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TIGER-1: Safety and Efficacy Study of Rociletinib (CO-1686) or Erlotinib in Patients With EGFR-mutant/Metastatic NSCLC Who Have Not Had Any Previous EGFR Directed Therapy (EGFR)

29 de abril de 2019 actualizado por: Clovis Oncology, Inc.

TIGER 1: A Randomized, Open-Label, Phase 2/3 Study of CO-1686 or Erlotinib as First-Line Treatment of Patients With EGFR-Mutant Advanced/Metastatic NSCLC

The purpose of this study is to compare the safety and anti-tumor effect of rociletinib with erlotinib in patients whose tumors have specific EGFR mutations and who have not previously received any treatment for advanced/metastatic EGFR mutated NSCLC. This study is a 'Randomized' Study. This means that upon entering the study, patients will be randomly assigned to be dosed with either rociletinib twice a day or erlotinib once a day. Patients will continue to take either rociletinib or erlotinib until it is no longer beneficial.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

This is a randomized, Phase 2/3 study of rociletinib versus erlotinib as a first-line treatment for patients with EGFR-mutant advanced/metastatic NSCLC whose tumors have EGFR-activating mutations. The study will consist of Phase 2 and Phase 3 parts which will use the same enrollment criteria and treatment assignment principles. Patients will be randomized 1:1 to erlotinib or rociletinib. The Phase 2 part is an open-label study. In the Phase 3 part, the sponsor will be blinded to the efficacy and safety results. The study will consist of a screening phase to establish study eligibility (including tumor genotype) and document baseline measurements, a treatment phase, in which patients will receive either rociletinib BID (twice a day) or erlotinib QD (once daily) to ascertain safety and efficacy until protocol-defined disease progression, and a follow-up phase, to monitor survival status and subsequent NSCLC cancer therapy. In the Phase 2 part only, patients initially randomized to erlotinib may be eligible to participate in an optional crossover phase to receive rociletinib if they demonstrate the T790M resistance mutation after radiographic progression on erlotinib treatment among other eligibility requirements. Patients eligible for this study must have EGFR-mutated NSCLC who have not been treated with an EGFR-directed therapy.Treatment with rociletinib or erlotinib is continuous. Each 28 day period of treatment will represent one cycle, with dosing initiated on Cycle 1 Day 1 (C1 D1).

Tipo de estudio

Intervencionista

Inscripción (Actual)

100

Fase

  • Fase 2
  • Fase 3

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

  • Alemania
      • Berlin, Alemania
        • Evangelische Lungenklinik Berlin
    • Bayern
      • Gauting, Bayern, Alemania, 82131
        • Asklepios Fachkliniken München-Gauting
    • Niedersachsen
      • Oldenburg, Niedersachsen, Alemania, 26121
        • Pius Hospital Oldenburg
    • Nordrhein-Westfalen
      • Köln, Nordrhein-Westfalen, Alemania, 50937
        • Universitätsklinikum Köln
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Alemania, 55131
        • Katholisches Klinikum Mainz, Sankt Hildegardis-Krankenhaus
  • Corea, república de
      • Busan, Corea, república de, 602-715
        • Dong-A University Hospital
      • Incheon, Corea, república de, 400-711
        • Inha University Hospital
      • Seongnam-si, Corea, república de, 463-707
        • Seoul National University Bundang Hospital
      • Seoul, Corea, república de, 135-710
        • Samsung Medical Center
      • Seoul, Corea, república de, 138-736
        • Asan Medical Center
      • Seoul, Corea, república de, 120-752
        • Severance Hospital, Yonsei University Health System
      • Suwon, Corea, república de, 442-723
        • The Catholic University of Korea Saint Vincent's Hospital
  • España
      • Barcelona, España, 08035
        • Hospital Universitario Vall d'Hebron
      • Madrid, España, 28034
        • Hospital Universitario Ramon Y Cajal
  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35294
        • University of Alabama at Birmingham
    • California
      • Burbank, California, Estados Unidos, 91505
        • East Valley Hematology and Oncology Medical Group, Inc.
      • Duarte, California, Estados Unidos, 91010
        • City of Hope
      • Fountain Valley, California, Estados Unidos, 92708
        • Compassionate Cancer Care Medical Group, Inc.
      • Fullerton, California, Estados Unidos, 92835-3825
        • St. Joseph Heritage Healthcare
      • La Jolla, California, Estados Unidos, 92093-0698
        • UC San Diego Moores Cancer Center
      • Los Angeles, California, Estados Unidos, 90089
        • University of Southern California, Norris Comprehensive Cancer Center
      • Sacramento, California, Estados Unidos, 95816
        • Sutter Medical Group
      • San Francisco, California, Estados Unidos, 94115
        • University of California San Francisco
      • Santa Barbara, California, Estados Unidos, 93105
        • Sansum Clinic
      • Santa Maria, California, Estados Unidos, 93454
        • Central Coast Medical Oncology Corporation
      • Santa Monica, California, Estados Unidos, 90404
        • UCLA Medical Center
      • Whittier, California, Estados Unidos, 90603
        • The Oncology Institute of Hope and Innovation
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045
        • University of Colorado Cancer Center
    • District of Columbia
      • Washington, District of Columbia, Estados Unidos, 20007
        • Georgetown University Medical Center
    • Florida
      • Fleming Island, Florida, Estados Unidos, 32003
        • Cancer Specialists of North Florida
      • Fort Myers, Florida, Estados Unidos, 33916
        • Florida Cancer Specialists and Research Institute
      • Miami, Florida, Estados Unidos, 33176
        • Advanced Medical Specialties
      • Orlando, Florida, Estados Unidos, 32804
        • Florida Hospital Cancer Institute
      • Saint Petersburg, Florida, Estados Unidos, 33705
        • Florida Cancer Specialists
      • Weston, Florida, Estados Unidos, 33331
        • Cleveland Clinic Florida
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60611
        • Northwestern University
      • Chicago, Illinois, Estados Unidos, 60612
        • University of Illinois Cancer Center
      • Niles, Illinois, Estados Unidos, 60714
        • Illinois Cancer Specialists
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21237
        • Harry and Jeanette Weinberg Cancer Institute at Franklin Square
      • Bethesda, Maryland, Estados Unidos, 20889
        • Walter Reed Army Institute of Research
    • Michigan
      • Detroit, Michigan, Estados Unidos, 48201
        • Barbara Ann Karmanos Cancer Institute
    • Nebraska
      • Omaha, Nebraska, Estados Unidos, 68130
        • Oncology Hematology West PC
    • Nevada
      • Henderson, Nevada, Estados Unidos, 89014
        • Comprehensive Cancer Centers of Nevada
    • New Jersey
      • East Brunswick, New Jersey, Estados Unidos, 08816
        • Regional Cancer Care Associates, LLC
      • Morristown, New Jersey, Estados Unidos, 07962
        • Regional Cancer Care Associates
    • New York
      • Bronx, New York, Estados Unidos, 10461
        • Montefiore Medical Center
      • Buffalo, New York, Estados Unidos, 14263
        • Roswell Park Cancer Institute
    • North Carolina
      • Durham, North Carolina, Estados Unidos, 27710
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45267
        • University of Cincinnati Medical Center
      • Cleveland, Ohio, Estados Unidos, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, Estados Unidos, 44106
        • University Hospitals Case Medical Center
    • Oregon
      • Portland, Oregon, Estados Unidos, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19107
        • Thomas Jefferson University Hospital
    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29425
        • Hollings Cancer Center
    • Tennessee
      • Chattanooga, Tennessee, Estados Unidos, 37404
        • Tennessee Oncology, PLLC
      • Nashville, Tennessee, Estados Unidos, 37203
        • Tennessee Oncology, PLLC
      • Nashville, Tennessee, Estados Unidos, 37212-3505
        • USC/Norris Comprehensive Cancer Center
    • Texas
      • Austin, Texas, Estados Unidos, 78745
        • Texas Oncology, PA
      • Beaumont, Texas, Estados Unidos, 77702
        • Texas Oncology-Beaumont
      • Bedford, Texas, Estados Unidos, 76022
        • Texas Oncology, P.A.
      • Dallas, Texas, Estados Unidos, 75390-8852
        • University of Texas Southwestern Medical Center
      • Houston, Texas, Estados Unidos, 77030
        • Houston Methodist Cancer Center
      • Houston, Texas, Estados Unidos, 77030
        • The University of Texas - MD Anderson Cancer Center
      • Plano, Texas, Estados Unidos, 75075-7753
        • Texas Oncology-Plano East
    • Virginia
      • Fairfax, Virginia, Estados Unidos, 22031
        • Virginia Cancer Specialists, PC
    • Washington
      • Seattle, Washington, Estados Unidos, 98109
        • University of Washington
      • Vancouver, Washington, Estados Unidos, 98684
        • Northwest Cancer Specialists, P.C.
      • Yakima, Washington, Estados Unidos, 98902
        • Yakima Valley Memorial Hospital, North Star Lodge
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
    • New Territories
      • Hong Kong, New Territories, Hong Kong
        • Prince of Wales Hospital
  • Italia
      • Livorno, Italia, 57124
        • Ospedale Civile di Livorno
  • Taiwán
      • Taichung, Taiwán, 40705
        • Taichung Veterans General Hospital
      • Taipei, Taiwán, 11217
        • Taipei Veterans General Hospital
      • Taoyuan, Taiwán, 33305
        • Chang Gung Memorial Hospital LinKou

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 y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Histologically or cytologically confirmed metastatic or unresectable locally advanced/metastatic NSCLC
  2. Documented evidence of a tumor with activating EGFR mutations by local testing. Patients with exon 20 insertions are not eligible with the exception of patients with documented evidence of the exon 20 insertion A763_Y764insFQEA in the EGFR gene
  3. Have undergone a biopsy or surgical resection of either primary or metastatic tumor tissue within 60 days of the first day of study treatment, C1D1, and have tissue available to send to sponsor laboratories or are able to undergo a biopsy during screening and provide tissue to sponsor laboratories
  4. Measureable disease according to RECIST Version 1.1
  5. Life expectancy of at least 3 months
  6. ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 1
  7. Minimum age 18 years (in certain territories, the minimum age requirement may be higher (e.g. 20 years in Japan and Taiwan)
  8. Adequate hematological and biological function, confirmed by defined laboratory values
  9. Written consent on an IRB/IEC-approved Informed Consent Form (ICF) prior to any study-specific evaluation

Exclusion Criteria:

  1. Documented evidence of an exon 20 insertion activating mutation other than A763_Y764insFQEA in the EGFR gene
  2. Prior treatment with cytotoxic chemotherapy for advanced NSCLC; neoadjuvant/adjuvant chemotherapy is permitted if at least 6 months has elapsed between the end of chemotherapy and randomization
  3. Active second malignancy; i.e., patient known to have potentially fatal cancer present for which he/she may be (but not necessarily) currently receiving treatment
  4. Patients with a history of malignancy that has been completely treated, and currently with no evidence of that cancer, are permitted to enroll in the trial provided all chemotherapy was completed > 6 months prior and/or bone marrow transplant > 2 years prior to first day of study treatment
  5. Known pre-existing interstitial lung disease
  6. Brain metastases
  7. Treatment with prohibited medications less than or equal to 14 days prior to first day of study treatment
  8. Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval if that treatment cannot be either discontinued or switched to a different medication prior to administration of study drug
  9. Prior treatment with EGFR TKIs (e.g. erlotinib, gefitinib, neratinib, afatinib, AZD9291, or dacomitinib), rociletinib or other drugs that target mutant EGFR
  10. Clinically significant abnormal 12-lead ECG, QT interval corrected using Fridericia's method (QTCF) > 450 ms
  11. Inability to measure QT interval on ECG
  12. Personal or family history of long QT syndrome
  13. Implantable pacemaker or implantable cardioverter defibrillator
  14. Resting bradycardia < 55 beats/min
  15. Non-study related surgical procedures less than or equal to 7 days prior to administration of study drug. In all cases, the patient must be sufficiently recovered and stable before treatment administration.
  16. Females who are pregnant or breastfeeding
  17. Refusal to use adequate contraception for fertile patients (females and males) for 12 weeks after the last dose of rociletinib and 2 weeks after the last dose of erlotinib
  18. Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study
  19. Any other reason the investigator considers the patient should not participate in the study

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: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Erlotinib Mono-Therapy
Droga: Erlotinib Mono-Therapy
Erlotinib will be administered once a day
Experimental: Rociletinib Mono-Therapy
Droga: Rociletinib Mono-Therapy
Rociletinib will be administered twice daily

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Progression Free Survival (PFS) According to RECIST Version 1.1 as Determined by Investigator Review (invPFS)
Periodo de tiempo: Cycle 1 Day 1 to End of Treatment, up to approximately 35 months
To compare the antitumor efficacy of oral single-agent rociletinib with that of erlotinib as measured by progression-free survival (PFS), when administered as a first-line targeted treatment to patients with EGFR-mutated, advanced NSCLC.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of one or more new lesions is also considered progression.
Cycle 1 Day 1 to End of Treatment, up to approximately 35 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Confirmed Response Rate
Periodo de tiempo: Cycle 1 Day 1 to End of Treatment, up to approximately 35 months.

Proportion of patients with a best overall confirmed response of partial response (PR) or complete response (CR) recorded from the start of the treatment until disease progression or recurrence.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as:

Complete Response (CR), is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

Partial Response (PR),at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.

Overall Response (OR),is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment was dependent on the achievement of both measurement and confirmation criteria.
Cycle 1 Day 1 to End of Treatment, up to approximately 35 months.
Duration of Response
Periodo de tiempo: Cycle 1 Day 1 to End of Treatment, up to approximately 35 months
Duration of Response in Patients with Confirmed Response per Investigator
Cycle 1 Day 1 to End of Treatment, up to approximately 35 months

Colaboradores e Investigadores

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

Patrocinador

Clovis Oncology, Inc.

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

1 de noviembre de 2014

Finalización primaria (Actual)

28 de junio de 2017

Finalización del estudio (Actual)

28 de junio de 2017

Fechas de registro del estudio

Enviado por primera vez

30 de junio de 2014

Primero enviado que cumplió con los criterios de control de calidad

7 de julio de 2014

Publicado por primera vez (Estimar)

10 de julio de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

7 de mayo de 2019

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

29 de abril de 2019

Última verificación

1 de abril de 2019

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CO-1686-022 (TIGER-1)

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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