Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

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 kwietnia 2019 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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).

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

100

Faza

  • Faza 2
  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Erlotinib Mono-Therapy
Lek: Erlotinib Mono-Therapy
Erlotinib will be administered once a day
Eksperymentalny: Rociletinib Mono-Therapy
Lek: Rociletinib Mono-Therapy
Rociletinib will be administered twice daily

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Progression Free Survival (PFS) According to RECIST Version 1.1 as Determined by Investigator Review (invPFS)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Confirmed Response Rate
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Clovis Oncology, Inc.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 listopada 2014

Zakończenie podstawowe (Rzeczywisty)

28 czerwca 2017

Ukończenie studiów (Rzeczywisty)

28 czerwca 2017

Daty rejestracji na studia

Pierwszy przesłany

30 czerwca 2014

Pierwszy przesłany, który spełnia kryteria kontroli jakości

7 lipca 2014

Pierwszy wysłany (Oszacować)

10 lipca 2014

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

7 maja 2019

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

29 kwietnia 2019

Ostatnia weryfikacja

1 kwietnia 2019

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CO-1686-022 (TIGER-1)

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Niedrobnokomórkowego raka płuca

Badania kliniczne na Erlotinib Mono-Therapy

Wyszukaj podobne próby

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Mozambique

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

Subskrybuj