E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Metastatic non-small cell lung cancer (NSCLC) |
Cáncer de pulmón no microcítico (CPNM) metastásico |
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E.1.1.1 | Medical condition in easily understood language |
Non-Small Cell Lung Cancer |
Cáncer de pulmón no microcítico |
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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 | 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) |
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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 compare progression-free survival (PFS) in Arm A (ociperlimab in combination with tislelizumab and chemotherapy) and Arm B (placebo in combination with tislelizumab and chemotherapy) in the Intent-to-Treat (ITT) Analysis Set, as assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) |
Comparar la supervivencia sin progresión (SSP) del grupo A (ociperlimab en combinación con tislelizumab y quimioterapia) y el grupo B (placebo en combinación con tislelizumab y quimioterapia) en el conjunto de análisis por intención de tratar (IDT), según la evaluación de los investigadores conforme a los Criterios de evaluación de la respuesta en tumores sólidos, versión 1.1 (RECIST v1.1) |
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E.2.2 | Secondary objectives of the trial |
• To evaluate overall response rate (ORR) and duration of response (DOR) in Arm A (ociperlimab in combination with tislelizumab and chemotherapy) versus Arm B (placebo in combination with tislelizumab and chemotherapy), as assessed by investigators per RECIST v1.1 • To compare overall survival (OS) between Arm A (ociperlimab in combination with tislelizumab and chemotherapy) and Arm B (placebo in combination with tislelizumab and chemotherapy) • To evaluate the safety and tolerability profile of ociperlimab in combination with tislelizumab and chemotherapy compared to tislelizumab in combination with chemotherapy • To characterize the pharmacokinetics (PK) of ociperlimab and tislelizumab • To determine host immunogenicity to ociperlimab and tislelizumab |
• Evaluar la tasa de respuesta global (TRG) y la duración de la respuesta (DR) del grupo A (ociperlimab en combinación con tislelizumab y quimioterapia) frente al grupo B (placebo en combinación con tislelizumab y quimioterapia), según la evaluación de los investigadores conforme a los criterios RECIST v1.1. • Comparar la supervivencia global (SG) del grupo A (ociperlimab en combinación con tislelizumab y quimioterapia) y el grupo B (placebo en combinación con tislelizumab y quimioterapia). • Evaluar el perfil de seguridad y tolerabilidad de ociperlimab en combinación con tislelizumab y quimioterapia en comparación con el de tislelizumab en combinación con quimioterapia. • Definir las características farmacocinéticas (FC) de ociperlimab y tislelizumab. • Determinar la inmunogenicidad del huésped con respecto a ociperlimab y tislelizumab |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Histologically confirmed metastatic (Stage IV) squamous or non-squamous NSCLC. 2. Treatment-naive for metastatic squamous or non-squamous NSCLC. 3. Agreement to provide archival tissue or fresh biopsy for the prospectively determination of PD-L1 levels and retrospective analysis of other biomarkers. 4. At least 1 measurable lesion as defined per RECIST v1.1. 5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
Please refer to the protocol for a full list of the inclusion criteria. |
1. CPNM epidermoide o no epidermoide metastásico (estadio IV) confirmado histológicamente. 2. Sin tratamiento previo para el CPNM epidermoide o no epidermoide metastásico. 3. Estar de acuerdo en proporcionar tejido de archivo o biopsia reciente para la determinación de los niveles de PD-L1 y los análisis retrospectivos de otros biomarcadores. 4. Al menos 1 lesión medible según la definición de los criterios RECIST v1.1. 5. Estado funcional ≤1 del Eastern Cooperative Oncology Group (Grupo Oncológico Cooperativo de la Costa Este, ECOG).
Consulte el protocolo para obtener una lista completa de los criterios de inclusión. |
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E.4 | Principal exclusion criteria |
1. Diagnosed with NSCLC that harbors an EGFR-sensitizing mutation or ALK gene translocation. 2. Prior therapy with an anti-programmed cell death protein (PD-1), anti-PD-L1, anti-programmed cell death ligand-2 (PD-L2), anti-TIGIT, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways. 3. Active leptomeningeal disease or uncontrolled, untreated brain metastasis. 4. Any active malignancy ≤ 2 years before randomization except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (for example, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast).
Please refer to the protocol for a full list of the exclusion criteria. |
1. Diagnóstico de CPNM con una mutación sensibilizante de EGFR o translocación del gen ALK. 2. Tratamiento previo con cualquier tratamiento antineoplásico sistémico aprobado, incluido el tratamiento hormonal, en los 28 días previos al inicio del tratamiento del estudio. 3. Enfermedad leptomeníngea activa o metástasis cerebral no controlada y no tratada. 4. Cualquier neoplasia activa ≤ 2 años antes de la aleatorización, excepto el cáncer específico que se investiga en este estudio y cualquier cáncer localmente recurrente que haya sido tratado de forma curativa (por ejemplo, cáncer de piel de células basales o escamosas resecado, cáncer superficial de vejiga, carcinoma in situ de cuello uterino o de mama).
Consulte el protocolo para obtener una lista completa de los criterios de exclusión. |
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E.5 End points |
E.5.1 | Primary end point(s) |
PFS (time from the date of randomization to the date of the first objectively documented tumor progression, or death, whichever occurs first) in the ITT Analysis Set of Arm A (ociperlimab in combination with tislelizumab and chemotherapy) versus Arm B (placebo in combination with tislelizumab and chemotherapy), as assessed by investigators per RECIST v1.1 |
SSP (tiempo transcurrido desde la fecha de aleatorización hasta la fecha de la primera progresión tumoral objetivamente documentada o la muerte, lo que ocurra primero) en el conjunto de análisis por IDT del grupo A (ociperlimab en combinación con tislelizumab y quimioterapia) frente al grupo B (placebo en combinación con tislelizumab y quimioterapia), según la evaluación de los investigadores conforme a los criterios RECIST v1.1 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
approximately 30 months |
aproximadamente 30 meses |
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E.5.2 | Secondary end point(s) |
• ORR as assessed by investigators (proportion of patients with a documented, confirmed complete response [CR] or partial response [PR] per RECIST v1.1) and DOR as assessed by investigators (time from the first determination of an objective response per RECIST v1.1 until the first documentation of progression or death, whichever occurs first) in Arm A (ociperlimab in combination with tislelizumab and chemotherapy) and Arm B (placebo in combination with tislelizumab and chemotherapy) • OS (time from the date of randomization to the date of death due to any cause) in the ITT Analysis Set of Arm A (ociperlimab in combination with tislelizumab and chemotherapy) versus Arm B (placebo in combination with tislelizumab plus chemotherapy) • The incidence and severity of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0) • Serum concentrations of ociperlimab and tislelizumab at specified timepoints • Immunogenic responses to ociperlimab and tislelizumab, evaluated through detection of anti-drug antibodies (ADAs) |
• TRG evaluada por los investigadores (proporción de pacientes con una respuesta completa [RC] o respuesta parcial [RP] documentada confirmada conforme a los criterios RECIST v1.1) y DR evaluada por los investigadores (tiempo transcurrido desde la primera determinación de una respuesta objetiva conforme a los criterios RECIST v1.1 hasta la primera documentación de progresión o muerte, lo que ocurra primero) en el grupo A (ociperlimab en combinación con tislelizumab y quimioterapia) y en el grupo B de placebo (placebo en combinación con tislelizumab y quimioterapia). • SG (tiempo transcurrido desde la fecha de aleatorización hasta la fecha de la muerte por cualquier causa) en el conjunto de análisis por IDT del grupo A (ociperlimab en combinación con tislelizumab y quimioterapia) frente al grupo B (placebo en combinación con tislelizumab y quimioterapia). • Incidencia y gravedad de los acontecimientos adversos según los Criterios terminológicos comunes para acontecimientos adversos (Common Terminology Criteria for Adverse Events, CTCAE), versión 5, del Instituto Nacional del Cáncer (National Cancer Institute, NCI) (CTCAE del NCI v5.0). • Concentraciones séricas de ociperlimab y tislelizumab en puntos temporales especificados previamente. • Respuestas inmunológicas a ociperlimab y tislelizumab, evaluadas mediante la detección de anticuerpos antifármaco (AAF). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
ORR, DOR & OS: approximately 30 months safety & tolerability: throughout the study PK & immunogenicity: Day 1 of every treatment cycle & EoS visit |
TRG, DR y SG: aproximadamente 30 meses seguridad y tolerabilidad: durante todo el estudio farmacocinética e inmunogenicidad: día 1 de cada ciclo de tratamiento y visita de fin de estudio |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
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) | 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 | 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) | No |
E.8.2.2 | Placebo | Yes |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
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 |
Australia |
China |
Korea, Republic of |
Ukraine |
United States |
France |
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 end of study is defined as the timepoint when the final data point is collected from the last patient in the study. This is when the last patient dies, withdraws consent, completes all study assessments, or is lost to follow-up. Alternatively, the end of study is when the sponsor decides to terminate the study. |
El final del estudio se define como el momento en el que se recoge el último punto de datos del último paciente del estudio. Esto ocurre cuando el último paciente muere, retira el consentimiento, completa todas las evaluaciones del estudio o se pierde el seguimiento. Alternativamente, el final del estudio es cuando el patrocinador decide terminar 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 | 2 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 15 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 7 |