E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Post-Chemotherapy Urothelial and Non-Urothelial Carcinoma of the Urinary Tract. First-line patients with extensive disease (Stage IV) small-cell lung cancer (SCLC). Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC) in treatment naive patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild type tumor pathology. Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) Various types of cancer ( dependent on parent study) |
Carcinoma urotelial y no urotelial de vías urinarias posquimioterapia Pacientes de primera línea con cáncer de pulmón de células pequeñas (CPCP) con enfermedad grave (etapa IV). Cáncer de pulmón de células no pequeñas avanzado o metastásico en pacientes sin tratamiento previo con receptor del factor de crecimiento epidérmico (EGFR) y patología tumoral de cepa silvestre de quinasa de linfoma anaplásico (ALK). Cáncer de pulmón de células no pequeñas no resecable, localmente avanzado (etapa III) |
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E.1.1.1 | Medical condition in easily understood language |
Various types of cancer ( dependent on the parent study) |
Diferentes tipos de cáncer (dependiendo del estudio de origen) |
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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 | 10061272 |
E.1.2 | Term | Malignant urinary tract neoplasm |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10025055 |
E.1.2 | Term | Lung cancer non-small cell stage IV |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049280 |
E.1.2 | Term | Solid tumour |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 | 10061873 |
E.1.2 | Term | Non-small cell lung cancer |
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 provide continuous study treatment to patients who continue to benefit at the end of a clinical study, while monitoring safety and tolerability. |
Proporcionar de forma continua el tratamiento del estudio a los pacientes que sigan beneficiándose de él al término de un estudio clínico, al tiempo que se vigila la seguridad y la tolerabilidad. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Provision of signed and dated, written ICF. 2. Patient is currently deriving clinical benefit, as judged by the Investigator, from continued treatment in an AZ parent study using an AZ compound that has met its endpoints, or has otherwise stopped, or the patient has reached maximum treatment duration allowed in the parent study’s protocol. |
1. Suministro de ICF escrito, firmado y fechado. 2. El paciente obtiene actualmente un beneficio clínico, según lo juzgado por el investigador, del tratamiento contínuo en un estudio de origen de AZ que utiliza un compuesto de AZ que alcanzó sus criterios de valoración, o se detuvo por aalgún motivo, o el paciente alcanzó la duración máxima del tratamiento permitida en el protocolo del estudio de origen. |
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E.4 | Principal exclusion criteria |
Core Protocol exclusion criteria: 1. Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study. 2. Currently receiving treatment with any prohibited medication(s). 3. Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. 4. Permanent discontinuation from the parent study due to toxicity or disease progression. 5. Local access to commercially-available drug at no cost to the patient as permitted by local/country regulation.
Additional exclusion criteria for the ROSY-D sub-study: 6. Active infection including COVID-19 (PCR confirmed and/or clinically suspected), tuberculosis, hepatitis B (known positive HBsAg result), hepatitis C, or HIV (positive HIV 1/2 antibodies). 7. Male or female patients of reproductive potential who are not willing to employ effective birth control from study inclusion up to 90 days after the last dose of durvalumab monotherapy. 8. Ongoing, unresolved, Grade 2 toxicity with an inability to reduce corticosteroid to a dose of </= 10 mg of prednisone per day (or equivalent) within 12 weeks after last dose of study treatment/study regimen, as per Toxicity Dose Modification and TMGs for Immune-mediated, Infusion-related, and Non-Immune-mediated Reactions Guidelines of the parent study. |
Criterios de exclusión del Protocolo principal: 1. Toxicidad en curso, no resuelta, de Grado 3 o superior que requiera la interrupción del tratamiento en el momento de la finalización del estudio de origen. 2. Actualmente recibie tratamiento con algún medicamento prohibido. 3. Estar inscrito simultáneamente en cualquier otro tipo de investigación médica que no se considere científica o médicamente compatible con este estudio. 4. Interrupción permanente del estudio de origen debido a toxicidad o progresión de la enfermedad. 5. Acceso local a medicamentos disponibles comercialmente sin costo para el paciente según lo permita la regulación local/del país.
Criterios de exclusión adicionales para el subestudio ROSY-D: 6. Infección activa incluyendo COVID-19 (confirmado por PCR y/o clínicamente sospechado), tuberculosis, hepatitis B (resultado positivo conocido de HBsAg), hepatitis C o VIH (anticuerpos VIH 1/2 positivos). 7. Pacientes masculinos o femeninos con potencial reproductivo que no estén dispuestos a emplear un método anticonceptivo eficaz desde la inclusión en el estudio hasta 90 días después de la última dosis de monoterapia con durvalumab. 8. Toxicidad de grado 2 en curso, no resuelta, con incapacidad para reducir el corticosteroide a una dosis de </= 10 mg de prednisona por día (o equivalente) en las 12 semanas posteriores a la última dosis del tratamiento del estudio/régimen del estudio, según Modificación de la dosis de toxicidad y TMG para las guías de reacciones inmunológicas, relacionadas con la infusión y no inmunológicas del estudio de origen. |
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E.5 End points |
E.5.1 | Primary end point(s) |
SAEs reported until 90 days after the last dose of study treatment. |
Acontecimientos adversos graves comunicados hasta 90 días después de la última dosis del tratamiento del estudio. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Throughout the study. |
Durante la duración del estudio |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.5 | Efficacy | No |
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 | 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) | 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 | 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.8.3 |
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 | 53 |
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 |
Argentina |
Australia |
Brazil |
Canada |
Chile |
China |
India |
Japan |
Korea, Republic of |
Malaysia |
Taiwan |
Thailand |
United States |
France |
Poland |
Bulgaria |
Netherlands |
Romania |
Spain |
Switzerland |
Czechia |
Germany |
Italy |
Belgium |
Hungary |
Russian Federation |
Turkey |
Ukraine |
United Kingdom |
Serbia |
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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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LSLV |
Última visita del último paciente |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 30 |
E.8.9.2 | In all countries concerned by the trial years | 3 |