woman with an early undetected pregnancy
11. The participant (or legally acceptable representative) has provided documented informed consent/assent for the study. The participant may also provide consent/assent for FBR. However, the participant may participate in the study without participating in FBR
12. Has adequate organ function as defined in the protocol. Specimens must be collected within 10 days before the start of study intervention |
1. Tiene un diagnóstico confirmado histológica o citológicamente de CPNM epidermoide o no epidermoide en estadio IV
2. Presenta enfermedad mensurable conforme a los criterios RECIST 1.1
3. Ha proporcionado tejido tumoral para determinar PD-L1 antes de la aleatorización.
4. Confirmación de tratamiento dirigido contra EGFR, ALK o ROS1 no indicado como tratamiento primario
5. No recibido previamente tratamiento sistémico para CPNM metastásico.
6. Varón o mujer con una edad mínima de 18 años a firma de IC.
7. Estado funcional del ECOG de 0 o 1 en los 7 días previos a aleatorización.
8. Esperanza de vida mínima de 3 meses.
9. Si es varón, se compromete durante período de intervención y al menos el tiempo necesario para eliminar cada intervención del estudio después de última dosis de ésta.
• Quimioterapia: al menos 95 días después de la última dosis.
• Abstenerse de donar semen y abstenerse de mantener relaciones heterosexuales o utilizar anticonceptivos (preservativo masculino más uso por la pareja de un método anticonceptivo adicional)
10. Podrán participar mujeres que no estén embarazadas ni en período de lactancia y que cumplan al menos 1 año de no estar en edad fértil o si está en edad fértil y utiliza un método anticonceptivo muy eficaz o practica la abstinencia a largo plazo y Persistente durante el período de intervención y durante el tiempo necesario para eliminar cada intervención del estudio después de recibir la última dosis de ésta. Se compromete a no donar óvulos a otras personas ni congelarlos /conservarlos para su propio uso. El tiempo que tendrá que mantenerse la anticoncepción con cada intervención del estudio es el siguiente:
◦ MK-7684A/pembrolizumab: 120 días.
◦ Quimioterapia: 180 días.
- Tiene un resultado negativo en prueba de embarazo de alta realizada en las 24h (orina) o las 72h (suero) previas a la 1ª dosis de la intervención del estudio. Prueba de embarazo en suero cuando no pueda confirmarse prueba en orina negativo.
- Abstenerse de dar pecho durante el período de intervención del estudio y durante al menos 120 días después de la última dosis de ésta.
- El investigador revisa antecedentes médicos, menstruales y actividad sexual para reducir el riesgo de incluir a una mujer con un embarazo de poco tiempo no detectado.
11. El participante (o su representante legal) ha otorgado su consentimiento informado documentado para el estudio. El participante también podrá otorgar su consentimiento o asentimiento para investigaciones biomédicas futuras. No obstante, podrá participar en el estudio principal sin necesidad de hacerlo en las investigaciones biomédicas futuras.
12. Función orgánica adecuada. Las muestras se obtendrán en los 10 días previos al comienzo de la intervención del estudio. |
|
| E.4 | Principal exclusion criteria |
1. Known additional malignancy that is progressing or has required active treatment within the past 3 years
2. Known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during study screening, are clinically stable and have not required steroid treatment for at least 14 days before the first dose of study intervention. Participants with asymptomatic brain metastases (ie, no neurological symptoms, no requirements for corticosteroids, no or minimal surrounding edema, and no lesion >1.5 cm) may participate
3. Severe hypersensitivity (≥Grade 3) to MK-7684, MK-7684A, pembrolizumab, chemotherapy components, and/or any of its excipients
4. Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study medication
5. Active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
6. History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
7. Active infection requiring systemic therapy
8. Known history of HIV infection. No HIV testing is required unless mandated by local health authority
9. Has a known history of Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection
10. History or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator
11. Known psychiatric or substance abuse disorder that would interfere with the participant’s ability to cooperate with the requirements of the study
12. Received prior therapy with an anti-TIGIT, anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137)
13. Received prior systemic anticancer therapy for metastatic disease
14. If the participant had major surgery, the participant must have recovered adequately from the procedure and/or any complications from the operation before starting study intervention
15. Received prior radiotherapy within 2 weeks of start of study intervention or have had a history of radiation pneumonitis
16. Received radiation therapy to the lung that is >30 Gray within 6 months of the first dose of study intervention
17. Received a live or live attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed
18. Is unable to interrupt aspirin or other NSAIDs, other than an aspirin dose ≤1.3 g/day, for a 5-day period (8-day period for long-acting agents, such as piroxicam)
19. Is unable or unwilling to take folic acid or vitamin B12 supplementation
20. Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
21. History of allogenic tissue/solid organ transplant |
1.Presencia de otra neoplasia maligna conocida que esté en progresión o que haya precisado tratamiento activo en los últimos 3 años.
2.Metástasis activas en el SNC y/o meningitis carcinomatosa conocidas. Los pacientes con metástasis cerebrales tratadas anteriormente podrán participar siempre que se encuentren radiológicamente estables (es decir, sin signos de progresión) durante al menos 4 semanas según la confirmación en estudios de imagen repetidos durante la selección para el estudio, estén clínicamente estables y no hayan necesitado tratamiento con corticoides durante al menos 14 días antes de la primera dosis de la intervención del estudio. Podrán participar pacientes con metástasis cerebrales asintomáticas (es decir, sin síntomas neurológicos, sin necesidad de corticoides, sin edema circundante [o solo mínimo] y sin lesiones de más de 1,5 cm).
3. Hipersensibilidad grave (grado ≥3) a MK-7684, MK-7684A, pembrolizumab, los componentes de la quimioterapia y/o a cualquiera de sus excipientes.
4. Diagnóstico de inmunodeficiencia o está recibiendo tratamiento sistémico crónico con esteroides (en dosis superiores a 10 mg diarios de equivalente de prednisona) o cualquier otra forma de tratamiento inmunodepresor en los 7 días previos a la primera dosis de la medicación del estudio.
5. Enfermedad autoinmunitaria activa que ha precisado tratamiento sistémico (es decir, fármacos modificadores de la enfermedad, corticoides o inmunodepresores) en los 2 últimos años. El tratamiento de reposición (ej: tiroxina, insulina o corticoides en dosis fisiológicas por insuficiencia suprarrenal o hipofisaria) no se considera una forma de tratamiento sistémico y se permite su uso.
6. Antecedentes de neumonitis (no infecciosa) /enfermedad pulmonar intersticial con necesidad de corticoides o presencia de neumonitis/enfermedad pulmonar intersticial.
7. Infección activa con necesidad de tratamiento sistémico.
8. Antecedentes conocidos de infección por el VIH. No será necesario realizar pruebas de VIH a menos que lo exijan las autoridades sanitarias locales.
9. Antecedentes de infección por el virus de la hepatitis B (reactividad del antígeno de superficie del virus de la hepatitis B [HBsAg]) o de infección activa por el virus de la hepatitis C (detección de ARN del VHC [cualitativo]).
10. Antecedentes o signos actuales de cualquier trastorno, tratamiento o anomalía analítica u otra circunstancia que, en opinión del investigador responsable del tratamiento, pueda confundir los resultados del estudio o interferir en la participación de la paciente durante todo el estudio, de modo que no le conviene participar.
11. Trastorno psiquiátrico o por abuso de sustancias que podría dificultar la capacidad del participante para colaborar en el cumplimiento de los requisitos del estudio.
12. Tratamiento previo con un fármaco anti-TIGIT, anti-PD-1, anti-PD-L1 o anti-PD-L2 o con un fármaco dirigido contra otro receptor de los linfocitos T estimulador o coinhibidor (p. ej., CTLA-4, OX-40 o CD137).
13. Tratamiento antineoplásico sistémico previo para las metástasis.
14. Si el participante se ha sometido a una operación de cirugía mayor, deberá haberse recuperado debidamente de la misma y/o de sus complicaciones antes de iniciar la intervención del estudio.
15. Ha recibido radioterapia en las 2 semanas previas al comienzo de la intervención del estudio o tiene antecedentes de neumonitis por radiación.
16. Radioterapia en el pulmón >30 Gy en los seis meses previos a la primera dosis de la intervención del estudio.
17. Administración de una vacuna de microorganismos vivos o vivos atenuados en los 30 días previos a la primera dosis de la intervención del estudio. Se permite la administración de vacunas inactivadas.
18. Imposibilidad de interrumpir el tratamiento con ácido acetilsalicílico u otros antiinflamatorios no esteroideos, excepto una dosis de ácido acetilsalicílico ≤1,3 g al día durante 5 días (8 días en caso de fármacos de acción prolongada, como piroxicam).
19. No puede o no está dispuesto a tomar un suplemento de ácido fólico o vitamina B12.
20. Está participando actualmente o ha participado en un estudio de un fármaco en investigación o ha usado un dispositivo en investigación en las cuatro semanas previas a la administración de la primera dosis de la intervención del estudio.
21. Antecedentes de un alotrasplante de órgano sólido o tejidos. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
1. Progression-Free Survival (PFS)
2. Overall Survival (OS) |
1. Supervivencia sin progresión (SSP)
2. Supervivencia global (SG) |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. Up to approximately 33 months
2. Up to approximately 42 months |
1. Hasta aproximadamente 33 meses
2. hasta aproximadamente 42 meses |
|
| E.5.2 | Secondary end point(s) |
1. Objective Response Rate (ORR)
2. Change from Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
3. Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
4. Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30
5. Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13)
6. Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ- LC13
7. Time to Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30
8. TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ- C30
9. TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30
10. TTD in Cough Score (Item 31) on the EORTC QLQ-LC13
11. TTD in Chest Pain Score (Item 40) on the EORTC QLQ-LC13
12. Number of Participants Who Experienced One or More Adverse Events (AEs)
13. Number of Participants Who Discontinued Study Intervention Due to an AE
14. Duration of Response (DOR) |
1.Tasa de respuestas objetivas (TRO)
2.Variación con respecto al momento basal del estado general de salud/CdV (apartados 29 y 30 del QLQ-C30 de la EORTC).
3.Variación con respecto al momento basal del funcionamiento físico (apartados 1-5 del QLQC30 de la EORTC).
4.Variación con respecto al momento basal de Disnea (apartado 8 del QLQC30 de la EORTC).
5.Variación con respecto al momento basal de Tos (apartado 31 del QLQ-LC13 de la EORTC).
6.Variación con respecto al momento basal de Dolor torácico (apartado 40 del QLQ-LC13 de la EORTC).
7.TDR Tiempo transcurrido entre el momento basal y el primer deterioro del estado general de salud/CdV (apartados 29 y 30 del QLQ-C30 de la EORTC).
8.TDR del funcionamiento físico (apartados 1-5 del QLQC30 de la EORTC).
9.TDR de Disnea (apartado 8 del QLQC30 de la EORTC).
10.TDR de Tos (apartado 31 del QLQ-LC13 de la EORTC).
11.TDR de Dolor torácico (apartado 40 del QLQ-LC13 de la EORTC).
12.Número de participantes que experimentan uno o más acontecimientos adversos (AA).
13.Número de participantes discontinuados del estudio por AA
14.DR tiempo transcurrido entre la primera prueba documentada de RC o RP y la progresión de la enfermedad o la muerte por cualquier causa. |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Up to approximately 42 months
2. Baseline and Up to approximately 42 months
3. Baseline and Up to approximately 42 months
4. Baseline and Up to approximately 42 months
5. Baseline and Up to approximately 42 months
6. Baseline and Up to approximately 42 months
7. Up to approximately 42 months
8. Up to approximately 42 months
9. Up to approximately 42 months
10. Up to approximately 42 months
11. Up to approximately 42 months
12. Up to approximately 42 months
13. Up to approximately 42 months
14. Up to approximately 42 months |
1.Hasta aproximadamente 42 meses
2.Momento basal y hasta aproximadamente 42 meses
3.Momento basal y hasta aproximadamente 42 meses
4.Momento basal y hasta aproximadamente 42 meses
5.Momento basal y hasta aproximadamente 42 meses
6.Momento basal y hasta aproximadamente 42 meses
7.Hasta aproximadamente 42 meses
8.Hasta aproximadamente 42 meses
9.Hasta aproximadamente 42 meses
10.Hasta aproximadamente 42 meses
11.Hasta aproximadamente 42 meses
12.Hasta aproximadamente 42 meses
13.Hasta aproximadamente 42 meses
14.Hasta aproximadamente 42 meses |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | Yes |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| 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 | 6 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 32 |
| 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 | No |
| 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 |
| Chile |
| Colombia |
| Mexico |
| Thailand |
| Turkey |
| Argentina |
| Austria |
| Brazil |
| China |
| Germany |
| Israel |
| Japan |
| Korea, Republic of |
| Poland |
| Russian Federation |
| Spain |
| Taiwan |
| Ukraine |
| United Kingdom |
| United States |
| France |
|
| 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
|
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 5 |
| 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 | 5 |
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