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MEDI4736 (Anti PD-L1) Combined With Gefitinib in Subjects With Non-Small Cell Lung Cancer(NSCLC).

22 de marzo de 2022 actualizado por: MedImmune LLC

A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Gefitinib in Combination With MEDI4736 (Anti PD-L1) in Subjects With Non-Small Cell Lung Cancer(NSCLC)

This a Phase I, Open-Label, Multicentre Study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of gefitinib in combination with MEDI4736 (anti PD-L1) in Subjects with Non-small cell lung cancer (NSCLC). The study consists of two phases: Escalation phase and an expansion phase to be conducted in locally advanced or metastatic NSCLC subjects

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

In Escalation phase: MEDI4736 and gefitinib in NSCLC subjects In Expansion phase: Subjects with EGFR mutation positive locally advanced or metastatic NSCLC will be enrolled in expansion arms. Initiation of expansion arms with the recommended dose of MEDI4736 in combination with gefitinib will be based on an adequate safety and tolerability profile of the combination from the escalation phase.

Tipo de estudio

Intervencionista

Inscripción (Actual)

56

Fase

  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Corea, república de
      • Seoul, Corea, república de, 05505
        • Research Site
      • Seoul, Corea, república de, 03080
        • Research Site
  • Estados Unidos
    • Florida
      • Tampa, Florida, Estados Unidos, 33612
        • Research Site
    • Texas
      • Houston, Texas, Estados Unidos, 77030
        • Research Site
    • Washington
      • Seattle, Washington, Estados Unidos, 98109
        • Research Site
  • Japón
      • Chuo-ku, Japón, 104-0045
        • Research Site
      • Matsuyama-shi, Japón, 791-0280
        • Research Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 130 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Key Inclusion Criteria:

  1. Provision of signed and dated, written informed consent
  2. Male or female aged 18 years and older.
  3. Subjects must have a. In the escalation phase, locally advanced or metastatic NSCLC subjects who have either failed to respond or relapsed following any line of standard treatment, were unable to tolerate, or were not eligible for standard treatment b. In the expansion phase, histologically or cytologically confirmed locally advanced or metastatic NSCLC that is EGFR mutation positive, naïve to EGFR TKI therapy, and sensitive to EGFR TKIs therapy
  4. a.For Escalation Phase: At least one lesion (measurable and/or non-measurable) b.For Expansion Phase: At least one measurable lesion.

  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

    • For Japan Escalation - the same as the global escalation I/E criteria except patients must be EGFR mutation positive

Key Exclusion Criteria:

  1. Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment.
  2. Any investigational agent, chemotherapy, immunotherapy, biologic, hormonal within 28 days of the first dose of study treatment
  3. Inadequate bone marrow reserve or organ function

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Escalation
MEDI4736 will be combined with gefitinib to assess safety and tolerability
Droga: Gefitinib
Gefitinib QD
Droga: MEDI4736
MEDI4736 IV Q2W
Experimental: Expansion Arm
MEDI4736 will be combined with gefitinib
Droga: Gefitinib
Gefitinib QD
Droga: MEDI4736
MEDI4736 IV Q2W

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Escalation Phase: safety and tolerability: AEs, laboratory data, vital signs, ECG changes and Echo. Expansion Phase: safety and tolerability of the recommended dose for MEDI4736; AEs, laboratory data, vital signs, ECG changes and Echo.
Periodo de tiempo: From first dose of study treatment until 90 days after the last dose, assessed up to 32 months
AEs: Type, incidence, severity, seriousness and relationship to study medications of adverse events (AE) (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE]; Safety Labs: Blood and urine samples for determination of clinical chemistry, hematology, coagulation, thyroid function tests and urinalysis will be taken at the visits; any laboratory abnormalities, and including dose-limiting toxicities (DLTs), ECG measurements and Creatinine Clearance
From first dose of study treatment until 90 days after the last dose, assessed up to 32 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
To obtain a preliminary assessment of the anti-tumour activity of gefitinib in combination with MEDI4736 by evaluation of tumour response
Periodo de tiempo: From baseline assessment to disease progression, assessed up to 30 months
At each visit subjects will be programmatically assigned a RECIST visit response of CR, PR, SD or PD depending on the status of their disease compared to baseline and previous assessments; Objective response rate: the percentage of subjects who have at least one visit response of CR or PR prior to any evidence of progression . Disease control rate: the percentage of subjects who have at least one visit response of CR or PR or SD prior to any evidence of progression. Progression Free Survival (PFS) : the time from start of study treatment to the first documentation of objective disease progression (PD) or death from any cause.
From baseline assessment to disease progression, assessed up to 30 months
To determine the immunogenicity of MEDI4736 in combination with gefitinib: anti-drug antibodies (ADAs)
Periodo de tiempo: From first dose of study treatment until 90 days after the last dose, assessed up to 32 months
Assessed by evaluating the number and percentage of subjects who develop detectable anti-drug antibodies (ADAs). The impact of ADAs on overall MEDI4736 PK will also be evaluated.
From first dose of study treatment until 90 days after the last dose, assessed up to 32 months
To determine the pharmacokinetics of MEDI4736
Periodo de tiempo: From first dose of study treatment until 90 days after the last dose, assessed up to 32 months
Individual MEDI4736 concentrations will be tabulated by dose cohort along with descriptive statistics. Noncompartmental PK data analysis will be performed
From first dose of study treatment until 90 days after the last dose, assessed up to 32 months
To assess MEDI4736 pharmacodynamics in subjects receiving MEDI4736 in combination with gefitinib.
Periodo de tiempo: From first dose of study treatment until 90 days after the last dose, assessed up to 32 months
PD-L1 levels before and after treatment with MEDI4736 will be measured to evaluate its association with response to treatment with MEDI4736 and clinical outcome
From first dose of study treatment until 90 days after the last dose, assessed up to 32 months
To determine overall survival (OS) in expansion Arm 1 and Arm 1a patients
Periodo de tiempo: From final safety follow-up visit after last dose until 1 year after the final patient discontinues investigational product (initial Medi4736).
Survival information may be obtained via telephone contact with the patient, patients family or by checking the patients notes, hospital records, contacting the patients general practitioner or public death registry, where it is possible to do so under applicable local laws.
From final safety follow-up visit after last dose until 1 year after the final patient discontinues investigational product (initial Medi4736).

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

MedImmune LLC

Colaboradores

AstraZeneca

Investigadores

  • Investigador principal: Sang-We Kim, MD, Asan Medical Center
  • Investigador principal: Laura Chow, MD, University of Washington
  • Investigador principal: Ben Creelan, MD, Moffit Cancer Center
  • Investigador principal: Don Gibbons, MD, M.D. Anderson Cancer Center
  • Investigador principal: Shinitaro Kanda, MD, National Cancer Center
  • Investigador principal: Naoyuki Nogami, Shikoku Cancer Center

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

24 de marzo de 2014

Finalización primaria (Actual)

9 de marzo de 2021

Finalización del estudio (Actual)

9 de marzo de 2021

Fechas de registro del estudio

Enviado por primera vez

7 de marzo de 2014

Primero enviado que cumplió con los criterios de control de calidad

12 de marzo de 2014

Publicado por primera vez (Estimar)

14 de marzo de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de abril de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

22 de marzo de 2022

Última verificación

1 de marzo de 2022

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • D791PC00001

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Marco de tiempo para compartir IPD

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Criterios de acceso compartido de IPD

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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