E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
First-line patients with extensive disease small-cell lung cancer (SCLC) |
Pacientes de primera línea con cáncer de pulmón microcítico (CPM) con enfermedad extendida |
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E.1.1.1 | Medical condition in easily understood language |
Treatment naïve patients with extensive-stage small-cell lung cancer |
Pacientes sin tratamiento previo con cáncer de pulmón microcítico en estadio extendido |
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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) |
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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 |
To evaluate the efficacy of AZD2811 + durvalumab by assessment of the proportion of participants alive and progression free at 12 months APF12 who have not progressed during EP-durvalumab based induction therapy. |
Evaluar la eficacia de AZD2811 + durvalumab mediante la evaluación de la proporción de participantes vivos y sin progresión a los 12 meses (VSP12) que no han progresado durante el tratamiento de inducción con EP-durvalumab. |
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E.2.2 | Secondary objectives of the trial |
- To evaluate efficacy of AZD2811 + durvalumab: - proportion of participants alive at 12 months OS12, 15 months OS15, and 18 months OS18 who have not progressed during induction. - proportion of participants alive and progression free at 6 months APF6 and 9 months APF9 who have not progressed during induction. - assessment of Objective response rate (ORR): - in all participants in induction. - in participants who had not progressed during induction. - assessment of PFS in participants who had not progressed during induction. - assessment of OS in participants who had not progressed during induction.
- To assess the safety and tolerability profile of study intervention in SCLC.
- To evaluate the PK of durvalumab and AZD2811.
- To evaluate the effect of AZD2811 + durvalumab on SCLC symptoms and health-related QoL using EORTC QLQ-C30 and QLQ-LC13. |
- Evaluar la eficacia de AZD2811 + durvalumab: - proporción de participantes vivos a los 12 meses (SG12), a los 15 meses (SG15) y a los 18 meses (SG18) que no han progresado durante la inducción. - proporción de participantes vivos y sin progresión a los 6 meses (VSP6) y a los 9 meses (VSP9) que no han progresado durante la inducción. - evaluación de la tasa de respuesta objetiva (TRO): - en todos los participantes en la inducción. - en participantes que no habían progresado durante la inducción. - evaluación de la SSP en participantes que no habían progresado durante la inducción. - evaluación de la SG en participantes que no habían progresado durante la inducción. - Evaluar el perfil de seguridad y tolerabilidad de la intervención del estudio en el CPM. - Evaluar la FC de durvalumab y AZD2811. - Evaluar el efecto de AZD2811 + durvalumab sobre los síntomas del CPM y la CdV relacionada con la salud utilizando QLQ-C30 y QLQ-LC13 de la EORTC. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Documented evidence of extensive stage SCLC (ES-SCLC) • Participants must be considered suitable to receive a platinum-based chemotherapy regimen, combined with durvalumab, as first-line treatment for ES-SCLC • No prior exposure to immune-mediated therapy • Life expectancy ≥12 weeks at Day 1. • ECOG 0 or 1 at enrolment. |
• Pruebas documentadas de CPM en estadio extendido (CPM-EE) • Los participantes deben considerarse aptos para recibir una pauta de quimioterapia con platino, combinada con durvalumab, como tratamiento de primera línea para el CPM-EE • Ausencia de exposición previa a tratamiento inmunomediado • Esperanza de vida ≥12 semanas en el día 1. • ECOG de 0 o 1 en la inscripción. |
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E.4 | Principal exclusion criteria |
• Any history of radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy • Has a paraneoplastic syndrome (PNS) of autoimmune systemic steroids or immunosuppressive agents) or has a clinical symptomatology suggesting worsening of PNS • Active infection including tuberculosis, HIV, hepatitis B and C • Active or prior documented autoimmune or inflammatory disorders • Uncontrolled intercurrent illness, including but not limited to interstitial lung disease. |
• Cualquier antecedente de radioterapia en el pecho antes del tratamiento sistémico o radioterapia torácica de consolidación prevista • Tiene un síndrome paraneoplásico (SPN) de corticoesteroides sistémicos autoinmunitarios o inmunodepresores) o tiene una sintomatología clínica que indica empeoramiento del SPN • Infección activa, incluida tuberculosis, VIH y hepatitis B y C • Trastornos autoinmunitarios o inflamatorios activos o previos documentados • Enfermedad intercurrente no controlada, incluida, entre otras, la enfermedad pulmonar intersticial. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Maintenance participants alive and progression free (APF12) |
Participantes de mantenimiento vivos y sin progresión (VSP12) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Up to 12 months |
Hasta 12 meses |
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E.5.2 | Secondary end point(s) |
1. Maintenance participants alive at 12 months (OS12), 15 months (OS15), and 18 months (OS18)
2. Maintenance participants alive and progression free at 6 months (APF6) and 9 months (APF9) using investigator assessments according to RECIST 1.1
3. Objective response rate (ORR) for all participants using investigator assessments according to RECIST 1.1.
4. Maintenance participants Progression-free survival (PFS) using investigator assessments according to RECIST 1.1
5. Overall survival (OS) in maintenance participants
6. The safety and tolerability profile of study intervention in SCLC.
7. The pharmacokinetics of durvalumab and AZD2811.
8. Disease-related symptoms & Health-related QoL measured by EORTC QLQ-LC30 & EORTC QLQ-LC13 |
1. Participantes de mantenimiento vivos a los 12 meses (SG12), 15 meses (SG15) y 18 meses (SG18) 2. Participantes de mantenimiento vivos y sin progresión a los 6 meses (VSP6) y 9 meses (VSP9) mediante las evaluaciones del investigador según RECIST 1.1 3. Tasa de respuesta objetiva (TRO) para todos los participantes mediante las evaluaciones del investigador según RECIST 1.1. 4. Participantes de mantenimiento con supervivencia sin progresión (SSP) mediante las evaluaciones del investigador según RECIST 1.1 5. Supervivencia general (SG) en los participantes de mantenimiento 6. Perfil de seguridad y tolerabilidad de la intervención del estudio en el CPM. 7. Farmacocinética de durvalumab y AZD2811. 8. Síntomas relacionados con la enfermedad y la CdV relacionada con la salud medidos según QLQ-C30 y QLQ-LC13 de la EORTC |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Up to 18 months
2. Up to 9 months
3. to 8. Up to approximately 3 years |
1. Hasta 18 meses
2. Hasta 9 meses
3. hasta 8. Hasta aproximadamente 3 años |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 22 |
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 |
Canada |
Korea, Republic of |
United States |
France |
Italy |
Poland |
Spain |
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E.8.7 | Trial has a data monitoring committee | No |
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
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The date of the last scheduled procedure for the last treated participant in the study. |
La fecha del último procedimiento programado para el último participante tratado en el estudio. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 5 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 1 |